DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE

K032473 · Stryker Instruments · HRX · Nov 7, 2003 · Orthopedic

Device Facts

• Record ID: K032473
• Device Name: DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE
• Applicant: Stryker Instruments
• Product Code: HRX · Orthopedic
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dekompressor™ Percutaneous Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.

Device Story

Single-use disposable probe; used with introducer cannula for percutaneous discectomy. Removes intervertebral disc nucleus pulposus via aspiration. Operated by physicians in clinical settings. Provides mechanical removal of disc material to decompress spine.

Technological Characteristics

Single-use disposable percutaneous discectomy probe; functions via aspiration; used in conjunction with an introducer cannula.

Indications for Use

Indicated for aspiration of disc material during percutaneous discectomies in lumbar, thoracic, and cervical spine regions.

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.

Predicate Devices

• Stryker Dekompressor™ Lumbar Discectomy Probe (K013513)
• Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator (K844131, K902778, K914282, K913145, K923525, K931109, K942987)
• Arthrocare Perc-D™ Spinewand™ family (K010811)

Submission Summary (Full Text)

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K032473 (\$\rho_j\$ 1-fi)

NOV - 7 2003

## stryker

510(k) Summary

4100 East Milham Avenue
Kalamazoo, MI 49001
Phone [phone]
[phone]

| Trade Name: | Stryker Dekompressor™ Percutaneous Discectomy Probe |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Percutaneous Discectomy Probe |
| Classification Name: | Arthroscope and Accessories, 21 CFR 888.1100 (a) |
| Equivalent to: | Stryker Dekompressor™ Lumbar Discectomy Probe (K013513),<br>Surgical Dynamics' Nucleotome Tissue Cutter/Aspirator<br>(K844131, K902778, K914282, K913145, K923525, K931109,<br>K942987), Arthrocare Perc-D™ Spinewand™ family (K010811) |
| Device Description: | The Dekompressor™ is a single use disposable discectomy probe<br>that passes through and works in conjunction with an introducer<br>cannula to remove intervertebral disc nucleus pulposus. |
| Intended Use: | The Dekompressor™ Percutaneous Discectomy Probe is intended<br>for use in aspiration of disc material during percutaneous<br>discectomies in the lumbar, thoracic and cervical regions of the<br>spine. |
| Technological<br>Comparison: | The Stryker Dekompressor™ Percutaneous Discectomy Probe<br>has the same technology as the Stryker Dekompressor™ Lumbar<br>Discectomy Probe. |
| Submitted by: | Dannielle C. Wheeler<br>Regulatory Affairs Representative<br>Stryker Instruments |
| | <br>Signature Date |
| Date Submitted: | August 11, 2003 |

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2003

Ms. Robin L. Rowe Regulatory Affairs Associate Manager Stryker Instruments 4100t Milham Avenue Kalamazoo, Michigan 49001

Re: K032473

Trade/Device Name: Stryker Dekompressor™ Percutaneous Discectomy Probe Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: August 7, 2003 Received: August 12, 2003

Dear Ms. Rowe:

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.

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.

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Page 2 - Ms. Robin L. Rowe

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 vour 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/dsma/dsmamain.html

Sincerely vours.

Mark N. Millikin

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

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K032473

510(k) Number:

Device Name:

Stryker Dekompressor™ Percutaneous Discectomy Probe

Indications For Use:

The Dekompressor™ Percutaneous Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The- Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N Milkerson
(Division Sign-off)

Division of General, Restorative and Neurological Devices

510(k) Number KD 32473