TE ME NA POLYSTIM NERVE STIMILATOR

K990323 · Te ME NA S.A.R.L. · BXN · Sep 28, 2001 · Anesthesiology

Device Facts

• Record ID: K990323
• Device Name: TE ME NA POLYSTIM NERVE STIMILATOR
• Applicant: Te ME NA S.A.R.L.
• Product Code: BXN · Anesthesiology
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FOR NEAVE STIMULATION AND TOENTIFICATION FOR 26616 WAL ANESTHESIA

Device Story

Polystim Nerve Stimulator is an electrical peripheral nerve stimulator used by clinicians to identify nerves during regional anesthesia procedures. The device delivers electrical impulses to stimulate nerves, assisting the practitioner in locating nerve targets. It is intended for prescription use in clinical settings.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electrical peripheral nerve stimulator; Class II device; Product Code BXN; 21 CFR 868.2775.

Indications for Use

Indicated for nerve stimulation and identification during regional anesthesia.

Regulatory Classification

Identification

An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.

Submission Summary (Full Text)

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SEP 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TE ME NA S.A.R.L. c/o Mr. Arthur J. Ward RMS Regulatory & Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572

Re: K990323

Trade Name: Polystim Nerve Stimulator Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II (two) Product Code: BXN Dated: July 11, 2001 Received: July 12, 2001

Dear Mr. Ward:

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.

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## Page 2 - Mr. Arthur J. Ward

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.

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,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Ports Tim NELVE stimulator

Indications For Use:

FOR NEAVE STIMULATION AND TOENTIFICATION FOR 26616 WAL ANESTHESIA

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dah Tuh

Division of Cardiovascular & Respiratory Devices
510(k) Number K990323

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)
*EXHIBIT 1* 276