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Seal-On™ Topical Hemostatic Spray is intended to be used for topical control of bleeding from minor cuts and abrasions of the skin surface.

Seal-On™ is a hemostatic powder spray containing Microdispersed Oxidized Cellulose in an aerosol form and is indicated for OTC use in the topical control of bleeding from minor cuts and abrasions of the skin surface.

The provided text is related to an FDA 510(k) clearance for a device called Seal-On™ Topical Hemostatic Powder Spray. It confirms the device's substantial equivalence to predicate devices for its intended use. However, the document does not contain specific details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The letter primarily covers:

• An administrative change in product code (from FRO to QSY).
• Confirmation of substantial equivalence based on a submission from 2002.
• The intended use of the device: "topical control of bleeding from minor cuts and abrasions of the skin surface."
• A brief description comparing the device to predicate devices, stating it uses microdispersed oxidized cellulose, which is derived from a plant source like the predicate devices' active components (alginate). It also mentions the low toxicity and antigenicity of oxidized cellulose and its history of safe use.
• A note that biocompatibility test results were included in the premarket notification.

Since the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text, I cannot complete the table or answer most of the questions.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not provided.
• Data provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not provided.
• Qualifications of experts: Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication method: Not provided. Evidence of a test set or clinical study is not detailed in the provided text.

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

• MRMC study: Not applicable. This device is a topical hemostatic powder spray, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of ground truth: Not explicitly stated. For a hemostatic device, this would typically involve direct observation of clotting time or cessation of bleeding in an appropriate model or trial, potentially with outcomes data confirming efficacy for minor cuts and abrasions. The document mentions "biocompatibility test results were included," but doesn't detail performance studies.

8. The sample size for the training set

• Sample size for training set: Not applicable as this is not an AI/ML device requiring a training set in the conventional sense. The "training" for such a device would be based on historical data, literature, and general scientific understanding of its components.

9. How the ground truth for the training set was established

• Ground truth for training set establishment: Not applicable. This is a physical medical device. The "ground truth" for its development would be established through established scientific principles of hemostasis, material science, and prior regulatory approvals of similar components (like oxidized cellulose).

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Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:

• Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
  Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.

This document is a 510(k) summary for the 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. It states that substantial equivalence was provided in previous 510(k) applications (K953781 and K980989) and that biocompatibility test results were also presented in those previous applications. Therefore, there is no new study or acceptance criteria information in the provided text to describe.

The letter explicitly states: "The 510(k) submission was not re-reviewed." (Page 0, K982638, Jun 11, 2023 letter) and "This letter corrects our substantially equivalent letter of August 21, 1998." (Page 1, K982638, Mar 1 9 2007 letter). This indicates that the current document is an administrative update and a correction to previous approvals, not a new submission with new performance studies.

Hence, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details. This information would have been contained in the original 510(k) submissions (K953781 and K980989) which are not provided here.

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