(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological interactions of a wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a wound dressing that aids in wound healing by maintaining a moist environment, absorbing exudate, and assisting autolytic debridement. These functions directly contribute to the treatment of medical conditions (wounds), classifying it as a therapeutic device.
No
The device, KA01 Chitosan Wound Dressing, is used for managing wounds by absorbing exudate and maintaining a moist environment for healing, not for diagnosing medical conditions.
No
The device description clearly states it is a "sterile non-woven chitosan dressing comprising 100% chitosan fibers," which is a physical wound dressing, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside of the body (in vitro).
- Device Description: The KA01 Chitosan Wound Dressing is a physical dressing applied to the body to manage wounds. It absorbs exudate and forms a gel to aid healing. It does not perform any diagnostic tests on samples.
- Intended Use: The intended use is for the management of wounds, not for diagnosing any condition.
- Lack of Diagnostic Metrics: The performance studies and key metrics described are related to the physical properties and safety of the dressing (absorbency, biocompatibility, sterilization), not diagnostic performance metrics like sensitivity, specificity, etc.
The KA01 Chitosan Wound Dressing is a therapeutic medical device, specifically a wound dressing.
N/A
Intended Use / Indications for 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
Product codes
FRO
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:
5 x 5cm, 7.5 x 12cm, 10 x 10cm,
10 x 12cm, 10 x 20 cm
Flat Rope Dressing Sizes:
1.5 x 45cm, 2.5x45 cm, 3 x 45cm,
3 x 30cm, 4x10 cm, 4x20 cm, 4x30 cm
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
Prescription Use (Part 21 CFR 801 Subpart D) and Over-The-Counter Use (21 CFR 801 Subpart C)
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)
To verify that device design met its functional performance and safety requirements, 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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.