(51 days)
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).
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.
The provided text is a 510(k) summary for the Endius® Atavi System, which is an endoscopic spinal access system. It describes the device, its indications for use, and states its substantial equivalence to previously cleared devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway that often relies on comparison of design, materials, and intended use, rather than extensive performance studies with acceptance criteria in the same way a de novo or PMA application might require.
Therefore, I cannot provide the requested information based on the input text. The sections of your request (1-9) would typically be found in detailed verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) filing.
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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 (508) 643-0983 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the upper half of the circle.
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.