(77 days)
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No
The summary describes a general purpose surgical tray and contains no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No.
The device is described as a "General Purpose Tray" for "performing or assisting in performing general surgical procedures," which are tools for procedures rather than therapeutic interventions themselves.
No
Explanation: The device is a general purpose tray used for general surgical procedures. Its intended use does not involve diagnosing a disease or condition. The document states that "The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use." without specifying any diagnostic purpose for the tray itself.
No
The 510(k) summary describes a "General Purpose Tray" used for assembling medical products for surgical procedures. This clearly indicates a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "performing or assisting in performing general surgical procedures." This indicates a direct interaction with the patient's body during a surgical procedure, not the examination of specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or treatment based on specimen analysis.
- Reagents, calibrators, or controls used for testing.
The device is described as a "General Purpose Tray" used in surgical procedures, which aligns with a surgical instrument or kit, not an IVD.
N/A
Intended Use / Indications for Use
Opportunity Inc.'s General Purpose Tray is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing general surgical procedures.
Product codes
LRO
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
licensed professional or other medical personnel
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
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 1997
Mr. James S. Sanders Sales Manager Opportunity, Inc ... ... 1200 Old Skokie Road Highland Park, Illinois 60035-3028
Rë: K971062 Trade Name: General Purpose Tray Regulatory Class: I Product Code: LRO Dated: February 24, 1997 Received: March 24, 1997
Dear Mr. Sanders:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your tray. 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 (Premarket Approval) it may be subject to additional controls. Existing maior regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and
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Page 2 - Mr. James S. Sanders
Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
In addition, we have determined that your device kit contains an alcohol pad and PVP swab stick which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063
This letter will allow you to begin marketing your device as described in your 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 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows the logo for OI Opportunity, Inc. The logo features a black circle and rectangle, along with illustrations of boxes, a can, and bottles. The text "K971062/A3" is handwritten in the top right corner of the image.
Page 1 of
5 106(k) Number: K971062
Device Name: General Purpose Tray
INDICATIONS FOR USE:
Opportunity Inc.'s General Purpose Tray is intended for use by a licensed
professional or other medical personnel as deemed appropriate by the using facility.
The intended use of the medical products assembled in these kits will not change
from the manufacturers original intended use. This kit is used for performing or assisting
in performing general surgical procedures.
Prescription Use
(Per 21 CFR 801.109)
colus D