← Product Code QSY · K240454 # RESPONDER® Polysaccharide Hemostat (K240454) _Starch Medical, Inc. · QSY · Mar 15, 2024 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K240454 ## Device Facts - **Applicant:** Starch Medical, Inc. - **Product Code:** QSY - **Decision Date:** Mar 15, 2024 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions, ## Device Story RESPONDER® Polysaccharide Hemostat is a topical hemostatic agent composed of absorbable modified polymer (AMP®) particles derived from plant starch. The device is used for the local management of minor bleeding, such as cuts, lacerations, and abrasions. It is intended for over-the-counter (OTC) use. Upon application to a bleeding site, the starch-based particles absorb fluid and form a gel barrier, which facilitates hemostasis. The device is biocompatible, non-pyrogenic, and contains no human or animal components. It is supplied in foil pouches and is available in multiple model sizes (2g, 3g, 5g). ## Clinical Evidence No clinical data provided. Performance and safety were verified based on the previously cleared predicate device (K220525), confirming identical biocompatibility, sterility, and hemostatic performance. ## Technological Characteristics Composed of absorbable modified polymer (AMP®) particles derived from plant starch. Physical form: granules/powder. Packaging: foil pouch. Mechanism of action: formation of a gel barrier to achieve hemostasis. Biocompatible and non-pyrogenic. Sterilization method is consistent with the predicate device. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - RESPONDER® Polysaccharide Hemostat ([K220525](/device/K220525.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 & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. March 15, 2024 Starch Medical, Inc. Alice Li Regulatory Affairs Project Manager 2150 Ringwood Ave. San Jose, California 95131 Re: K240454 Trade/Device Name: RESPONDER® Polysaccharide Hemostat Regulatory Class: Unclassified Product Code: QSY Dated: February 15, 2024 Received: February 15, 2024 Dear Alice Li: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Yu-chieh Chiu -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K240454 Device Name RESPONDER® Polysaccharide Hemostat Indications for Use (Describe) RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." {3}------------------------------------------------ ## 510(k) Summary [As required by 21 CFR 807.92] #### 1. Submitter's Information | Name of Sponsor: | Starch Medical Inc. | |------------------|----------------------------------------------| | Address: | 2150 Ringwood Avenue San Jose California USA | | Contact Name: | Alice Li | | Telephone No.: | 408-428-9818 | | Fax No.: | 408-383-9189 | | Email Address: | alice@starchmedical.com | #### 2. Correspondent's Information | Company Name: | Starch Medical Inc. | |---------------------|-------------------------| | Correspondent Name: | Alice Li | | Telephone No.: | 408-428-9818 | | Email Address: | alice@starchmedical.com | ### 3. Trade Name, Common Name, Classification | Trade Name: | RESPONDER® | |---------------------------|------------------------------------| | Device Name: | Responder® Polysaccharide Hemostat | | Mode Name: | RP0002/RP0003/RP0005 | | Regulation Classification | Unclassified | | Product Code: | QSY | | Classification Panel: | General and Plastic Surgery | Device Class: ### 4. Identification of Predicate Device(s) The identified predicates within this submission are as follows: Responder® Polysaccharide Hemostat has been cleared by FDA through K220525 (Decision Date- December 04, 2023) {4}------------------------------------------------ #### 5. Description of the Device Responder® Polysaccharide Hemostat has been cleared by FDA through K220525 (Decision Date- December 04, 2023) for both Rx and OTC indications. This submission is intended to add three models containing smaller hemostatic powder of 2q, 3g and 5q to the OTC indications. There are no changes on raw material, production technique, packaging, sterilization, and indications for these three new models comparing with cleared products. RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyroqenic and derived from plant starch. The device contains no human or animal components. #### 6. Intended Use/Indication for Use RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as minor lacerations, minor cuts and minor abrasions, #### 7. Technological Characteristics The three new models RP0002, RP0003 and RP0005 are identical with RESPONDER® Polysaccharide Hemostat (K220525) in aspects of composition, form of device, method of application, sterilization, mechanism of action, biocompatibility, and resorption performance. The intended use is identical with the OTC indications of RESPONDER® Polysaccharide Hemostat (K220525) as well. It is concluded that the subject device is substantially equivalent with the predicate device RESPONDER® Polysaccharide Hemostat (K220525) in OTC indications. #### 8. Performance The subject device has the same physical structure (Granules), same packaging (Foil Pouch) and same shelf life as that of the predicate. Both of the devices can achieve hemostasis by forming a gel barrier. The bio-compatibility, sterility and performance of the subject device have been verified in the submission of RESPONDER® Polysaccharide Hemostat (K220525).It is concluded that the proposed device is as safe as the predicate device. #### 9. Conclusion In accordance with the Federal Food, Druq and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Starch Medical Inc. concludes that RESPONDER® Polysaccharide Hemostat is substantially equivalent to predicate devices with reqard to safety and performance. --- **Source:** [https://fda.innolitics.com/device/K240454](https://fda.innolitics.com/device/K240454) **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. 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