SELECTIVA GUIDEWIRE

K013024 · Neometrics, Inc. · DQX · Dec 4, 2001 · Cardiovascular

Device Facts

• Record ID: K013024
• Device Name: SELECTIVA GUIDEWIRE
• Applicant: Neometrics, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 4, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The NeoMetrics Selectiva™ 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™ Guidewire is a catheter guidewire used to facilitate placement of diagnostic and interventional devices. Device consists of a PES-coated Nitinol or stainless steel shaft with a tapered distal end secured to a platinum or stainless steel helical coil. Silicone fluid coating provides lubricity. Available in diameters 0.018"-0.035" and lengths 60 cm-260 cm. Used by clinicians in diagnostic or interventional settings. Device provides mechanical guidance for catheter placement; does not involve electronic processing or software.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence demonstrated through functional and safety testing (dimensional, visual, tip flexibility, tensile strength, torqueability, coating durability) and biocompatibility testing.

Technological Characteristics

Shaft: PES-coated Nitinol or stainless steel. Distal tip: platinum or stainless steel helical coil. Coating: silicone fluid. Diameters: 0.018"-0.035". Lengths: 60 cm-260 cm. Sterile, single-use. Mechanical device; no software or energy source.

Indications for Use

Indicated for facilitating the placement of devices during diagnostic and interventional procedures. Not indicated 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

• Lake Region Manufacturing Mandrel Guidewire Assembly (K011084)

Submission Summary (Full Text)

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# Section 8 Summary of Safety and Effectiveness

K013024

## Submitter

NeoMetrics, Inc. 15301 Highway 55 West DEC 0 4 2001 Plymouth, MN 55447 Telephone: [phone] Fax: [phone] Contact Person: Gene Champeau, President Date: August 31, 2001

#### Product

Classification Name: Common Name: Trade/Proprietary Name:

Catheter Guidewire (21 CFR 870.1330) Guidewire, catheter guidewire, and wire guide Selectiva™ Guidewire

### Substantially Equivalent Product

Lake Region Manufacturing Mandrel Guidewire Assembly (K011084).

#### Description

The Selective™ Guidewire is used to facilitate the placement of devices for diagnostic and interventional procedures. The shaft of the device is constructed of PES (polyethersulfone) coated Nitinol or stainless steel with a tapered distal end secured to a platinum or stainless steel helical coil. A selection of distal tapers imparts different tip flexibilities. The guidewire is coated with silicone fluid to improve lubricity. The Selectiva™ Guidewire will be offered in diameters of 0.018" - 0.035" and lengths of 60 cm - 260 cm. It will be supplied sterile, intended for one-time use.

### Indications for Use

To facilitate the placement of devices for diagnostic and interventional procedures. NOTE: These guidewires are not intended for PTCA use.

#### Physical Characteristics

The Selectiva™ Guidewire and the predicate device were compared in all functional and safety tests including dimensional, visual, tip flexibility, tensile strength, torqueability, and coating durability, to demonstrate equivalency in terms of safety and effectiveness. Biocompatibility testing of finished devices has been successfully completed in addition to the independent laboratory testing demonstrating equivalence of materials.

# Conclusion

Based on performance data and comparisons of intended use, labeling, and design, the Selectiva™ Guidewire is considered substantially equivalent to the currently marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gene Champeau President NeoMetrics, Inc. 15301 Highway 55 West Plymouth, MN 55447

DEC 0 4 2001

Re: K013024 Seletiva™ Guidewire Regulation Number: 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: September 6, 2001 Received: September 7, 2001

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 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.

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Page 2 - Mr. Gene Champeau

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ough maing of substantial equivalence of your device to a legally prematication. The PDF intently sification 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 and If you desire specific acriso as for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Furt 007.10 Additionally, for questions on the promotion and advertising of Compliance it [phone]. The of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general information 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,

Vatty Hill

Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 3
Indications for Use ~ K013074

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

for thaghostic and interves are not intended for PTCA use.

Division of Cardiovascular & Respiratory Devices
510(k) Number K013624

Prescription Use
(Per 21 CFR 801.109)