VASCUPUNCTURE PICC GUIDEWIRE

K031652 · Neometrics, Inc. · DQX · Sep 30, 2003 · Cardiovascular

Device Facts

• Record ID: K031652
• Device Name: VASCUPUNCTURE PICC GUIDEWIRE
• Applicant: Neometrics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.

Device Story

VascuPuncture PICC Guidewire; stainless steel and nickel titanium alloy construction; lubricious coating; diameters 0.014 and 0.018 inches; lengths 45-145 cm. Used for percutaneous peripheral vessel entry via Seldinger Technique. Operated by clinicians. Facilitates catheter placement; aids vascular access.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

Materials: stainless steel, nickel titanium alloy, lubricious coating. Diameters: 0.014 and 0.018 inches. Lengths: 45-145 cm. Mechanical guidewire.

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 Access Wire (K012861)
• Selectiva Guidewire (K013024)

Submission Summary (Full Text)

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'K031652

## Attachment 5 510(k) Summary

| Submitter: | NeoMetrics, Inc.<br>14800 28th Avenue South, Suite 150<br>Plymouth, MN 55447<br>Telephone: [phone]<br>Fax: [phone] |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gene Champeau<br>President<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | May 21, 2003 |
| Trade Name: | VascuPuncture PICC Guidewire |
| Classification Name<br>and Number: | Wire, Guide, Catheter<br>870.1330 |
| Product Code: | DQX |
| Predicate Device(s): | VascuPuncture Access Wire, 510(k) number K012861, and Selectiva<br>Guidewire cleared via the 510(k) K013024. |
| Device Description: | The VascuPuncture PICC Guidewires are guidewires constructed of<br>stainless steel and nickel titanium alloy with a lubricious coating. Devices<br>are available in diameters of 0.014 and 0.018 inches and in lengths ranging<br>from 45 to 145 cm. |
| Intended Use: | The VascuPuncture PICC Guidewire is intended for percutaneous entry of<br>peripheral vessels using the Seldinger Technique. VascuPuncture<br>Guidewires are not intended for use in the coronary or cerebral vasculature. |
| Functional and Safety<br>Testing: | Representative samples of the device underwent bench testing to<br>demonstrate appropriate functional and performance characteristics<br>compared to the predicate device. |
| Conclusion: | The VascuPuncture PICC Guidewire modified as proposed in this<br>submission, is substantially equivalent to the predicate devices.<br><br>This conclusion is based upon the similarity in design, principles of<br>operation, materials, and performance and of the modified device<br>compared to the originally, cleared device. |

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three parallel lines that curve and converge, resembling a stylized human figure or a bird in flight. The overall design is simple and recognizable, representing the department's mission and identity.

SEP 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neo Metrics, Inc. C/O Gene Champeau 14800 28th Ave North Plymouth, MN 55447

Re: K031652

Trade/Device Name: VascuPuncture PICC Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II (two) Product Code: DQX Dated: September 2, 2003 Received: September 3, 2003

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. 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/dsma/dsmamain.html

Sincerely yours,

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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Indications for Use Page

510(k) Number (if known): K031652

VascuPuncture PICC Guidewire Device Name:

Indications for Use:

The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sig-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K091652 |

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Over-the-Counter Use ___________

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