MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039

K070705 · Vygon Corp. · FOZ · Nov 30, 2007 · General Hospital

Device Facts

• Record ID: K070705
• Device Name: MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
• Applicant: Vygon Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Nov 30, 2007
• 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 needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latexfree Bionector is a Male/Female Luer, neutral displacement device. It does not displace fluid upon either connection or disconnection. Latex-free Bionector may be flushed with saline only or heparinized saline, in accordance with hospital protocol. The Latex-free Bionector is MR Conditional.

Device Story

Latex-free Bionector is a closed, needle-free IV connector; functions as a male/female Luer interface for catheter access. Device features a disinfectable membrane that closes automatically upon disconnection. Neutral displacement design prevents fluid movement during connection/disconnection. Used in clinical settings for blood sampling, medication injection, or continuous fluid infusion. Operated by healthcare professionals. MR Conditional status allows use in magnetic resonance environments. Benefits include reduced needle-stick risk and maintenance of closed system integrity during vascular access procedures.

Clinical Evidence

Bench testing only. Biocompatibility data confirms materials are non-irritant and non-toxic. Performance testing demonstrates substantial equivalence to predicate.

Technological Characteristics

Closed, needle-free, male/female Luer connector. Features a disinfectable membrane. Neutral displacement mechanism. MR Conditional. Materials are biocompatible (non-irritant, non-toxic).

Indications for Use

Indicated for use as a multi-purpose 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

• Latex Free Bionector (K052881)

Submission Summary (Full Text)

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K070705

(f. 1 or 2)

2495 General Armistead Avenue

Norristown, PA 19403-3685

[phone] [phone] Fax [phone] http://www.vygonusa.com

## PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)

Date of Preparation: March 7, 2007

Courtney Smith, Regulatory Affairs Manager

Applicant:

Vygon Corporation 2495 General Armistead Ave. Norristown, PA 19403

610-539-9300 Ext. 110

NOV 2 0 2007

Contact Individual:

Trade Name: Latex-free Bionector

Common Name: Bionector

Regulation Number: 880.5200

Product Code: FOZ

Classification Name: Catheter, Intravascular, Therapeutic, Short-term, less than 30-days

Classification: Class II

Predicate Device Name: Latex Free Bionector (K052881)

Device Description: The Latex-free Bionector is a multi-purpose, closed, needle-free IV connector to be used for the purpose of sampling, injection, or continuous infusion of fluids or drugs. The Latex-free Bionector has a disinfectable membrane (disinfection must be carried out before and after use) which closes automatically when the infusion line or the syringe is disconnected.

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LATEX-FREE BIONECTOR is a multi-purpose Intended Use: catheter accessory; a closed needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer system. Latexfree Bionector is a Male/Female Luer, neutral displacement device. It does not displace fluid upon either connection or disconnection. Latex-free Bionector may be flushed with saline only or heparinized saline, in accordance with hospital protocol. The Latex-free Bionector is MR Conditional.

Technology Characteristics: The Latex-free Bionector is substantially equivalent to the predicate devices.

## Summary of Design Control Activities:

Biocompatibility data demonstrates that the materials used are nonirritant and non-toxic. Performance testing demonstrates that the device is substantially equivalent to the predicate devices. Risk Assessment was conducted in compliance with ISO 14971.

Biocompatibility testing, performance testing and risk assessment Conclusion: demonstrate that the Latex-free Bionector is substantially equivalent to the predicate devices, and safe and effective to use, when used in accordance with the supplied instructions for use.

Courtney Smith 11/30/07
Courtney Smith Date

Courtney Smith Regulatory Affairs Manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Public Health Service

NOV 3 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Courtney Smith Regulatory Affairs Manager Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403

Re: K070705

Trade/Device Name: Latex-Free Bionector Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 26, 2007 Received: November 27, 2007

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. 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,

Clare

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): K070705

Latex-free Bionector Device Name:

Indications For Use:

LATEX-FREE BIONECTOR is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Male/Female Luer system which does not displace fluid upon either connection or disconnection.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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