VYGON LATEX FREE BIONECTOR

K052881 · Vygon Corp. · FOZ · Mar 2, 2006 · General Hospital

Device Facts

• Record ID: K052881
• Device Name: VYGON LATEX FREE BIONECTOR
• Applicant: Vygon Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Mar 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

Latex Free Bionector is a multi-purpose catheter accessory; a closed 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.

Device Story

Latex Free Bionector is a closed, needle-free, male/female Luer catheter accessory; facilitates blood sampling, intermittent injection, or continuous infusion of fluids/medications. Device features a disinfectable membrane that closes automatically upon disconnection of infusion lines or syringes. Operates via Luer system connection; displaces a positive bolus during disconnection of male Luer devices to maintain catheter patency. Used in clinical settings for intravascular therapy. Benefits include needle-free access and reduced risk of contamination via closed system design.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed the device is non-irritant and non-toxic. Performance testing verified that the material change does not affect device functionality.

Technological Characteristics

Male/Female Luer catheter accessory; disinfectable membrane; closed, needle-free system; positive bolus displacement mechanism. Resistant to lipid emulsions, cytotoxic drugs, and antiseptics. Latex-free construction. Risk assessment conducted per ISO 14971.

Indications for Use

Indicated for use as a multi-purpose, closed, needle-free catheter accessory for blood sampling, intermittent injection, or continuous infusion of fluids or medications in patients requiring intravascular access.

Regulatory Classification

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.

Predicate Devices

• Bionector (K941678)

Submission Summary (Full Text)

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K052881 page 1 of 2

VYGON CORPORATION

2495 General Armistead Avenue Norristown, PA 19403-3685

> [phone] [phone] Fax [phone]

## 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:

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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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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 [phone]. 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 [phone] or [phone] 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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K052881

## 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

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