(151 days)
OTC:
StatSeal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns.
Rx:
StatSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
Components - StatSeal Disc is composed of two main components: Potassium ferrate, and hydrophilic polymer.
Mechanism of Action - StatSeal Disc achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.
The provided document is a 510(k) premarket notification for the StatSeal Disc, which aims to demonstrate its substantial equivalence to predicate devices. It does not contain acceptance criteria for specific performance metrics nor a detailed study proving the device meets acceptance criteria in the manner typically described for AI/ML medical devices.
The document focuses on:
- Substantial Equivalence: Arguing that the StatSeal Disc is substantially equivalent to existing predicate devices (Biolife, L.L.C.; PRO QR (Quick Relief) ® Powder (K080210) and Hemaderm (K021678)) based on identical claims, mechanism of action, and composition.
- Performance Testing Summary: Briefly listing types of tests performed (biocompatibility, in vitro, in vivo) without providing acceptance criteria or detailed results.
Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies (typical for AI/ML device evaluations) cannot be extracted from this document.
However, I can provide the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary criterion is "substantial equivalence" to predicate devices, implying similar safety and effectiveness.
- Reported Device Performance:
- Biocompatibility: "All required biocompatibility testing was conducted on PRO QR Powder (K080520) with no adverse results." Since StatSeal Disc and PRO QR Powder have identical composition, "no change in biocompatibility is expected."
- In vitro Testing: Studies performed include "Absorption Study, Scanning Electron Microscopy (SEM) Comparison, Hemostatic Properties of StatSeal Disc, Disintegration Study, Friability Study." No specific performance results or acceptance criteria are provided.
- In-vivo Testing: "A comparative Study Evaluating Vascular Access Hemostasis Properties of StatSeal Disc in GottinGen Minipigs." No specific performance results or acceptance criteria are provided. The conclusion states "StatSeal Disc induces hemostasis by fluid dehydration, protein coagulation and agglomeration."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified for any of the studies listed.
- Data Provenance: Not specified. The in-vivo study involved "GottinGen Minipigs," which are laboratory animals.
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)
- Not applicable/Not provided. The studies conducted are laboratory and animal studies, not human clinical trials requiring expert ground truth for diagnostic or prognostic purposes, and no mention is made of human expert review as a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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
- Not applicable. This is a medical device for hemostasis, not an AI/ML diagnostic or prognostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm. The in-vivo study assessed the device's performance in minipigs, which can be considered "standalone" in the sense that the device's intrinsic function was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the in-vivo study in minipigs, the ground truth would inherently be physiological measurements of hemostasis (e.g., time to hemostasis, blood loss) directly observed and quantified in the animals, rather than expert consensus or pathology in the human diagnostic sense. Specific metrics are not detailed in this summary.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that uses training sets.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
April 21, 2023
Biolife, LLC Claudia Masselink Director Quality Assurance 8163 25th Court East Sarasota, Florida 34243
Re: K130324 Trade/Device Name: Statseal Disc Regulatory Class: Unclassified Product Code: QSY
Dear Claudia Masselink:
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 July 9, 2013. 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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three curved lines representing snakes intertwined around a staff.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-GB19 Silver Spring, MD 20993-002
Biolife, L.L.C. % Ms. Claudia Masselink Director Quality Assurance 8163 25th Court East Sarasota, Florida 34243
Re: K130324
Trade/Device Name: StatSeal Disc Regulatory Class: Unclassified Product Code: FRO Dated: May 09, 2013 Received: May 13, 2013
Dear Ms. Masselink:
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 controls provisions 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
July 9, 2013
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Page 2 – Ms. Claudia Masselink
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification K130324 STATSEA
510(k) Number : K130324
Device Name: StatSeal Disc
Indications for Use:
OTC:
StatSeal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns.
Rx:
StatSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130324
Biolife. L.L.C. 8163 25" Court East, Sarasota, FL 34243
×
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510(k) Premarket Notification K130324 STATSEAL.
510(k) SUMMARY
This section contains the following information:
JUL 0 9 2013
·
l
| Section | Description | Page |
|---|---|---|
| 1 | Sponsor | 2 |
| 2 | Date Summary was Prepared | 2 |
| 3 | Device Information | 2 |
| 4 | Predicate Device | 2 |
| 5 | Device Description | 3 |
| 6 | Intended Use | 3 |
| 7 | Substantial Equivalence | 3 |
| 8 | Performance Testing | 4 |
| 9 | Conclusion | 4 |
:
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510(k) Premarket Notification K130324 STATSEAL
510(k) SUMMARY
1. Sponsor
Biolife, LLC
8163 25th Court East
Sarasota, FL 34243
Telephone: 941-360-1300
Fax: 941-360-1310
Registration Number: 1066421
Contact Person: Claudia A. Masselink
- Date Summary was Prepared
May 6, 2013
3. Device Information
| Proprietary Name: | StatSeal Disc |
|---|---|
| Common Name: | Hemostatic Disc Wound Dressing |
| Classification Name: | Dressing, Unclassified |
4. Predicate Device
Biolife, L.L.C.; PRO QR (Quick Relief) ® Powder (K080210)
Hemaderm (K021678)
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510(k) Premarket Notification K130324 STATSEAL.
5. Device Description
Components - StatSeal Disc is composed of two main components: Potassium ferrate, and hydrophilic polymer.
Mechanism of Action - StatSeal Disc achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.
6. Intended Use
OTC:
StatSeal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns.
Rx:
StatSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
7. Substantial Equivalence
StatSeal Disc has substantially equivalent claims to Biolife, L.L.C.; PRO QR (Quick Relief) ® Powder (K080210) predicate, in that it is indicated for topical application as an aid in the control of minor bleeding wounds. StatSeal Disc uses the same safe and effective technology as PRO QR (Quick Relief) ® Powder (K080210). The subject and predicate are identical devices. They are made from materials which have demonstrated satisfactory biocompatibility, are highly absorbent for collecting body fluids, and are sterile, single use devices.
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510(k) Premarket Notification K130324 STAT SEAL.
StatSeal Disc has identical claims to the HemaDerm (K021678) predicate in that it is intended to be applied to a vascular access site to control bleeding. Both HemaDerm and StatSeal Disc share a mechanism of action i.e. both products rapidly dehydrate blood.
8. Performance Testing
Biocompatibility Testing:
All required biocompatibility testing was conducted on PRO QR Powder (K080520) with no adverse results. StatSeal Disc and PRO QR Powder have identical composition therefore no change in biocompatibility is expected.
In vitro Testing:
Absorption Study, Scanning Electron Microscopy (SEM) Comparison, Hemostatic Properties of StatSeal Disc, Disintegration Study, Friability Study.
In-vivo Testing:
A comparative Study Evaluating Vascular Access Hemostasis Properties of StatSeal Disc in GottinGen Minipigs.
9. Conclusion
StatSeal Disc has the same intended use as the PRO QR Powder and HemaDerm predicate devices. StatSeal Disc raises no issues of safety or effectiveness. StatSeal Disc induces hemostasis by fluid dehydration, protein coagulation and agglomeration.
Biolife, LLC believes that, StatSeal Disc is safe and effective for temporary external control of minor bleeding from minor wounds, and for temporary external control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
N/A