← Product Code QSY · K120958 # POSISEP AND POSISEP X HEMOSTAT DRESSINGS (K120958) _Hemostasis, LLC · QSY · Jul 25, 2012 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K120958 ## Device Facts - **Applicant:** Hemostasis, LLC - **Product Code:** QSY - **Decision Date:** Jul 25, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended 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. ## Device Story PosiSep™ and PosiSep™ X are sterile, foam-type topical hemostat dressings; composed of modified chitosan particles and polysaccharide binders (carboxymethylcellulose and hydroxyethylcellulose). Applied topically to bleeding wounds by healthcare providers; mechanism involves rapid dehydration of blood cells; causes hemoconcentration of platelets, serum proteins, and fibrinogen; promotes rapid clotting to control bleeding and edema. Used in clinical settings for surgical, dermatological, and ENT applications. ## Clinical Evidence No clinical data. Evidence consists of bench testing and biocompatibility evaluation per ISO 10993 and FDA G95-1 guidance. Design verification testing confirmed physical and functional requirements. ## Technological Characteristics Sterile foam dressing; materials: modified chitosan, carboxymethylcellulose, hydroxyethylcellulose. Sterilization: gamma radiation (SAL 10^-6). ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Hemostasis ExcelArrest® Foam ([K072900](/device/K072900.md)) - Hemostasis NexFoam® Topical Hemostat ([K102459](/device/K102459.md)) - HemCon Bandage ([K043050](/device/K043050.md)/[K072486](/device/K072486.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ # 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ # 510(k) Number (if known):_K12095B # PosiSep™ and PosiSep™ X Hemostat Dressings: #### 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. 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 {4}------------------------------------------------ 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: 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. #### 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. {5}------------------------------------------------ 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. --- **Source:** [https://fda.innolitics.com/device/K120958](https://fda.innolitics.com/device/K120958) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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