(131 days)
Not Found
No
The device description and performance studies focus on the physical properties and hemostatic mechanism of the polysaccharide powder, with no mention of AI or ML.
Yes
The device is indicated for external temporary use as a topical dressing on minor bleeding wounds to achieve hemostasis, which is a therapeutic function.
No
The device is a hemostatic powder used as a topical dressing for minor bleeding wounds, which is a therapeutic function, not a diagnostic one. It aids in clotting blood rather than identifying a medical condition.
No
The device is a physical powder, not software. The description clearly states it is comprised of plant-based polysaccharides and functions through physical adsorption of water in blood.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "external temporary use as a topical dressing on minor bleeding wounds". This describes a device applied directly to the body for a therapeutic purpose (hemostasis).
- Device Description: The description explains how the powder works by absorbing water from blood to form a clot on the wound. This is a physical interaction with blood outside the body, not an analysis of blood or other biological samples in vitro (in a test tube or lab setting).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health or condition. IVDs are used to diagnose diseases, monitor treatments, or screen for conditions.
This device falls under the category of a topical hemostatic agent, which is a medical device used to control bleeding on the surface of the body.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
OSY
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.
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
Medical professionals
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 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.
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 shows the logos of the Department of Health & Human Services and the Food and 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.
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
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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, Zhuhai |
| 519040, P.R.China | |
| Contact person | Chen Yun |
| engineer15@honestmc.com | |
| Phone | +86-756-2992696 |
2. Correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times |
| Square, Nanshan District, Shenzhen | |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| 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 Without |
| Thrombin Or Other Biologics | |
| Review Panel: | General & Plastic Surgery |
| Product Code: | QSY |
| Device Class: | Unclassified |
4. Legally Marketed Predicate Device
| Trade Name | StopsBleeding™ Topical Hemostat Powder
and 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
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.
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.
| Comparison
item | Subject Device:
Polysaccharide
Hemostatic Powder (HP-
2, HP-3, HP-5)
(K240097) | Predicate Device:
StopsBleeding™ Topical
Hemostat Powder and Foam
(K140313) | Comments |
|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product
Code | QSY | QSY, LYA | Same |
| Classificatio
n | Unclassified | Unclassified | Same |
| Type of use | Prescription Use | Prescription Use, OTC | Same |
| Intended
use &
Indication
s 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. | The CoAg Medical, LLC
StopsBleeding™ Topical
Hemostat Powder and Foam
are intended for use as
topical dressings for the
management of bleeding
wounds and are available for
prescription use and over-the-
counter use.
Prescription: StopsBleeding™
Rx Topical Hemostat Powder
and Foam are indicated for
use as a topical dressing for
the temporary treatment of
moderate to severely
bleeding wounds such as
surgical wounds (post-
operative, donor sites,
dermatological), cuts and
lacerations and are also | Same |
| Comparison
item | Subject Device:
Polysaccharide
Hemostatic Powder (HP-
2, HP-3, HP-5)
(K240097) | Predicate Device:
StopsBleeding™ Topical
Hemostat Powder and Foam
(K140313) | Comments |
| | | indicated for control of
bleeding from the skin at
percutaneous needle access,
vascular access and
percutaneous catheter access
sites. StopsBleeding™ Rx is
intended for use under the
care of a health care
professional. | |
| | | OTC: StopsBleeding™ OTC
Topical Hemostat Powder
and Foam are indicated for
use as a topical dressing on
minor bleeding wounds such
as cuts, lacerations and
abrasions and for minor nose
bleeds. | |
| Applicable
user | Medical professionals | Medical professionals,
layman | Same |
| Single
/repeat use | Single use | Single use | Same |
| Sterile /non-
sterile | Sterile | Sterile | Same |
| Sterilization
method and
SAL | ETO sterile
SAL=10-6 | Gamma radiation
SAL=10-6 | Different
(issue 1) |
| Materials | Sodium Starch Glycolate | Sodium Starch Glycolate | Same |
| Patient -
contact
potential
(Duration
and type of
contact) | Breached or
compromised surfaces,
Up to 24 hours | Breached or compromised
surfaces,
Prolonged exposure of 24
hours 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.