MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS
Device Facts
| Record ID | K102073 |
|---|---|
| Device Name | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS |
| Applicant | Benlan, Inc. |
| Product Code | FPA · General Hospital |
| Decision Date | Nov 8, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Indications for Use
The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.
Device Story
The MED-RX Transfer Set is a sterile, single-use intravascular administration set used in hospital settings to transfer contrast media or saline from a spikeable container into a syringe. The device consists of a spike, PVC tubing (18"–44"), and a distal connector (dual-check valve, 3-way stopcock, or swabbable luer valve). Most models include a pinch clamp and luer caps. The device allows for multiple fillings from a single reservoir up to a 6-hour time limit. It is operated by healthcare professionals to facilitate fluid delivery, potentially benefiting patients by enabling efficient, sterile contrast or saline administration.
Clinical Evidence
Bench testing only. Performance testing conducted per ISO 8536-4:2007 included tensile strength, leakage under pressure, liquid leakage, particulate contamination, flow rate, and air filter efficiency. Biocompatibility testing performed per ISO 10993 and ASTM F-756-00, including hemolysis, acute systemic injection, pyrogenicity, intracutaneous reactivity, sensitization, and cytotoxicity. All tests passed.
Technological Characteristics
Materials: PVC (DEHP-free) tubing, cyclohexanone/light cure adhesive. Components: Spike, tubing, pinch clamp, distal valve (dual-check, 3-way stopcock, or swabbable luer). Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 8536-4:2007, ISO 10993, ASTM F-756-00. No software or electronic components.
Indications for Use
Indicated for the delivery of contrast media or saline from a spikeable container into a syringe in a hospital setting. Prescription use only.
Regulatory Classification
Identification
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.
Special Controls
*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Benlan MED-RX Transfer Sets. The logo consists of a stylized water drop symbol on the left, followed by the word "Benlan" in bold, sans-serif font. Below the word "Benlan" is the text "MED-RX Transfer Sets", with the "RX" having a registered trademark symbol.
### SECTION 5 - 510(K) SUMMARY
K102073
NOV - 8
Image /page/0/Picture/4 description: The image shows a close-up of a curved surface covered in small, circular shapes. The shapes appear to be raised or textured, creating a bumpy surface. The lighting in the image is uneven, with the top portion appearing darker and more shadowed than the bottom portion. The overall impression is that of a detailed, textured surface with varying degrees of light and shadow.
Date of Summary: September 22, 2010
### Benlan Inc
| 2760 Brighton Road | Tel (905) 829-5004 |
|----------------------|------------------------------------------------------------------------------|
| Oakville, ON L6H 5T4 | Fax (905) 829-5006 |
| Official Contact: | Cheryl Brown - QA / RA Manager |
| Proprietary Name: | MED-RX Transfer Set |
| Common Name: | Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set, 880.5440 Intravascular Administration Set. |
| Class: | Class II |
| Product Code: | FPA |
| Predicate Device: | Medrad Transfer Set (K022431) |
| | Medrad Swabbable Valve Transfer Set (K031808) |
### Device Description
The MED-RX Transfer Set is offered in four (4) different models: 10-1227TS, 10-1300TS, 10-1305TS, and 10-1306TS. The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe. The MED-RX Transfer Sets each consist of a spike, tubing, and either a valve (swabbable or dual check) or 3-way stopcock. All sets but the 10-1306TS also have a pinch clamp. The tube is made of polyvinyl chloride (PVC) and is available in lengths from 18″ – 44″. The MED-RX Transfer Sets are provided sterile and are not to be resterilized.
### Indications for Use
The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.
### Substantial Equivalence
The information provided in the premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed MED-RX Transfer Sets are substantially equivalent to the predicate Medrad Transfer Set (K022431) and Medrad Swabbable Valve Transfer Set (K031808). All devices have the same intended use to deliver contrast media or saline from a spikeable container into a syringe. All devices allow multiple filling from one reservoir up to a 6 hour time limit.
A comparison of features and principles of operation between the proposed device and predicate device is provided in Table 1 below.
05 829 5004 F 905 829 5006 € benlon@benlan.com 2760 Brighton Rd. Oakville ON L6H 5T4 www.benlon.com
{1}------------------------------------------------
K-102073
# MED-RX® Transfer Sets
Table 1: Comparison between MED-RX Transfer Set, Medrad Transfer Set (K022431), and Medrad Swabbable Valves Transfer Set (K031808)
| ATTRIBUTE | PROPOSED DEVICE<br>MED-RX Transfer Set | PREDICATE DEVICE<br>Medrad Transfer Set<br>(K022431) | PREDICATE DEVICE<br>Medrad Swabbable<br>Valve Transfer Set<br>(K031808) |
|-----------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------|
| General Indications | | | |
| Indications for Use | Delivery of contrast<br>media or saline from a<br>spikeable container into a<br>syringe | Same | Same |
| System Configuration | 1 Part System – multi-fill<br>spike system | Same | Same |
| Time Limit | 6 hours maximum | Same | Same |
| Multi - fill | Yes, until reservoir is<br>empty or time limit<br>reached | Yes | Yes |
| Shelf Container | For use with one<br>container of media only | Same | Same |
| Prescription | Yes | Yes | Yes |
| Intended Environment of Use | Hospital | Same | Same |
| Material Composition | | | |
| Tubing | Polyvinyl Chloride - DEHP<br>free | PVC - medical grade | PVC - medical grade |
| Adhesive | Cyclohexanone and 3921<br>Light Cure Adhesive | Cyclohexanone and 3321<br>Light Cure Adhesive | Cyclohexanone and 3321<br>Light Cure Adhesive |
| Packaging and Sterilization | | | |
| Sterile | Yes | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EO) | Same | Same |
| Packaging Configuration | Medical grade peelable<br>paper/ poly pouch | Same | Same |
| | DIFFERENCES | | |
| Physical Specifications | | | |
| Tubing outer diameter (OD) | 0.158" - 0.168" | 0.160" | 0.160" |
| Tubing inner diameter (ID) | 0.095" - 0.111" | 0.110" | 0.120" |
| Tubing length | 18", 20", 31", 44" | 20" | 23" |
| Design Features | | | |
| Distal Configuration | Dual check valve OR 3-<br>way stopcock OR<br>swabbable luer valve | One-way stopcock | Swabbable threaded<br>valve |
| Proximal Configuration | Universal spike OR<br>Vented spike | Hyperal vented spike | Hyperal vented spike |
| Clamp | Pinch clamp<br>(except for 10-1306) | Pinch clamp | None |
| Caps | Luer caps (except for 10-<br>1306) | Luer caps | None |
## ് ()Benlan
్రామెల్లి విశ
ു ത
{2}------------------------------------------------
### Summary of Differences
There are no significant differences between the proposed MED-RX Transfer Sets and the predicate devices, Medrad Transfer Set (K022431) and Medrad Swabbable Valve Transfer Set (K031808). Similarities between the proposed device and the predicate devices include identical indications for use and duration of use. The MED-RX Transfer Sets and the Medrad Transfer Set and Medrad Swabbable Valve Transfer Set are sterile, disposable devices, packaged in peelable paper/poly pouches and sterilized using ethylene oxide.
The proposed MED-RX Transfer Sets to be offered utilize either a dual-check valve, a stopcock, or a luer compatible swabbable valve on the distal end of the set. The predicate Medrad Transfer Set has a stopcock while the predicate Medrad Swabbable Valve Transfer Set has a luer threaded swabbable valve. The dual-check valve used on the MED-RX Transfer Set is not offered on either of the predicate devices, but is a very similar component to the stopcock utilized, both of which are luer compatible, with two user-accessible ports.
Therefore, any minor differences between the proposed device and the predicate have been evaluated to have no impact on safety or effectiveness of the MED-RX Transfer Sets. Therefore the proposed device can be considered substantially equivalent to legally market devices.
### Non-Clinical Test Summary
Verification of functional performance of the MED-RX Transfer Sets has been performed as per ISO 8536-4: 2007. The MED-RX Transfer Sets were subject to numerous performance tests including tensile strength, resistance to leakage under pressure and also for resistance to liquid leakage, particulate contamination, and for chemical requirements. The MED-RX Transfer Sets have successfully completed all required performance testing following the applicable guidelines of ISO 8536-4: 2007 and were tested for natural rubber latex content. Please refer to Table 2.
| Particulate Contamination | ISO 8536-4: 2007 | Samples met contamination<br>index limit. |
|--------------------------------|------------------|-------------------------------------------|
| Leakage under Pressure | ISO 8536-4:2007 | Pass |
| Liquid Leakage | ISO 8536-4:2007 | Pass |
| Tensile Strength —Tubing/Spike | ISO 8536-4:2007 | Withstand 15 N for 15<br>Seconds = Pass |
Table 2: Non-Clinical Test Summary
5-3 R1
905 829 5004 F 905 829 5006 € benlan@benlon.com
2760 Brighton Rd. Oakville ON L6H 5T4 www.benlan.com
{3}------------------------------------------------
| Test | Standard | Results |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------------------|
| Tensile Strength – Tubing/Valve | ISO 8536-4:2007 | Withstand 15 N for 15<br>Seconds = Pass |
| Demonstrate MED-RX Transfer<br>Sets are capable of withstanding<br>the designated test force without<br>damage or separation. | ISO 8536-4:2007 | Pass |
| Efficiency of the Air Filter | ISO 8536-4:2007 | Pass |
| Flow Rate Test | ISO 8536-4:2007 | Pass |
| Chemical Requirements | ISO 8536-4:2007 PER<br>Clause5 & 7 | Pass |
| Natural Rubber Latex Content | Modified Lowry Method | Device does not contain<br>natural rubber latex |
### Summary of Sterilization
Each MED-RX Transfer Set is individually packaged using a medical grade peelable synthetic polymer reinforced paper with a film backing, and sterilized using ethylene oxide. Please see Table 3 for a summary.
Table 3: Sterilization Summary
| Test Description | Standard | Results |
|----------------------------|--------------------------|--------------------------------------------------------------|
| Method of Validation | ANSI/AMMI/ISO 11135:1994 | Validated to a Sterility Assurance<br>Level of $1 x 10^{-6}$ |
| EO Sterilization Residuals | ISO 10993-7: 2008 | Pass |
| Bacterial Endotoxins | ANSI/AAMI ST72:2002 | Pass |
Image /page/3/Picture/11 description: The image shows the logo for Benlan. The logo consists of a stylized letter "O" on the left and the word "Benlan" on the right. The letter "O" is not a complete circle, but rather an open shape that resembles a crescent moon or a horseshoe.
x 2760 Brighton Rd. Oakville ON L6H ST4 www.benlan.com ·
{4}------------------------------------------------
Image /page/4/Picture/2 description: The image shows a microscopic view of a biological sample. The sample appears to be a tubular structure, possibly a vessel or duct, filled with numerous small, circular or oval-shaped objects. These objects are densely packed in some areas and more sparsely distributed in others, suggesting varying concentrations within the structure.
### Summary of Biocompatibility Tests
Biocompatibility testing was successfully completed on sterile finished devices. The MED-RX Transfer Sets are classified as external communicating devices with limited indirect blood path contact. A summary of the testing completed and the relevant standards are listed in Table 4.
### Table 4: Biocompatibility Test Summary
| Test Description | Standard | Results |
|-----------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------------------------------------------------------|
| Hemolysis Assay – Extract<br>Method | ASTM F-756-00 | Product code 10-1300, 10-1305, 10-1306 and<br>10-1227 is considered non-hemolytic and passes<br>the test. |
| Acute Systemic Injection<br>Test | ISO 10993-11 | The findings indicate that the requirements of<br>the ISO Acute Systemic Injection Test have been<br>met. |
| Materials Mediated Rabbit<br>Pyrogen Test | USP 32:2009 <151> | Product code 10-1300, 10-1305, 10-1306 and<br>10-1227 was determined to be non-pyrogenic. |
| Intracutaneous Reactivity<br>Test | ISO 10993-10:2002 | Product code 10-1300, 10-1305, 10-1306 and<br>10-1227 would be considered a non-irritant. |
| Guinea Pig Maximization<br>Sensitization Test (Method<br>of Biomaterial Extracts) | ISO 10993-10:2002 | Product code 10-1300, 10-1305, 10-1306 and<br>10-1227 did not elicit a sensitization response. |
| ISO MEM Elution with<br>L-929 Mouse Fibroblast<br>Cells (Cytotoxicity) | ISO 10993-5: 2009 | Product code 10-1300, 10-1305, 10-1306 and<br>10-1227 are considered non-toxic. |
Image /page/4/Picture/9 description: The image shows the logo for Benlan, with the company name in bold black letters next to a circular graphic. Below the logo are the company's phone and fax numbers, as well as their email address. The phone number is 905-829-5004, the fax number is 905-829-5006, and the email address is benlan@benlan.com.
ג 2760 Brighton Rd. Oakville ON L6H 5T4 ששוש.benlan.com
{5}------------------------------------------------
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Benlan, Incorporated C/O Mr. E.J. Smith Smiths Associates P.O.Box 4341 Crofton, Maryland 21114
NOV - 8 2010
Re: K102073
Trade/Device Name: MED-RX Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 27, 2010 Received: October 28, 2010
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{6}------------------------------------------------
Page 2- Mr. Smith
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm] 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Benlan MED-RX Transfer Sets. The logo consists of a stylized letter O with a drop-like shape inside, followed by the word "Benlan" in bold, sans-serif font. Below "Benlan" is the text "MED-RX Transfer Sets", with the "RX" having a registered trademark symbol.
K102073
### SECTION 4 - INDICATIONS FOR USE
NOV - 8 2010
510(K) Number (If Known): K102073
Device Name: MED-RX Transfer Set
Indications For Use:
The MED-RX Transfer Set is intended to be used in the delivery of contrast media or saline from a spikeable container into a syringe.
| Prescription Use: | <span style="font-size: 2em;">✓</span> |
|-----------------------------|----------------------------------------|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-the-Counter Use | |
| (21 CFR 801 Subpart C) | |
| N/A | |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhad C. Chaym 11/5/2010
Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthesionogy !
Infection Control, Dental Devices
510(k) Number: _ . .
