(29 days)
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.
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.
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Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state acceptance criteria in a quantitative or qualitative manner against which the Endius Atavi System's performance is measured. Instead, it refers to "validation testing (performance testing)" as part of a Special 510(k) submission, confirming compliance with design control requirements.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text. The basis for substantial equivalence is primarily rooted in comparison to predicate devices, indications for use, and technological characteristics, rather than specific performance metrics against pre-defined acceptance criteria.
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Sample Size Used for the Test Set and Data Provenance:
The document does not provide information regarding a specific "test set" with a sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission is a "Special 510(k): Device Modification," which focuses on demonstrating compliance with design control requirements and relevant validation testing for the modification. This type of submission typically doesn't involve clinical studies with test sets in the same way as a de novo or traditional 510(k) for a new device might. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The document does not describe a study involving a "test set" for which ground truth was established by experts. -
Adjudication Method for the Test Set:
Not applicable. The document does not describe a study involving a "test set" that would require an adjudication method. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence based on technological characteristics and indications for use compared to predicate devices, and design control compliance for modifications, not on measuring human reader improvement with or without AI assistance. -
Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
No, a standalone (algorithm only) study was not done. The Endius Atavi System is an endoscopic spinal access system, a physical medical device, not an algorithm or AI. -
Type of Ground Truth Used:
Not applicable. The document does not describe a study that established "ground truth" using expert consensus, pathology, or outcomes data. The submission is a Special 510(k) for a device modification, focusing on verifying that the modified device continues to meet its intended purpose and safety requirements in line with predicate devices. -
Sample Size for the Training Set:
Not applicable. The Endius Atavi System is a physical medical device, not an AI or algorithm that would require a "training set." -
How Ground Truth for the Training Set Was Established:
Not applicable. As the device is not an AI or algorithm, there is no "training set" or "ground truth" establishment process for it in this context.
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JUN 2 6 2002
Section 7 - 510(k) Summary
| 7.1Statement | 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 "... adequatesummary of any information respecting safety and effectiveness or state thatsuch information will be made available upon request of any person." Endius,Inc. chooses to submit a summary of information respecting safety andeffectiveness. According to §513(i)(3)(B), "Any summary undersubparagraph (A) respecting a device shall contain detailed informationregarding data concerning adverse health effects..."The summary regarding the adverse health effects of the modified device,Endius Atavi System is provided below. |
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| 7.2Submitter | Endius, Inc.23 West Bacon StreetPlainville, MA. 02762 (USA) |
| 7.3CompanyContact | Christine Kuntz-NassifDirector, Regulatory AffairsEndius, Inc.508-643-0983 |
| 7.4Device Name/Classification | Proprietary Name: Endius Atavi SystemCommon Name: Endoscopic Spinal Access SystemClassification Name: Endoscope and AccessoriesThe devices in the Endoscopic Atavi System can be classified as class II,876.1500 Endoscope and Accessories. The primary device in the system is theendoscope. The accessory equipment is needed to gain access for placementof the endoscope, to support the endoscope in position, or to work with theendoscope for the purpose of visualization. |
| 7.5PredicateLegallyMarketedDevices | Endius Endoscopic Access System: K991794, K994425, K002437 |
| 7.6 DeviceDescription | The Endius Atavi System includes instruments used to access the spine bydilation of the overlying tissues, as well as a retracting device that is used tomaintain the access. The visualization components of the system include, anendoscope, a light source, light guide, a camera control unit, and a camerahead. |
| 7.7 Indicationsfor Use | The Endius Atavi System is indicated for use in instrumented posterolateralfusion procedures where the TriFix Spinal Instrumentation System is utilized.The Endius Atavi System is also intended to be used for posterior endoscopicaccess to the lumbar spine for various endoscopic spinal procedures such asdiscectomy, nucleotomy, non-instrumented posterolateral fusion procedures. |
| 7.7Safety andPerformance | This submission is a Special 510(k): Device Modification as described inFDA's guidance document entitled "The New 510(k) Paradigm - AlternateDemonstrating Substantial Equivalence in PremarketApproaches toNotifications."In support of this 510(k), Endius, Inc. has providedcertification of compliance to 21 CFR 820.30 Design Control requirements,and the results of validation testing (performance testing) for the devicemodification. |
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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
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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.
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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 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
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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.
§ 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.