Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions.

Device Description

The Polysaccharide Hemostatic Powder (HP-2, HP-5) are sterile, topical wound dressings comprised of plant base polysaccharides. The hemostatic particles contained in powder absorb the water in the blood through physical adsorption, so that the blood components are concentrated to form a stable clot and achieve the purpose of hemostasis.

AI/ML Overview

The information provided pertains to the regulatory submission for a medical device (Polysaccharide Hemostatic Powder) and does not describe acceptance criteria for a study showing device performance in the way typically associated with AI/ML-based diagnostic devices. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through non-clinical testing.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable or not explicitly detailed in this type of submission.

However, I can extract the non-clinical testing performed and the conclusions drawn to fulfill the spirit of the request regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of this regulatory document.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Demonstrated through Non-Clinical Testing)	Reported Device Performance (Summary of Non-Clinical Testing)
Sterilization: Sterilization procedure validated per ISO 11135:2014.	Sterilization procedure validated in accordance with ISO 11135:2014, for ETO sterilization.
Shelf-Life: Demonstrate essential performance is achieved before and after shelf-life test at 2 years, validated per ASTM F1980-21 and packaging requirements per ISO 11607-1:2006.	Shelf-life for two years validated via accelerated testing (ASTM F1980-21) and packaging requirements (ISO 11607-1:2006) met. Essential performance achieved before and after shelf-life test.
Biocompatibility: Meet biocompatibility requirements per 2020 FDA Guidance (Use of International Standard ISO-10993-1) for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and pyrogenicity.	Biocompatibility evaluations conducted per FDA Guidance document 'Use of International Standard ISO-10993-1'. Tests performed for cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity.
Physical & Functional Requirements: Design verification testing demonstrates physical and functional requirements are met.	Design verification testing performed to demonstrate physical and functional requirements were met.
Safety and Effectiveness (Substantial Equivalence): Performed substantially equivalent to the predicate device in an animal model.	Safety and effectiveness study performed on a porcine animal model demonstrated substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in terms of numerical size for the animal model or other non-clinical tests. The document only mentions "a porcine animal model."
Data Provenance: The animal study was performed (implied as part of the manufacturer's testing). No country of origin for the data is specified, nor is it classified as retrospective or prospective (animal studies are typically prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This information is typically required for studies involving human clinicians interpreting data or images. The current submission describes non-clinical and animal testing.

4. Adjudication method for the test set

Not Applicable. Again, this is relevant for studies involving human interpretation and disagreement resolution, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. No MRMC study was conducted, as this device is a physical hemostatic powder, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used

For the animal study ("safety and effectiveness study on a porcine animal model"), the "ground truth" would likely be derived from direct observation of hemostasis and potentially histological examination of the wound site, compared to the performance of the predicate device. For other non-clinical tests (sterilization, shelf-life, biocompatibility, design verification), the ground truth is established by meeting predefined scientific and regulatory standards (e.g., bioassay results meeting specified limits, physical tests meeting design specifications).

8. The sample size for the training set

Not Applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/ML device requiring a training set.

Summary

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May 22, 2024

Ushare Medical Inc. % Joyce Yang Official Correspondent Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A. Zhongguan Times Square Nanshan District Shenzhen, 518000 China

Re: K240097

Trade/Device Name: Polysaccharide Hemostatic Powder (HP-2. HP-3. HP-5) Regulatory Class: Unclassified Product Code: OSY Dated: December 13, 2023 Received: January 12, 2024

Dear Joyce Yang:

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.

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Page

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).

Your device is also subject to, among other requirements, the Quality System (QS) 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.

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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,

Mustafa A. Mazher -S

for 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 Ouality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240097

Device Name

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

Indications for Use (Describe)

Polysaccharide Hemostatic Powder is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date of Summary prepare: May 22, 2024

1. Submitter

Applicant Name	Ushare Medical Inc.
Address	#445, Anji Zhong Road, Sanzao Town, Zhuhai519040, P.R.China
Contact person	Chen Yun
Email	engineer15@honestmc.com
Phone	+86-756-2992696

2. Correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen
Post Code	518000
Phone No.	+86-755-86069197
Contact Person	Joyce Yang
Email	joyce@cefda.com

Device Identification 3.

Type of 510(k) submission:	Traditional
Trade/Proprietary Name:	Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
Common name:	Hemostatic Wound Dressing WithoutThrombin Or Other Biologics
Review Panel:	General & Plastic Surgery
Product Code:	QSY
Device Class:	Unclassified

4. Legally Marketed Predicate Device

Trade Name	StopsBleeding™ Topical Hemostat Powderand Foam
Device Class	Unclassified
Review Panel	General & Plastic Surgery
510(k) Number	K140313
Product Code	QSY, LYA
Manufacturer	CoAg Medical LLC

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5. Device Description

6. Intended Use/ Indications for Use

Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) is indicated for external temporary use as a topical dressing on minor bleeding wounds such as minor cuts, minor lacerations and minor abrasions.

Comparisonitem	Subject Device:PolysaccharideHemostatic Powder (HP-2, HP-3, HP-5)(K240097)	Predicate Device:StopsBleeding™ TopicalHemostat Powder and Foam(K140313)	Comments
ProductCode	QSY	QSY, LYA	Same
Classification	Unclassified	Unclassified	Same
Type of use	Prescription Use	Prescription Use, OTC	Same
Intendeduse &Indications for Use	PolysaccharideHemostatic Powder (HP-2, HP-3, HP-5) isindicated for externaltemporary use as atopical dressing on minorbleeding wounds such asminor cuts, minorlacerations and minorabrasions.	The CoAg Medical, LLCStopsBleeding™ TopicalHemostat Powder and Foamare intended for use astopical dressings for themanagement of bleedingwounds and are available forprescription use and over-the-counter use.Prescription: StopsBleeding™Rx Topical Hemostat Powderand Foam are indicated foruse as a topical dressing forthe temporary treatment ofmoderate to severelybleeding wounds such assurgical wounds (post-operative, donor sites,dermatological), cuts andlacerations and are also	Same
Comparisonitem	Subject Device:PolysaccharideHemostatic Powder (HP-2, HP-3, HP-5)(K240097)	Predicate Device:StopsBleeding™ TopicalHemostat Powder and Foam(K140313)	Comments
		indicated for control ofbleeding from the skin atpercutaneous needle access,vascular access andpercutaneous catheter accesssites. StopsBleeding™ Rx isintended for use under thecare of a health careprofessional.
		OTC: StopsBleeding™ OTCTopical Hemostat Powderand Foam are indicated foruse as a topical dressing onminor bleeding wounds suchas cuts, lacerations andabrasions and for minor nosebleeds.
Applicableuser	Medical professionals	Medical professionals,layman	Same
Single/repeat use	Single use	Single use	Same
Sterile /non-sterile	Sterile	Sterile	Same
Sterilizationmethod andSAL	ETO sterileSAL=10-6	Gamma radiationSAL=10-6	Different(issue 1)
Materials	Sodium Starch Glycolate	Sodium Starch Glycolate	Same
Patient -contactpotential(Durationand type ofcontact)	Breached orcompromised surfaces,Up to 24 hours	Breached or compromisedsurfaces,Prolonged exposure of 24hours to 30 days	Different(issue 2)

7. Technological characteristics comparison

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Issue 1: The sterilization procedure has been validated in accordance with ISO 11135:2014. Therefore, it can be considered that this difference does not introduce new risks

lssue 2: The subject device is intended for emergency hemostasis and requires debridement within 24 hours. The contact time between the product and the patient shall not exceed 24 hours. The contact nature of this product is limited contact. Biocompatibility tests have been conducted according to Guidance of Use of International Standard ISO 10993-1, for cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity. Therefore, it can be considered that this difference does not introduce new risks.

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8. Summary of non-clinical testing

The Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) are sterilized by EO, and the sterilization procedure has been validated in accordance with ISO 11135:2014.

The shelf-life for two years had been validated in accelerated testing according to ASTM F1980-21 and the requirements on packaging for terminally sterilized medical device per ISO 11607-1:2006 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf-life test.

The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity and pyrogen tests were performed to demonstrate the biocompatibility of the device.

Design verification testing was performed on Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) to demonstrate the physical and functional requirements were met.

The safety and effectiveness study were performed on a porcine animal model demonstrate that the Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) performed substantially equivalent to the predicate device.

9. Brief discussion of clinical tests

No clinical tests were performed.

10. Conclusions

The conclusion drawn from the intended use and technological characteristics, supported by the non-clinical testing demonstrates that the subject device, Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) are as safe and effective, and is substantially equivalent to the legally marketed predicate device cleared under K140313.

Regulation Number and Section

N/A