Who is the manufacturer of ENDIUS ATAVI SYSTEM?

Endius, Inc. filed the 510(k) submission for ENDIUS ATAVI SYSTEM (K021748).

What is the FDA product code for ENDIUS ATAVI SYSTEM?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ENDIUS ATAVI SYSTEM?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like ENDIUS ATAVI SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ENDIUS ATAVI SYSTEM

Q: What are the predicate devices for ENDIUS ATAVI SYSTEM?

Endius Endoscopic Access System (K991794, K994425, K002437).

K021748 · Endius, Inc. · HRX · Jun 26, 2002 · Orthopedic

Device Facts

Record ID	K021748
Device Name	ENDIUS ATAVI SYSTEM
Applicant	Endius, Inc.
Product Code	HRX · Orthopedic
Decision Date	Jun 26, 2002
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.1100
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized. The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures.

Device Story

Endius Atavi System provides endoscopic access to lumbar spine. Components include tissue dilators, retracting device for access maintenance, endoscope, light source, light guide, camera control unit, and camera head. Used in OR by surgeons to visualize surgical site during spinal procedures. System facilitates minimally invasive access; allows surgeon to perform discectomy, nucleotomy, or fusion under endoscopic visualization. Benefits include reduced tissue trauma compared to open surgery.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench performance testing and certification of compliance to design control requirements.

Technological Characteristics

Endoscopic spinal access system comprising tissue dilators, retractors, endoscope, light source, light guide, and camera system. Class II device. Operates as an endoscopic visualization and access tool. No specific materials or software algorithms detailed.

Indications for Use

Indicated for patients undergoing posterior endoscopic lumbar spine procedures, including discectomy, nucleotomy, and posterolateral fusion (instrumented with TriFix system or non-instrumented).

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 Endoscopic Access System (K991794, K994425, K002437)

Related Devices

K061345 — MODIFICATION TO ENDIUS ATAVI SYSTEM · Endius, Inc. · Jun 6, 2006
K053267 — ENDIUS ATAVI SYSTEM · Endius, Inc. · Jan 13, 2006
K022199 — ENDIUS ATAVI SYSTEM · Endius, Inc. · Oct 2, 2002
K991794 — ENDOSCOPIC SPINAL ACCESS SYSTEM · Endius, Inc. · Aug 13, 1999
K994425 — MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM · Endius, Inc. · Feb 16, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ JUN 2 6 2002 K021742 ## Section 7 - 510(k) Summary | 7.1 Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Endius, Inc. chooses to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..." The summary regarding the adverse health effects of the modified device, Endius Atavi System is provided below. | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 7.2 Submitter | Endius, Inc. 23 West Bacon Street Plainville, MA. 02762 (USA) | | 7.3 Company Contact | Christine Kuntz-Nassif Director, Regulatory Affairs Endius, Inc. 508-643-0983 | | 7.4 Device Name/ Classification | Proprietary Name: Endius Atavi System Common Name: Endoscopic Spinal Access System Classification Name: Endoscope and Accessories The devices in the Endoscopic Atavi System can be classified as class II, 876.1500 Endoscope and Accessories. The primary device in the system is the endoscope. The accessory equipment is needed to gain access for placement of the endoscope, to support the endoscope in position, or to work with the endoscope for the purpose of visualization. | | 7.5 Predicate Legally Marketed Devices | Endius Endoscopic Access System: K991794, K994425, K002437 | | 7.6 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 visualization components of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head. | | 7.7 Indications for Use | The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized. The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, non-instrumented posterolateral fusion procedures. | | 7.7 Safety and Performance | This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Demonstrating Substantial Equivalence in Premarket Approaches to Notifications." In support of this 510(k), Endius, Inc. has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and the results of validation testing (performance testing) for the device modification. | {1}------------------------------------------------ ﻢ s {2}------------------------------------------------ 7.8 Substantial Equivalence Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Endius Atavi System has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. Applicant Date 5/24/02 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, composed of three curved lines that suggest the shape of a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Christine Kuntz-Nassif Director, Regulatory Affairs Endius, Inc. 23 West Bacon Street Plainville, MA 02762 JUN 2 6 2002 Re: K021748 Trade/Device Name: Endius® Atavi™ System Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 24, 2002 Received: May 28, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ ## 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 you 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Stypt Rhodes a M. Witten, Ph.D., M.D. of Celi Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): 021748 Device Name: Endius® Atavi™ System ## Indications for Use: The Endius Atavi System is indicated for use in instrumented posterolateral fusion procedures where the TriFix Spinal Instrumentation System is utilized. The Endius Atavi System is also intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy, nucleotomy, noninstrumented posterolateral fusion procedures. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Image /page/5/Picture/7 description: This image shows a document related to the Concurrence of CDRH, Office of Device Evaluation (ODE). It indicates that the document was posted on July 1, 1998, with an optional format date of 3-10-98. The document includes a division sign-off for the Division of General, Restorative, and Neurological Devices. The 510(k) number is listed as K021748, and the document number is 000002.