← Product Code QSY · K072900 # EXCELARREST FOAM (K072900) _Hemostasis, LLC · QSY · Oct 26, 2007 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K072900 ## Device Facts - **Applicant:** Hemostasis, LLC - **Product Code:** QSY - **Decision Date:** Oct 26, 2007 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds. Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. OTC: ExcelArrest™ is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds. ## Device Story ExcelArrest™ is a topical hemostatic foam bandage; composed of modified chitin particles and polysaccharide binders (sodium carboxymethylcellulose, hydroxyethylcellulose). Device functions by dehydrating blood cells upon contact; causes rapid hemoconcentration of platelets, serum proteins, and fibrinogen; accelerates clotting to control bleeding. Used in clinical settings (surgical/vascular access) and home/OTC settings (minor wounds/nose bleeds). Applied by clinicians or patients as a dressing. Benefits include rapid bleeding control in moderate to severe wounds and minor injuries. ## Clinical Evidence Bench testing and porcine model performance testing conducted. Devices met performance criteria. Biocompatibility evaluated per ISO 10993 and FDA G95-1 guidance; criteria satisfied. ## Technological Characteristics Foam bandage composed of modified chitin particles and polysaccharide binders (sodium carboxymethylcellulose, hydroxyethylcellulose). Manufactured via lyophilization process. Provided sterile. Biocompatibility tested per ISO 10993. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Hemostasis, LLC bandages ([K070211](/device/K070211.md)) - Hemcon bandage (K0303946) - Vascular Solutions bandage ([K050511](/device/K050511.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 shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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. June 11, 2023 Hemostasis, LLC Corporation % Keith Roberts Technical Business Development 5000 Township Parkway St. Paul, Minnesota 55110 Re: K072900 Trade/Device Name: ExcelArrest™ Foam Hemostat Bandage Regulatory Class: Unclassified Product Code: QSY, LYA Dear Keith Roberts: 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 October 26, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA. 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. Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is listed as an Assistant Director. The signature block includes the office she works in, DHT4B: Division of Infection Control and Plastic Surgery Devices. It also includes OHT4: Office of Surgical and Infection Control Devices, and the Office of Product Evaluation and Quality. Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The seal is in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Hemostasis, LLC Corporation % Mr. Keith Roberts Technical Business Development 5000 Township Parkway St. Paul, MN 55110 OCT 26 2007 Re: K072900 Trade/Device Name: ExcelArrest™ Foam Hemostat Bandage Regulatory Class: Unclassified Product Code: FRO Dated: November 6, 2007 Received: November 11, 2007 Dear Mr. Roberts: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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. {2}------------------------------------------------ ## Page 2 - Mr. Keith Roberts This letter will allow you to begin 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Intended Use/ Indications for Use 510(k) Number (if known): Device Name: Indications for Use: The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds. Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative, do noralites, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. OTC: ExcelArrest™ is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds. 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 OF NEEDED) Concurrence of Office of Device Evaluation (ODE) a see and service and superior and consistences ion Sign-Off Division of General. Resto and Neurological Devices **510(k) Number** L072900 {4}------------------------------------------------ K072900 page 1/2 510(k) Summary APPLICANT Hemostasis, LLC Corporation 5000 Township Parkway, St. Paul, MN 55110 Telephone: 651-855-1466 Fax: 651-651-855-1465 Contact: Keith Roberts Title: Technical Business Development 36 2 6 7001 Company Name: Hemostasis, LLC Classification Name: Dressing, Unclassified, Product Code - FRO Common/Usual Name: Topical hemostatic foam Proprietary Name: ExcelArrest™ (Rx) and (OTC) foam, Establishment Registration Number and Manufacturing Location: To be Assigned Hemostasis, LLC is located at 5000 Township Parkway, St. Paul, MN 55110. #### Performance Standards: N/A Substantial Equivalence: The Hemostasis, LLC ExcelArrest™ foam hemostat is Substantially Equivalent to the Hemostasis, LLC products that were the subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K050511. ### DESCRIPTION As described above, the Hemostasis, LLC hemostats are comprised of modified chitin particles and polysaccharide binders. The particles are dissolved in water, poured into appropriate trays and using a lyophylization process, the water is removed to form a foam bandage. Chitin has well known hemostasis properties and when combined with the sodium carboxymethylcellulose and hydroxyethylcellulose binders, has an affinity to hold water. The Hemostasis foam quickly dehydrates blood cells, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding in moderate to severe lacerations. # INDICATIONS FOR USE The Hemostasis, LLC wound dressings are intended for use as topical dressings for the management of bleeding wounds. Prescription: ExcelArrest™ is indicated for use as a topical dressing for the temporary treatment of moderate to severely bleeding wounds such as surgical wounds (post-operative a ) tradities, dermatological), cuts and lacerations and is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access and percutaneous catheter access sites. OTC: ExcelArrest™ foam is indicated for use as a topical dressing on minor bleeding wounds such as cuts, lacerations and abrasions and for minor nose bleeds. {5}------------------------------------------------ K072900 page 2/2 # PREDICATE DEVICES Hemostasis, LLC bandages subject of premarket notification K070211, the Hemcon bandage which was subject of premarket notification K0303946 and the Vascular Solutions bandage which was subject of premarket notification K050511. ### BIOCOMPATIBILITY The classification and applicable testing of the Hemostasis device was determined using guidelines of 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 criteria have been satisfied for biocompatibility. ### PORCINE MODEL FOR PERFORMANCE TESTING Comparative testing was performed using a Porcine Model and the devices met the performance criteria. The Hemostasis, LLC products will be provided sterile. ## CONCLUSION Through the data and information presented, Hemostasis, LLC considers the devices substantially equivalent to legally marketed predicated devices cited in this Premarket Notification. --- **Source:** [https://fda.innolitics.com/device/K072900](https://fda.innolitics.com/device/K072900) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com