SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE

K081051 · Spine View, Inc. · HRX · Aug 7, 2008 · Orthopedic

Device Facts

• Record ID: K081051
• Device Name: SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
• Applicant: Spine View, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Aug 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Device Story

SESS kit comprises arthroscopic surgical accessories and SpineVu MiniScope; includes bipolar RF electrosurgical CoagProbe. System provides endoscopic access and visualization of cervical, thoracic, or lumbar spine. Used by surgeons in clinical settings for interventional procedures (discectomy, nucleotomy, foraminotomy). MiniScope utilizes fiber-optic illumination for percutaneous evaluation of intervertebral spaces. CoagProbe uses RF energy for ablation and coagulation of disc material under direct endoscopic visualization. Output is visual feedback for the surgeon to guide surgical tools; enables minimally invasive spinal intervention; benefits patient through reduced surgical trauma.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing per ISO 10993, bench testing for compliance with standards and labeling, and cadaver testing to demonstrate intended use in human anatomy.

Technological Characteristics

Fiber-optic illumination and visualization system; bipolar RF electrosurgical accessory. Materials compliant with ISO 10993. System includes arthroscope and surgical/coagulation tools for percutaneous use.

Indications for Use

Indicated for endoscopic access and visualization of cervical, thoracic, or lumbar spine for interventional procedures including discectomy, nucleotomy, and foraminotomy.

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

• Kess Instrument set (K000046)
• Disc-FX System (K052241)
• Perc-D Spine Wand (K010811)
• Kinetics Interchangeable Spine System (K061246)
• Atavi System (K061345)

Submission Summary (Full Text)

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Kosios1

SpineView, Inc.

SpineVu Endoscopic Spine System (SESS) Premarket Notification

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# Section 5: 510(k) Summary

Device Information:

AUG - 7 2008

| Device Information: | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Category | Comments |
| Sponsor: | Roy Chin<br>President & CEO<br>SpineView, Inc<br>48541 Warm Springs Blvd.<br>Suite 507<br>Fremont, CA 94539<br>Tel: [phone] |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone]<br>Fax: [phone] |
| Device Common Name: | Arthroscopic Intervention Kit |
| Device Classification &<br>Code: | Arthroscope: Class II, HRX<br>Arthroscope Accessories: Class I, NBH<br>Electrosurgical Accessory: Class II, GEI |
| Device Classification<br>Name: | 21CFR888.1100: Arthroscope &<br>Accessories<br>21CFR878.4400: Electrosurgical Cutting<br>& Coagulation Device and Accessories |
| Device Proprietary Name: | SpineVu Endoscopic Spine System (SESS)<br>SpineVu MiniScope |

# Predicate Device Information:

| Predicate Devices: | Kess Instrument<br>set | Disc-FX System | Perc-D Spine<br>Wand |
|-------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device<br>Manufacturers: | Richard Wolf<br>Medical<br>Instruments | Ellman<br>International | ArthroCare |
| K#s | K000046 | K052241 | K010811 |
| Predicate Device<br>Common Name: | Arthroscope &<br>accessories | Arthroscope &<br>accessories;<br>electrosurgical<br>accessories | Arthroscope &<br>accessories;<br>electrosurgical<br>accessories |
| Predicate Device<br>Classification: | 21CFR888.1100:<br>Arthroscope &<br>Accessories | 21CFR888.1100:<br>Arthroscope &<br>Accessories<br>21CFR878.4400:<br>Electrosurgical<br>Cutting &<br>Coagulation<br>Device and<br>Accessories | 21CFR888.1100:<br>Arthroscope &<br>Accessories<br>21CFR878.4400:<br>Electrosurgical<br>Cutting &<br>Coagulation<br>Device and<br>Accessories |

CONFIDENTIAL

Page 1

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K061051

SpineView, Inc.

SpineVu Endoscopic Spine System (SESS) Premarket Notification

| Predicate Device<br>Classification &<br>Code: | Class 2, HRX | Class 2, HRX &<br>GEI | Class 2, HRX &<br>GEI |
|-----------------------------------------------|--------------|-----------------------|-----------------------|
|-----------------------------------------------|--------------|-----------------------|-----------------------|

#### Predicate Device Information, continued:

| Predicate Devices: | Kinetics<br>Interchangeable<br>Spine System | Atavi System |
|-----------------------------------------------|------------------------------------------------|------------------------------------------------|
| Predicate Device<br>Manufacturers: | Arthro Kinetics | Endius |
| K#s | K061246 | K061345 |
| Predicate Device<br>Common Name: | Arthroscope &<br>accessories | Arthroscope &<br>accessories |
| Predicate Device<br>Classification: | 21CFR888.1100:<br>Arthroscope &<br>Accessories | 21CFR888.1100:<br>Arthroscope &<br>Accessories |
| Predicate Device<br>Classification &<br>Code: | Class 2, HRX | Class 2, HRX |

#### b. Date Summary Prepared

10 April 2008

#### c. Description of Device

The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.

#### d. Intended Use

The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

#### e. Comparison to Predicate Device

SESS Kit

Nearly all of the components of the SESS kit are Class I exempt (NBH) as Arthroscope accessories (21CFR888.1100). The only exception is the SpineVu CoagProbe. The CoagProbe is a Class II electrosurgical accessory (21CFR878.4440, GEI).

The SpineVu CoagProbe is substantially equivalent in intended use as the coagulation probes found in the Arthrocare Perc-D Spine Wand (K010811) and the Ellman Disc-FX Systems (K052241). Each is used for the ablation and coagulation of intervertebral disc material. The designs of the probes are similar in that all are intended to be used under direct visualization via an endoscope. All of the probes are bipolar and use RF energy to ablate and coagulate the disc material.

SpineView concludes that the SESS is substantially equivalent to the predicate arthroscopic surgical kits.

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### SpineView, Inc.

SpineVu Endoscopic Spine System (SESS) Premarket Notification

#### SpineVu MiniScope

The Spine Vu MiniScope is substantially equivalent in intended use and design as the arthroscopes in the "Kess" instrument set (K000046), the Arthro Kinetics Spine System (K061246) and the Endius Atavi System (K061345). All are fiber-optic illumination and visualization systems for percutaneous evaluation of intervertebral spaces in the spinal column.

Spinc View concludes that the SpineVu MiniScope is substantially equivalent to the predicate arthroscopes.

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

SpineView concludes that the devices are substantially equivalent.

#### f. Summary of Supporting Data

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

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

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

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Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2008

Spine View, Inc. % Coombs Medical Device Consulting, Inc. Mr. Craig Coombs 1193 Sherman Street Alameda, California 94501

Re: K081051

Trade/Device Name: SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, GEI Dated: July 18, 2008 Received: July 22, 2008

Dear Mr. Coombs:

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

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Page 2 - Mr. Craig Coombs

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.

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 the reporting 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 vours.

Mark M. Mulhausen

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):

SpineVu Endoscopic Spine System (SESS™) and SpineVu Device Name: MiniScope

Indications For Use:

The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

| Prescription Use | X | AND/OR | Over-The-Counter Use |
|-----------------------------|---|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (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) | |
|------------------------------------------------------------|-------------|
| (Division Sign-Off) | Page 1 of 1 |
| Division of General, Restorative, and Neurological Devices | |
| CONFIDENTIAL | Section 4 |
| 510(k) Number | K041051 |