COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE

K992721 · Radionics, Inc. · HAW · Sep 10, 1999 · Neurology

Device Facts

• Record ID: K992721
• Device Name: COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE
• Applicant: Radionics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

For the precise depth control of probes during stereotactic neurosurgical procedures.

Device Story

The Cosman Robert Wells Functional Probe Microdrive (CRW-FMD) is a stereotaxic instrument used in neurosurgical procedures. It mounts to a stereotaxic frame to provide precise depth control for probes advanced along the z-axis of a stereotactic trajectory. The device is manually operated by a surgeon. System components include a guide block base, stanchion probe holder, drive stanchion, drive box, digital display, and cable. The digital display provides feedback to the clinician regarding probe depth, facilitating accurate positioning during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stereotaxic instrument; manually operated mechanical drive system. Components: guide block base, stanchion probe holder, drive stanchion, drive box, digital display, and cable. Connectivity: wired (cable).

Indications for Use

Indicated for precise depth control of probes during stereotactic neurosurgical procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Microdrive for Probes (accessory for the Todd Wells Stereotaxic Guide)

Submission Summary (Full Text)

{0}------------------------------------------------

## 7.0 510(k) Summary:

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Tel .: [phone] Fax: [phone]

This summary was prepared on August 12, 1999.

- 2.0 The name of the device is the Cosman Robert Wells Functional Probe Microdrive (CRW-FMD). The common name is microdrive for stereotaxic frame, and it is classified as a stereotaxic instrument.
- 3.0 The CRW-FMD is substantially equivalent to the Microdrive for Probes, an accessory for the Todd Wells Stereotaxic Guide that was commercially available prior to May 28, 1976.
- 4.0 The CRW-FMD is designed for the precise depth control of probes during stereotactic neurosurgical procedures. The CRW-FMD is mounted to a stereotaxic frame, and manually operated to advance a probe along the z-axis of a stereotactic trajectory. The main components of the system are: guide block base, stanchion probe holder, drive stanchion, drive box, digital display, and cable
- 5.0 The CRW-FMD like its predicate is intended for the precise depth control of probes during stereotactic neurosurgical procedures.
- 6.0 The technological characteristics are the same or similar to those found with the predicate device.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1999

Mr. Kevin J. O'Connell Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803

Re: K992721 Trade Name: Cosman Robert Wells Functional Probe Microdrive Regulatory Class: II Product Code: HAW Dated: August 12, 1999 Received: August 13, 1999

Dear Mr. O'Connell:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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.

{2}------------------------------------------------

## Page 2 - Mr. Kevin J. O'Connell

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 vour 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[signature]

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K9924d 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Cosman Robert Wells Functional Probe Microdrive

Indications for use: For the precise depth control of probes during stereotactic neurosurgical procedures.

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

t cotlefo

(Division Sign-Off)
Division of General Restorative Devices K99272/
510(k) Number

PRESCRIPTION USE _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use

(Per 21 CFR 801.109

(Optional Format 1-2-96)