(29 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The device description is simply "Orthopedic Kit or Tray".
No
The device is described as an "Orthopedic Kit or Tray," which are typically tools used during surgical procedures or for organizing orthopedic instruments, rather than actively providing a therapeutic effect themselves. There is no information provided about an intended use or indications for use.
No
The device is described as an "Orthopedic Kit or Tray," which typically contains instruments used for surgical procedures or medical treatments, not for diagnosing conditions. There is no information provided in the "Intended Use / Indications for Use" section that would suggest a diagnostic purpose.
No
The device description explicitly states "Orthopedic Kit or Tray," which strongly suggests a physical hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- No mention of IVD-related terms: The description "Orthopedic Kit or Tray" and the lack of information about intended use, anatomical site, or any biological samples strongly suggest a device used in surgical or procedural settings, not for testing biological samples in vitro.
- Lack of IVD-specific information: IVD submissions typically include details about analytes, sample types, assay principles, and performance characteristics related to diagnostic testing. None of this information is present.
- Orthopedic context: The term "Orthopedic Kit or Tray" directly points towards a device used in orthopedic procedures, which are typically surgical and involve the musculoskeletal system, not in vitro diagnostic testing.
Therefore, based on the available information, this device appears to be an orthopedic surgical kit or tray, not an IVD.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains three lowercase letters: 'm', 'd', and 'i'. The letters are written in a bold, outlined font, giving them a distinct appearance. The letters are arranged horizontally, with 'm' on the left, 'd' in the center, and 'i' on the right.
Attachment 1 510(k) Summary
MAY - 8 1997
K9713/7
National Healthcare Manufacturing Corp. Orthopedic Kit or Tray
Submitter Information:
Alice Gibson General Manager National Healthcare Manufacturing Corp. 251 Sulteaux Crescent Winnipeg, Manitoba R3J 3C7 Canada
510(k) Summary Prepared by:
Carolann Kotula Official Correspondent for NHMC c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021
| Phone: | (516) 482-9001 |
|---|---|
| Fax: | (516) 482-0186 |
Date 510(k) Summary Prepared:
April 1, 1997
Name/Classification of the Device:
Classification Name:
A classification name could not be located for these devices.
Common Name:
Orthopedic Pack, Tray, or Kit
Page - 1
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