(47 days)
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed.
Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package).
The provided text is a 510(k) premarket notification letter from the FDA regarding the Markwell Gauze Sponge. This document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
The letter is a regulatory document stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses general controls, classification, and responsibilities under the Federal Food, Drug, and Cosmetic Act.
Specifically, the document lacks the following information which would be necessary to answer the prompt:
- A table of acceptance criteria and the reported device performance: This type of data is not present in the regulatory notification.
- Sample size, data provenance, number of experts, qualifications, adjudication method related to a performance study: No such study is described.
- MRMC comparative effectiveness study or standalone performance study: These types of studies are not mentioned.
- Type of ground truth used or how it was established: Not applicable, as no performance study is detailed.
- Sample size for the training set: Not applicable, as no algorithm or AI is mentioned.
The "Indications for Use" section simply describes how the gauze sponges are to be used (nonsterile, external use, direct application, repacking and sterilization by domestic manufacturer if applicable). This is not a performance specification or acceptance criteria based on a study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 1998
Mr. Sean Wanq ·Vice President Markwell International, Inc. 2550 West Main Street, Suite 212 Alhambra, California 91801
Re: K982260 Trade Name: Markwell Gauze Sponge Requlatory Class: Unclassified Product Code: EFO Dated: June 22, 1998 Received: June 26, 1998
Dear Mr. Wang:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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 requlations.
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Page 2 - Mr. Sean Wang
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.qov/cdrh/dsmamain.html".
Sincerely yours,
Russell U. Sayer
& 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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510 (k) NUMBER (IF KNOWN) : K982260 DEVICE NAME: Markwell Gauze Sponge INDICATIONS FOR USE:
Markwell Gauze Sponges are nonsterile and for external use. It is supplied in bulk package (100/200pcs per package). To use it, simply apply the gauze pad to the area and change it when wet, or more often if needed.
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Markwell Gauze Sponges may be repacked and sterilized by domestic manufacturer. If so, users have to follow the manufacturer's instructions to use it.
Vessell, /. Eugene fr. IZO
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use √
(Optional Format 1-2-96)
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§ 880.2740 Surgical sponge scale.
(a)
Identification. A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.(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. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.