← Product Code QSY · K172324 # Axiostat Chitosan Hemostatic Dressing (K172324) _Advamedica, Inc. · QSY · Feb 23, 2018 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K172324 ## Device Facts - **Applicant:** Advamedica, Inc. - **Product Code:** QSY - **Decision Date:** Feb 23, 2018 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions. ## Device Story Axiostat Chitosan Hemostatic Dressing is a single-use, sterile, chitosan-based dressing designed for topical hemostasis. It functions as a mechanical barrier to bleeding when applied with firm pressure to lacerations, minor cuts, or abrasions. The device is intended for over-the-counter use by patients or caregivers in home or clinical settings. It is available in various sizes, packaged in foil, and sterilized via gamma irradiation. The dressing is applied directly to the wound site and is intended for a maximum duration of 24 hours. By facilitating rapid hemostasis, the device aids in the management of minor external wounds. ## Clinical Evidence No human clinical data provided. Evidence consists of non-clinical bench testing and animal studies. Biocompatibility testing performed per ISO 10993-1:2009 (cytotoxicity, skin irritation, skin sensitization, acute systemic toxicity, hemolysis, pyrogenicity). Bench testing included physical properties, absorbency, moisture content, pH, tensile strength, and in-vitro hemostatic activity. An in-vivo rabbit hemostasis study was conducted. Heavy metal testing (Cd, Pb, As, Hg) met USP-232 limits. ## Technological Characteristics Material: 100% chitosan (natural polysaccharide). Form factor: Dressing in six sizes (2x2cm to 10x10cm). Principle: Mechanical barrier to bleeding. Sterilization: Gamma irradiation (ISO 11137-1:2006, ISO 11137-2:2013). Packaging: Foil bag, validated for 3-year shelf life per ASTM F-1980. Biocompatibility: ISO 10993-1:2009 compliant. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Chito-SAM™ Active ([K133121](/device/K133121.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 logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text. April 21, 2023 Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, California 92108 Re: K172324 Trade/Device Name: Axiostat Chitosan Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY Dear Alan Donald: 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 February 23, 2018. 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 23, 2018 Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, California 92108 Re: K172324 Trade/Device Name: Axiostat Chitosan Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 22, 2018 Received: January 23, 2018 Dear Alan Donald: We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); 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}------------------------------------------------ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ## David Krause -S Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K172324 Device Name Axiostat Chitosan Hemostatic Dressing Indications for Use (Describe) Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions. Type of Use (Select one or both, as applicable) __ Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for Advamedica. The logo consists of a stylized teal-colored mountain range to the left of the company name. The company name "ADVAMEDICA" is written in a gray sans-serif font, with all letters capitalized. 510(k) Summary {5}------------------------------------------------ K172324 p 2/6 ### 510(k) SUMMARY - K172324 Advamedica, Inc. ### AXIOSTAT CHITOSAN HEMOSTATIC DRESSING ### ADMINISTRATIVE INFORMATION - Date of Preparation: February 23, 2018 a. | b. | Submitter: | Advamedica Inc.
485 Massachusetts Avenue,
Suite 300, Cambridge,
Massachusetts 02139, USA
Tel: +1 973-718-7575
Fax: +1 888-584-8237 | |----|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | C. | Official Contact: | Mr. Leo Mavely, President
Email: office@advamedica.com
Web: www.advamedica.com | | d. | Prepared By: | Mr. Leo Mavely, President
Advamedica, Inc. | #### 2. DEVICE NAME AND CLASSIFICATION | a. | Trade/Proprietary Names: | Axiostat Chitosan Hemostatic Dressing | |----|--------------------------|---------------------------------------| | b. | Common Name: | Hemostatic Dressing | | c. | Classification Name: | Dressing, Wound, Drug | | d. | Device Class: | Unclassified | | e. | Product Codes: | FRO | | f. | Classification Panel: | General and Plastic Surgery | #### 3. PREDICATE DEVICE | Proprietary/Trade name | Chito-SAM™ Active | |------------------------|---------------------------| | Manufacturer | SAM Medical Products | | Classification Name | Dressing, Wound, Drug | | Device Class | Unclassified | | Panel | General & Plastic Surgery | | Product Code | FRO | | 510(k) Number | K133121 | #### DEVICE DESCRIPTION 4. Axiostat is a single use, hemostatic dressing made of 100% chitosan is a wellknown natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties. When applied on the bleeding site with firm pressure, the Axiostat {6}------------------------------------------------ ![ADVANMEDICA](https://i.imgur.com/9999999.png) Chitosan Hemostatic Dressing acts as a mechanical barrier against bleeding. The Axiostat is intended for a maximum duration of use of 24 hours, including bandage changes that may be needed. Axiostat is individually packaged in foil bags and sterilized using gamma irradiation. Axiostat is provided in six different sizes for over the counter use as listed below. | Axiostat Sizes | |----------------| | 10 x 10 cm | | 8 x 8 cm | | 8 x 5 cm | | 5 x 5 cm | | 3.5 x 3.5 cm | | 2 x 2 cm | #### INDICATIONS FOR USE ડ. Axiostat Chitosan Hemostatic Dressing is indicated to control bleeding of lacerations, minor cuts and abrasions. #### NON-CLINICAL TESTING 6. The subject device has been evaluated through a series of nonclinical studies. ### A. Biocompatibility testing: Biocompatibility tests have been performed per the requirements of ISO 10993-1:2009, under the section "surface devices used in breached and compromised surfaces with limited exposure (<24 hrs)". The following tests have been performed as per these requirements, - 1. Cytotoxicity - 2. Skin Irritation - 3. Skin Sensitization - 4. Acute Intravenous Systemic Toxicity - Acute Intraperitoneal Systemic Toxicity న్. - 6. Hemolysis Test - 7. Pyrogenicity Test ### B. Heavy metal testing The subject device was tested for cadmium, lead, arsenic and mercury. The levels for all elements were found to be fewer than 1 ppm. which meets the USP-232 limits. ### C. Bench performance testing: - 1. Physical Properties - 2. Absorbency Testing - 3. Moisture Content {7}------------------------------------------------ K172324 p 4/6 - 4. pH Testing - న్. Tensile strength - In-Vitro Hemostatic Activity 6. - 7. In Vivo rabbit hemostasis study #### STERILIZATION & PACKAGING 7. Axiostat Chitosan Haemostatic Dressing is supplied sterile in a foil bag. It is sterilized using gamma radiation to a sterility assurance level (SAL) of 106. Gamma sterilization validation was performed in compliance with the ISO 11137 Part-1:2006 and ISO 11137 Part-2:2013 standards. Following the gamma sterilization, the packaging was subjected to sterile barrier testing to validate a shelf life of three (3) years as per ISO and ASTM standards. - The stability and effectiveness of packaging of the sterilized product during the shelf-life a. period was confirmed by real time stability studies and accelerated aging test, per ASTM F-1980. - Package seal strength (Wet/Dry) per ISO11607-1:2006 b. - Dye penetration test as per ASTM F1929:15 C. - d. Sterility test as per US Pharmacopeia <71>. #### SUBSTANTIAL EQUIVALENCE DETERMINATION 8. The Axiostat Chitosan Hemostatic Dressing is substantially equivalent in intended use, indications for use, technology, material, design, packaging, sterilization, and performance claims to the predicate device, Chito-SAM™ Active (K133121). The following tables show the key characteristics of the subject and predicate devices. | | Subject device | Predicate device | Notes | |---------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------| | Manufacturer | Advamedica Inc. | SAM Medical Products | -- | | Model/Trade
Name | Axiostat Chitosan Hemostatic
Dressing | Chito-SAM™ Active | -- | | 510K Identifier | New device | K133121 | -- | | Common Name | Hemostatic dressing | Hemostatic Dressing | Same | | Classification | Unclassified | Unclassified | Same | | Product Code | FRO | FRO | Same | | Material | Chitosan | Chitosan | Same | | Intended Use | Hemostasis | Hemostasis | Same | | Indications for use | Axiostat Chitosan Hemostatic
Dressing is indicated to control
bleeding of lacerations, minor cuts
and abrasions. | Chito-SAM™ Active is indicated
to control bleeding of lacerations,
minor cuts and abrasions. | Same | Table 1: Comparison of technological characteristics of subject and predicate devices {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the words "TRADITIONAL 510K" in bold, uppercase letters. Below that, the words "Axiostat Chitosan Hemostatic Dressing" are also in bold. The text appears to be advertising a traditional product called Axiostat Chitosan Hemostatic Dressing. MEDICA | OTC/ Prescription | OTC | OTC | Same | |-------------------|-----------------------------------------------------------------------|--------------------------------------|------| | Anatomical Site | External wounds | External wounds | Same | | Package material | Foil Bag | Foil bag | Same | | Sterilization | Gamma irradiation | Gamma irradiation | Same | | Sizes | Axiostat:
10x10cm
8x8cm
8x5cm
5x5cm
3.5x3.5cm
2x2cm | 4 x 4-inch
3-inch x 6-foot Z-fold | -- | Table 2: Comparison of biocompatibility tests on subject and predicate devices | Biocompatibility Tests | Subject device
Axiostat Chitosan Hemostatic
Dressing | Predicate device
Chito-SAM™ Active
(K133121) | |--------------------------------------------------|------------------------------------------------------------|----------------------------------------------------| | Cytotoxicity Test | Non-cytotoxic | Non-cytotoxic | | Skin Irritation Study | Negative | Negative | | Skin Sensitization Study | Negative | Negative | | Acute Intravenous Systemic
Toxicity Study | Negative | Negative | | Acute Intraperitoneal Systemic
Toxicity Study | Negative | Negative | | Hemolysis | Negative | Negative | | Pyrogenicity Test | Negative | -- | The intended use and "Indications for Use" for the predicate device are identical to those of the Axiostat Chitosan Hemostatic Dressing. The chemical composition of the chitosan material in both products is the same. The technological and performance characteristics of the Axiostat are equivalent to the predicate device. No new issues regarding safety or efficacy are introduced by the Axiostat Chitosan Hemostatic Dressing. #### 9. SIMILARITY AND DIFFERENCES The subject device has the following similarities to the predicate devices: - > the same intended use - V the same material (chitosan) - > same indications of use - > identical biocompatibility characteristics - > same sterilization method. The minor differences in dimensions and form between the proposed device and predicate device do not affect the performance of proposed device or raise any safety concerns. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for ADVAMEDICA. The logo consists of a stylized "M" shape in teal, followed by the word "ADVAMEDICA" in gray. Above the logo, the text "K172324 p 6/6" is displayed in black. ### 10. CONCLUSION The Axiostat Chitosan Hemostatic Dressing shares its chemical composition and performance characteristics with the predicate device. The results of the performance testing confirm that the Axiostat Chitosan Hemostatic Dressing functions to its specifications, performs as intended, and exhibits the appropriate characteristics of a hemostatic dressing. The Axiostat is substantially equivalent to the predicate device in terms of materials, technological characteristics, intended use, indications for use, and performance. No new issues of safety or effectiveness are raised by the Axiostat Chitosan Hemostatic Dressing. --- **Source:** [https://fda.innolitics.com/device/K172324](https://fda.innolitics.com/device/K172324) **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