SELECTIVA SB GUIDEWIRE

K033321 · Neometrics, Inc. · DQX · Nov 5, 2003 · Cardiovascular

Device Facts

• Record ID: K033321
• Device Name: SELECTIVA SB GUIDEWIRE
• Applicant: Neometrics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Indications for Use

The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.

Device Story

Selectiva SB Guidewire is a medical device used to facilitate placement of other diagnostic or interventional devices within the vasculature. Constructed of nickel-titanium alloy with a PTFE polymer jacket; available in 0.035-inch diameter and lengths from 40 to 300 cm. Operated by clinicians during interventional procedures. Device provides a track for catheter advancement. Benefits include improved device navigation and placement during procedures. Not intended for PTCA use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nickel-titanium alloy core; PTFE polymer jacket. Diameter: 0.035 inches. Lengths: 40-300 cm. Mechanical guidewire.

Indications for Use

Indicated for facilitating placement of diagnostic and interventional devices. Not for PTCA use.

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

• NeoMetrics Selectiva™ Guidewire (K013024)
• FlexMedics FlexFinder Guidewire (K943390)

Submission Summary (Full Text)

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## NOV - 5 2003

## Section 9 510(k) Summary

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| Submitter: | NeoMetrics, Inc.<br>14800 28th Avenue South, Suite 150<br>Plymouth, MN 55447<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Mark Pederson<br>Product Development Engineer<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date<br>Prepared: | October 14, 2003 |
| Trade Name: | Selectiva SB Guidewire |
| Classification<br>Name and<br>Number: | Wire, Guide, Catheter<br>870.1330 |
| Product Code: | DQX |
| Predicate<br>Device(s): | NeoMetrics Selectiva™ Guidewire (K013024)<br>FlexMedics FlexFinder Guidewire (K943390) |
| Device<br>Description: | The Selectiva SB Guidewires are constructed of a nickel-titanium<br>alloy with a PTFE polymer jacket. Devices are available in a<br>diameter of 0.035 inches and in lengths ranging from 40 to 300 cm. |
| Intended Use: | The NeoMetrics Selectiva SB Guidewire is intended to facilitate<br>the placement of devices for diagnostic and interventional<br>procedures.<br>NOTE: These guidewires are not intended for PTCA use. |
| Functional and<br>Safety Testing: | Representative samples of the device underwent bench testing to<br>demonstrate appropriate functional and performance characteristics<br>compared to the predicate device(s). |
| Conclusion: | The NeoMetrics Selectiva SB 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 of the modified device<br>compared to the originally, cleared device.<br><br> |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV = 5 2003

NeoMetrics, Inc. c/o Mr. Mark Pederson Product Development Engineer 14800 28th Avenue South, Suite 150 Plymouth, MN 55447

Re: K033321 Selectiva SB Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: October 14, 2003 Received: October 21, 2003

Dear Mr. Pederson:

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. Mark Pederson

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 vours.

Elsie D. Harvey Jr

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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## Section 3 Indications for Use

The NeoMetrics Selectiva SB Guidewire is intended to facilitate the placement of devices for diagnostic and interventional procedures.

NOTE: These guidewires are not intended for PTCA use.

Prescription Use
(Per 21 CFR 801.109)

Elyn Ots
Bran Zadema
11/4/03

Division of Cardiovascular & Respiratory Devices
510(k) Number K033321

Shaugh BD