ALGS6 Ag Alginate Wound Dressing

K172570 · Foshan United Medical Technologies, Ltd. · FRO · May 11, 2018 · SU

Device Facts

• Record ID: K172570
• Device Name: ALGS6 Ag Alginate Wound Dressing
• Applicant: Foshan United Medical Technologies, Ltd.
• Product Code: FRO · SU
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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

Device Story

ALGS6 Ag Alginate Wound Dressing is a sterile, single-use, nonwoven pad or ribbon dressing composed of calcium alginate fiber, Lyocell fiber, and 1.7% ionic silver. Used in clinical or home settings, the dressing is applied to wounds to absorb exudate and bacteria. Upon contact with wound fluid, the dressing transforms into a soft, cohesive gel, maintaining a moist healing environment. The ionic silver acts as a preservative to inhibit bacterial growth within the dressing. The dressing is secured with a secondary dressing. It supports the body's natural healing process by managing moisture and controlling bacterial colonization within the dressing matrix. It is intended for both professional clinical management of complex wounds and OTC management of minor injuries.

Clinical Evidence

Bench testing included weight, dimensions, absorbency, pH, silver content/release, and antibacterial effectiveness (greater than 4 log reduction for 8 organisms). Biocompatibility testing included irritation, sensitization, acute systemic toxicity, pyrogenicity, and subchronic systemic toxicity. An animal wound healing study compared the subject device to the predicate, showing similar macroscopic and microscopic healing outcomes with no delay in wound healing.

Technological Characteristics

Nonwoven pad/ribbon dressing; materials: calcium alginate fiber, Lyocell fiber, 1.7% ionic silver. Sensing/actuation: passive absorption and gel formation. Dimensions: cut-to-fit. Connectivity: none. Sterilization: Gamma radiation (SAL 10^-6).

Indications for Use

Indicated for management of acute and chronic, partial and full thickness wounds (pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, 1st/2nd degree burns) under professional supervision. OTC use indicated for minor abrasions, lacerations, cuts, scalds, and burns.

Predicate Devices

• AQUACEL™ Ag EXTRA™ Hydrofiber™ Dressing with Silver and Strengthening Fiber (K121275)

Reference Devices

• KerraCel Ag Gelling Fiber Silver Dressing (K162508)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: [phone]

[e-mail] 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<br>ALGS6 Ag Alginate Wound Dressing | Predicate Device<br>AQUACEL™ Ag EXTRATM Hydrofiber™<br>Dressing with Silver and Strengthening Fiber,<br>ConvaTec Inc | Substantially<br>Equivalent or Not<br>Substantially<br>Equivalent |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| 510(k) Number<br>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<br>Configurations)<br>Under the supervision of a healthcare<br>professional, ALGS6 Ag Alginate Wound<br>Dressing may be used for management of<br>acute and chronic, partial and full<br>thickness wounds including pressure<br>ulcers, leg ulcers, diabetic foot ulcers,<br>surgical wounds, traumatic wounds, first<br>and second-degree burns. | AQUACEL™ Ag EXTRA™ Hydrofiber™<br>Dressing with Silver and Strengthening Fiber<br>may be used for the management of:<br>- Wounds as an effective barrier to bacterial<br>penetration of the dressing as this<br>may help reduce infection;<br>- Partial thickness (second degree) burns;<br>- Diabetic foot ulcers, leg ulcers, (venous stasis<br>ulcers, arterial ulcers and leg<br>ulcers of mixed etiology) and pressure<br>ulcers/sores (partial & full thickness);<br>- Surgical wounds left to heal by secondary<br>intention such as dlehisced surgical<br>incisions;<br>- Surgical wounds that heal by primary intent<br>such as dermatological and surgical<br>incisions (e.g. orthopedic and vascular);<br>- Traumatic wounds;<br>- Wounds that are prone to bleeding, such as<br>wounds that have been mechanically or<br>surgicaliy debrided and donor sites;- Oncology<br>wounds with exudate, such as fungoides-<br>cutaneous tumors, fungating carcinoma,<br>cutaneous metastasis, Kaposi's sarcoma, and<br>angiosarcoma;<br>- Painful wounds;<br>-Infected wounds | Substantially Equivalent |
| | For Over-the-Counter use, (Pad<br>Configuration)<br>ALGS6 Ag Alginate Wound Dressing may<br>be used for<br>- Minor Abrasions<br>- Minor Lacerations<br>- Minor cuts<br>- Minor scalds and burns | For Over-the-Counter Use:<br>AQUACELTMAg EXTRATM Hydrofiber™<br>Dressing with Silver and Strengthening Fiber<br>(K121275) may be<br>used for:<br>- Abrasions<br>- Lacerations<br>- Minor cuts<br>- Minor scalds and burns | |
| Device Design | Highly absorbable, single layer, needle<br>punched non-woven pad or ribbon<br>dressing that can be cut or folded. | Highly absorbable, two layers of ionic silver<br>impregnated sodium carboxymethylcellulose<br>stitched together with strengthening fibers, needle<br>punched non-woven pad dressing that can be cut<br>or folded. | Substantially Equivalent |
| Parameter | Subject Device<br>ALGS6 Ag Alginate Wound Dressing | Predicate Device<br>AQUACEL™ Ag EXTRATM HydrofiberTM<br>Dressing with Silver and Strengthening Fiber,<br>ConvaTec Inc | Substantially<br>Equivalent or Not<br>Substantially<br>Equivalent |
| Mechanism of<br>Action | Conformable, highly absorbent<br>hydrophilic dressing that forms a soft,<br>cohesive gel on contact with wound<br>exudate which maintains a moist<br>environment for optimal wound healing;<br>ionic silver inhibits bacterial colonization<br>of the dressing. | Same | Substantially Equivalent |
| Antibacterial<br>Material | Ionic silver | Ionic Silver | Substantially Equivalent |
| Antibacterial<br>Effectiveness within<br>the Dressing | Greater than 4 log reduction for 8<br>organisms<br>(4 gram positive, 4 gram negative) | Log reduction for 3 organisms (1 gram positive, 1<br>gram negative , 1 fungi) and Zone of Inhibition<br>for 19 organisms | Substantially Equivalent |
| Hydrophilic<br>Material | Alginate | Sodium carboxymethylcellulose | Substantially Equivalent |
| Method of<br>Affixation | Covered and secured with an appropriate<br>secondary dressing | Same | Substantially Equivalent |
| Wear Time per<br>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 |

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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.