TIGER DISCECTOMY DEVICE

K081240 · Spinal Devices, LLC · HRX · Feb 27, 2009 · Orthopedic

Device Facts

• Record ID: K081240
• Device Name: TIGER DISCECTOMY DEVICE
• Applicant: Spinal Devices, LLC
• Product Code: HRX · Orthopedic
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.

Device Story

Tiger Discectomy Device is a single-use manual instrument for spinal surgery. Components include a T-handle, shaft, two cutting blades (8mm, 10mm, 12mm), blade holder, retaining pins, and a blunt tip. A cannula is provided for endoscopic applications. Operated by a surgeon in an OR setting to assist in the mechanical removal of fibrous disc material. Device is provided sterile. Benefits include facilitating disc material removal during spinal procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, single-use surgical instrument. Components: T-handle, shaft, cutting blades, blade holder, retaining pins, blunt tip. Available in 8mm, 10mm, and 12mm blade widths. Includes cannula for endoscopic use. Provided sterile.

Indications for Use

Indicated for patients undergoing endoscopic or non-endoscopic spinal procedures requiring removal of fibrous disc material between T12 and S1 spinal segments.

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

• Disk Whisk Cutting Device (K971342)
• Trans1 Trans-sacral Spinal Access and Preparation Device (K032891)

Submission Summary (Full Text)

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Kori2iyo

# 510(k) Summary according to 807.92(c)

| Contact: | Tim Lusby<br>Amendia, LLC<br>1155 Allgood Road, Suite 6<br>Marietta, GA 30062<br>770-874-0935 | FEB 27 2009 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name: | Tiger Discectomy ® Device | |
| Product Class: | Class II | |
| Classification: | 888.4540 | |
| Product Codes: | HTT | |
| Panel Code: | 87 | |
| Indications for Use: | The Tiger Discectomy Device is indicated for use in endoscopic<br>and non-endoscopic spinal procedures to assist in the removal of<br>fibrous disc material between the T12 to S1 spinal segments. | |
| Device Description: | The Tiger Discectomy Device is a single-use manual instrument.<br>The components of the device include a "T" handle, a shaft, two<br>cutting blades and blade holder, retaining pins and a blunt tip.<br>Cutting blades are available in 8mm, 10mm and 12mm widths. A<br>cannula is provided for endoscopic applications. The device is<br>provided sterile. | |
| Predicate Device(s): | The predicate device previously cleared by FDA is the<br>Disk Whisk Cutting Device (K971342) and the Trans1<br>Trans-sacral Spinal Access and Preparation Device<br>(K032891). | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 2 7 2009

Spinal Devices, LLC % Silver Pine Consulting Mr. Richard Jansen 13540 Guild Avenue Apple Valley, Minnesota 55124

Re: K081240

Trade/Device Name: Tiger Discectomy Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope . Regulatory Class: II Product Code: HRX Dated: January 9, 2009 Received: January 12, 2009

Dear Mr. Jansen:

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 (OS) 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 - Mr. Richard Jansen

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Daniel Kione

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

510(k) Number K081240

Indications for Use:

The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.

Prescription Use ﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Neil RP Ryder formxm

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

K081240 510(k) Number_

Concurrence of CDRH, Office of Device Evaluation (ODE)