(30 days)
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not intended for use in the coronary or cerebral vasculature.
The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with or without lubricious coatings. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 40 to 145 cm. with a variety of coil material options available.
This document describes the VascuPuncture™ PICC Guidewire by NeoMetrics, Inc. and its 510(k) premarket notification. However, it does not contain the detailed acceptance criteria or results from a study proving the device meets those criteria in the format explicitly requested for AI/medical device performance evaluation.
The provided text focuses on the device's substantial equivalence to predicate devices based on:
- Functional and performance characteristics demonstrated through equivalence with the predicate device and testing of representative device samples as part of Design Verification Testing.
- Biocompatibility demonstrated through successful completion of Biocompatibility Testing in accordance with ISO 10993.
- Shelf Life demonstrated through successful completion of accelerated aging studies and subsequent testing in accordance with ISO 11070.
This information is typical for a 510(k) submission for a conventional medical device like a guidewire, which relies on demonstrating equivalence to an already legally marketed predicate device rather than on clinical AI performance metrics.
Therefore, I cannot populate the requested table and study details as they are not present in the provided text.
Specifically, the following information is NOT present in the provided document:
- A table of acceptance criteria and the reported device performance: While general areas of testing (functional, performance, biocompatibility, shelf life) are mentioned, specific acceptance criteria (e.g., tensile strength minimum, kink resistance maximum) and their corresponding reported values are absent.
- Sample size used for the test set and the data provenance: No information on the number of guidewires tested or where the test data was generated (e.g., country, retrospective/prospective).
- Number of experts used to establish the ground truth and their qualifications: Not applicable, as this is not an AI device relying on expert-annotated ground truth.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable, as this is a physical medical device, not an AI model requiring ground truth for diagnosis/detection.
- The sample size for the training set: Not applicable, as there is no AI model or "training set" for this device.
- How the ground truth for the training set was established: Not applicable.
The document states that the conclusion of substantial equivalence is based upon "functional design, indications for use, principles of operation, risk analysis, and performance characteristics." The "performance characteristics" are demonstrated through "testing of representative device samples as part of Design Verification Testing" and compliance with ISO standards for biocompatibility and shelf life. This indicates that bench testing was performed for mechanical and material properties, rather than clinical studies with human participants for diagnostic performance.
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VascuPuncture™ PICC Guidewire NeoMetrics, Inc.
..............................................................................................................................................................................
.
p. Loft Special 510(k)
4070150
Appendix J
FEB 1 5 2007
510(k) Summary
| Submitter: | NeoMetrics, Inc.14800 28th Ave. N., Suite 150Plymouth, MN 55447 |
|---|---|
| Contact Person: | Gene ChampeauPresident763-559-4440 (voice)763-559-7676 (fax) |
| Date Prepared: | January 12, 2007 |
| Trade Name: | VascuPuncture™ PICC Guidewire |
| Classification Nameand Number: | Wire, Guide, Catheter: 21 CFR 870.1330 |
| Product Code: | DQX |
| Predicate DeviceName and 510(k)Number | VascuPuncture PICC Guidewire, K031652, K040786, K043398 |
| Device Description: | DEVICE DESCRIPTIONThe VascuPuncture™ PICC Guidewires are guidewiresconstructed of stainless steel and nickel titanium alloy with orwithout lubricious coatings. Devices are available in diametersof 0.014 to 0.018 inches and in lengths ranging from 40 to 145cm. with a variety of coil material options available. |
| Intended Use: | The VascuPuncture PICC Guidewire is indicated forpercutaneous entry of peripheral vessels using the SeldingerTechnique. The device is not intended for use in the coronaryor cerebral vasculature. |
| Statement ofTechnologicalComparison | Functional and performance characteristics are demonstratedthrough equivalence with the predicate device and testing ofrepresentative device samples as part of Design VerificationTesting. Comparison is summarized in Table 1 below:Biocompatibility is demonstrated through successfulcompletion of Biocompatibility Testing in accordance with ISO10993Shelf Life is demonstrated through successful completion ofaccelerated aging studies and subsequent testing in accordancewith ISO 11070 |
| Conclusion: | VascuPuncture™ PICC Guidewire with additional coatings andcoil material are safe and equivalent to the predicate product.This conclusion is based upon the fact that this device issubstantially equivalent to the predicate devices in terms offunctional design, indications for use, principles of operation,risk analysis, and performance characteristics |
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CONFIDENTIAL
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 7007
NeoMetrics, Inc. c/o Mr. Gene Champeau President 14800 28th Avenue, N. Suite 150 Plymouth, MN 55447
Re: K070150
VascuPuncture™ PICC Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DQX Dated: January 12, 2007 Received: January 16, 2007
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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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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B.zimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VascuPuncture™ PICC Guidewire NeoMetrics, Inc.
Special 510(k)
Indications for Use
510(k) Number (if known): K070150
Device Name: VascuPuncture™ PICC Guidewire
Indications for Use:
The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not intended for use in the coronary or cerebral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Bymmmn
Division Sign Off
Division of Cardiovascular Devices 510(k) Number
Page of of a
(Posted November 13, 2003)
02/08/2007
CONFIDENTIAL
§ 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.