MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE

K043398 · Neometrics, Inc. · DQX · Mar 1, 2005 · Cardiovascular

Device Facts

• Record ID: K043398
• Device Name: MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
• Applicant: Neometrics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 1, 2005
• 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. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.

Device Story

VascuPuncture PICC Guidewire facilitates percutaneous vascular access; utilizes Seldinger technique. Device consists of stainless steel and nickel titanium alloy wire with lubricious coating; includes tungsten or gold-plated tungsten components. Used by clinicians in clinical settings for peripheral vessel entry. Provides mechanical guidance for catheter placement; assists in establishing vascular access. Benefits patient by enabling minimally invasive peripheral vessel entry.

Clinical Evidence

Bench testing only. Equivalence demonstrated through performance testing of representative device samples and biocompatibility assessment.

Technological Characteristics

Materials: stainless steel, nickel titanium alloy, tungsten or gold-plated tungsten. Coating: lubricious. Dimensions: 0.014 to 0.018 inch diameter; 45 to 135 cm length. Principle: mechanical guidewire for catheter placement. Sterilization: not specified.

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)

Submission Summary (Full Text)

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MAR 1 - 2005

K 043398

## Appendix G

## 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: | December 8th, 2004 |
| 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 and K040786 |
| Device Description: | DEVICE DESCRIPTION<br>The VascuPuncture™ PICC Guidewires are guidewires<br>constructed of stainless steel and nickel titanium alloy with a<br>lubricious coating. Devices are available in diameters of 0.014<br>to 0.018 inches and in lengths ranging from 45 to 135 cm. |
| Intended Use: | The VascuPuncture PICC Guidewire is indicated for<br>percutaneous entry of peripheral vessels using the Seldinger<br>Technique. VascuPuncture Guidewires are not indicated for use<br>in the coronary 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.<br>Biocompatibility is demonstrated through equivalence with<br>legally marketed predicate devices and the result of ICPMS and<br>prior biocompatibility testing. |
| Conclusion: | VascuPuncture™ PICC Guidewire with a tungsten or gold<br>plated tungsten is substantially equivalent to the<br>VascuPuncture™ PICC Guidewire. This conclusion is based<br>upon the fact that this device is substantially equivalent to the<br>predicate devices in terms of functional design, indications for<br>use, principles of operation and performance characteristics |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized design that resembles a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 - 2005

Mr. Gene Champeau President NeoMetrics, Inc. 14800 28th Ave. N., Suite 150 Plymouth, MN 55447

K043398 Re:

Trade/Device Name: VascuPuncture PICC Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: December 8, 2004 Received: December 10 ,2004

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.

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

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Page 2 – Mr. Gene Champeau

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,

R. Wachner

A 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

510(k) Number (if known):

K043398

Device Name:

VascuPuncture™ PICC Guidewire

Indications For Use:

The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique

Prescription Use __XXX__ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)

DURING P. Le Lane 1

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k643398

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