EPIDURAL NEEDLE

K980536 · Manan Medical Products, Inc. · BSP · Jul 31, 1998 · Anesthesiology

Device Facts

• Record ID: K980536
• Device Name: EPIDURAL NEEDLE
• Applicant: Manan Medical Products, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Jul 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.

Device Story

Epidural needle (Touhy, Hustead, Crawford, Weiss styles) used by clinicians for regional anesthesia administration. Device facilitates placement of anesthetic agents into epidural space, either directly or via catheter. Used in clinical settings for pain management or surgical anesthesia. Provides access for anesthetic delivery; assists in achieving regional nerve block.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual epidural needle available in Touhy, Hustead, Crawford, and Weiss configurations. Sterile, single-use device.

Indications for Use

Indicated for patients requiring regional anesthesia via epidural placement of anesthetic agents, either directly or through a catheter.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 1998

Mr. Michael Plishka Manan Medical Products, Inc. 2200 Carlson Drive Northbrook, IL 60062

Re: K980536 Epidural Needle Requlatory Class: II (two) Product Code: 73 BSP May 14, 1998 Dated: Received: May 15, 1998

Dear Mr. Plishka:

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 requlations 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 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.

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## Page 2 - Mr. Michael Plishka

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,

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K980536 510(K) Number (if known):

Device Name:

Epidural Needle (Touhy, Hustead, Crawford, Weiss) -

Indications For Use:

For the epidural placement, directly or through a catheter, of anesthetic agents to elicit regional anesthesia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) OR

(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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