TE ME NA EPIDURAL CATHETER

K991259 · Te ME NA S.A.R.L. · BSO · Feb 21, 2001 · Anesthesiology

Device Facts

• Record ID: K991259
• Device Name: TE ME NA EPIDURAL CATHETER
• Applicant: Te ME NA S.A.R.L.
• Product Code: BSO · Anesthesiology
• Decision Date: Feb 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of local anesthetics for regional anesthesia, including Epidural and Caudal anesthesia for up to 72 hours.

Device Story

The Polymedic Epidural Anesthesia Catheter is a medical device used for the delivery of local anesthetics to the epidural or caudal space. It is intended for use by healthcare professionals in clinical settings to provide regional anesthesia for up to 72 hours. The device facilitates the administration of medication to manage pain or provide anesthesia during or after surgical procedures. By providing a controlled pathway for anesthetic delivery, it assists clinicians in maintaining patient comfort and anesthesia levels. The device is a single-use, sterile catheter designed for short-term indwelling application.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is an epidural catheter designed for the administration of local anesthetics. It is a sterile, single-use device intended for short-term (up to 72 hours) indwelling use in the epidural or caudal space.

Indications for Use

Indicated for administration of local anesthetics for regional anesthesia, including Epidural and Caudal anesthesia, for patients requiring anesthesia for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2001

Mr. Joe Harms Te Me Na S.A.R.L. c/o Avid-Nit, Inc. 390 Scarlet Boulevard Oldsmar, FL 34677

Re:

K991259 Model C20900-03 Polymedic Epidural Catheter Regulatory Class: II (two) Product Code: 73 BSO Dated: November 22, 2000 Received: November 27, 2000

Dear Mr. Harms:

We have reviewed your Section 510(k) 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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish

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## Page 2 - Mr. Joe Harms

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act 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"(21 CFR 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,

Hypt Rhodes

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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): K991259

Te me na SARL Polymedic Epidural Anesthesia Catheter Device Name:

## Indications For Use:

The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of Iocal The Te me na Polymedic Epidural Anesuesia Catinece 15 michied of Caudal anesthesia for up to 72 hours.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyatt Claude
(Division Sign-Off)

Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) Number k991259

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)