(256 days)
No
The device description and performance studies focus on the material properties and antibacterial effectiveness of a wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing used for the management and healing of various types of wounds, which is a therapeutic purpose.
No
Explanation: This device is described as a wound dressing, designed to absorb wound fluid, assist in maintaining a moist environment, and prevent bacterial growth within the dressing to support the body's healing process. Its function is to facilitate healing, not to diagnose a condition or disease.
No
The device description clearly states it is a physical wound dressing composed of fibers and silver, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Description and Intended Use: The description and intended use of the ALGS6 Ag Alginate Wound Dressing clearly indicate it is a topical wound dressing. It is applied directly to wounds to absorb fluid, maintain a moist environment, and prevent bacterial growth within the dressing. It does not perform any diagnostic tests on bodily samples.
The information provided focuses on the physical properties of the dressing, its ability to absorb wound exudate, the presence of silver for antibacterial purposes within the dressing, and its performance in wound healing compared to a predicate device. None of this aligns with the function of an IVD.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, ALGS6 Ag Alginate Wound Dressing may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree bums. For Over-the-Counter use, ALGS6 Ag Alginate Wound Dressing may be used for: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
ALGS6 Ag Alginate Wound Dressing is a highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad) dressing composed of calcium alginate fiber, Lyocell fiber and 1.7% ionic silver which allows for a maximum of 30.6 mg of silver for a 4-inch dressing (0.306 mg per square centimeter). Silver is present in the dressing as a preservative to prevent or inhibit growth of bacteria within the dressing. The dressing absorbs high amounts of wound fluid and the bacteria contained in the wound fluid. The absorbed wound fluid in the dressing creates a soft and cohesive gel which assists in maintaining a moist environment. The moist wound healing environment and control of dressing bacteria supports the body's healing process.
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
Under the supervision of a healthcare professional, Over-the-Counter use
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 (weight and dimensions, absorbency, moisture content, pH, silver content, silver release, effective concentration, antibacterial effectiveness within the dressing), biocompatibility testing (irritation, sensitization, acute systemic toxicity, animal wound healing study, pyrogenicity testing, subchronic systemic toxicity study), packaging testing (pouch seal and transportation), sterilization validation testing, and shelf life stability testing (real time). ALGS6 Ag Alginate Wound Dressing (subject device) generally was observed to produce wound healing that was similar to AQUACEL ® Ag EXTRA™ (the predicate device) both macroscopically and microscopically. The ALGS6 Ag Alginate Wound Dressing does not cause any delay in wound healing in comparison to the predicate device.
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.
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 11, 2018
Foshan United Medical Technologies, Ltd. % Albert Rego Albert Rego, Ph.D. Inc. 27001 La Paz Road. Suite #314 Mission Viejo, California 92691
Re: K172570
Trade/Device Name: ALGS6 Ag Alginate Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 9, 2018 Received: April 12, 2018
Dear Albert Rego:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K172570
Device Name
ALGS6 Ag Alginate Wound Dressing (Pad and Ribbons Configurations)
Indications for Use (Describe)
Rx Only
Under the supervision of a healthcare professional, ALGS6 Ag Alginate Wound Dressing may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree bums.
| 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 Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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."
3
Indications for Use
510(k) Number (if known) K172570
Device Name
ALGS6 Ag Alginate Wound Dressing (Pad Configuration)
Indications for Use (Describe)
For Over-the-Counter use, ALGS6 Ag Alginate Wound Dressing may be used for:
- · Minor Abrasions
- · Minor Lacerations
- · Minor cuts
- · Minor scalds and burns
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 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."
4
K172570
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
Una Chen, Regulatory Affairs Manager
2. Submission Correspondent
Dr Albert Rego, Ph.D. 27001 La Paz Road, Suite #314 Mission Viejo, CA 92691 USA
Office: 949-770-8710 Cell: 949-632-8126 Fax: 949- 770-8715
albert@rego.com www.albert.rego.com
3. Date Prepared
July 31, 2017
4. Device Identification
| Trade/Proprietary Name: | ALGS6 Ag Alginate Wound Dressing |
|---|---|
| Common/Usual Name: | Dressing, Wound, Drug |
| Classification Name: | Unclassified |
| Classification Regulation: | Unclassified |
| Product Code: | FRO |
| Device Class: | Unclassified |
| Classification Panel: | General and Plastic Surgery |
5. Predicate Device
AQUACEL™ Ag EXTRATM Hydrofiber™ Dressing with Silver and K121275 Strengthening Fiber, ConvaTec Inc
6. Reference Device
K162508 KerraCel Ag Gelling Fiber Silver Dressing
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7. Device Description
ALGS6 Ag Alginate Wound Dressing is a highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad) dressing composed of calcium alginate fiber, Lyocell fiber and 1.7% ionic silver which allows for a maximum of 30.6 mg of silver for a 4-inch dressing (0.306 mg per square centimeter). Silver is present in the dressing as a preservative to prevent or inhibit growth of bacteria within the dressing. The dressing absorbs high amounts of wound fluid and the bacteria contained in the wound fluid. The absorbed wound fluid in the dressing creates a soft and cohesive gel which assists in maintaining a moist environment. The moist wound healing environment and control of dressing bacteria supports the body's healing process.
8. Indication for Use Rx Only (Pad and ribbon Configurations)
Under the supervision of a healthcare professional, ALGS6 Ag Alginate Wound Dressing may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second-degree burns.
For Over-the-Counter use (Pad Configuration), ALGS6 Ag Alginate Wound Dressing may be used for:
- Minor Abrasions
- . Minor Lacerations
- Minor cuts
- Minor scalds and burns
9. Comparison to Predicate
The intended use, device design, mechanism of action, material and performance testing of ALGS6 Ag Alginate Wound Dressing, as designed and manufactured, are determined to be substantially equivalent to the predicate device. ConvaTec's AOUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber, K121275. The differences between the ALGS6 Ag Alginate Wound Dressing and the predicate device do not raise different questions regarding its safety and effectiveness.
Exciton's KerraCel Ag Gelling Fiber Silver Dressing (K162508) has been identified as the Reference Device as K162508. It is also a gelling fiber dressing impregnated with silver and its silver content is the same as that for the subject device.
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| Parameter | Subject Device
ALGS6 Ag Alginate Wound Dressing | Predicate Device
AQUACEL™ Ag EXTRATM Hydrofiber™
Dressing with Silver and Strengthening Fiber,
ConvaTec Inc | Substantially
Equivalent or Not
Substantially
Equivalent |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| 510(k) Number
Decision Date | K172570 | K121275 | N/A |
| Manufacturer | Foshan United Medical Technologies Ltd | ConvaTec | N/A |
| Product Code | FRO | FRO | Substantially Equivalent |
| Indications for Use | Rx Only (Pad and Ribbon
Configurations)
Under the supervision of a healthcare
professional, ALGS6 Ag Alginate Wound
Dressing may be used for management of
acute and chronic, partial and full
thickness wounds including pressure
ulcers, leg ulcers, diabetic foot ulcers,
surgical wounds, traumatic wounds, first
and second-degree burns. | AQUACEL™ Ag EXTRA™ Hydrofiber™
Dressing with Silver and Strengthening Fiber
may be used for the management of:
- Wounds as an effective barrier to bacterial
penetration of the dressing as this
may help reduce infection; - Partial thickness (second degree) burns;
- Diabetic foot ulcers, leg ulcers, (venous stasis
ulcers, arterial ulcers and leg
ulcers of mixed etiology) and pressure
ulcers/sores (partial & full thickness); - Surgical wounds left to heal by secondary
intention such as dlehisced surgical
incisions; - Surgical wounds that heal by primary intent
such as dermatological and surgical
incisions (e.g. orthopedic and vascular); - Traumatic wounds;
- Wounds that are prone to bleeding, such as
wounds that have been mechanically or
surgicaliy debrided and donor sites;- Oncology
wounds with exudate, such as fungoides-
cutaneous tumors, fungating carcinoma,
cutaneous metastasis, Kaposi's sarcoma, and
angiosarcoma; - Painful wounds;
-Infected wounds | Substantially Equivalent |
| | For Over-the-Counter use, (Pad
Configuration)
ALGS6 Ag Alginate Wound Dressing may
be used for - Minor Abrasions
- Minor Lacerations
- Minor cuts
- Minor scalds and burns | For Over-the-Counter Use:
AQUACELTMAg EXTRATM Hydrofiber™
Dressing with Silver and Strengthening Fiber
(K121275) may be
used for: - Abrasions
- Lacerations
- Minor cuts
- Minor scalds and burns | |
| Device Design | Highly absorbable, single layer, needle
punched non-woven pad or ribbon
dressing that can be cut or folded. | Highly absorbable, two layers of ionic silver
impregnated sodium carboxymethylcellulose
stitched together with strengthening fibers, needle
punched non-woven pad dressing that can be cut
or folded. | Substantially Equivalent |
| Parameter | Subject Device
ALGS6 Ag Alginate Wound Dressing | Predicate Device
AQUACEL™ Ag EXTRATM HydrofiberTM
Dressing with Silver and Strengthening Fiber,
ConvaTec Inc | Substantially
Equivalent or Not
Substantially
Equivalent |
| Mechanism of
Action | Conformable, highly absorbent
hydrophilic dressing that forms a soft,
cohesive gel on contact with wound
exudate which maintains a moist
environment for optimal wound healing;
ionic silver inhibits bacterial colonization
of the dressing. | Same | Substantially Equivalent |
| Antibacterial
Material | Ionic silver | Ionic Silver | Substantially Equivalent |
| Antibacterial
Effectiveness within
the Dressing | Greater than 4 log reduction for 8
organisms
(4 gram positive, 4 gram negative) | Log reduction for 3 organisms (1 gram positive, 1
gram negative , 1 fungi) and Zone of Inhibition
for 19 organisms | Substantially Equivalent |
| Hydrophilic
Material | Alginate | Sodium carboxymethylcellulose | Substantially Equivalent |
| Method of
Affixation | Covered and secured with an appropriate
secondary dressing | Same | Substantially Equivalent |
| Wear Time per
Dressing | Up to 7 days | Up to 7-14 days | Substantially Equivalent |
| Integral Removal | Yes | Same | Substantially Equivalent |
| Single Use | Yes | Same | Substantially Equivalent |
| Biocompatible | Yes | Same | Substantially Equivalent |
| Sterilization | Gamma radiation (SAL 10-6) | Same | Substantially Equivalent |
| Primary Packaging | Foil pouch | Same | Substantially Equivalent |
7
Foshan United Medical Technologies Ltd 佛山市优特医疗科技有限公司
Traditional 510(k)
a) Summary of Technologies Characteristics
ALGS6 Ag Alginate Wound Dressing consists of alginate fiber with ionic silver and some structure material (Lyocell fibers). Alginate forms gel when in contact with wound fluid. The predicate device consists of carboxyethyl cellulose fiber impregnated with ionic silver. The predicate device also contains some structure material (Tencel fiber). Carboxyethy) cellulose fiber gels when in contact with wound fluid. The primary function of both devices is absorption of wound exudates and moist wound healing. Differences in process do not affect the safety and efficacy of the device.
- b) Summary of Performance Data
To verify that device design met its functional performance and safety requirements, representative samples of the device underwent testing including bench testing (weight and dimensions, absorbency, moisture content, pH, silver content, silver release, effective concentration, antibacterial effectiveness within the dressing), biocompatibility testing (irritation, sensitization, acute systemic toxicity, animal wound healing study, pyrogenicity testing, subchronic systemic toxicity study), packaging testing (pouch seal and transportation), sterilization validation testing, and shelf life stability testing (real time).
8
c) Wound Healing Study
ALGS6 Ag Alginate Wound Dressing (subject device) generally was observed to produce wound healing that was similar to AQUACEL ® Ag EXTRA™ (the predicate device) both macroscopically and microscopically. The ALGS6 Ag Alginate Wound Dressing does not cause any delay in wound healing in comparison to the predicate device.
10. Conclusion:
Foshan United Medical Technologies Ltd considers the ALGS6 Ag Alginate Wound Dressing to be substantially equivalent to the predicate device. This conclusion is based upon comparison of the subject device's similarities, and differences in intended use, design, mechanisms of action, technology, and performance testing data.