(374 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of a wound dressing, with no mention of AI or ML.
Yes.
Explanation: The device is a wound dressing indicated for the management of various wounds, including postoperative wounds, leg ulcers, pressure ulcers, and diabetic ulcers, which classifies it as a therapeutic device.
No
This device, a Sterile Silver Alginate Wound Dressing, is indicated for the management of wounds by absorbing exudate and releasing silver ions to reduce bacteria within the dressing. It is a wound care product designed for treatment and healing, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical wound dressing composed of calcium alginate and silver antibacterial agent, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "Sterile Silver Alginate Wound Dressing." It is a physical dressing applied to wounds.
- Intended Use: The intended use is for the management of wounds, both prescription and over-the-counter. This involves direct application to the body's surface, not testing of samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, use of reagents, or diagnostic purposes.
Therefore, this device falls under the category of a wound dressing, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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, 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.
Product codes
FRO
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.
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
Not Found
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
Non-Clinical Performance Test Conclusion:
- Biocompatibility: The subject device was evaluated for Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Subacute systemic toxicity, Implantation, Material-mediated pyrogenicity.
- Performance Bench Testing: Tests were conducted to verify the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The tests included Liquid absorbency (EN 13726-1-2002), Loss on Drying (USP ), pH Value (USP pH), Antimicrobial Efficacy (AATCC 100-2019), Minimum Bacteriostatic Concentration Test (AATCC 100-2019).
Clinical Test Conclusion: No clinical study is included in this submission.
Key Metrics
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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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: +86 18669829719 Email: yunlong.deng@bmsg.com
Submission Correspondent: Deng yunlong Email: yunlong.deng@bmsg.com Tel:+86 18669829719
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 |
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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 | ||||
| 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% |
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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 | |||
| Product Code | FRO | FRO | Same |
| Classification | |||
| Regulation | Unclassified | Unclassified | Same |
| Indications for 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. | Prescription: | ||
| Silver Alginate 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: | |||
| Antibacterial Alginate Wound | |||
| Dressing (OTC) is first aid to help | |||
| in minor abrasions, minor cuts. | Same |
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| | minor lacerations, minor scrapes,
minor scalds and minor burns. | minor lacerations, minor scrapes,
minor scalds and minor burns. | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------|
| Mechanism | Alginate for absorbing liquid,
silver present in the alginate for
reducing bacteria in the dressing. | Alginate for absorbing liquid,
silver present in the alginate for
reducing bacteria in the dressing. | Same |
| Material | Calcium alginate,
Carboxymethylcellulose sodium,
Silver sodium zirconium
hydrogenphosphate | Alginate and silver | Different |
| Antibacterial
Duration | 7 days | 7 days | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Biocompatibility in accordance
to 10993-1(breached or
compromised surfaces with
prolonged contact(>24h to 30d)) | Biocompatibility in accordance
to 10993-1(breached or
compromised surfaces with
prolonged contact(>24h to 30d)) | Same |
| Sterilization | Gamma Irradiation
SAL:10-6 | Radiation
SAL:10-6 | Same |
| Free Swell
Absorption
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:
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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 pH Value: USP 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).