SOLMED is a responsible supplier of Medical Devices and as such only offers products that are proven clinically and are good for the Clinician.

Halkey-Roberts® new swabable luer valves were developed as needlefree injection ports in IV applications. They are designed to aspirate or inject fluids on demand. The valves allow multiple usages and require no cap. Valve stems and bodies will mate securely with all standard luer syringes and luer connectors.

All materials are Gamma resistant, ISO 10993 compliant, DEHP-free and latex-free.

The Straight valves are available in polycarbonate or in copolyester for easy bonding.

Produced under GMP: Halkey-Roberts is an ISO 9001-2000, ISO 13485-2003 and FDA registered manufacturing facility. Luer fittings are compatible with American National Standards for luer and taper fittings under ANSI/HIMA MD 70.1-83 and ISO 594.

 

 

 

 

 

 

 

 

 

 

 

 

 

PERFORMANCE CHARACTERISTICS

Priming volume: 0.09ml

Flow Rate Averages

Flow Rate @ 1 psi: 500ml / minute 
(30,000ml/hr @ 30 inch height)

Flow Rate @ 3 psi: 600ml / minute

Flow Rate @ 5 psi: 750ml / minute

 

 

CHARACTERISTICS	SPECIFICATIONS	TYPICAL / TESTED
Back Pressure	> 30 PSIG	40 PSIG
Activation Force	< 4 LB	1.9 LB
Priming Volume	< 0.20 ml	0.09 ml
Residual Volume	N/A	0.11 ml
Flow
@ 1 PSIG head pressure	> 50 ml/ min	360 ml/ min
@ 3 PSIG	N/A	600 ml/ min
@ 5 PSIG	N/A	750 ml/ min
Leak During Use
@ 1 PSIG	None	None
@ 5 PSIG	None	None
@ 30 PSIG	None	None
Multiple Use	Leak Free after 100 activations, >30 PSIG	36 PSIG
Extended Use	Leak Free after 24 Hrs engagement, <30 PSIG	37 PSIG
Microbial Barrier	Passes Microbial Challenge for repeated access using 70% IPA as a surface disinfectant and Staphylococcus aureus ATCC  #6538 as a challenge organism	PASS (12 activations in 3 days interval) PASS (140 activations in 7 days interval)
Sterilization	Sterilize by ETO	PASS

 

Summary of Biocompatibility Test Results ISO 10993-1 Standard Testing Procedures

 

Test performed	Interpretation	510(k) FDA	Results
Cytotoxicity	The test article is considered  non-cytotoxic	K002689	Pass
Acute Systemic  Toxicity	The test article extracts would not be considered systemically toxic	K002689	Pass
Acute Intracutaneous Reactivity	No evidence of significant irritation or toxicity from the extracts injected intracutaneously into rabbits	K002689	Pass
Hemolysis (direct  contact and chemical)	The test article was determined to be nonhemolytic (less than 5%)	K002689	Pass
Pyrogen Study – Material Mediated	The test article extract was judged as non-pyrogenic	K002689	Pass
Guinea Pig  Maximization	The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig	K002689	Pass

 

ROBERTSITE® 7 DAY MICROBIAL CHALLENGE EVALUATION

The inoculated sites were allowed to sit undisturbed for thirty minutes. Valves were then swabbed as described above with 70% IPA followed by drying for a minimum of one (1) minute. After drying, each valve was accessed using a new, sterile syringe and flushed with 10 ml of sterile saline. The saline was collected and filtered through a 0.45-micron membrane filter. The filter was placed on TSA and incubated at 30 – 35 C for 48 hours. Following the incubation period, the CFU’s for each valve filtrate were enumerated. 

Purpose:

To demonstrate the integrity of the Robertsite Luer Activated Injection Site (valve) microbial barrier properties after seven days (168 hours) of simulated worst case clinical use (140 activations) using a common nosocomial infection organism, Staphylococcus aureus.
Protocol Summary:
AppTec Laboratory Services,Marietta,GA, performed all laboratory testing. Each of 20 devices was accessed 20 times per day for seven days (140 total activations) Each sample was challenged daily after repeated activations using approximately 1.0 x 103 colony forming units (CFU)/ 0.01ml of the challenge organism (Staphylococcus aureus). After routine disinfection of the device, 10 ml of sterile saline was injected through it and passed through a .45μ membrane filter. The filters were incubated on Tryptic Soy Agar (TSA) at 30 - 35ºC. for 48 ± 4 hours and the colony forming units (CFUs) enumerated.

The study included two positive, two negative and three sterility control samples. Each of the test samples and positive controls were challenged using the simulated clinical use model. They were swabbed and accessed 20 times each day. Inoculation and CFU determinations were done after the last activation for the day, as well as the first activation on Day 1. Prior to each access the injection site of each valve was swabbed with a fresh sterile 70% isopropyl alcohol (IPA) pad folded once for 25 – 30 seconds followed by drying for a minimum of one (1) minute. After drying, each valve was accessed using a new, sterile syringe and flushed with 10 ml of sterile saline.

Inoculum: 
A fresh culture of Staphylococcus aureus was used each day. A suspension was prepared and diluted to approximately 1.0 x 103 Colony Forming Units (CFU)/0.01 ml for use as an inoculant and stored at 2-8°C. The inoculum population during the seven day test period ranged from 9.3 x 102 to 5.4 x 103 CFU/0.01 ml.

Prior to inoculation of test samples and positive controls, each seal was swabbed as described above and was allowed to dry for a minimum of one (1) minute. 0.01 ml of inoculum was placed directly on the top of bed and accessed twenty times each day as described above. After the last access of the day, the saline was collected and filtered through a 0.45-micron membrane filter. The filter was placed on TSA and incubated at 30 – 35 C for 48 hours. Following the incubation period, the CFU’s for each valve were counted.

The sterility controls (sterilized devices) were placed in 30 ml tubes of tryptic soy broth and incubated at 30 – 35 C for seven days. 

Results: 
During the seven days and 140 accesses of the test study using the method described above, the Robertsite valve test samples and the challenge organism, positive controls exhibited growth typical of the challenge organism. The recovery ranged from 5 x 100 to 9.4 x 102 CFU with a mean count of 1.86 x 102CFU.

Sterility controls demonstrated absence of growth after seven days of incubation.

Conclusion: 
The Robertsite Luer Activated Valve, when used with an adequate disinfection procedure, maintains its microbial barrier properties after 140 activations over a 7-day period. The study was conducted using a higher concentration of challenge organism than typically found in a hospital environment and a non-typical extended time period.

FLUSHING STUDY FOR ROBERTSITE® SWABABLE VALVES

Purpose:

To demonstrate the flushing efficiency of Robertsite Swabable valves. Tested samples were: Halkey-Roberts Robertsite® “Swabable Straight Valve” 
Protocol Summary:

AppTec Laboratory Services,St. Paul,MN, performed all laboratory testing. Three (3) Halkey-Roberts Robertsite®

“Swabable Straight Valves” were tested. 5 mL of human blood was aspirated through each valve. The valves were exposed to the blood for 10 minutes at room temperature. The blood was removed by the attached syringe immediately prior to initiation of flushing. Each valve was flushed with 1mL deionized water. The flushing was repeated five times. The eluates were collected into sample tubes and analyzed for total hemoglobin concentration and flushing efficiency (% clearance).

Method:

The study included positive and negative controls. The positive controls were filled with a solution of 5.0 mL of sterile water mixed with 0.35 mL of whole blood. The negative controls were filled with water only.

Test samples: 5 mL of blood was aspirated through each sample valve and left for 10 minutes at room temperature. The syringe was then removed immediately prior to flushing. The valve tip was blotted, and a new syringe with flushing fluid was attached. Each valve was flushed with 1 mL of deionized water and the flush was collected into labeled tubes. The flush was repeated five times. The hemoglobin concentration in the samples was determined using Drabkin’s reagent at 1:1 ratio. After a 15 minute incubation at room temperature, the absorbance of each sample was read using a spectrophotometer at a wavelength of 545 nm. Controls were tested concurrently.

The total hemoglobin concentration and % clearance were determined for each flush separately. 

Results:

100 % clearance was achieved by the 3^rd flush for the Halkey-Roberts Robertsite® “Swabable Straight Valve” 

Conclusion:

The Robertsite valve has demonstrated that it can be effectively flushed using the methods performed in this study. 

 

ROBERTSITE® MULTIPLE USE EVALUATION

Purpose:

To demonstrate Robertsite Luer Activated Injection Site integrity after 200 activations.

Background:

Robertsite valves were tested for sealing performance before and after 200 activations.

Results:

Assembled Robertsite valves passed back pressure sealing performance testing after 100 activations and after 200 activations.

The mean back pressure range was 46 to 48 psig. The -3 values ranged from 37 to 42 psig. All samples fell within a +/-3 distribution.

Conclusion:

The Robertsite valves were assembled per HRC procedures and accessed by a standard luer (ISO594-1/-2) connector. After 200 accesses, all Robertsite devices passed the HRC specification for back pressure seal performance (30 psig minimum).

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