Who is the manufacturer of KA01 Chitosan Wound Dressing?

Foshan United Medical Technologies, Ltd. filed the 510(k) submission for KA01 Chitosan Wound Dressing (K143124).

What is the FDA product code for KA01 Chitosan Wound Dressing?

KGN. as a Class U device in the SU panel.

What is the regulatory pathway for KA01 Chitosan Wound Dressing?

510(k) clearance (submission type: Traditional).

What are the predicate devices for KA01 Chitosan Wound Dressing?

MedTrade Products Aquanova Super-Absorbent Dressing (K070175); Convatec Aquacel Hydrofibre Wound Dressing (K063271).

Who can help prepare an FDA 510(k) submission like KA01 Chitosan Wound Dressing?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

KA01 Chitosan Wound Dressing

K143124 · Foshan United Medical Technologies, Ltd. · KGN · Jan 26, 2015 · SU

Device Facts

Record ID	K143124
Device Name	KA01 Chitosan Wound Dressing
Applicant	Foshan United Medical Technologies, Ltd.
Product Code	KGN · SU
Decision Date	Jan 26, 2015
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for the management of: - Pressure sores - Diabetic ulcers - Leg ulcers - Donor sites and Graft sites - Surgical wounds - Skin abrasions and lacerations - 1st and 2nd degree burns - Trauma wounds The KA01 Chitosan Wound Dressing may be used for the management of: - Minor cuts - Minor scalds and 1st degree burns - Abrasions - Lacerations

Device Story

Sterile, non-woven, 100% chitosan fiber wound dressing; available as flat pads or ropes. Applied as primary dressing to chronic/acute wounds; secured with semi-permeable adhesive secondary dressing. Absorbs wound exudate to form soft, clear gel; maintains moist wound environment; aids autolytic debridement; allows painless, intact removal. Used in clinical or home settings; applied by healthcare professionals or patients. Remains in place up to 7 days. Benefits include optimal healing environment, patient comfort, and ease of removal.

Clinical Evidence

Bench testing only. Testing included absorbency, gel retention, moisture content, pH, viral inactivation, biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity), packaging integrity, sterilization validation (SAL 10^-6), and shelf-life stability (accelerated and real-time).

Technological Characteristics

100% chitosan fiber non-woven dressing. Absorbable, conformable, single-layer pad or ribbon. Dimensions: 25cm2 to 220cm2. Sterilization: Terminal sterilization to SAL 10^-6. Single-use. No electronic components or software.

Indications for Use

Indicated for management of moderately to heavily exuding chronic and acute wounds, including pressure sores, diabetic/leg ulcers, donor/graft sites, surgical wounds, abrasions, lacerations, 1st/2nd degree burns, and trauma wounds. OTC use indicated for minor cuts, scalds, 1st degree burns, abrasions, and lacerations.

Predicate Devices

MedTrade Products Aquanova Super-Absorbent Dressing (K070175)
Convatec Aquacel Hydrofibre Wound Dressing (K063271)

Related Devices

K172010 — gel-e Bandage · Gel-E, Inc. (Formerly Remedium Technologies, Inc.) · Dec 7, 2017
K212766 — Maxiocel Chitosan Wound Dressing · Advamedica, Inc. · Aug 24, 2023
K173005 — SURECELL Gelling Fiber Wound Dressing · Jiangsu Newvalue Medical Producst Co.,Ltd · May 25, 2018
K213473 — Antimicrobial Gelling Fiber Dressing with PHMB · Advanced Medical Solutions, Ltd. · Oct 26, 2023
K183645 — Silver High Performance Dressing · Advanced Medical Solutions, Ltd. · May 29, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 26, 2015 Foshan United Medical Technologies LTD % Ms. Marcia Palma NAMSA 4050 Olson Memorial Highway, Suite 450 Minneapolis, Minnesota 55422 Re: K143124 Trade/Device Name: KA01 Chitosan Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 30, 2014 Received: October 31, 2014 Dear Ms. Palma: 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K143124 Device Name KA01 Chitosan Wound Dressing Indications for Use (Describe) The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for the management of: - · Pressure sores - · Diabetic ulcers - · Leg ulcers - · Donor sites and Graft sites - · Surgical wounds - · Skin abrasions and lacerations - · 1st and 2nd degree burns - · Trauma wounds Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 Drug 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. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K143124 Device Name KA01 Chitosan Wound Dressing #### Indications for Use (Describe) The KA01 Chitosan Wound Dressing may be used for the management of: · Minor cuts - · Minor scalds and 1st degree burns - · Abrasions - · Lacerations 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) ,在线 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 Drug 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}------------------------------------------------ ## 510(k) Summary ## 1. Submission Sponsor Foshan United Medical Technologies Ltd 89 Taoyuan East Road, Shishan, Nanhai, Foshan Guangdong Province, 528225, P.R. China Office number: +86 (0)757 - 8120 8559 John Cen, Quality Assurance and Regulatory Affairs Manager #### 2. Submission Correspondent NAMSA 4050 Olson Memorial Hwy Suite 450 Minneapolis, MN 55422 Marcia Palma Senior Principal Consultant Office: 763-588-9847 Mobile: 612-269-3520 Fax: 763-287-3836 Email: mpalma@namsa.com ## 3. Date Prepared January 22, 2015 #### 4. Device Identification Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification Regulation: Product Code: Device Class: Classification Panel: KA01 Chitosan Wound Dressing Dressing, Wound, Drug Unclassified Unclassified FRO Unclassified General and Plastic Surgery ## 5. Predicate Devices | Primary: K070175 | MedTrade Products Aquanova Super-Absorbent Dressing | |--------------------|-----------------------------------------------------| | Secondary: K063271 | Convatec Aquacel Hydrofibre Wound Dressing | {5}------------------------------------------------ ## 6. Device Description The KA01 Chitosan Wound Dressing is a sterile non-woven chitosan dressing comprising 100% chitosan fibers. The KA01 Chitosan Wound Dressing is a highly absorbent, conformable and wet integral. As wound exudate is absorbed the chitosan forms a gel, which assists in maintaining a moist environment for optimal wound healing, aids autolytic debridement, and allows intact removal. The KA01 Chitosan Wound Dressing is intended for use as a primary dressing on a variety of chronic and acute wounds. It is intended to be secured with a semi permeable adhesive secondary dressing and to remain in place up to 7 days depending on the level of exudate. Dressings are individually packed in paper/poly pouches and terminally sterilized to achieve a SAL 106. A range of dressing sizes between 25cm2 and 220cm2 is available. | Flat Dressing Sizes: | Flat Rope Dressing Sizes: | |---------------------------------|-------------------------------------| | 5 x 5cm, 7.5 x 12cm, 10 x 10cm, | 1.5 x 45cm, 2.5x45 cm, 3 x 45cm, | | 10 x 12cm, 10 x 20 cm | 3 x 30cm, 4x10 cm, 4x20 cm, 4x30 cm | ## 7. Indication for Use Rx: The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for management of: - Pressure sores ● - Diabetic ulcers ● - Leg ulcers - Donor sites and graft sites - . Surgical wounds - Skin abrasions and lacerations - 1st and 2nd degree burns ● - Trauma wounds ● #### OTC: The KA01 Chitosan Wound Dressing may be used for the management of: - Minor cuts - Minor scalds and 1st degree burns ● - Abrasions - Lacerations {6}------------------------------------------------ ## 8. Comparison to Predicates The intended use, device design, mechanism of action, material and performance testing of KA01 Chitosan Wound Dressing, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate devices. The differences between the KA01 Chitosan Wound Dressing and the predicate devices do not raise any questions regarding its safety and effectiveness. | Comparison to Predicate Devices | | | | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameter | KA01 Chitosan Wound Dressings | Primary: Aquanova Super- Absorbent Dressing | Secondary: Aquacel Dressing | | 510(k) Number Decision Date | TBD | K070175 | K063271 | | Manufacturer | Foshan United Medical Technologies Ltd | MedTrade Products | Convatec | | Classification | Unclassified | Same | Class I | | Product Code | FRO | Same | NAC | | Regulation Number and Name | Unclassified | Same | 878.4018 Hydrophilic wound dressing | | Indications for Use | Rx: The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for the management of: • Pressure sores • Diabetic ulcers • Leg ulcers • Donor sites and Graft sites • Surgical wounds • Skin abrasions and lacerations • 1st and 2nd degree burns • Trauma wounds OTC: The KA01 Chitosan Wound Dressing may be used for the management of: • Minor cuts • Minor scalds and 1st degree burns • Abrasions • Lacerations | Under the supervision of a healthcare professional AQUANOVA may be used for wounds such as leg ulcers (Stages I-IV), diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree) and the management of surgical or traumatic wounds which have been left to heal by secondary intention. AQUANOVA may also be used for the local management of wounds that are prone to bleeding such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic | Under the supervision of a health care professional, Aquacel may be used for management of: - leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers - surgical wounds (post-operative, donor sites, dermatological) - second degree burns - surgical or traumatic wounds left to heal by secondary intention - local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds - the management of painful wounds | {7}------------------------------------------------ | Comparison to Predicate Devices | | | | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Parameter | KA01 Chitosan Wound Dressings | Primary: Aquanova Super- Absorbent Dressing | Secondary: Aquacel Dressing | | | | wounds. AQUANOVA can also be used in the control of minor bleeding. | For Over the Counter Use: Aquacel Hydrofiber Wound Dressing may be used for: | | | | AQUANOVA Super- Absorbent OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin. | -abrasions -lacerations -minor cuts -minor scalds and burns | | Intended Use | Intended for prescription use in the management of chronic wounds, postoperative wounds and traumatic wounds. Also intended for over-the-counter use for minor cuts, burns, abrasions and lacerations. | Same | Same | | Device Design | Absorbable, single layer, needle punched non-woven pad or ribbon dressing that can be cut or folded | Same | Same | | Material | 100% Chitosan fibers | Chitosan, chitosan derivatives, and structural material | Hydrocolloid fibers (sodium carboxymethyl- cellulose) | | Mechanism of Action | Conformable, highly absorbent dressing that forms a soft clear gel on contact with wound exudate which maintains a moist environment for optimal wound healing, provides patient comfort and allows painless intact removal. | Same | Same | | Sterility | SAL 10-6 | Same | Same | | Single Use | Yes | Same | Same | | Biocompatible | Yes | Same | Same | # 9. Functional and Safety Testing To verify that device design met its functional performance and safety requirements, {8}------------------------------------------------ representative samples of the device underwent testing including bench testing (absorbency, gel absorbency retention, moisture content, pH), viral inactivation testing, biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity), packaging testing (pouch seal and transportation), sterilization validation testing, and shelf life stability testing (accelerated aged and real time). #### 10. Conclusion Foshan United Medical Technologies Ltd considers the KA01 Chitosan Wound Dressing to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in intended use, design, mechanisms of action, technology and materials.