(209 days)
AnsCare ChitoClot Pad is indicated for use of bleeding wound management. It promotes rapid control of wound bleeding and exudates absorption.
AnsCare ChitoClot Pad is indicated for use in wound management and to provide barrier to bacteria.
It is indicated for the following wounds, including lacerations, abrasions, hemodialysis wound and puncture sites for vascular procedures.
AnsCare ChitoClot Pad is made from cross-linked chitosan with glutaraldehyde. It works as a topical wound dressing intended to promote hemostasis when in contact with a bleeding wound. AnsCare ChitoClot Pad is made from chitosan whose hemostatic effect is independent of anticoagulant. Chitosan has a long clinical history of safety and effectiveness.
The provided text describes the AnsCare ChitoClot Pad, a wound dressing intended to promote hemostasis and provide a bacterial barrier.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document states, "All the test results demonstrate that AnsCare ChitoClot Pad meet the requirements of its pre-defined acceptance criteria and intended uses." However, it does not explicitly list specific numerical or qualitative acceptance criteria for each test performed. It only lists the tests themselves. Therefore, a table comparing acceptance criteria to reported performance cannot be fully constructed from the provided text.
The reported device performance, in a general sense, is that it "meet[s] the requirements of its pre-defined acceptance criteria and intended uses."
Table of Tests Performed and General Performance:
| Test Category | Test | Reported Performance |
|---|---|---|
| Biocompatibility | In Vitro Cytotoxicity Test | Met requirements (implied by overall statement) |
| Skin Irritation Study in White Rabbits | Met requirements (implied by overall statement) | |
| Skin Sensitization Study in Guinea Pigs | Met requirements (implied by overall statement) | |
| Acute Intravenous Systemic Toxicity Study in Mice | Met requirements (implied by overall statement) | |
| Acute Intraperitoneal Systemic Toxicity Study in Mice | Met requirements (implied by overall statement) | |
| Hemolysis Test | Met requirements (implied by overall statement) | |
| Pyrogen Test in White Rabbits | Met requirements (implied by overall statement) | |
| Bench Performance | Absorbency Testing | Met requirements (implied by overall statement) |
| pH Testing | Met requirements (implied by overall statement) | |
| Dimension and weight Testing | Met requirements (implied by overall statement) | |
| Barrier to bacteria Testing | Met requirements (implied by overall statement) | |
| Competitor analysis | Met requirements (implied by overall statement) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the non-clinical tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The animal studies mentioned (white rabbits, guinea pigs, mice) imply laboratory conditions, but no further details are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described are primarily non-clinical (biocompatibility and bench performance) and do not typically involve human expert interpretation for ground truth establishment in the way clinical studies with image analysis or diagnostics would.
4. Adjudication method for the test set
This information is not applicable/not provided. The listed tests are laboratory-based and generally have objective endpoints rather than requiring adjudication methods like those used in clinical trials with human readers.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in the context of this device. The device is a wound dressing, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical wound dressing and does not involve an algorithm.
7. The type of ground truth used
For the non-clinical biocompatibility and bench performance tests, the "ground truth" would be established by the standard scientific and regulatory protocols for each specific test (e.g., cell viability assays for cytotoxicity, physiological responses for irritation, specific absorption measurements for absorbency, microbial growth inhibition for barrier to bacteria). These are objective measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical wound dressing, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
April 21, 2023
BenQ Materials Corporation Ms. Kenix Chang Regulatory Affairs Specialist No. 29, Jianguo E. Rd. Gueishan 33341 Taoyuan, Taiwan (R.O.C.)
Re: K150963 Trade/Device Name: AnsCare ChitoClot Pad Regulatory Class: Unclassified Product Code: QSY
Dear Ms. Kenix Chang:
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 November 5, 2015. 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
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2015
BenQ Materials Corporation Ms. Kenix Chang Regulatory Affairs Specialist 29, Jianguo E. Road Gueshan 33341 Taoyuan, Taiwan (R.O.C)
Re: K150963
Trade/Device Name: AnsCare ChitoClot Pad Regulatory Class: Unclassified Product Code: FRO Dated: September 29, 2015 Received: October 5, 2015
Dear Ms. Chang:
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 (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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
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Indications for Use
510(k) Number (if known) K150963
Device Name AnsCare ChitoClot Pad
Indications for Use (Describe)
Ans Care ChitoClot Pad is indicated for use of bleeding wound management. It promotes rapid control of wound bleeding and exudates absorption.
AnsCare ChitoClot Pad is indicated for use in wound management and to provide barrier to bacteria.
It is indicated for the following wounds, including lacerations, abrasions, hemodialysis wound and puncture sites for vascular procedures.
| 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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AnsCare ChitoClot Pad
510(k) Summary
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Preparation Date: | April 2, 2015 |
| 5.3 | Submitter: | BenQ Materials Corporation |
| Address: | 29, Jianguo E. Rd., Gueishan 33341,Taoyuan, Taiwan (R.O.C) | |
| Phone: | +886-3-3748800 | |
| Fax: | +886-3-3763030 | |
| Contact: | Kenix Chang, Regulatory Affairs Specialist(Kenix.Chang@BenQMaterials.com) |
5.4 Identification of the Device:
| Proprietary/Trade name: | AnsCare ChitoClot Pad | |
|---|---|---|
| Classification Name: | Dressing, Wound, Drug | |
| Device Classification: | Unclassified | |
| Regulation Number: | — | |
| Panel: | General & Plastic Surgery | |
| Product Code: | FRO | |
| 5.5 | Identification of the Predicate Device: | |
| Predicate Device Name: | Clo-SurPLUS P.A.D. | |
| Manufacturer: | Scion Cardio-Vascular, Inc. | |
| Classification Name: | Dressing, Wound, Drug | |
| Device Classification: | Unclassified | |
| Regulation Number: | — | |
| Panel: | General & Plastic Surgery | |
| Product Code: | FRO | |
| 510(k) Number: | K032986 |
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5.6 Intended Use and Indications for Use of the subject device.
AnsCare ChitoClot Pad is indicated for use of bleeding wound management. It promotes rapid control of wound bleeding and exudates absorption.
AnsCare ChitoClot Pad is indicated for use in wound management and to provide barrier to bacteria.
It is indicated for the following wounds, including lacerations, abrasions, hemodialysis wound and puncture sites for vascular procedures.
5.7 Device Description
AnsCare ChitoClot Pad is made from cross-linked chitosan with glutaraldehyde. It works as a topical wound dressing intended to promote hemostasis when in contact with a bleeding wound. AnsCare ChitoClot Pad is made from chitosan whose hemostatic effect is independent of anticoagulant. Chitosan has a long clinical history of safety and effectiveness.
5.8 Non-clinical Testing
A series of non-clinical studies were conducted on the proposed device. All the test results demonstrate that AnsCare ChitoClot Pad meet the requirements of its pre-defined acceptance criteria and intended uses.
Biocompatibility testing:
- In Vitro Cytotoxicity Test
- . Skin Irritation Study in White Rabbits
- . Skin Sensitization Study in Guinea Pigs
- Acute Intravenous Systemic Toxicity Study in Mice
- . Acute Intraperitoneal Systemic Toxicity Study in Mice
- . Hemolysis Test
- Pyrogen Test in White Rabbits
Bench performance testing:
- . Absorbency Testing
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- . pH Testing
- . Dimension and weight Testing
- . Barrier to bacteria Testing
- Competitor analysis
5.9 Substantial Equivalence Determination
The AnsCare ChitoClot Pad submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the cleared Clo-SurPLUS P.A.D. (K032986). Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
| Proposed device | Predicate device | |
|---|---|---|
| Item | AnsCare ChitoClot Pad | Clo-SurPLUS P.A.D. |
| K number | – | K032986 |
| RegulationNumber | – | – |
| Classification | Unclassified | Unclassified |
| Product Code | FRO | FRO |
| Indicationsfor Use | AnsCare ChitoClot Pad is indicatedfor use of bleeding woundmanagement. It promotes rapidcontrol of wound bleeding andexudates absorption.AnsCare ChitoClot Pad is indicatedfor use in wound management andto provide barrier to bacteria.It is indicated for the followingwounds, including lacerations,abrasions, hemodialysis wound andpuncture sites for vascularprocedures. | The Scion Cardio-VascularClo-SurPLUS P.A.D., is intended forthe local management of bleedingwounds and to provide a barrier tobacterial penetration of the dressingin all patients and for the promotionof rapid control (hemostasis) ofbleeding in patients followinghemodialysis and for those onanticoagulation therapy.The dressing is indicated for thefollowing wounds: lacerations,abrasions, nose bleeds and the skin |
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| surface puncture sites for vascularprocedures, percutaneous cathetersor tubes. | ||
|---|---|---|
| AnatomicalSite | External wounds | External wounds |
| Material | Poly D-glucosamine and polyN-acetylglucosamine derived fromchitosan | Poly D-glucosamine and polyN-acetylglucosamine derived fromchitosan |
| Sterility | Gamma irradiation | Gamma irradiation |
| Packagematerial | foil bag | foil bag |
| Quantity | 1 Pc/Box | 10 Pc/Box |
| Size | 2 x 3 cm2 x 6 cm6 x 6 cm3 x 3 cm | 4 x 4 cm |
5.10 Similarity and differences
The differences between the proposed device and the predicate device are size and quantity. The proposed device has tested on safety and performance and the results were complied with the test requests. Therefore, the difference of proposed device and predicate device did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in intended use, design and performance claims.
5.11 Conclusion
After analyzing bench tests, device description and intended use/indications for use, it can be concluded that AnsCare ChitoClot Pad is as safe and effective as the predicate device.
N/A