(297 days)
Prescription Use:
"Polyver Silver Alginate Dressing" 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 Use:
First aid to help in minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns
"Polyver Silver Alginate Dressing (Prescription and OTC)" is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which releases silver ions within the dressing and absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment.
The dressing may be used for periods up to 7 days, and can be removed intact during dressing changes
The alginate material consists of silver that controls bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against Gram positive and Gram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis.
Based on in vitro testing, the silver effectively reduces bacterial growth within the dressing for up to seven days. Use of this device should be discontinued completely after 7 days.
No clinical benefit has been demonstrated regarding the effectiveness of silver in the subject dressing.
The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Stability study shows the product has a shelf life of three years.
The provided text is a 510(k) summary for a medical device called "Polyver Silver Alginate Dressing." It details the device's description, indications for use, and comparison to predicate devices to establish substantial equivalence.
However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. The device described is a silver alginate wound dressing, which is a physical medical device, not a software-based or AI/ML product.
Therefore, I cannot extract the requested information regarding:
- Table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size and data provenance for an AI/ML test set.
- Number of experts and qualifications for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study for AI/ML.
- Standalone (algorithm only) performance for AI/ML.
- Type of ground truth used for AI/ML (expert consensus, pathology, etc.).
- Training set sample size for AI/ML.
- How ground truth for the training set was established for AI/ML.
The document does mention:
- Performance: "Antibacterial activity was measured following AATCC 100-2004 for total of six clinical relevant bacteria to evaluate antibacterial preservative effectiveness. 'Polyver Silver Alginate Dressing (Prescription and OTC)' is effective (>99.99% reduction) for seven days for all six bacteria..." This is a performance claim for the physical dressing's antibacterial properties, not for an AI/ML algorithm.
- Testing Method: Antibacterial activity was measured following AATCC 100-2004, and Biocompatibility was evaluated per ISO 10993-1: 2009. These are standard tests for material properties and an antibacterial agent, not AI/ML validation.
In summary, the provided text is relevant to a traditional medical device's 510(k) submission, not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 17, 2023
Roosin Medical Co., Ltd. % Charles Shen Director Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K230190
Trade/Device Name: Polyver Silver Alginate Dressing (Prescription and OTC) Regulatory Class: Unclassified Product Code: FRO Dated: February 21, 2023 Received: February 21, 2023
Dear Charles Shen:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Yu-chieh Chiu -S
Yu-Chieh Chiu, 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
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Indications for Use
510(k) Number (if known) K230190
Device Name
Polyver Silver Alginate Dressing (Prescription and OTC)
Indications for Use (Describe)
Prescription Use:
"Polyver Silver Alginate Dressing" 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 Use:
First aid to help in minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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:
This510(K) Summary is being submitted in accordance with the requirements of 21CFR 807.92
1.0 Submitter & Foreign Manufacture Identification
Roosin Medical Co., Ltd. 8 Yuandong Road, KouAn Town, Gaogang, Taizhou, Jiangsu Province, China 225321 Tel: (086) 523-86908085 Submitter's FDA Registration Number: 3007124979
2.0 Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
3.0 Date of Summary: November 15, 2023
4.0 Device Name:
| Trade Name: | Polyver Silver Alginate Dressing (Prescription and OTC) |
|---|---|
| Common Name: | Silver Alginate Dressing |
| Device Common Name: | Dressing, wound, Drug |
| Product Code: | FRO |
| Classification: | Unclassified |
| Review Panel: | General & Plastic Surgery |
5.0 Predicate Device Information:
- K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical (1) Solutions Ltd", located in Winsford, Cheshire, United Kingdom
- (2) K143335, "Roosin Silver Calcium Alginate Dressing/Roosin Antibacterial Calcium Alginate Dressing", manufactured by "Roosin Medical Co., Ltd." located in Taizhou, Jiangsu Province, China
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6.0 Device description:
"Polyver Silver Alginate Dressing (Prescription and OTC)" is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which releases silver ions within the dressing and absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment.
The dressing may be used for periods up to 7 days, and can be removed intact during dressing changes
The alginate material consists of silver that controls bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against Gram positive andGram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis.
Based on in vitro testing, the silver effectively reduces bacterial growth within the dressing for up to seven days. Use of this device should be discontinued completely after 7 days.
No clinical benefit has been demonstrated regarding the effectiveness of silver in the subject dressing.
The dressing has an off-white appearance and is available in the form of pad and in various different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.
Stability study shows the product has a shelf life of three years.
| Antibacterial Agent: | Silver Particles |
|---|---|
| Target Pathogens: | Gram positive bacteria and Gram negative bacteria. |
| Spectrum of Activity: | Based on in vitro testing, the silver effectivelyreduces bacterial growth within the dressing for upto seven days for Gram positive bacteria and Gramnegative bacteria, such as Escherichia coli ,Klebsiella pneumonia, Pseudomonas aeruginosa,Staphylococcus aureus, Staphylococcusepidermidis, Enterococcus faecalis. |
Product Information:
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| Concentration on the device: | Each dressing contains 0.3% w/w silver particles |
|---|---|
| ------------------------------ | -------------------------------------------------- |
7.0 Indications for Use:
Prescription Use:
"Polyver Silver Alginate Dressing" 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 Use:
First aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns
8.0 Comparison to Predicate Devices
The following table shows similarities and differences of use, design, material, and chemical treatment between our device and the predicate devices.
| Description | Subject Device | Predicate Device 1(K041316) | Predicate Device 2 (K143335) |
|---|---|---|---|
| Indication forUse | OTC:First aid to help in minorabrasions, minor cuts, minorlacerations, minor scrapes, minorscalds and minor burns.Prescription"Polyver Silver AlginateDressing" is indicated for themanagement of moderate toheavily exuding partial to fullthickness wounds, including,postoperative wounds, traumawounds, leg ulcers, pressureulcers, diabetic ulcers, graft anddonor sites | Prescription:"Silver Alginate II Dressing"is indicated for themanagement of moderate toheavily exuding partial to fullthickness wounds, including,postoperative wounds,trauma wounds, leg ulcers,pressure ulcers, diabeticulcers, graft and donor sites | OTC:First aid to help in minorabrasions, minor cuts,lacerations, scrapes, minorscalds and burns.PrescriptionRoosin Silver Calcium AlginateDressing is indicated for themanagement of moderate toheavily exuding partial to fullthickness wounds, including,postoperative wounds, traumawounds, leg ulcers, pressureulcers, diabetic ulcers, graft anddonor sites |
| Prescription/OTC | Prescription and OTC | Prescription | Prescription and OTC |
| Mechanism | Silver for antibacterial effect;calcium alginate for exudateabsorption and wound care | Silver for antibacterial effect;calcium alginate for exudateabsorption and wound care | Silver for antibacterial effect;calcium alginate for exudateabsorption and wound care |
| Design/Material | Calcium alginate, CMC, andsilver | Calcium alginate, CMC, andsilver | Calcium alginate and silver |
Table 5.1: Comparison of Intended Use, Design, and Material
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| Single Use | Yes | Yes | Yes |
|---|---|---|---|
| Sterile | Sterile | Sterile | Sterile |
"Polyver Silver Alginate Dressing (Prescription and OTC)" and its predicate devices are made from same materials, utilize same principles of operation, and have same indications for use.
Biocompatibility was evaluated per ISO 10993-1: 2009, and it was found that the subject device is as biocompatible as the predicate device. The following biocompatibility endpoints were considered:
Cytotoxicity (ISO 10993-5) Irritation & Sensitization (ISO 10993-10) Acute Systematic Toxicity (ISO 10993-11) Subacute Systematic Toxicity (ISO 10993-11) Material-Mediated Pyrogenicity (ISO 10993-11) Implantation (ISO 10993-6)
Antibacterial activity was measured following AATCC 100-2004 for total of six clinical relevant bacteria to evaluate antibacterial preservative effectiveness. "Polyver Silver Alginate Dressing (Prescription and OTC)'' is effective (>99.99% reduction) for seven days for all six bacteria, such as Escherichia coli , Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Enterococcus faecalis, within the dressing.
9.0 Substantial Equivalent Statement
Based on the comparison of intended use, design, materials, and performance, "Polyver Silver Alginate Dressing (Prescription and OTC)" is substantially equivalent to its predicate devices.
N/A