(261 days)
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.
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.
The provided text describes a medical device, the Latex-free Bionector, and its FDA 510(k) premarket notification. However, it does not contain any information regarding acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert involvement, adjudication methods), comparative effectiveness studies, standalone performance, or ground truth establishment relevant to the request.
The document primarily focuses on:
- Device Description and Intended Use: What the Latex-free Bionector is and what it's used for.
- Regulatory Classification: Its classification details and predicate device.
- Summary of Design Control Activities: Stating that biocompatibility data, performance testing, and risk assessment were conducted, demonstrating substantial equivalence to predicate devices.
- FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets those criteria, as this information is not present in the provided text.
The document states "Performance testing demonstrates that the device is substantially equivalent to the predicate devices," but it does not elaborate on what specific performance tests were performed, what the acceptance criteria for those tests were, or what the results of those tests were.
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(f. 1 or 2)
2495 General Armistead Avenue
Norristown, PA 19403-3685
(800) 544-4907 (610) 630-3350 Fax (610) 630-3835 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.
Image /page/0/Picture/19 description: The image shows the word "VYCON" in white letters. The letters are in a rounded rectangle shape. The background of the image is made up of small, dark shapes.
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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 (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,
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
Page 1 of _ 1_
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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§ 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).