ENDIUS ATAVI SYSTEM

K053267 · Endius, Inc. · HRX · Jan 13, 2006 · Orthopedic

Device Facts

• Record ID: K053267
• Device Name: ENDIUS ATAVI SYSTEM
• Applicant: Endius, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jan 13, 2006
• 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 provides endoscopic access and visualization for spinal and orthopedic surgery. System components include endoscope, light source, light guide, camera control unit, camera head, tissue dilators, and retracting device. Surgeon uses dilators to access surgical site; retracting device maintains access; endoscope provides visualization. Used in OR by surgeons to perform procedures like discectomy, fusion, and decompression. Output is visual feed for surgeon to guide surgical instruments. Benefits include minimally invasive access to spinal and joint structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic spinal access system consisting of endoscope, light source, light guide, camera control unit, camera head, tissue dilators, and retractors. Class II device (21 CFR 888.1100).

Indications for Use

Indicated for patients requiring posterior or anterior surgical access and visualization of the cervical, thoracic, or lumbar spine for procedures including discectomy, nucleotomy, spinal fusion, spinal decompression, and implant insertion. Also indicated for generic surgical use in the 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

• Endius Atavi System (K991794)
• Endius Atavi System (K994425)
• Endius Atavi System (K002437)
• Endius Atavi System (K021748)
• Endius Atavi System (K022199)

Submission Summary (Full Text)

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## Section 5 - 510(k) Summary

#### 5.1 Statement

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is required to Pursuant to §313(1)(3)(7)(7)(7) of the Pood, Dreg, and See summary of any information
submit with this Premarket Notification either an "... adequate summary of any informati Submit will and effectiveness or state that such information will be made available upon respecting safety and effectiveness or submit a summary of information respecting request of ally person. "Enclus, file: entresses (A(3)(B), "Any summary under subparagraph (A) Salery and crectiveness: Trecording to 35 36 (0) >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> effects ... "

The summary regarding the adverse health effects of the modified device, Endius® Atavi System is provided below.

#### 5.2 Submitter

Endius, Inc. 23 West Bacon Street Plainville, MA. 02762 Establishment Registration:1057469

#### 5.3 Company Contact

Christine Kuntz-Nassif Director, Regulatory Affairs/Quality Assurance [phone] x114 cnassif(@endius.com

#### 5.4 Device Name

Proprietary Name: Endius Atavi System Common Name: Endoscopic Spinal Access System Classification Name: Endoscope and Accessories

The devices in the Endoscopic Spinal Access System can be classified as class II, 876.1500 The devices in the Endosopro operimary device in the system is the endoscope. The accessory Endoscope and I lecessorien access for placement of the endoscope, to support the endoscope in equipment or to work with the endoscope for the purpose of visualization.

#### 5.5 Predicate Devices

Device Name(s): Endius Atavi System 510(k) Number(s): K991794, K994425, K002437, K021748, K022199

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### 5.6 Device Description

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The overying tobace, as were of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.

# 5.7 Device Indications and 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).

## 5.8 Substantial Equivalence

The proposed Endius Atavi System is substantially equivalent to the current Endius Atavi System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

Ms. Christine Kuntz-Nassif Director, Regulatory Affairs & Quality Assurance Endius, Inc. 23 West Bacon Street Plainville, Massachusetts 02762

Re: K053267

Trade/Device Name: Endius® Atavi System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: November 22, 2005 Received: November 23, 2005

Dear Ms. Kuntz-Nassif:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for doo barantiar 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 I ou mayyutus 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. Kuntz-Nassif

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow you to ough mating of substantial equivalence of your device to a legally premaired predicated 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 If you desire specific advice ion 704 [phone]. Also, please note the regulation entitled, Contact the Office of Crication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Mark N. Melkerson

రు Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko53267

## Indications for Use

510(k) Number (if known): K05xxxxx

Device Name: Endius Atavi System

Indications For Use:

The Endius Atavi System is indicated for use for posterior or anterior access and visualization in r he Lindlus Atarr Cyclem is thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal of surgiour spinal problem of spinal implants. Other examples of generic surgical use of the decompression, and mould be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

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

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)

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(Division Sign-Off) Division of General, Restorative, and Neurological Devi. 3. 3

**510(k) Number** K053267

000911