← Product Code QSY · K150963 # AnsCare ChitoClot Pad (K150963) _Benq Materials Corporation · QSY · Nov 5, 2015 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K150963 ## Device Facts - **Applicant:** Benq Materials Corporation - **Product Code:** QSY - **Decision Date:** Nov 5, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended 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. ## Device Story AnsCare ChitoClot Pad is a topical wound dressing composed of cross-linked chitosan; designed to promote hemostasis upon contact with bleeding wounds; functions independently of anticoagulants. Device provides exudate absorption and a physical barrier to bacteria. Used in clinical settings for management of lacerations, abrasions, hemodialysis wounds, and vascular puncture sites. Healthcare providers apply the pad directly to the wound site to control bleeding and manage the wound environment. Benefits include rapid hemostasis and protection against bacterial contamination. ## Clinical Evidence Bench testing only. Non-clinical evidence includes biocompatibility (cytotoxicity, skin irritation, skin sensitization, acute systemic toxicity, hemolysis, pyrogenicity) and bench performance testing (absorbency, pH, dimensions/weight, bacterial barrier). ## Technological Characteristics Material: Cross-linked chitosan (poly D-glucosamine and poly N-acetylglucosamine) with glutaraldehyde. Form factor: Pads of various dimensions (2x3 cm, 2x6 cm, 6x6 cm, 3x3 cm). Sterilization: Gamma irradiation. Packaging: Foil bag. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - Clo-SurPLUS P.A.D. ([K032986](/device/K032986.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 {3}------------------------------------------------ ### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ 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 | {5}------------------------------------------------ ### 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 | {7}------------------------------------------------ | | | 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. --- **Source:** [https://fda.innolitics.com/device/K150963](https://fda.innolitics.com/device/K150963) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com