DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR

K020400 · Meps, LLC · GWF · Aug 23, 2002 · Neurology

Device Facts

• Record ID: K020400
• Device Name: DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR
• Applicant: Meps, LLC
• Product Code: GWF · Neurology
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Digitimer D185 is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

Device Story

Digitimer D185 is an evoked response electrical stimulator used intraoperatively. Device delivers electrical pulses to stimulate neural pathways; monitors corticospinal axonal conduction to detect acute dysfunction resulting from mechanical trauma or vascular insufficiency. Operated by clinical staff in surgical settings. Output allows surgeons to assess neural integrity during procedures, facilitating real-time clinical decision-making to prevent or mitigate permanent neurological damage.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device classification and intended use.

Technological Characteristics

Evoked response electrical stimulator; delivers electrical pulses for neural stimulation. Class II device. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for intraoperative diagnosis of acute corticospinal axonal conduction dysfunction caused by mechanical trauma or vascular insufficiency in patients undergoing surgery.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**AUG 23 2002**

MEPS. LLC. Harry J. Benedict One East Broward Boulevard, #700 Fort Lauderdale, Florida 33301

Re: K020400

Trade Name: Digitimer D185 Multipulse Cortical Stimulator Regulation Number: 882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: II Product Code: GWF Dated: August 2, 2002 Received: August 19, 2002

Dear Mr. Benedict:

We have reviewed your Section 510(k) premarket 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) 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. Harry J. Benedict

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely, yours,

Mark A. Milliken

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

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## Indications for Use

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510(k) Number: K020400

Device Name: DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR

Indications for use:

The Digitimer D185 is used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Milliken

ivision of General, Restorative and Neurological Devices 020400

510(k) Number _