POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE

K990100 · Te ME NA S.A.R.L. · GXZ · Aug 2, 2000 · Neurology

Device Facts

• Record ID: K990100
• Device Name: POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
• Applicant: Te ME NA S.A.R.L.
• Product Code: GXZ · Neurology
• Decision Date: Aug 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves when used with a nerve stimulator) and administration of anesthesia drugs.

Device Story

Polymedic UPA, UPC, Polyplex N, and Polyplex C are nerve stimulation needles used in regional anesthesia. Needles facilitate peripheral nerve location when connected to external nerve stimulator; allow administration of anesthetic agents. Used in clinical settings by anesthesiologists or trained professionals. Device assists in precise needle placement relative to nerves, potentially improving anesthesia delivery accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nerve stimulation needles for regional anesthesia. Mechanical device; no software or electronic components. Materials and specifications not detailed in provided text.

Indications for Use

Indicated for use in regional anesthesia procedures by anesthesiologists or trained professionals for peripheral nerve location and administration of anesthesia drugs.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2000

Te Me Na Sarl C/O Arthur Ward Regulatory and Marketing Services, Inc. 3234 Ella Lane New Pork Rickey, Fl 34655

K990100 Re: K990100
Polymedic UPA, UPC, Polyplex N, and Polyplex C Nerve Stimulation Needles Regulatory Class: II (two) Product Code: 84 GXZ, 73 CAZ Dated: May 18, 2000 Received: June 16, 2000

Dear Mr. Ward:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your beceion on (i) and determined the device is the device ferenced above and indications for use stated in the substantially equivalence (102 cordicate devices marketed in enclosure) to regally marked production the enactment date of the Incelstate Commerce pros, or to devices that have been reclassified Medical Device Amendales, of over of the Federal Food, Drug, and In accordance with the provinsy, therefore, market the device, subject to the general controls provisions of the Act. The general controls the general controls provibions of the annual registration, provisions of the not manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device 15 claboried (boo aboroval), it may be subject to such Controls, or class III (Freinan major regulations affecting your device auditional concertir. Eniosing and Regulations, Title 21, Parts 800 and in the ocus equivalent determination assumes compliance to 895. co oss. It babbeanound in ufacturing Practice requirements, as set with the Ourchio Sty System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS General regulation (2) on Drug Administration (FDA) will verify such Inspections, the rood and bray with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this eonecriing your actification submission does not affect any response to your premained inder sections 531 through 542 of the Act

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Page 2 - Mr. Ward

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,
for Mark N. Millikan

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

Enclosure

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510(k) Number (if known): K990100

Polymedic Nerve Stimulator Needle Device Name:

Indications For Use:

The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves when used with a nerve stimulator) and administration of anesthesia drugs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Mulken

f Cardiovascular & Respiratory

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)