VASCUPUNCTURE PICC GUIDEWIRE

K070150 · Neometrics, Inc. · DQX · Feb 15, 2007 · Cardiovascular

Device Facts

• Record ID: K070150
• Device Name: VASCUPUNCTURE PICC GUIDEWIRE
• Applicant: Neometrics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended 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.

Device Story

VascuPuncture PICC Guidewire is a medical guidewire used to facilitate percutaneous entry of peripheral vessels via the Seldinger Technique. The device is constructed from stainless steel and nickel titanium alloy, with optional lubricious coatings and various coil material configurations. It is available in diameters of 0.014 to 0.018 inches and lengths of 40 to 145 cm. The device is intended for use by clinicians in a clinical setting. It functions as a mechanical guide for catheter placement. The device does not involve electronic components, software, or automated analysis.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993. Shelf life validated through accelerated aging studies in accordance with ISO 11070.

Technological Characteristics

Materials: stainless steel, nickel titanium alloy. Dimensions: 0.014-0.018 inch diameter, 40-145 cm length. Features: optional lubricious coatings, various coil materials. Standards: ISO 10993 (biocompatibility), ISO 11070 (shelf life/aging). Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for percutaneous entry of peripheral vessels via Seldinger Technique. Contraindicated for use in coronary or cerebral vasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• VascuPuncture PICC Guidewire (K031652)
• VascuPuncture PICC Guidewire (K040786)
• VascuPuncture PICC Guidewire (K043398)

Submission Summary (Full Text)

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VascuPuncture™ PICC Guidewire NeoMetrics, Inc.

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p. Loft Special 510(k)

4070150

## Appendix J

FEB 1 5 2007

## 510(k) Summary

| Submitter: | NeoMetrics, Inc.<br>14800 28th Ave. N., Suite 150<br>Plymouth, MN 55447 |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gene Champeau<br>President<br>763-559-4440 (voice)<br>763-559-7676 (fax) |
| Date Prepared: | January 12, 2007 |
| Trade Name: | VascuPuncture™ PICC Guidewire |
| Classification Name<br>and Number: | Wire, Guide, Catheter: 21 CFR 870.1330 |
| Product Code: | DQX |
| Predicate Device<br>Name and 510(k)<br>Number | VascuPuncture PICC Guidewire, K031652, K040786, K043398 |
| Device Description: | DEVICE DESCRIPTION<br>The VascuPuncture™ PICC Guidewires are guidewires<br>constructed of stainless steel and nickel titanium alloy with or<br>without lubricious coatings. Devices are available in diameters<br>of 0.014 to 0.018 inches and in lengths ranging from 40 to 145<br>cm. with a variety of coil material options available. |
| Intended Use: | The VascuPuncture PICC Guidewire is indicated for<br>percutaneous entry of peripheral vessels using the Seldinger<br>Technique. The device is not intended for use in the coronary<br>or cerebral vasculature. |
| Statement of<br>Technological<br>Comparison | Functional and performance characteristics are demonstrated<br>through equivalence with the predicate device and testing of<br>representative device samples as part of Design Verification<br>Testing. Comparison is summarized in Table 1 below:<br>Biocompatibility is demonstrated through successful<br>completion of Biocompatibility Testing in accordance with ISO<br>10993<br>Shelf Life is demonstrated through successful completion of<br>accelerated aging studies and subsequent testing in accordance<br>with ISO 11070 |
| Conclusion: | VascuPuncture™ PICC Guidewire with additional coatings and<br>coil material are safe and equivalent to the predicate product.<br>This conclusion is based upon the fact that this device is<br>substantially equivalent to the predicate devices in terms of<br>functional design, indications for use, principles of operation,<br>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 [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,

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