LOCKING STYLET 2

K970690 · Cook Pacemaker Corp. · DQX · May 20, 1997 · Cardiovascular

Device Facts

• Record ID: K970690
• Device Name: LOCKING STYLET 2
• Applicant: Cook Pacemaker Corp.
• Product Code: DQX · Cardiovascular
• Decision Date: May 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.

Device Story

Locking Stylet 2 is a manual surgical instrument used for percutaneous removal of cardiac leads, indwelling catheters, and foreign objects with a central lumen. The device is inserted into the lumen of the object to be retrieved; it functions by locking onto the object to facilitate extraction. Used in clinical settings by physicians. The device is supplied sterile for single-use. It benefits patients by providing a minimally invasive method for removing indwelling medical devices.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarity to the predicate device.

Technological Characteristics

Manual surgical instrument; single-use; sterile. Materials have established history of use in medical product manufacturing. No electronic components, software, or energy sources.

Indications for Use

Indicated for percutaneous removal of cardiac leads, indwelling catheters, and other foreign objects with a central lumen in patients requiring such removal.

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

• Locking Wire Guide Stylet

Submission Summary (Full Text)

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510(k) Premarket Notification
Locking Stylet 2
MAY 20 1997
K970690

# I. 510(K) SUMMARY

## Submitted By:

Neal E. Fearnot, Ph.D., E.E.
President
MED Institute, Incorporated
P.O. Box 2402
West Lafayette, IN 47906
[phone]
February 24, 1997

## Device:

Trade Name: Locking Stylet 2
Common/Usual Name: Stylet, Wire Guide Stylet, Catheter Retrieval Device
Proposed Classification Name: Predicate devices of this type with similar intended uses have been classified into Class I or Class II.

## Predicate Devices:

The Locking Stylet 2 is similar to the predicate Locking Wire Guide Stylet that is currently marketed with respect to intended use, material composition, and method of operation.

## Device Description:

The Locking Stylet 2 is used during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Locking Stylet 2 is provided by their established history of use in medical product manufacturing by COOK Vascular™ Incorporated.

## Substantial Equivalence:

The Locking Stylet 2 will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently marketed and distributed by COOK Vascular™ Incorporated. This device is similar with respect to indications for use, materials, and physical construction to predicate devices in terms of section 510(k) substantial equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 20 1997

Neal E. Fearnot, Ph.D.
President
MED Institute, Inc.
A Cook Group Company
1400 Cumberland Avenue
West Lafayette, Indiana 47906

Re: K970690
Locking Stylet 2
Regulatory Class: II (two)
Product Code: DQX
Dated: February 24, 1997
Received: February 25, 1997

Dear Dr. Fearnot:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in

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regulatory action. In addition, FDA may publish further announcements concerning your device in the *Federal Register*. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K97####

Device Name: Locking Stylet 2

Indications For Use:

The Locking Stylet 2 is intended for use during the percutaneous removal of cardiac leads, indwelling catheters and other foreign objects having a central lumen.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K970690

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)