(29 days)
Not Found
No
The summary describes a physical hemostatic device made of plant-derived particles and does not mention any software, image processing, or AI/ML terms.
No
The device is a hemostat used for the local management of bleeding, which is a treatment and not a diagnostic function.
No
The device is described as a hemostat for managing bleeding, not for diagnosing conditions.
No
The device description explicitly states it is composed of "absorbable modified polymer (AMP®) particles," which are a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management of bleeding such as lacerations, minor cuts and abrasions." This describes a direct application to the body for a therapeutic purpose (stopping bleeding).
- Device Description: The device is a "medical device composed of absorbable modified polymer (AMP®) particles" applied topically.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
Therefore, RESPONDER® Polysaccharide Hemostat OTC is a topical hemostatic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
QSY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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)
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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.