ENDIUS ATAVI SYSTEM

K022199 · Endius, Inc. · HRX · Oct 2, 2002 · Orthopedic

Device Facts

• Record ID: K022199
• Device Name: ENDIUS ATAVI SYSTEM
• Applicant: Endius, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Oct 2, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The Endius® Atavi™ System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius® Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

Device Story

Endius Atavi System is an endoscopic spinal access system. Components include tissue dilation instruments, retracting device for access maintenance, endoscope, light source, light guide, camera control unit, and camera head. Used in surgical settings by surgeons to provide visualization and access to the spine or joints. System facilitates minimally invasive procedures by allowing surgeon to perform discectomy, fusion, decompression, and implant insertion through a retracted access portal. Output is visual feed for surgeon to guide surgical instruments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic spinal access system comprising dilation instruments, retractors, endoscope, light source, and camera system. Class II device (888.1100).

Indications for Use

Indicated for posterior or anterior access and visualization in cervical, thoracic, or lumbar spine for surgical procedures (discectomy, nucleotomy, fusion, decompression, implant insertion). Also indicated for use in knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

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

• Sofamor Danek Microendoscopic Discectomy System
• Medtronic Sofamor Danek METRx System (K002931)

Submission Summary (Full Text)

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# OCT 02 2002

022199

# Section 7 - 510(k) Summary of Safety and Effectiveness

| 7.1<br>Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc.<br>is required to submit with this Premarket Notification either an "... adequate<br>summary of any information respecting safety and effectiveness or state that<br>such information will be made available upon request of any person." Endius,<br>Inc. chooses to submit a summary of information respecting safety and<br>effectiveness. According to §513(i)(3)(B), "Any summary under<br>subparagraph (A) respecting a device shall contain detailed information<br>regarding data concerning adverse health effects..."<br>The summary regarding the adverse health effects of the modified device,<br>Endius Atavi System is provided below. |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2<br>Submitter | Endius, Inc.<br>23 West Bacon Street<br>Plainville, MA. 02762 (USA) |
| 7.3<br>Company<br>Contact | Christine Kuntz Nassif<br>Director, Regulatory Affairs<br>Endius, Inc.<br>508-643-0983 |
| 7.4<br>Device Name/<br>Classification | Proprietary Name: Endius Atavi System<br>Common Name: Endoscopic Spinal Access System<br>Classification Name: Endoscope and Accessories<br>The devices in the Endoscopic Spinal Access System can be classified as<br>class II, 876.1500 Endoscope and Accessories. The primary device in the<br>system is the endoscope. The accessory equipment is needed to gain access<br>for placement of the endoscope, to support the endoscope in position, or to<br>work with the endoscope for the purpose of visualization. |
| 7.5<br>Predicate<br>Legally<br>Marketed<br>Devices | Sofamor Danek Microendoscopic Discectomy System<br>(Sofamor Danek Memphis, Tennessee)<br>Medtronic Sofamor Danek METRx System, K002931 |
| 7.6 Device<br>Description | The Endius Atavi System includes instruments used to access the spine by<br>dilation of the overlying tissues, as well as a retracting device that is used to<br>maintain the access. The visualization components of the system include, an<br>endoscope, a light source, light guide, a camera control unit, and a camera<br>head. |
| 7.7 Indications<br>for Use | The Endius® Atavi™ System is indicated for use for posterior or anterior<br>access and visualization in the surgical area of the cervical, thoracic, or<br>lumbar spine allowing the surgeon to perform any type of surgical spinal<br>procedures such as discectomy, nucleotomy, spinal fusion, spinal<br>decompression, and insertion of spinal implants. Other examples of generic<br>surgical use of the Endius® Atavi™ System would be for use in the knee,<br>ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ). |
| 7.8<br>Substantial<br>Equivalence | The Endius Atavi System is substantially equivalent to the Sofamor Danek<br>USA Microendoscopic System (Memphis, TN)and the METRx System. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

OCT 02 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Endius, Inc. Christine Kuntz Nassif Director, Regulatory Affairs 23 West Bacon Street Plainville, Massachusetts 02762

Re: K022199

Trade/Device Name: Endius Atavi System Regulation Number: 888.1100 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: HRX Dated: July 3, 2002 Received: July 5, 2002

Dear Ms. Kuntz Nassif:

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. Christine Kuntz Nassif

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

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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#### 15022199 510(k) Number (if known):

Device Name: Endius® Atavi™ System

#### Indications for Use:

The Endius® Atavi™ System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius® Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

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### Concurence of CDRH, Office of Device Evaulation (ODE)

(Optional Format 3-10-98)

(Posted July 1, 1998)

Hyatt Gurdie

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

510(k) Number K022199

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