(209 days)
Not Found
No
The summary describes a topical wound dressing made of chitosan, focusing on its material properties and hemostatic function. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are standard biocompatibility and bench tests for a wound dressing.
Yes
The device is described as promoting rapid control of wound bleeding and exudate absorption, and providing a barrier to bacteria for wound management, which are therapeutic functions.
No
The device is a topical wound dressing intended to promote hemostasis and absorb exudates, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is a "topical wound dressing" made from "cross-linked chitosan," indicating it is a physical material, 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 "bleeding wound management," "rapid control of wound bleeding and exudates absorption," and to "provide barrier to bacteria." These are all related to treating and managing external wounds on the body.
- Device Description: The device is described as a "topical wound dressing intended to promote hemostasis when in contact with a bleeding wound." This is a physical interaction with the wound itself.
- Lack of In Vitro Testing: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of this device and its testing focuses on its physical properties and interaction with the wound, not on analyzing bodily fluids or tissues.
- Bench Performance Testing: The bench testing listed (Absorbency, pH, Dimension, Barrier to bacteria) are all relevant to a wound dressing, not an IVD.
In summary, the AnsCare ChitoClot Pad is a wound dressing that acts topically on external wounds. It does not perform diagnostic testing on specimens taken from the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External wounds
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)
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
- pH Testing
- Dimension and weight Testing
- Barrier to bacteria Testing
- Competitor analysis
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 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
1
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
2
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
6
- . 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 |
| Regulation | ||
| Number | – | – |
| Classification | Unclassified | Unclassified |
| Product Code | FRO | FRO |
| Indications | ||
| for Use | 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. | The Scion Cardio-Vascular | |
| Clo-SurPLUS P.A.D., is intended for | ||
| the local management of bleeding | ||
| wounds and to provide a barrier to | ||
| bacterial penetration of the dressing | ||
| in all patients and for the promotion | ||
| of rapid control (hemostasis) of | ||
| bleeding in patients following | ||
| hemodialysis and for those on | ||
| anticoagulation therapy. | ||
| The dressing is indicated for the | ||
| following wounds: lacerations, | ||
| abrasions, nose bleeds and the skin |
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| | | surface puncture sites for vascular
procedures, percutaneous catheters
or tubes. |
|---------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Anatomical
Site | External wounds | External wounds |
| Material | Poly D-glucosamine and poly
N-acetylglucosamine derived from
chitosan | Poly D-glucosamine and poly
N-acetylglucosamine derived from
chitosan |
| Sterility | Gamma irradiation | Gamma irradiation |
| Package
material | foil bag | foil bag |
| Quantity | 1 Pc/Box | 10 Pc/Box |
| Size | 2 x 3 cm
2 x 6 cm
6 x 6 cm
3 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.