(176 days)
Not Found
Not Found
No
The 510(k) summary describes a simple dressing change tray 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 a dressing change tray, which is used for performing or assisting in changing dressings. This is a support activity rather than a direct therapeutic intervention.
No
The "Intended Use / Indications for Use" states that the device is "used for performing or assisting in performing in the change of dressings," which is a care or treatment function, not a diagnostic one.
No
The 510(k) summary describes a "Dressing Change Tray," which is a physical kit containing medical products. There is no mention of software in the provided text.
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 the change of dressings. This is a procedure performed on the patient's body surface, not on a sample taken from the body (like blood, urine, or tissue).
- Device Description: While the description is "Not Found," the intended use clearly points to a physical procedure rather than a diagnostic test performed on a sample.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory testing.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Dressing Change Tray's function is entirely in vivo (within the body or on the body surface).
N/A
Intended Use / Indications for Use
Opportunity Inc.'s Dressing Change 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 in the change of dressings.
Product codes
EFQ, KKX, KMF, MGP, EFO
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
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
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
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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 heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
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 (EFO) 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 travs. 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 Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 Watts
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 a logo for "Opportunity, Inc." The logo features a collection of various containers, including boxes, cans, and bottles, arranged to the left of the text. The word "Opportunity, Inc." is written in a bold, sans-serif font, with a horizontal line underlining the text. The overall design is simple and monochrome.
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510(k) Number: K971090
Device Name: Opportunity Dressing Change Tray
INDICATIONS FOR USE:
Opportunity Inc.'s Dressing Change 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 in the change of dressings.
A. Clay West
(Division Sign-Off) Division of General Restor 510(k) Number __
Prescription Use
(Per 21 CFR 801.109)
1200 Old Skokie Road · Highland Park, IL 60035-3028 · Phone 847.831.9400 · Fax 847.831.9418 Toll Free 888.MEDPACK