PosiSep " and PosiSep" X Hemostat Dressings are topical dressings for the temporary treatment of bleeding wounds such as surgical wounds (post operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. PosiSep"" and PosiSep"" X are intended for use under the direction of a licensed healthcare provider.

Device Description

The Hemostasis PosiSep™ and PosiSep™X Hemostat Dressings are sterile hemostats comprised of modified Chitosan particles and polysaccharide binders. Chitosan has well known hemostasis properties and, when combined with carboxymethylcellulose and hydroxyethylcellylose binders, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep" and PosiSep™ X Hemostat Dressings have the identical material composition as the currently market cleared Hemostasis ExcelArrest Topical Hemostat. The PosiSep " and PosiSep " X Hemostat Dressings are used for topical wounds. The dressings quickly dehydrate blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.

AI/ML Overview

The provided text describes the 510(k) summary for PosiSep™ and PosiSep™ X Hemostat Dressings. However, it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it relies on a "substantial equivalence" argument to predicate devices.

The available information regarding testing is general:

Biocompatibility testing was performed using ISO 10993 and FDA guidance.
Sterilization was validated using gamma radiation to assure a sterility assurance level (SAL) of 10⁻⁶.
Performance Bench Testing was performed for PosiSep™ X Hemostat Dressings to demonstrate physical and functional requirements were met.

Since specific performance data and acceptance criteria are not explicitly detailed in the provided text, the response below will reflect the lack of this information.

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for PosiSep™ and PosiSep™ X Hemostat Dressings does not explicitly state specific acceptance criteria or report detailed device performance results in a manner that would typically be seen in a clinical or robust standalone performance study demonstrating adherence to pre-defined criteria.

Instead, the submission primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "Conclusion" section states, "Through the data and information presented, Hemostasis, LLC considers the PosiSep™ and PosiSep™ X Hemostat Dressings substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness."

Here's an breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Functionality	"Physical and functional requirements were met" (for PosiSep™ X Hemostat Dressings based on Performance Bench Testing). However, no specific metrics or thresholds are provided.
Biocompatibility	"Pass the biocompatibility requirements for their intended use" based on ISO 10993 and FDA guidance. No specific test results or acceptance values are given.
Sterility	Sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 10⁻⁶. This implies meeting the SAL requirement.
Hemostatic Efficacy	No specific performance metrics (e.g., time to hemostasis, percentage of successful hemostasis) or acceptance criteria are reported in this document. The claim is based on being substantially equivalent to predicates known for hemostatic properties.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the mentioned tests (Biocompatibility, Sterilization, Performance Bench Testing).
- Data Provenance: Not specified.
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 specified. The provided document points to bench testing and biocompatibility assessments, not a study involving expert-established ground truth for performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.
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 device is a topical hemostat dressing, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system. Its performance evaluation would be through bench testing, in-vitro, or in-vivo (animal or human) studies. The document only vaguely mentions "Performance Bench Testing" for "physical and functional requirements."
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly defined in the provided document for its performance claims. For biocompatibility, the "ground truth" would be the established acceptable limits for biological response as defined by ISO 10993. For sterilization, it's the demonstration of SAL 10⁻⁶. For hemostatic efficacy, the document does not provide details on how "ground truth" was established, relying instead on substantial equivalence.
The sample size for the training set
- Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML model that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The FDA part of the logo is in blue.

July 28, 2023

Hemostasis, LLC Bernard Horwath Hemostasis Regulatory Affairs 5000 Township Parkway Saint Paul, Minnesota 55110

Re: K120958 Trade/Device Name: Posisep™ and Posisep™ X Hemostat Dressings Regulatory Class: Unclassified Product Code: QSY, LYA, NHB

Dear Bernard Horwath:

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 25, 2012. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY, LYA and NHB.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL 25 2012

Hemostasis, LLC % Mr. Bernard Horwath Hemastosis, Regulatory Affairs 5000 Township Parkway Saint Paul, Minnesota 55110

Re: K120958

Trade/Device Name: PosiSep™ and PosiSep™ X Hermostat Dressings Regulatory Class: Unclassified Product Code: FRO Dated: July 11, 2011 Received: July 12, 2011

Dear Mr. Horwath:

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 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Bernard Horwath

forth in the quality systems (QS) 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/ucm115809.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Eric Keith

Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_K12095B

PosiSep™ and PosiSep™ X Hemostat Dressings:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Office of Device Evaluation (ODE)

David Kraefer, MAS
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120958

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Kl20958 Page 1/2

510(k) Summary PosiSep™ and PosiSep™ X Hemostat Dressings

JUL 25 2012

Date Prepared: March 26, 2012 and revised July 9, 2012

Hemostasis, LLC Submitter: 5000 Township Parkway St. Paul, MN 55110 Telephone: 651- 855-1466 Fax: 651-855-1465
Mr. Bernard Horwath Contact: Hemostasis Regulatory Affairs 5000 Township Parkway St. Paul, MN 55110 Telephone: 651- 361-8041 Fax: 651-855-1465

Proprietary Name: PosiSep™ and PosiSep™ X Hemostat Dressings

Common/Usual Name: Topical Hemostat

Classification Name: Topical Hemostat, Unclassified, Product Code FRO

Establishment Registration Number: 3007225047

Description:

Indications for Use:

PosiSep™ and PosiSep™ X Hemostat Dressings are topical dressings for the temporary treatment of bleeding wounds such as surgical wounds (post operative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. PosiSep"" and PosiSep"" X are intended for use under the direction of a licensed healthcare provider.

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K120958. page 2/2

Substantial Equivalence:

The PosiSep" and PosiSep" X Hemostat Dressings are substantially equivalent to the following predicate devices:

Hemostasis ExcelArrest® Foam K072900 .
Hemostasis NexFoam® Topical Hemostat K102459 ●
HemCon Bandage K043050/K072486 .

Biocompatibility:

Biocompatibility testing was performed using ISO 10993 - Biological Evaluation of Medical Devices and FDA guidance document Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1). The PosiSep™ X Hemostat Dressings pass the biocompatibility requirements for their intended use.

Sterilization:

The PosiSep" and PosiSep" X Hemostat Dressings are sterilized using a validated gamma radiation method to assure a sterility assurance level (SAL) of 10°.

Performance Bench Testing:

Design verification testing was performed for the PosiSep™ X Hemostat Dressings to demonstrate physical and functional requirements were met.

Conclusion:

Through the data and information presented, Hemostasis, LLC considers the PosiSep" and PosiSep" X Hemostat Dressings substantially equivalent to the predicate devices already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design and functional performance and present no new concerns about safety and effectiveness.

Regulation Number and Section

N/A