(191 days)
Prescription Use: Under the supervision of a healthcare professional. Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites; Traumatic wounds. OTC Use: Extra Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns.
Extra Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose (CMC) fibers, strengthening fibers and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment. A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.
This document is an FDA 510(k) summary for a medical device called "Extra Silver Gelling Fiber Dressing". It describes the device and compares it to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and study information provided, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for this type of device (wound dressing) typically relies on demonstrating substantial equivalence to a predicate device rather than strict quantitative performance acceptance criteria for clinical efficacy in the same way a diagnostic AI device might. However, it does specify acceptance criteria for non-clinical tests.
| Acceptance Criteria (Non-Clinical Standard) | Reported Device Performance (Summary) |
|---|---|
| ISO 10993-5:2009 (Cytotoxicity) | Complies with standard |
| ISO 10993-10:2010 (Irritation & Sensitization) | Complies with standard |
| ISO 10993-11:2017 (Systemic Toxicity) | Complies with standard |
| ASTM F88/F88M-15 (Seal Strength) | Complies with standard |
| ASTM F1929-15 (Detecting Seal Leaks) | Complies with standard |
| USP <85> (Bacterial Endotoxins) | Complies with standard |
| AATCC 100-2012 (Antibacterial Finishes) | Demonstrates > 4 log-reduction against 4 gram-positive bacteria and 4 gram-negative bacteria within 7 days. |
| Biocompatibility (ISO 10993-1) | Test results meet requirements for breached or compromised surfaces with prolonged contact (>24h to 30d). |
| Absorbency Performance | Equivalent to the predicate device. |
| Tensile Strength Performance | Superior to the predicate device due to strengthening fibers. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical laboratory testing and equivalence comparisons. It does not involve a "test set" in the context of clinical data for an AI algorithm.
- Sample Size for Test Set: Not applicable in the context of clinical data for AI; non-clinical tests typically use replicate samples of the device itself.
- Data Provenance: Not applicable for clinical data; non-clinical lab tests are performed according to recognized standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a wound dressing, not an AI diagnostic system requiring expert-established ground truth for a clinical test set.
4. Adjudication Method for the Test Set
Not applicable. This document pertains to non-clinical testing and substantial equivalence for a physical medical device, not a diagnostic AI system with an adjudication process for a test set.
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-assisted diagnostic 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the specific parameters and methods outlined in the referenced ISO, ASTM, USP, and AATCC standards. For example, for cytotoxicity, the "ground truth" is the observation of cell viability against negative/positive controls as per ISO 10993-5. For antibacterial effectiveness, it's the measured log-reduction of bacterial colonies as per AATCC 100-2012.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
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December 21, 2022
Winner Medical Co., Ltd. Mingni Liu Regulator Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, Guangdong 518109 China
Re: K221720
Trade/Device Name: Extra Silver Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 25, 2022 Received: November 25, 2022
Dear Mingni Liu:
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
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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) 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 (QS) 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 medical devices and radiation-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
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Indications for Use
510(k) Number (if known) K221720
Device Name
Extra Silver Gelling Fiber Dressing
Indications for Use (Describe)
Prescription Use:
Under the supervision of a healthcare professional. Extra Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow:
- · Partial thickness (second degree) burns;
- · Pressure ulcers (partial and full thickness);
- · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
- · Diabetic foot ulcers;
- · Surgical wounds that heal by primary intent such as dermatological and surgical incisions;
- · Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites;
- · Traumatic wounds
OTC Use:
Extra Silver Gelling Fiber Dressing may be used for the management of:
- · 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
The assigned 510(k) Number: K221720
-
- Date of Submission: December 14, 2022
2. Submitter Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China
Contact Person: Mingni Liu
Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email: 2346@winnermedical.com
3. Identification of Proposed Device
Trade/Proprietary Name: Extra Silver Gelling Fiber Dressing Common name: Wound or Burn Dressing
Regulatory Information
Classification Name: Dressing, Wound, Drug; Classification: Unclassified Product Code: FRO; Review Panel: General & Plastic Surgery;
4. Identification of Predicate Device
Predicate Device: 510(k) Number: K210466 Product Name: Silver Gelling Fiber Dressing Manufacturer: Winner Medical Co., Ltd. Reference Device: 510(k) Number: K121275 Product Name: AQUACEL™ Ag EXTRATM Hydrofiber™ Dressing with Silver and Strengthening Fiber Manufacturer: ConvaTec Inc.
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5. Device Description
Extra Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose (CMC) fibers, strengthening fibers and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment. A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days.
The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size.
All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.
6. Indications for use
OTC Use:
Extra Silver Gelling Fiber Dressing may be used for the management of:
- Minor Abrasions
- Minor Lacerations
- Minor cuts
- Minor scalds and burns
Prescription Use:
Under the supervision of a healthcare professional. Extra Silver Gelling Fiber Dressing may be used for the management of wounds as follow:
- · Partial thickness (second degree) burns;
- · Pressure ulcers (partial and full thickness);
- · Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
- Diabetic foot ulcers;
- · Surgical wounds that heal by primary intent such as dermatological and surgical incisions;
• Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites;
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• Traumatic wounds
The indications for use are identical to the primary predicate device (K210466).
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications.
The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-11:2017 Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity.
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical
Packaging by Dye Penetration
USP <85> Bacterial Endotoxins Test AATCC 100-2012 Antibacterial Finishes on Textile Materials: Assessment of
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Technological Characteristics Comparison
Extra Silver Gelling Fiber Dressing has the same intended use and indications for use as the predicate device but has an additional tensile strength performance than the predicate device. This is achieved by addition strengthening fibers. The differences in the composition and technology, as detailed below, is explained by the addition of strengthening fibers in the proposed device as compared to the predicate device. There are no differences in operation and directions for use between Extra Silver Gelling Fiber Dressing and the predicate device.
Table 1 Comparison of Intended use, Design and Technological Characteristics
| Item | Proposed Device | Predicate Device (K210466) | Comparison |
|---|---|---|---|
| ------ | ----------------- | ---------------------------- | ------------ |
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| ProductCode | FRO | FRO | Equivalent |
|---|---|---|---|
| Class | Unclassified | Unclassified | Equivalent |
| Indicationfor Use | Over-the-Counter Use:Silver Gelling Fiber Dressing maybe used for the management of:• Minor abrasions• Minor lacerations• Minor cuts• Minor scalds and burnsPrescription Use:Under the supervision of ahealthcare professional:Silver Gelling Fiber Dressing maybe used for the management ofwounds as follow:• Partial thickness (second degree)burns;• Pressure ulcers (partial and fullthickness);• Leg ulcers (venous stasis ulcers,arterial ulcers and leg ulcers ofmixed etiology);• Diabetic foot ulcers;• Surgical wounds that heal byprimary intent such asdermatological and surgicalincisions;• Surgical wounds left to heal bysecondary intention such asdehisced surgical incisions anddonor sites;• Traumatic wounds | Over-the-Counter Use:Silver Gelling Fiber Dressingmay be used for themanagement of:• Minor abrasions• Minor lacerations• Minor cuts• Minor scalds and burnsPrescription Use:Under the supervision of ahealthcare professional:Silver Gelling Fiber Dressingmay be used for themanagement of wounds asfollow:• Partial thickness (seconddegree) burns;• Pressure ulcers (partial andfull thickness);• Leg ulcers (venous stasisulcers, arterial ulcers and legulcers of mixed etiology);• Diabetic foot ulcers;• Surgical wounds that healby primary intent such asdermatological and surgicalincisions;• Surgical wounds left to healby secondary intention such asdehisced surgical incisions anddonor sites;• Traumatic wounds | Equivalent |
| Principleofoperation | The dressing absorbs wound fluidand creates a soft, conformable gel,which maintains a moist woundenvironment to support the healingprocess. Silver ionic present in thefiber for reducing bacteriacolonization in the dressing. | The dressing absorbs woundfluid and creates a soft,conformable gel, whichmaintains a moist woundenvironment to support thehealing process. Silver ionicpresent in the fiber forreducing bacteria colonizationin the dressing. | Equivalent |
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| Materialcomponents | Composed of sodiumcarboxymethylcellulose,strengthening fibers (polyesterthread) and ionic silver | Composed of sodiumcarboxymethylcellulose andionic silver | Similar |
|---|---|---|---|
| Technology | Silver impregnated sodiumcarboxymethylcellulose fibersneedling together and stitchbonded with polyester thread tonon-woven pad or ribbon; | Silver impregnated sodiumcarboxymethylcellulosefibers needling together tonon-woven pad or ribbon | Similar |
| Characteristics | • Sterile• Absorbs exudate (includingbacteria)• Forms a soft conformable gel• The silver in the dressing killsbacteria held in the dressing• May require a secondary dressing | • Sterile• Absorbs exudate (includingbacteria)• Forms a soft conformablegel• The silver in the dressingkills bacteria held in thedressing• May require a secondarydressing | Equivalent |
| AntibacterialDuration | 7 days | 7 days | Equivalent |
| Single Use | Yes | Yes | Equivalent |
| Sterilization | Gamma Radiation | Gamma Radiation | Equivalent |
| Biocompatibility | Biocompatibility in accordance to10993-1(breached or compromisedsurfaces with prolongedcontact(>24h to 30d)) | Biocompatibility inaccordance to 10993-1(breached or compromisedsurfaces with prolongedcontact(>24h to 30d)) | Equivalent |
The proposed device has same intended use, principle of operation and characteristics to the predicate device.
10. Non-Clinical Testing - Performance
Mechanical testing was conducted for this submission. Absorbency performance is equivalent to the predicate device; tensile strength performance is superior to the predicate device due to the addition strengthening fibers design modification.
Extra Silver Gelling Fiber Dressing in vitro testing has demonstrated > 4 logreduction of four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA)), four
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gram negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days.
11. Non-Clinical Testing – Biocompatibility
Biocompatibility testing was conducted for this submission in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO - 10993: 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and test results meet the requirements.
12. Conclusions
The proposed device and the predicate device underwent evaluation that demonstrates substantial equivalence in the intended use of each device, biocompatibility, safety, efficacy, environment of use, and the principles of operation. Therefore, the proposed device demonstrates substantial equivalence to the predicate device.
N/A