(165 days)
THE NEOMETRICS VASCUPUNCTURE ACCESS WIRE IS IN DICATED FOR PERCUTANEOUS VASCULAR ENTRY USING THE SELDINGER TECHNIQUE,
This guidewire has a 0.0175" diameter and is available in lengths of 45-120 cm. It features gradual diameter changes in the distal section to facilitate vascular insertion and compatibility with various introducers and catheters. A variety of distal tapers impart different tip flexibilities.
This request requires the extraction of very specific information about acceptance criteria and study design, which is not present in the provided text. The document is a 510(k) summary for a medical device (guidewire) and primarily focuses on establishing substantial equivalence to predicate devices, not on detailed performance studies or specific acceptance criteria with reported device performance.
Therefore, I cannot provide the requested table or detailed study information. The text explicitly states: "NeoMetrics Access Wires and predicate devices were subjected to bench and biocompatibility testing to demonstrate equivalency in terms of safety and effectiveness." However, it does not provide:
- A table of acceptance criteria (e.g., minimum tensile strength, maximum friction) or reported device performance against those criteria.
- Details about the sample size for any test set, data provenance, or number/qualifications of experts used to establish ground truth.
- Information on adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth, or training set specifics (as these are typically relevant for AI/software-based devices, not a physical guidewire).
The provided text focuses on the regulatory submission process and the determination of substantial equivalence for a physical medical device.
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K01286|
Appendix 8 FEB 0 5 2002 Summary of Safety and Effectiveness
| Submitter: | NeoMetrics, Inc. |
|---|---|
| 15301 Highway 55 West | |
| Plymouth, MN 55447 | |
| Telephone: (763) 559-4440 | |
| Fax: (763) 559-7676 | |
| Product: | |
| Classification Name: | Catheter Guidewire (21 CFR 870.1330) |
| Common Name: | Guidewire, catheter guidewire, and wire guide |
| Trade/Proprietary Name: | Vascupuncture™ Access Wire |
Substantially Equivalent Products:
Lake Region Manufacturing CCA Guidewires (K971322) and other commercially distributed devices.
- This guidewire has a 0.0175" diameter and is available in lengths of 45-120 Description: cm. It features gradual diameter changes in the distal section to facilitate vascular insertion and compatibility with various introducers and catheters. A variety of distal tapers impart different tip flexibilities.
Indications for Use:
For percutaneous vascular entry using the Seldinger technique.
Comparison To Substantially Equivalent Products:
Predicate devices have the same intended use and have similar designs and materials. NeoMetrics Access Wires and predicate devices were subjected to bench and biocompatibility testing to demonstrate equivalency in terms of safety and effectiveness.
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the symbol of the Department of Health and Human Services, which is a stylized caduceus with three lines representing the snakes and a central staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following the curve of the seal's edge.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 5 2002
Mr. Gene Champeau President NeoMetrics, Inc. 15301 Highway 55 West Plymouth, MN 55447
Re: K012861
Vascupuncture™ Access Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: November 28, 2001 Received: November 29, 2001
Dear Mr. Champeau:
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 - Mr. Gene Champeau
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. Page 2 - Mr. gene Champeau
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Deakin Tiller
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
510(k) Number (if known):
Device Name: NEOMETRICS VASCUPUNCTURE ACCESS WIRE
Indications For Use:
THE NEOMETRICS VASCUPUNCTURE ACCESS WIRE IS IN DICATED FOR PERCUTANEOUS VASCULAR ENTRY USING THE SELDINGER TECHNIQUE,
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number 12017861
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.