(141 days)
Not Found
No
The summary describes a mechanical IV connection accessory and explicitly states that AI, DNN, or ML were not found in the description.
No.
The device is described as a catheter accessory for fluid and medication transfer, not as treating or mitigating a disease or condition itself.
No
The device is described as a multi-purpose catheter accessory for fluid and medication administration, not for diagnosis.
No
The device description clearly indicates a physical, hardware medical device (a multi-purpose catheter accessory) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states its purpose is for "blood sampling, intermittent injection or continuous infusion of fluids or medications" and is a "multi-purpose catheter accessory." These are all related to administering or withdrawing substances from the body, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces its use as a "closed, needle-free IV connection accessory for sampling, injection or continuous infusion." Again, this points to its function in patient care, not laboratory testing.
- Lack of IVD-related terms: There is no mention of analyzing biological samples, diagnostic testing, or any other activities typically associated with IVDs.
The device is a medical device used in patient care, specifically for intravenous access and fluid management.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The Latex Free Bionector is a multi-purpose, closed, needle-free IV connection accessory for sampling, injection or continuous infusion of fluids or drugs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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.
2
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.
3
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
4
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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