(193 days)
Prescription:
Roosin 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:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
Roosin Silver Calcium Alginate Dressing/ Roosin Alginate Dressing with Preservative is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which absorbs wound exudate and releases silver in the presence of wound fluid. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
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 both Gram positive and Gram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes. The in vitro test was for one day only, so the user is advised to change the dressing every day for antibacterial preservative use.
The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 60 x 70 mm, 100 mm, 100 mm, 100 mm x 150 mm, and 20 mm x 300 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. 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.
The provided text describes a medical device, the Roosin Silver Calcium Alginate Dressing, and its substantial equivalence to a predicate device. However, it does not contain information about a study that establishes acceptance criteria for performance, nor does it detail a study proving the device meets specific acceptance criteria related to efficacy beyond basic antibacterial activity.
The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device (K120181) based on intended use, design, materials, specifications, and performance. The "performance" mentioned primarily refers to bacteriostatic properties of the silver within the dressing and biocompatibility.
Here's an analysis of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy (as would be relevant for an AI/imaging device). It mentions that the device "meets the requirements of its pre-defined acceptance criteria and intended uses" but these criteria are not detailed.
However, it does provide specific performance data for its antibacterial properties against certain pathogens:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Meets requirements per ISO 10993-10 and ISO 10993-11. (Pass/Fail) |
| Sterility | Sterilized by radiation using conditions validated following ISO 11137-2: 2012. (Pass/Fail) |
| Antibacterial Efficacy | >99.99% reduction in bacterial growth (Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes) for 24 hours (tested in vitro following AATCC 100-2004). This implies the acceptance criterion was "greater than 99.99% reduction for listed bacteria for 24 hours". |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The antibacterial testing was an in vitro laboratory test, not a clinical study on a patient sample set. The sample size for this test would refer to the number of bacterial cultures or dressing samples tested, which is not specified but is typically much smaller than clinical study sample sizes.
- Data Provenance: The antibacterial activity test was an in vitro laboratory test. The document does not specify the country where this lab testing was performed, but the manufacturer is in China. The study was not a human data study (retrospective or prospective).
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)
- Not applicable. This device is a medical dressing, not an AI or diagnostic device that requires expert ground truth for interpretation of images or clinical data. The "ground truth" for the antibacterial test would be the observed bacterial growth reduction in the lab, which is a quantitative measurement, not an expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for studies involving human interpretation or consensus, such as in diagnostic imaging.
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
- Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/algorithm device. The "standalone" performance here would refer to the dressing's inherent physical and chemical properties and antibacterial function, which were tested in vitro.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For antibacterial efficacy: The ground truth was based on quantitative microbiological measurements of bacterial reduction in a laboratory setting.
- For biocompatibility: The ground truth was based on standardized in vitro and in vivo toxicology tests as per ISO 10993.
- No "expert consensus" or "outcomes data" were used for establishing the primary performance characteristics described.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of the "Study" mentioned:
The document refers to in vitro laboratory testing for evaluating the antibacterial preservative effectiveness of the dressing.
- Methodology: Antibacterial activity was measured following AATCC 100-2004.
- Test Organisms: Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes (Gram positive and Gram negative bacteria).
- Duration of Effect Tested: One day (24 hours).
- Results: The device demonstrated effectiveness (>99.99% reduction) for all six tested bacteria.
- Comparison: These results were deemed comparable to the predicate device when used for preservative purposes and changed at 24-hour intervals.
- Key missing information: The exact number of dressing samples or bacterial replicates tested in this AATCC 100-2004 study is not provided in this summary. There were no human subjects or clinical data in this study; it was an in vitro (laboratory bench) study.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2015
Roosin Medical Co., Ltd. % Mr. Charles Shen Manton Business and Technology Services 853 Dorchester Lane, Unit-B New Milford, New Jersey 07646
Re: K143335
Trade/Device Name: Roosin Silver Calcium Alginate Dressing (Prescription); Roosin Alginate Dressing with Preservative (OTC) Regulatory Class: Unclassified Product Code: FRO Dated: June 1, 2015 Received: June 1, 2015
Dear Mr. Shen:
This letter corrects our substantially equivalent letter of June 1, 2015.
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
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Page 2 - Mr. Charles Shen
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K143335
Device Name
Roosin Silver Calcium Alginate Dressing (Prescription) Roosin Alginate Dressing with Preservative (OTC)
Indications for Use (Describe)
Prescription:
Roosin 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:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, 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)
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Section 5: 510k Summary
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
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: 3007735241
US Agent and Contact Person
Charles Shen Manton Business and Technology Services 853 Dorchester LN, Unit-B New Milford, NJ 07646 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: June 1, 2015
Device Name:
| Trade Name: | Roosin Silver Calcium Alginate Dressing (Prescription)Roosin Alginate Dressing with Preservative (OTC) |
|---|---|
| Common Name: | Silver Alginate Dressing |
| Classification Name: | Dressing, wound, Drug |
| Product Code: | FRO |
| Regulation Number: | Unclassified |
| Review Panel: | General & Plastic Surgery |
Predicate Device Information:
- K 120181: "Luofucon Silver Alginate Dressing (Prescription Use)/ Luofucon (1) Antibacterial Alginate Dressing (OTC Use)", manufactured by "Huizhou Foryou Medical devices Co., Ltd." located in Huizhou, Guangdong Province, China
Device description:
Roosin Silver Calcium Alginate Dressing/ Roosin Alginate Dressing with Preservative is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and silver particles, which absorbs wound exudate and releases silver in the presence of
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Section 5: 510k Summary
wound fluid. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
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 both Gram positive and Gram negative bacteria, such as Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus pyogenes. The in vitro test was for one day only, so the user is advised to change the dressing every day for antibacterial preservative use.
The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 60 x 70 mm, 100 mm, 100 mm, 100 mm x 150 mm, and 20 mm x 300 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. 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.
| Preservative Agent: | Silver Particles |
|---|---|
| Target Pathogens: | Gram positive and Gram negative bacteria |
| Spectrum of Activity: | In vitro test results show antibacterial preservativeeffect for 24 hours against Gram positive andGram negative bacteria such as Escherichia coli,Klebsiella pneumonia, Pseudomonas aeruginosa,Staphylococcus aureus, Staphylococcus epidermidis,and Streptococcus pyogenes. |
| Concentration on the device: | Each 100 mm x 100 mm dressing contains 16.0 mg(1.4% w/w) silver particles |
Product Information:
Intended Use:
Prescription:
Roosin Silver Calcium 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:
First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
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Section 5: 510k Summary
Comparison to Predicate Devices
Roosin Silver Calcium Alginate Dressing/ Roosin Alginate Dressing with Preservative is compared with the following Predicate Devices in terms of intended use, design, material. specifications, and performance.
- K 120181: "Luofucon Silver Alginate Dressing (Prescription Use)// Luofucon (1) Antibacterial Alginate Dressing (OTC Use)", manufactured by "Huizhou Foryou Medical devices Co., Ltd." located in Huizhou, Guangdong Province, China
Both Roosin Silver Calcium Alginate Dressing/Roosin Alginate Dressing with Preservative and its predicate devices utilize silver to control bacterial growth within the dressing.
Both Roosin Silver Calcium Alginate Dressing/Roosin Alginate Dressing with Preservative and its predicate device utilize calcium alginate for the exudate absorption and wound management.
Roosin Silver Calcium Alginate Dressing/Roosin Alginate Dressing with Preservative and its predicate devices are made from similar materials, utilize the same mechanism to preserve the dressing, and have the same intended use.
Roosin Silver Calcium Alginate Dressing/Roosin Alginate Dressing with Preservative meets biocompatibility requirements per ISO 10993-10, and ISO 10993-11. It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2012. The product is safe and effective for its intended use.
Antibacterial activity was measured following AATCC 100-2004 for total of six clinical relevant bacteria to evaluate antibacterial preservative effectiveness. Roosin Silver Calcium Alginate Dressing/Roosin Alginate Dressing with Preservative is effective (>99.99% reduction) for all 6 bacteria and effect lasts for one day.
The results are comparable to the predicate devices when the dressings are used for preservative purpose and changed at 24-hour time intervals. Clinical data is not provided for this device.
Substantial Equivalent Statement
Based on the comparison of intended use, design, materials, and performance, our Roosin Silver Calcium Alginate Dressing/Roosin Alginate Dressing with Preservative is substantial equivalent to its predicate devices.
N/A