Sterile Silver Alginate Wound Dressing

K220673 · Qingdao Bright Moon Biomedical Materials Co., Ltd. · FRO · Mar 16, 2023 · SU

Device Facts

• Record ID: K220673
• Device Name: Sterile Silver Alginate Wound Dressing
• Applicant: Qingdao Bright Moon Biomedical Materials Co., Ltd.
• Product Code: FRO · SU
• Decision Date: Mar 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Prescription Use: Sterile Silver Alginate Wound Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites. OTC: Sterile Silver Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

Device Story

Sterile, single-use wound dressing composed of calcium alginate, carboxymethylcellulose sodium, and silver sodium zirconium hydrogenphosphate. Functions by vertically absorbing wound exudate to form a gel, maintaining a moist wound environment, and releasing silver ions to reduce bacteria within the dressing. Intended for use in clinical or home settings. Applied by clinicians or patients. Silver component inhibits bacterial growth for up to seven days based on in-vitro testing. Facilitates intact removal of dressing. No clinical benefit demonstrated regarding antibacterial effectiveness.

Clinical Evidence

No clinical data. Evidence consists of bench testing including biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, implantation, pyrogenicity), liquid absorbency (EN 13726-1), and antimicrobial efficacy (AATCC 100-2019).

Technological Characteristics

Materials: Calcium alginate, carboxymethylcellulose sodium, silver sodium zirconium hydrogenphosphate. Principle: Alginate gel formation for moisture management and silver ion release for antibacterial effect. Dimensions: Various sheet/ribbon sizes. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 10993-1 (biocompatibility), EN 13726-1 (absorbency), USP <731> (loss on drying), USP <791> (pH), AATCC 100-2019 (antimicrobial efficacy).

Indications for Use

Indicated for management of moderate to heavily exuding partial to full thickness wounds (postoperative, trauma, leg/pressure/diabetic ulcers, graft/donor sites) in patients requiring prescription care, or as first aid for minor abrasions, cuts, lacerations, scrapes, scalds, and burns in the general population.

Predicate Devices

• Silver Alginate Dressing (Prescription use), Antibacterial Alginate Wound Dressing (OTC use) (K202982)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

March 16, 2023

Oingdao Bright Moon Biomedical Materials Co., Ltd. Deng Yunlong R&D Department Manager No. 788, Bright Moon Road, Huangdao District Qingdao, Shandong 266400 China

Re: K220673

Trade/Device Name: Sterile Silver Alginate Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 13, 2023 Received: February 14, 2023

Dear Deng Yunlong:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K220673

Device Name Sterile Silver Alginate Wound Dressing

Indications for Use (Describe)

Prescription Use:

Sterile Silver Alginate Wound Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

#### OTC:

Sterile Silver Alginate Wound Dressing (OTC) is first aid to help in minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

X 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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

{3}------------------------------------------------

## 510(K) Summary - K220673

This 510(K) Summary information is being submitted in accordance with 21 CFR 807.92.

## I. SUBMITTER:

Qingdao Bright Moon Biomedical Materials Co., Ltd. No. 788, Bright Moon Road, Huangdao District, Qingdao, Shandong,China Contact Person: Deng yunlong Title: R&D Department Manager Tel: [phone] Email: [e-mail]

Submission Correspondent: Deng yunlong Email: [e-mail] Tel:[phone]

Summary prepared: March 14th, 2023

## II. SUBJECT DEVICE

Name of Device: Sterile Silver Alginate Wound Dressing Classification Name: Dressing, Wound, Drug FDA Panel: General and Plastic Surgery Regulatory Class: Unclassified Product Code: FRO III. PREDICATE DEVICE

| Predicate Device: | Silver Alginate Dressing (Prescription use), Antibacterial |
|----------------------|------------------------------------------------------------|
| | Alginate Wound Dressing (OTC use) (K202982) |
| Classification Name: | Dressing, Wound, Drug |
| FDA Panel: | General and Plastic Surgery |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |

{4}------------------------------------------------

### IV. DEVICE DESCRIPTION

Sterile Silver Alginate Wound Dressing is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent. This highly absorbent dressing vertically absorbs wound exudate and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment and allows intact removal. Based on in-vitro testing, the silver in the dressing inhibits bacterial growth in the dressing for up to seven days. No clinical benefit has been demonstrated regarding the antibacterial effectiveness of the silver component.

## V. AVAILABLE MODELS

The proposed device is available in different sizes, as shown in the following table: Table 1 Device model of Sterile Silver Alginate Wound Dressing

| Model Name | Shape | Ref | Specification (cm) | Tolerance |
|-------------------------------------------|-------|------|--------------------|-----------|
| Sterile Silver Alginate<br>Wound Dressing | Sheet | YD05 | $5\times5$ | ±5% |
| | | YD10 | $7.5\times12$ | ±5% |
| | | YD15 | $10\times10$ | ±5% |
| | | YD20 | $10\times15$ | ±5% |
| | | YD25 | $10\times20$ | ±5% |
| | | YD30 | $12.5\times12.5$ | ±5% |
| | | YD40 | $15\times15$ | ±5% |
| | | YD50 | $15\times20$ | ±5% |
| | | YD60 | $15\times25$ | ±5% |
| | | YD65 | $20\times20$ | ±5% |
| | | YF01 | $2\times5$ | ±5% |
| | | YF02 | $2\times10$ | ±5% |
| | | YF03 | $2\times30$ | ±5% |
| | | YF04 | $2\times44$ | ±5% |
| | | YF05 | $3\times30$ | ±5% |
| | | YF06 | $4\times30$ | ±5% |

{5}------------------------------------------------

## VI. INTENDED USE per 21 CFR 807.92(A)(5)

### Prescription Use:

Sterile Silver Alginate Wound Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

## OTC:

Sterile Silver Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. THE PREDICATE DEVICE per 21 CFR 807.92(a)(6)

The Sterile Silver Alginate Wound Dressing is compared with the predicate device Silver Alginate Dressing (Prescription use), Antibacterial Alginate Wound Dressing (OTC use) (K202982), manufactured by Winner Medical Co., Ltd.

The results are shown below in the Technological Characteristics Comparison Table:

# Table 2 Technological Characteristics Comparison Table Between Subject Device and Predicate Device

| Item | Subject Device (K220673) | Predicate Device (K202982) | Comparison |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification<br>Product Code | FRO | FRO | Same |
| Classification<br>Regulation | Unclassified | Unclassified | Same |
| Indications for Use | Prescription Use:<br>Sterile Silver Alginate Wound<br>Dressing (Rx only) is indicated<br>for the management of moderate<br>to heavily exuding partial to full<br>thickness wounds, including,<br>postoperative wounds, trauma<br>wounds, leg ulcers, pressure<br>ulcers, diabetic ulcers, graft and<br>donor sites.<br>OTC:<br>Sterile Silver Alginate Wound<br>Dressing (OTC) is first aid to help<br>in minor abrasions, minor cuts. | Prescription:<br>Silver Alginate Dressing (Rx<br>only) is indicated for the<br>management of moderate to<br>heavily exuding partial to full<br>thickness wounds, including,<br>postoperative wounds, trauma<br>wounds, leg ulcers, pressure<br>ulcers, diabetic ulcers, graft and<br>donor sites.<br>OTC:<br>Antibacterial Alginate Wound<br>Dressing (OTC) is first aid to help<br>in minor abrasions, minor cuts. | Same |

{6}------------------------------------------------

| | minor lacerations, minor scrapes,<br>minor scalds and minor burns. | minor lacerations, minor scrapes,<br>minor scalds and minor burns. | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------|
| Mechanism | Alginate for absorbing liquid,<br>silver present in the alginate for<br>reducing bacteria in the dressing. | Alginate for absorbing liquid,<br>silver present in the alginate for<br>reducing bacteria in the dressing. | Same |
| Material | Calcium alginate,<br>Carboxymethylcellulose sodium,<br>Silver sodium zirconium<br>hydrogenphosphate | Alginate and silver | Different |
| Antibacterial<br>Duration | 7 days | 7 days | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Biocompatibility in accordance<br>to 10993-1(breached or<br>compromised surfaces with<br>prolonged contact(>24h to 30d)) | Biocompatibility in accordance<br>to 10993-1(breached or<br>compromised surfaces with<br>prolonged contact(>24h to 30d)) | Same |
| Sterilization | Gamma Irradiation<br>SAL:10-6 | Radiation<br>SAL:10-6 | Same |
| Free Swell<br>Absorption<br>Capacity | 15.7g/g | 14.2g/g | Different |

#### VIII. SUBSTANTIAL EQUIVALENCE DISCUSSION per 21 CFR 807.92(b)

Sterile Silver Alginate Wound Dressing has been conducted biocompatibility studies in accordance with ISO 10993 to demonstrate the device is as safe as its predicate device. The performance bench testing was conducted to demonstrate that the subject device is as effective as its predicate device.

### IX. PERFORMANCE DATA

#### Non-Clinical Performance Test Conclusion

#### Biocompatibility

Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1 Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with breached or compromised surface with prolonged duration. The subject device was evaluated for:

{7}------------------------------------------------

Cytotoxicity Sensitization Irritation Acute systemic toxicity Subacute systemic toxicity Implantation Material-mediated pyrogenicity

#### Performance Bench Testing

Performance testing were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Sterile Silver Alginate Wound Dressing complies with the following standards:

Liquid absorbency EN 13726-1-2002 Loss on Drying: USP <731> pH Value: USP <791> pH Antimicrobial Efficacy: AATCC 100-2019 Minimum Bacteriostatic Concentration Test: AATCC 100-2019

#### Clinical Test Conclusion

No clinical study is included in this submission.

### X. CONCLUSION per 21 CFR 807.92(c)

The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Sterile Silver Alginate Wound Dressing is as safe, as effective, and performs as well as or better than the legally marketed predicate device Silver Alginate Dressing (Prescription use), Antibacterial Alginate Wound Dressing (OTC use) (K202982).