(613 days)
To relieve nipples that are sore and cracked from breastfeeding.
Not Found
I'm sorry, but the provided text from the FDA 510(k) clearance letter for the "Soothing Gel Patch" does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.
This document is a clearance letter, which means the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This type of clearance typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, rather than requiring a full clinical study with specific acceptance criteria and detailed performance metrics to be proven.
The letter focuses on regulatory compliance and categorization, not on the technical performance data of the device itself.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance (i.e., algorithm only without human-in-the-loop) was done (This question is not relevant as it's a physical device, not an algorithm)
- The type of ground truth used
- The sample size for the training set (This question is not relevant as it's a physical device, not an AI/ML algorithm)
- How the ground truth for the training set was established (This question is not relevant as it's a physical device, not an AI/ML algorithm)
To obtain this kind of information, you would typically need to review the full 510(k) submission summary or associated testing reports, which are not included in this FDA clearance letter.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2004
Mr. Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs MedTrade Products, Limited Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
Re: K030901
Trade/Device Name: Soothing Gel Patch Regulation Number: 880.5630 Regulation Name: Nursing Pad, Hydrogel Regulatory Class: I Product Code: NTC Dated: September 27, 2004 Received: September 27, 2004
Dear Mr. Ranfield:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register.
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Page 2 - Mr. Ranfield
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KOCX-1(
Indications for Use
510(k) Number (if known) K030901
Device Name: MedTrade Product's Soothing Gel Patch
Indications for Use:
To relieve nipples that are sore and cracked from breastfeeding.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton Drmic
(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental Device
510(k) Number: K
§ 880.5630 Nipple shield.
(a)
Identification. A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.(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.