(146 days)
Antibacterial bandages are to be applied topically to the skin to help prevent infoctlon in minor cuts, scrapes, and burns.
Not Found
The provided text is a compilation of an FDA 510(k) clearance letter and an "INDICATIONS PAGE" for a medical device. This documentation announces the clearance of "Care Band Antibacterial Bandages" (and private label equivalents) and specifies their intended use.
Crucially, this document does not include information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth methods.
The letter from the FDA confirms that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has been determined to be as safe and effective as a similar device already on the market. This substantial equivalence is typically established by comparing the new device's technological characteristics and intended use to the predicate device, not necessarily through de novo performance studies against explicit acceptance criteria in the 510(k) submission itself.
Therefore, for the request, I can only provide the following, with the understanding that most of the requested information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. | Not provided in the document. The FDA clearance letter states the device is "substantially equivalent" to predicate devices, implying its performance is comparable to devices already on the market. The intended use is "to help prevent infection in minor cuts, scrapes, and burns." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The document implies a comparison to historically marketed devices for substantial equivalence, but details of any test set or its origin are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication method for the test set
- Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable/Not provided. This device is not an AI/software-as-a-medical-device that typically undergoes MRMC studies involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This is a physical antibacterial bandage, not an algorithm.
7. The type of ground truth used
- Not provided. For this type of device, ground truth for performance might involve antimicrobial efficacy testing (in vitro or in vivo) or clinical outcomes, but these details are not in the document.
8. The sample size for the training set
- Not provided.
9. How the ground truth for the training set was established
- Not provided.
In summary, the provided FDA 510(k) clearance letter and indications page confirm the 'Care Band Antibacterial Bandages' have received market clearance based on substantial equivalence to existing devices. However, this documentation does not contain the detailed study information often found in more extensive regulatory submissions or clinical trial reports that would specify acceptance criteria, explicit performance metrics, or study methodologies for demonstrating de novo performance.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 1999
Ms. Joan Rubendall Director, Quality Assurance and Regulatory Affairs ASO Corporation 300 Sarasota Center Boulevard Sarasota, Florida 34240
Re: K983368
Trade Name: Care Band Antibacterial Bandages Regulatory Class: Class I Product Code: KGX Dated: January 6, 1999 Received: January 6, 1999
Dear Ms. Rubendall:
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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 such 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. 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.
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Page 2 - Ms. Joan Rubendall
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 809.10 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 vours.
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
Enclosure
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Image /page/2/Picture/3 description: The image shows a series of numbers and a letter written in a calligraphic style. The characters are 'K983363'. The numbers are written in a bold, brushstroke style, with thick lines and rounded shapes. The letter 'K' is written in a similar style, with a long, flowing stroke.
Aso Corporation 510(k) Submission - Antibacterial Bandages Page 4 of 7 Revised: 10/8/1998
INDICATIONS PAGE
K983368 510(k) Number:
Device Name: Care Band Antibactarial Bandages, as well as other private label brands identified with the customer's name or trade name, such as XYZ Antibacterial Bandages or XYZ Antibacterial Strips.
INDICATIONS FOR USE:
Antibacterial bandages are to be applied topically to the skin to help prevent infoctlon in minor cuts, scrapes, and burns.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Usc OR Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Divisit Division of General Restorativ 510(k) Number
§ 880.5240 Medical adhesive tape and adhesive bandage.
(a)
Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.(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 § 880.9.