ENDOSCOPIC SPINE SYSTEM

K061246 · Arthro Kinetics, Inc. · HRX · Aug 23, 2006 · Orthopedic

Device Facts

• Record ID: K061246
• Device Name: ENDOSCOPIC SPINE SYSTEM
• Applicant: Arthro Kinetics, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Aug 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.

Device Story

The Arthro Kinetics Endoscopic Spine System is a reusable, minimally invasive spinal access system. It comprises an endoscope, light source, light guide, sheaths, camera head, and camera control unit. The system functions by inserting an outer sheath into a cannulated incision, which serves as an access portal for the endoscope and manual surgical instruments while providing suction and irrigation to the surgical site. Surgeons operate the device in a clinical setting to visualize the operative site, guided by patient feedback. The endoscope includes a working channel for instrument insertion. By providing direct visualization, the system assists surgeons in performing procedures like nucleotomy, discectomy, and foraminotomy, potentially reducing invasiveness compared to traditional open surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

System includes fiberoptic or rod-lens endoscope, camera, control unit, and light source. Features working and irrigation channels for surgical access and site maintenance. Reusable design for minimally invasive spinal procedures.

Indications for Use

Indicated for patients undergoing diagnostic and surgical spinal procedures, including nucleotomy, discectomy, and foraminotomy, requiring visualization through a cannulated incision.

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

• Endius Atari System (K053267)
• Henke-Sass Wolf Endoscope (K941967)
• Joimax Thessys Multiscope (K051827)
• Viking Systems CCD camera (K941919)

Submission Summary (Full Text)

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# AUG 2 3 2006

## 510(k) Summary

## for

# Arthro Kinetics Endoscopic Spine System

#### 1. SPONSOR

Arthro Kinetics Inc. 8 Faneuil Hall, 3d Floor Boston, MA 02109

| Contact Person: | James Hobbs |
|-----------------|--------------|
| Telephone: | 508-735-3810 |

Date Prepared: July 26, 2006

#### 2. DEVICE NAME

| Proprietary Name: | Endoscopic Spine System |
|----------------------|-----------------------------|
| Common/Usual Name: | Spinal Access System |
| Classification Name: | Arthroscope and Accessories |

#### 3. PREDICATE DEVICES

- Endius Atari System (K053267) .
- Henke-Sass Wolf Endoscope ( K941967) .
- . Joimax Thessys Multiscope (K051827)
- Viking Systems CCD camera (K941919) .

#### 4. DEVICE DESCRIPTION

The Arthro Kinetics Endoscopic Spine System consists of an Endoscope, light source, light guide, sheaths, camera head, and camera control unit and is a reusable minimally invasive system that enables surgeons to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy. The outer sheath acts to facilitate

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suction / irrigation to the surgical site, serving as a cannula to provide an access portal for the endoscope to be inserted into the patient for viewing or the placing of manual surgical instruments. By inserting the endoscope into the outer sheath the surgeon will be able to view the operative site whilst being guided to the pain source

by the ongoing feedback from the patient. The endoscope also has a working channel to allow surgical instruments to be inserted into the operative site.

### ડ. INTENDED USE

The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectorny, and foraminotomy.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Arthro Kinetics Endoscopic Spine System and the predicate devices all include working channels and/or irrigation channels used to visualize and irrigate the operative site. The proposed and predicate devices include a fiberoptic or rodflens endoscope, camera and light source for visualization. Additionally, they all contain working channels and irrigation channels for various surgical procedures.

The technological characteristics of the Arthro Kinetics Endoscopic Spine System and the predicate products are substantially equivalent in that they all consist of an endoscope, camera, control unit and light source for visualization during Endoscopic spine procedures. The Arthro Kinetics Endoscopic Spine System and the predicate devices are also similar in that they all are intended specifically for spine procedures. The labeling for the Arthro Kinetics Endoscopic Spine System is essentially identical to the labeling cleared for the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2006

Arthro Kinetics, Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760

Re: K061246

Trade/Device Name: Endoscopes Spine System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: July 26, 2006 Received: July 27, 2006

Dear Ms. McNamara-Cullinane:

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 - Ms. Mary McNamara-Cullinane

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 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/industry/support/index.html.

Sincerely yours.

Yen

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

Enclosure

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Kob146

510(k) Number (if known):

Device Name: Endoscopic Spine System

Indications For Use:

The Arthro Kinetics' Endoscopic Spine System (Kinetics Interchangeable Spine System) is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as nucleotomy, discectomy, and foraminotomy.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

P.thm
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K061246