(176 days)
Not Found
Not Found
No
The summary describes a surgical tray for incision and drainage procedures and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an "Incision and Drainage Tray," which is used for performing medical procedures rather than providing therapy. It facilitates a procedure but doesn't inherently deliver a therapeutic effect itself.
No
The device is described as an "Incision and Drainage Tray" used for "performing or assisting in performing incision and drainage procedures." These are therapeutic/procedural actions, not diagnostic ones.
No
The 510(k) summary describes a physical medical device (an Incision and Drainage Tray) which is a collection of medical products, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for performing or assisting in performing incision and drainage procedures. This is a surgical/procedural use, not a diagnostic test performed on samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: While the description is "Not Found," the intended use clearly points to a procedural device.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
Opportunity Inc.'s Incision and Drainage 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 incision and drainage procedures.
Product codes
EFQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professional or other medical personnel as deemed appropriate by the using facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1997
Mr. James S. Sanders Sales Manager Opportunity, Inc. 1200 Old Skokie Road Highland Park, Illinois 60035-3028
K971088, K971089, K971090, K971091, K971093, K971095 Re: Trade Names: Opportunity Incision and Drainage Tray Opportunity Laceration Tray Opportunity Dressing Change Tray Opportunity Tracheostomy Care Kit Opportunity I.V. Start Kit Opportunity Suture Removal Kit Regulatory Class: K971088 (Unclassified) K971089 (II) K971090 (Unclassified) K971091 (Unclassified) K971093 (Unclassified) K971095 (Unclassified) Product Code: K971088 (EFQ) K971089 (KKX) K971090 (KMF) K971091 (KMF) K971093 (MGP) K971095 (EFQ) Dated: Undated Received: June 18, 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 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 kits and trays listed above have either been determined as substantially equivalent under the premarket notification process
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Page 2 - Mr. James S. Sanders
(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 kits and trays. 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 major 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and 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 alcohol swabsticks, PVP swabsticks, alcohol prep pads, and PVP prep pads 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) 594-0101
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.
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Page 2 - Mr. James S. Sanders
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) 594-4692. 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,
Lila wth
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/3/Picture/0 description: The image shows the logo for OI Opportunity, Inc. The logo features a collection of containers, including boxes, bottles, and a can, to the left of the text. The text "OPPORTUNITY, INC." is written in a bold, sans-serif font and is underlined.
Page 1 of
510(k) Number: K971088
Device Name: Opportunity Incision and DrainageTray
INDICATIONS FOR USE:
.
Opportunity Inc.'s Incision and Drainage 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 incision and drainage procedures.
Ola Wils
(Division Sign-Off)
of General Restorative Devices
KS71088
(Division Sig
Division of General Rest
510(k) Number K971002
Prescription Use
(Per 21 CFR 801.109)