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K Number
K022199
Device Name
ENDIUS ATAVI SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2002-10-02

(89 days)

Product Code
HRX
Regulation Number
888.1100
Type
Traditional
Panel
OR
Reference & Predicate Devices
K002931
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 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.

AI/ML Overview

The provided text does NOT contain information about acceptance criteria, device performance metrics, or any study details that would typically be associated with proving a device meets specific acceptance criteria. This document is a 510(k) summary for the Endius Atavi System, which primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

The document discusses:

  • Device Name: Endius Atavi System
  • Submitter and Contact Information: Endius, Inc.
  • Classification: Class II, Endoscope and Accessories
  • Predicate Devices: Sofamor Danek Microendoscopic Discectomy System and Medtronic Sofamor Danek METRx System (K002931)
  • Device Description: Instruments for tissue dilation, retracting device, visualization components (endoscope, light source, light guide, camera control unit, camera head).
  • Indications for Use: Posterior or anterior access and visualization in cervical, thoracic, or lumbar spine for surgical procedures like discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Also, generic surgical use in knee, ankle, shoulder, hand, wrist, and TMJ.
  • Substantial Equivalence: Claimed to the listed predicate devices.
  • FDA Response Letter: Confirms substantial equivalence and allows marketing.

There is no mention of:

  1. Acceptance criteria or reported device performance (e.g., accuracy, sensitivity, specificity, resolution, field of view, etc.).
  2. Sample sizes for test sets or training sets.
  3. Data provenance (country of origin, retrospective/prospective).
  4. Number of experts or their qualifications.
  5. Adjudication method.
  6. MRMC comparative effectiveness study or effect size with AI assistance.
  7. Standalone algorithm performance.
  8. Type of ground truth used.
  9. How ground truth was established.

§ 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.