(141 days)
Latex Free Bionector is a multi-purpose catheter accessory; a closed needieless system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latex Free Bionector is a Male/Female Luer device that displaces a positive bolus during disconnection of the Male Luer devices connected to it.
The Latex Free Bionector is a multi-purpose, closed, needle-free IV connection accessory for sampling, injection or continuous infusion of fluids or drugs.
The Vygon Latex Free Bionector is a multi-purpose, closed, needle-free IV connection accessory. The submission K052881 seeks to demonstrate its substantial equivalence to the predicate device, Vygon Bionector (K941678).
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria as a quantitative threshold in the typical sense for a diagnostic device. Instead, it focuses on demonstrating that the new Latex Free Bionector performs equivalently to the predicate device and meets safety standards despite a material change. The "acceptance criteria" here are implied through the successful completion of testing confirming functionality and safety.
| Acceptance Criteria (Implied) | Reported (Demonstrated) Device Performance |
|---|---|
| Non-irritant (Biocompatibility) | Biocompatibility testing of the Latex Free Bionector demonstrates that it is non-irritant. |
| Non-toxic (Biocompatibility) | Biocompatibility testing of the Latex Free Bionector demonstrates that it is non-toxic. |
| Device functionality unaffected by material change | Performance testing demonstrates that the change in material (removal of latex) does not affect device functionality. |
| Compliance with ISO 14971 (Risk Management) | Risk Assessment was conducted in compliance with ISO 14971. |
| Disinfectable membrane | The Bionector has a disinfectable membrane. (This is a characteristic, not a performance criterion, but listed as a key technology characteristic that would need to be maintained post-material change). |
| Automatic closure upon disconnection | The Bionector's membrane closes automatically when the infusion line or syringe is disconnected. (Again, a characteristic that must be maintained). |
| Resistance to lipid emulsions, cytotoxic drugs, and antiseptics | The Bionector is resistant to lipid emulsions, most cytotoxic drugs, and antiseptics. (Characteristic that must be maintained). |
| Substantial equivalence to predicate device (K941668) in intended use | The Latex Free Bionector's intended use and technological characteristics (excluding latex content) are described as substantially equivalent to the predicate device (K941678). Both are multi-purpose catheter accessories for sampling, injection, or continuous infusion with Luer systems. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the performance and biocompatibility testing. The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective, performed specifically for this 510(k) submission to evaluate the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For biocompatibility and performance testing of a medical device, the "ground truth" is typically established by recognized standards, validated testing methodologies, and expert interpretation of results by qualified laboratory personnel, rather than a consensus of clinical experts for a diagnostic output.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (biocompatibility, performance testing against specifications), a consensus-based adjudication method for a "test set" is not typically applicable in the same way it would be for a diagnostic image review. The results would be interpreted against established acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. This device is a medical accessory, not a diagnostic imaging device that requires human interpretation.
6. Standalone Performance Study
Yes, standalone performance studies were conducted. The "Performance testing" mentioned in the "Summary of Design Control Activities" section appears to be a standalone evaluation of the device's functionality. This testing directly addressed whether the change in material affected device performance. Biocompatibility testing was also a standalone evaluation.
7. Type of Ground Truth Used
The ground truth for the performance and biocompatibility testing was established through:
- Established Biocompatibility Standards: "Biocompatibility testing... demonstrate that it is non-irritant and non-toxic," implying testing against recognized standards for biocompatibility (e.g., ISO 10993 series).
- Device Functionality Specifications: "Performance testing demonstrates that the change in material does not affect device functionality," indicating that critical functional parameters were tested against predefined specifications derived from those of the predicate device.
- Risk Management Standards: "Risk Assessment was conducted in compliance with ISO 14971."
8. Sample Size for the Training Set
No training set is applicable or mentioned. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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K052881 page 1 of 2
VYGON CORPORATION
2495 General Armistead Avenue Norristown, PA 19403-3685
(800) 544-4907 (610) 630-3350 Fax (610) 630-3835
510K Premarket Notification Submission Summary of Safety and Efficacy
Date of Preparation: February 27, 2006
Vygon Corporation Applicant: 2495 General Armistead Ave. Norristown, PA 19403 Courtney Smith, Regulatory Affairs Manager Contact Individual: 610-539-9300 Ext. 110 Vygon Latex Free Bionector Trade Name: Bionector Common Name: 880.5200 Regulation Number: FOZ Product Code: Catheter,intravascular,therapeutic,short-term less than 30 days Classification Name: Class II Classification: Vygon Bionector (K941678) Predicate Device Name:
Image /page/0/Picture/7 description: The image shows the word "VYGON" in white letters on a black, rounded rectangle. A black triangle is above the letter "V". The letters are bold and sans-serif.
2006 MAR Z
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K052881 page 2 of 2
The Latex Free Bionector is a multi-purpose, closed, needle-free IV Device Description: connection accessory for sampling, injection or continuous infusion of fluids or drugs.
Latex Free Bionector is a multi-purpose catheter accessory; a closed Intended Use: needleless system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latex Free Bionector is a Male/Female Luer device that displaces a positive bolus during disconnection of the Male Luer devices connected to it.
Technology Characteristics: The Bionector has a disinfectable membrane which closes automatically when the infusion line or the syringe is disconnected. The Bionector is resistant to lipid emulsions, most cytotoxic drugs and antiseptics. The Latex free is substantially equivalent to the predicate device (Bionector K941678) except that it does not contain latex.
Summary of Design Control Activities:
Biocompatibility testing of the Latex Free Bionector demonstrate that it is non-irritant and non-toxic. Performance testing demonstrates that the change in material does not affect device functionality. Risk Assessment was conducted in compliance with ISO 14971.
Only change between the predicate device (Bionector K941678) and the Conclusion: Latex Free Bionector is the change in material. Biocompatibility testing, performance testing and risk assessment demonstrate that the Latex Free Bionector is safe and effective to use, when used in accordance with the supplied instructions for use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff entwined with snakes, which is often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2006
Ms. Courtney Smith Regulatory Affairs/ Quality Assurance Manager Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403
Re: K052881
Trade/Device Name: Latex Free Bionector Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 31, 2006 Received: February 6, 2006
Dear Ms. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Courtney 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runser
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052881
Device Name: Latex Free Bionector
Indications For Use:
- Latex Free Bionector is a multi-purpose catheter accessory; a closed needieless . system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system.
- Latex Free Bionector is a Male/Female Luer device that displaces a positive . bolus during disconnection of the Male Luer devices connected to it.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pearcy
the clory General Hospical Dantal Davices
Page 1 of
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).