(286 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document refers to "substantial equivalence" to predicate devices for its intended use, implying performance was deemed comparable in terms of achieving hemostasis for minor cuts and abrasions. | Not explicitly quantified in the document. The document states "Oxidized cellulose has very low systemic toxicity and virtually no antigenicity or immunogenicity and has a long history of safe and effective use as an absorbable hemostatic agent during surgical procedures where it is partially or fully absorbed." It also notes that "Appropriate biocompatibility test results were included in the premarket notification." |
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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June 11, 2023
Alltracel Pharma Ltd. c/o Charles H. Kyper Kyper and Associates 103 Nolen Lane Chapel Hill, North Carolina 27516
Re: K010933 Trade/Device Name: Seal-On™ Topical Hemostatic Powder Spray Regulatory Class: Unclassified Product Code: QSY
Dear Charles H. Kyper:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 8, 2002. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2002
Alltracel Pharma Ltd. c/o Mr. Charles H. Kyper Kyper and Associates 103 Nolen Lane Chapel Hill, North Carolina 27516
Re: K010933/S3
Seal-On™ Hemostatic Powder Spray Regulatory Class: unclassified Product Code: FRO Dated: November 22, 2001 Received: November 26, 2001
Dear Mr. Kyper:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becermined the device is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate for associated in the encreations of the enactment date of the Medical Device Amendments or to conniner of the first in 110) 2011 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Oosmette He Act. The general controls provisions of the Act include requirements for annual provisions of the Previous and 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 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 Federal Register.
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 or any I vith 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 Orth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic roll in and ation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. Page 2 - Mr. Charles H. Kyper
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Page 2 - Mr. Charles H. Kyper
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Stypt Rhodes
Witten, Ph.D., Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Kol 09 33
3. STATEMENT OF INTENDED USE
Seal-On™ Topical Hemostatic Spray is intended to be used for topical control of bleeding from minor cuts and abrasions of the skin surface.
NRo for cmis
(Division Sign-Off) (Division of C neral, Restorative Division of ical Devices
510(k) Number K010983
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10. 510(k) Summary
JAN 0 8 2002
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Submitter: Alltracel Pharma Ltd. 10 Church Place Sallynoggin, Co, Dublin Republic of Ireland
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Contact Person: Dr. Ivan Santar, Scientific Director & QA Officer Phone: 011 353 1 2352162 or 011 420 504 410154
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Device Name: Seal-On™ Hemostatic Powder Spray
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Classification Name: Liquid Bandage (21 CFR 880.5090)
6. Device Description and Intended Use:
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.
7. Substantial Equivalence:
The intended use of Seal-On™ is consistent with that for the cited predicate devices. It differs from the predicate devices in that its active component is microdispersed oxidized cellulose that, similar to the predicate devices, is derived from a plant source. Oxidized cellulose has very low systemic toxicity and virtually no antigenicity or immunogenicity and has a long history of safe and effective use as an absorbable hemostatic agent during surgical procedures where it is partially or fully absorbed. The intended use of Seal-On™ results in extremely minimal absorption at best. Appropriate biocompatibility test results were included in the premarket notification.
N/A