TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR

K042350 · Cadwell Laboratories, Inc. · GWF · Nov 3, 2004 · Neurology

Device Facts

• Record ID: K042350
• Device Name: TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
• Applicant: Cadwell Laboratories, Inc.
• Product Code: GWF · Neurology
• Decision Date: Nov 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Cadwell TES-1 constant voltage electrical stimulator is intended for cortical stimulation. The TES-1 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. The Cadwell TES-1 Constant Voltage Stimulator is an accessory to the Cadwell Cascade Intra-operative monitoring system only. It is not a stand-alone device nor is it compatible with other systems.

Device Story

TES-1 Constant Voltage Electrical Stimulator; accessory to Cadwell Cascade Intra-operative monitoring system. Provides electrical stimulation for cortical stimulation; enables intraoperative diagnosis of acute corticospinal axonal conduction dysfunction due to mechanical trauma or vascular insufficiency. Operated by clinicians in intraoperative settings. Device functions as a component of the Cascade system; not for stand-alone use. Output facilitates real-time monitoring of neural pathways during surgery; aids clinical decision-making regarding surgical intervention or patient status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constant voltage electrical stimulator; accessory to Cadwell Cascade system. Class II device (21 CFR 882.1870). Product code GWF. Not a stand-alone device; requires integration with Cascade system for operation.

Indications for Use

Indicated for intraoperative diagnosis of acute corticospinal axonal conduction dysfunction caused by mechanical trauma or vascular insufficiency. Used as an accessory to the Cadwell Cascade Intra-operative monitoring system.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 3 2004

Mr. Chris L. Bolkan Regulatory Specialist Cadwell Laboratories 909 N. Kellogg Street Kennewick, Washington 99336

Re: K042350

Trade/Device Name: TES-1 Constant Voltage Electrical Stimulator Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: October 22, 2004 Received: October 25, 2004

Dear Mr. Bolkan:

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.

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

Page 2 - Mr. Chris L. Bolkan

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.

Miriam C. Provost.

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

Enclosure

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

## Indications for Use

510(k) Number (if known): K042350

Device Name: TES-1 Constant Voltage Electrical Stimulator

Indications for Use: The Cadwell TES-1 constant voltage electrical stimulator is intended for cortical stimulation. The TES-1 is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

> The Cadwell TES-1 Constant Voltage Stimulator is an accessory to the Cadwell Cascade Intra-operative monitoring system only. It is not a stand-alone device nor is it compatible with other systems.

Prescription Use X (Part 21 CFR 801 Subpart D)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

mindering n. hands and announcement in and result and and a view , 1994 , 1994 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 1991 , 19

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

> Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

رام

510(k) Number_________________________________________________________________________________________________________________________________________________________________