(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.
§ 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.