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

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.

AI/ML Overview

The provided document is a 510(k) summary for the ALGS6 Ag Alginate Wound Dressing, seeking substantial equivalence to a predicate device. It describes the device, its intended use, and comparative testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" as pass/fail thresholds for clinical performance or diagnostic accuracy. Instead, it demonstrates substantial equivalence to a predicate device by comparing various performance parameters. The "acceptance criteria" can be inferred as being "substantially equivalent" to the predicate device in the parameters listed.

Parameter	Acceptance Criteria (inferred: Substantially Equivalent to Predicate)	Reported Device Performance (ALGS6 Ag Alginate Wound Dressing)	Proof of Criteria Met
Indications for Use (Rx Only)	Substantially Equivalent	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.	Stated as "Substantially Equivalent" to predicate device, which also manages these wound types. The listed indications for both are very similar, covering a wide range of acute and chronic wounds.
Indications for Use (OTC)	Substantially Equivalent	Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns.	Stated as "Substantially Equivalent" to predicate device, which has identical OTC indications.
Device Design	Substantially Equivalent	Highly absorbable, single layer, needle punched non-woven pad or ribbon dressing that can be cut or folded.	Stated as "Substantially Equivalent" to predicate device, which is also a highly absorbable, needle-punched non-woven pad dressing that can be cut or folded, though the predicate is described as two layers. The document argues this difference does not raise safety/effectiveness concerns.
Mechanism of Action	Substantially Equivalent	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.	Stated as "Same" as the predicate device. Both are hydrophilic dressings that gel in contact with exudate, providing a moist environment and using ionic silver for antibacterial effects.
Antibacterial Material	Substantially Equivalent	Ionic silver	Stated as "Same" as the predicate device.
Antibacterial Effectiveness within the Dressing	Substantially Equivalent	Greater than 4 log reduction for 8 organisms (4 gram positive, 4 gram negative).	Stated as "Substantially Equivalent." While the predicate tested log reduction for 3 organisms and Zone of Inhibition for 19, the subject device demonstrated a strong log reduction for a broader range of tested organisms. The implication is that this level of antibacterial effectiveness is comparable or superior in performance.
Hydrophilic Material	Substantially Equivalent	Alginate	Stated as "Substantially Equivalent." The document acknowledges the predicate uses sodium carboxymethylcellulose, but states that both materials perform the same primary function of absorption and moist wound healing, implying functional equivalence.
Method of Affixation	Substantially Equivalent	Covered and secured with an appropriate secondary dressing.	Stated as "Same" as the predicate device.
Wear Time per Dressing	Substantially Equivalent	Up to 7 days	Stated as "Substantially Equivalent." The predicate lists "Up to 7-14 days," but a 7-day wear time is considered within the range of equivalence.
Integral Removal	Substantially Equivalent	Yes	Stated as "Same" as the predicate device.
Single Use	Substantially Equivalent	Yes	Stated as "Same" as the predicate device.
Biocompatible	Substantially Equivalent	Yes	Stated as "Same" as the predicate device. This is supported by specific biocompatibility testing (irritation, sensitization, acute systemic toxicity, animal wound healing study, pyrogenicity testing, subchronic systemic toxicity study).
Sterilization	Substantially Equivalent	Gamma radiation (SAL 10-6)	Stated as "Same" as the predicate device. Supported by sterilization validation testing.
Primary Packaging	Substantially Equivalent	Foil pouch	Stated as "Same" as the predicate device. Supported by packaging testing.
Wound Healing Study	Non-inferiority to Predicate	Produced wound healing similar to the predicate device macroscopically and microscopically, and did not cause any delay in wound healing.	Animal wound healing study directly compared the subject device to the predicate device and found similar outcomes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and an animal wound healing study for performance evaluation. It does not mention human clinical trials or a "test set" in the context of diagnostic performance (e.g., patient images or data used to evaluate an AI algorithm).

Bench Testing: The sample size for each specific bench test (e.g., absorbency, silver content) is not specified.
Animal Wound Healing Study: The number of animals or wounds studied is not specified.
Data Provenance: The location of the testing is not explicitly stated. The manufacturer is in China, and the correspondent is in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the submission is for a wound dressing, not a diagnostic device that requires expert interpretation to establish ground truth for a test set. The wound healing study involved macroscopic and microscopic observation, likely by veterinary or histopathological experts, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the reasons stated above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable as the device is a wound dressing, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a wound dressing, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance testing:

Bench Testing: The "ground truth" for parameters like absorbency, silver content, pH, and antibacterial effectiveness is established by standardized laboratory methods and measurements.
Wound Healing Study: The "ground truth" for wound healing was based on macroscopic and microscopic observations of the wounds in animals, likely involving histopathological analysis (a form of pathology).
Biocompatibility Testing: The "ground truth" is based on standardized toxicity and reaction tests in biological systems (e.g., irritation, sensitization, systemic toxicity).

8. The sample size for the training set

This section is not applicable as the device is a physical wound dressing and does not involve an AI algorithm with a "training set."

9. How the ground truth for the training set was established

This section is not applicable as the device is a physical wound dressing and does not involve an AI algorithm with a "training set" or corresponding ground truth.

In summary, the provided document describes a 510(k) submission for a wound dressing, focusing on demonstrating substantial equivalence to a predicate device through a series of bench tests and an animal wound healing study. It does not involve AI, human reader studies, or diagnostic performance evaluation with expert consensus ground truth, which are typically found in submissions for AI/CADe medical devices.

Summary

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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.

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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:

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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."

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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."

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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

8. Indication for Use Rx Only (Pad and ribbon Configurations)

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 DeviceALGS6 Ag Alginate Wound Dressing	Predicate DeviceAQUACEL™ Ag EXTRATM Hydrofiber™Dressing with Silver and Strengthening Fiber,ConvaTec Inc	SubstantiallyEquivalent or NotSubstantiallyEquivalent
510(k) NumberDecision 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 RibbonConfigurations)Under the supervision of a healthcareprofessional, ALGS6 Ag Alginate WoundDressing may be used for management ofacute and chronic, partial and fullthickness wounds including pressureulcers, leg ulcers, diabetic foot ulcers,surgical wounds, traumatic wounds, firstand second-degree burns.	AQUACEL™ Ag EXTRA™ Hydrofiber™Dressing with Silver and Strengthening Fibermay be used for the management of:- Wounds as an effective barrier to bacterialpenetration of the dressing as thismay help reduce infection;- Partial thickness (second degree) burns;- Diabetic foot ulcers, leg ulcers, (venous stasisulcers, arterial ulcers and legulcers of mixed etiology) and pressureulcers/sores (partial & full thickness);- Surgical wounds left to heal by secondaryintention such as dlehisced surgicalincisions;- Surgical wounds that heal by primary intentsuch as dermatological and surgicalincisions (e.g. orthopedic and vascular);- Traumatic wounds;- Wounds that are prone to bleeding, such aswounds that have been mechanically orsurgicaliy debrided and donor sites;- Oncologywounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma,cutaneous metastasis, Kaposi's sarcoma, andangiosarcoma;- Painful wounds;-Infected wounds	Substantially Equivalent
	For Over-the-Counter use, (PadConfiguration)ALGS6 Ag Alginate Wound Dressing maybe 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 beused for:- Abrasions- Lacerations- Minor cuts- Minor scalds and burns
Device Design	Highly absorbable, single layer, needlepunched non-woven pad or ribbondressing that can be cut or folded.	Highly absorbable, two layers of ionic silverimpregnated sodium carboxymethylcellulosestitched together with strengthening fibers, needlepunched non-woven pad dressing that can be cutor folded.	Substantially Equivalent
Parameter	Subject DeviceALGS6 Ag Alginate Wound Dressing	Predicate DeviceAQUACEL™ Ag EXTRATM HydrofiberTMDressing with Silver and Strengthening Fiber,ConvaTec Inc	SubstantiallyEquivalent or NotSubstantiallyEquivalent
Mechanism ofAction	Conformable, highly absorbenthydrophilic dressing that forms a soft,cohesive gel on contact with woundexudate which maintains a moistenvironment for optimal wound healing;ionic silver inhibits bacterial colonizationof the dressing.	Same	Substantially Equivalent
AntibacterialMaterial	Ionic silver	Ionic Silver	Substantially Equivalent
AntibacterialEffectiveness withinthe Dressing	Greater than 4 log reduction for 8organisms(4 gram positive, 4 gram negative)	Log reduction for 3 organisms (1 gram positive, 1gram negative , 1 fungi) and Zone of Inhibitionfor 19 organisms	Substantially Equivalent
HydrophilicMaterial	Alginate	Sodium carboxymethylcellulose	Substantially Equivalent
Method ofAffixation	Covered and secured with an appropriatesecondary dressing	Same	Substantially Equivalent
Wear Time perDressing	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

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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).

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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.

Regulation Number and Section

N/A