POLYPLEX STIMULATING CATHETER SYSTEM

K060186 · Te ME NA Sas · CAZ · Jul 18, 2006 · Anesthesiology

Device Facts

• Record ID: K060186
• Device Name: POLYPLEX STIMULATING CATHETER SYSTEM
• Applicant: Te ME NA Sas
• Product Code: CAZ · Anesthesiology
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Device Story

Polyplex Stimulating Catheter System is an electrically conductive anesthesia conduction catheter. Used by clinicians to locate specific nerves or nerve plexuses via peripheral nerve stimulation. Facilitates continuous nerve block anesthesia or analgesia. Supplied as a sterile kit including accessories for procedure performance and catheter fixation. Used in clinical settings for short-term pain management (up to 72 hours).

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison.

Technological Characteristics

Electrically conductive anesthesia conduction catheter. Kit includes catheter and fixation accessories. Sterile. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring continuous nerve block anesthesia or analgesia via catheter placement near nerves or nerve plexuses for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• Te me na Polymedic Epidural Anesthesia Catheter (K991259)
• Arrow International StimuCath Continuous Nerve Block Set (K021567)

Submission Summary (Full Text)

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# 510(K) SUMMARY - #K060186 (as required by 807.92(c))

JUL 1 8 2006

| Submitter of 510(k): | TE ME NA SAS<br>16, Rue Des Entrepreneurs<br>Carriere Sur Seine, FRANCE 78420 |
|-------------------------|-------------------------------------------------------------------------------|
| | Phone: [phone] |
| Contact Person: | Wilhelm Waskonig |
| Date of Summary: | January 3, 2006 |
| Trade/Proprietary Name: | Polyplex Stimulating Catheter System |
| Classification Name: | Catheter, Conduction, Anesthetic |
| Product Code: | BSO, CAZ |

#### Device Description:

The Polyplex Stimulating Catheter System is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia.

The Polyplex Stimulating Catheter System is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.

### Predicate Device:

Te me na – Polymedic Epidural Anesthesia Catheter K991259 Arrow International - StimuCath Continuous Nerve Block Set K021567

#### Substantial Equivalence:

Te me na claims the proposed device system to be substantially equivalent to the devices previously cleared by FDA in K991259 and K021567. The modifications to the previously have been described in Section 5 of this submission. Te me na claims this equivylence he cause the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational and biological specification as compared to the predicate devices.

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The similarities and differences between the proposed and predicate devices have been identified and explained in the Comparison Matrix which has been included in Section 9 of this submission. These differences have no effect on safety and effectiveness.

## Intended Use:

The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, represented by curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2006

Te Me Na Sas C/O Mr. Arthur Ward RMS Regulatory & Marketing Services, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K060186

Trade/Device Name: Polyplex Stimulating Catheter System Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: July 10, 2006 Received: July 13, 2006

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. 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). 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

#### 510(k) Number (if known): K060186

Device Name: POLYPLEX Stimulating Catheter System

Indications for Use:

The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Aury Solomon

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on of Anesthesiology, General Hospital, tion Control, Dental Devices