DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE

K013513 · Pain Concepts, Inc. · HRX · Jan 17, 2002 · Orthopedic

Device Facts

• Record ID: K013513
• Device Name: DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
• Applicant: Pain Concepts, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pain Concepts' Dekompressor™ Percutaneous Lumbar Discectomy Probe is intended for use for the aspiration of disc material during percutaneous lumbar discectomies.

Device Story

Dekompressor™ Percutaneous Lumbar Discectomy Probe is a surgical instrument used for the aspiration of disc material. Operated by a physician during percutaneous lumbar discectomy procedures in a clinical or surgical setting. The device functions by mechanically removing herniated or diseased disc tissue to relieve pressure on spinal nerves. It serves as an accessory to arthroscopic or percutaneous spinal surgery equipment. By enabling minimally invasive tissue removal, the device aims to reduce patient recovery time and alleviate symptoms associated with lumbar disc herniation.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Percutaneous lumbar discectomy probe; mechanical aspiration instrument; classified as an arthroscope accessory (21 CFR 888.1100).

Indications for Use

Indicated for the aspiration of disc material during percutaneous lumbar discectomies in patients requiring such procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 7 2002

Russell Pflueger President and CEO Pain Concepts, Inc. 8001 Irvine Center Drive, 4th Floor Irvine, California 92618

Re: K013513

Trade Name: Dekompressorтм Percutaneous Lumbar Discectomy Probe Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: October 19, 2001 Received: October 22, 2001

Dear Mr. Pflueger:

We have reviewed your Section 510(k) premarket 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 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.

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.

{1}------------------------------------------------

Page 2 & Mr. Russell Pflueger

This letter will allow you to begin marketing your device as described in your Section 510(k) rms lot 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,

Sincerely yours,

Mark N. McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## STATEMENT OF INTENDED USE

Page of of of ________________________________________________________________________________________________________________________________________________________________

Kol3513 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Dekompressor™ Percutaneous Lumbar Discectomy Probe

Indications for Use: The Pain Concepts' Dekompressor™ Percutaneous Lumbar Discectomy Probe is intended for use for the aspiration of disc material during percutaneous lumbar discectomies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR

Over-The-Counter Use ... ... ..

(Per 21 CFR 801.109)

fo Mark N. Millikinn

Division Sign-Off) Division of General, Restorative and Neurological Devices

53 510(k) Nr. -- Lor