ENSPIRE DEBRIDER SYSTEM

K090278 · Spine View, Inc. · HRX · Apr 15, 2009 · Orthopedic

Device Facts

• Record ID: K090278
• Device Name: ENSPIRE DEBRIDER SYSTEM
• Applicant: Spine View, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

Device Story

The ENSPIRE™ Debrider is a single-use mechanical discectomy device. It utilizes an internal auger mechanism to cut and grind intervertebral disc material; the auger simultaneously retrieves the excised debris and ejects it into an integrated collection chamber. The device is intended for use by surgeons during discectomy procedures in the cervical, thoracic, and lumbar spine. By facilitating the removal of diseased disc material, the device assists in the surgical treatment of spinal conditions. It is operated manually by the surgeon during the procedure.

Clinical Evidence

No clinical trials were conducted. Evidence consists of biocompatibility testing per ISO 10993, bench testing to verify compliance with performance standards and labeling requirements, and cadaver testing to demonstrate functional use in human anatomy.

Technological Characteristics

Single-use mechanical discectomy device featuring an auger mechanism for cutting, grinding, and aspiration. Materials comply with ISO 10993 biocompatibility standards. The device is a manual surgical instrument; no energy source, software, or connectivity is described.

Indications for Use

Indicated for patients undergoing discectomy procedures in the cervical, thoracic, and lumbar spine requiring the cutting, grinding, and aspiration of intervertebral disc material.

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 Percutaneous Discectomy Probe (K032473)
• SpineVu Endoscopic Spine System (SESS) (K081051)

Submission Summary (Full Text)

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# K090278

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SpineView, Inc.

### APR 1 5 2009 ENSPIRE™ Debrider System Traditional 510(k) Premarket Notification

# Section 5: 510(k) Summary

2

## Device Information:

| Category | Comments |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Spine View, Inc.<br>48541-Warm Springs Blvd., Suite 507<br>Fremont, CA 94539 |
| Correspondent Contact<br>Information: | Sandra Sundell<br>Director, Regulatory Affairs<br>SpineView, Inc.<br>48541 Warm Springs Blvd., Suite 507<br>Fremont, CA 94539<br>Tel: [phone]<br>Fax: [phone]<br>Email:[e-mail] |
| Device Common Name: | Arthroscope and Accessories |
| Device Classification &<br>Code: | Arthroscope: Class II, HRX<br>Arthroscope Accessories: Class I, NBH |
| Device Classification<br>Name: | 21 CFR § 888.1100 Arthroscope and<br>Accessories |
| Device Proprietary Name: | ENSPIRE™ Debrider System |

## Predicate Device Information:

| Predicate Devices: | Stryker Dekompressor<br>Percutaneous Discectomy<br>Probe | SpineVu Endoscopic Spine<br>System (SESS) |
|--------------------------------------------|-------------------------------------------------------------------|---------------------------------------------|
| Predicate Device<br>Manufacturers: | Stryker Instruments | SpineView, Inc. |
| K#s | K032473 | K081051 |
| Predicate Device Common<br>Name: | Percutaneous Discectomy<br>Probe Arthroscopic<br>Intervention Kit | Arthroscopic Intervention Kit |
| Predicate Device<br>Classification: | 21CFR888.1100:<br>Arthroscope & Accessories | 21CFR888.1100: Arthroscope<br>& Accessories |
| Predicate Device<br>Classification & Code: | Class II, HRX | Class II, HRX |

#### b. Date Summary Prepared

February 3, 2009

#### Description of Device C.

The SpineView ENSPIRE™ Debrider is a single-use discectomy device that is designed to cut and grind intervertebral disc material. Its auger mechaeo mechaeo um retrieves the excised debris and ejects it into a collection chamber.

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SpineView, Inc.

#### d. Intended Use

The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

#### e. Comparison to Predicate Device

The SpineView ENSPIRE™ Debrider is substantially equivalent in intended use and technology to the currently marketed predicate devices the Debrider component of the SpineVu Endoscopic Spine System (K081051) and the Stryker Dekompressor Percutaneous Discectomy Probe (K032473). Both the Application device and the predicate devices provide a means to aspirate and grind disc material during discectomies in the lumbar, thoracic and cervical regions of the spine. The SpineView ENSPIRE™ Debrider and the predicate devices are all intended to be used to cut and remove diseased disc material in the same anatomical location.

#### f. Summary of Supporting Data

Biocompatibility testing demonstrates that the device is in compliance with ISO 10993.

Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling.

Cadaver testing demonstrated that the device can be used as intended in humans.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine View, Inc. % Ms. Sandra Sundell Director, Regulatory Affairs 48541 Warm Springs Boulevard Suite 507 Fremont, California 94539

APR 1 5 2009

Re: K090278

Trade/Device Name: ENSPIRE™ Debrider System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Product Code: HRX Dated: March 23, 2009 Received: March 24, 2009

Dear Ms. Sundell:

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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

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Page 2 - Ms. Sandra Sundell

[phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

for Don Rim

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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SpineView, Inc.

# Section 4: Indications for Use Statement

510(k) Number (if known):

Device Name: ENSPIRE™ Debrider System

Indications For Use: The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.R. Oglesby L.r.m.x.m

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

AND/OR

**510(k) Number** K090278