(332 days)
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 technology.
Yes.
The device is indicated for the management of various wounds, including partial thickness burns, pressure ulcers, leg ulcers, and diabetic foot ulcers, by absorbing wound fluid, maintaining a moist environment, aiding autolytic debridement, and reducing bacterial colonization, all of which are therapeutic actions aimed at promoting healing and managing the wound condition.
No
The device is a wound dressing designed to absorb wound fluid, maintain a moist environment, aid in debridement, and reduce bacterial colonization. It does not provide any diagnostic information or assessment of a medical condition.
No
The device description clearly states it is a "soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver," which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Silver Gelling Fiber Dressing is a wound dressing applied externally to the body. Its function is to absorb wound fluid, create a moist environment, aid in debridement, and potentially reduce bacterial colonization within the dressing. It does not analyze biological specimens to provide diagnostic information about the patient's health.
- Intended Use: The intended use clearly describes the management of various types of wounds, which is a therapeutic and protective function, not a diagnostic one.
Therefore, based on the provided information, the Silver Gelling Fiber Dressing is a medical device, but it falls under the category of a wound dressing, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OTC Use: 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. 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;
- Traumatic wounds
Product codes
FRO
Device Description
Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose 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 and aids in the removal of non-viable tissue from the wound (autolytic debridement). 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (e.g. burn, pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use: Under the supervision of a healthcare professional.
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
Non clinical tests 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 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 Bacterial Endotoxins Test
AATCC 100-2012 Antibacterial Finishes on Textile Materials: Assessment of
Silver Gelling Fiber Dressing in vitro testing has demonstrated ≥ 4 log-reduction of four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA)), four gram negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days.
A porcine wound healing study was carried out to evaluate the silver cytotoxicity of subject device. The study demonstrated that there were no biologically relevant differences between the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing) in terms of wound healing performance characteristics and local tolerance after wound creation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests 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 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 Bacterial Endotoxins Test
AATCC 100-2012 Antibacterial Finishes on Textile Materials: Assessment of
Silver Gelling Fiber Dressing in vitro testing has demonstrated ≥ 4 log-reduction of four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA)), four gram negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days.
A porcine wound healing study was carried out to evaluate the silver cytotoxicity of subject device. The study demonstrated that there were no biologically relevant differences between the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing) in terms of wound healing performance characteristics and local tolerance after wound creation.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 14, 2022
Winner Medical Co., Ltd. Haoyuan He Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, Guangdong 51809 China
Re: K210466
Trade/Device Name: Silver Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 17, 2021 Received: September 27, 2021
Dear Haoyuan He:
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 Morabito, Ph.D. Acting 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)
Device Name Silver Gelling Fiber Dressing
Indications for Use (Describe)
Prescription Use:
Under the supervision of a healthcare professional. 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:
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Tab #7 510(k) Summary
-
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K210466 -
- Date of Submission: February 9, 2021
2. Submitter Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China
Contact Person: Haoyuan He
Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email: hyhe@winnermedical.com
3. Identification of Proposed Device
Trade/Proprietary Name: 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
Primary Predicate Device: 510(k) Number: K080383 Product Name: AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING Manufacturer: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C
4
5. Device Description
Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose 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 and aids in the removal of non-viable tissue from the wound (autolytic debridement). 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:
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. 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;
5
· Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites;
• Traumatic wounds
7. Non-Clinical Test Conclusion
Non clinical tests 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 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 Bacterial Endotoxins Test
AATCC 100-2012 Antibacterial Finishes on Textile Materials: Assessment of
Silver Gelling Fiber Dressing in vitro testing has demonstrated ≥ ≥ 4 log-reduction of four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA)), four gram negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days.
A porcine wound healing study was carried out to evaluate the silver cytotoxicity of subject device. The study demonstrated that there were no biologically relevant differences between the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing) in terms of wound healing performance characteristics and local tolerance after wound creation.
8. Clinical Test Conclusion
No clinical study is included in this submission.
6
9. Substantially Equivalent (SE) Comparison
Silver Gelling Fiber Dressing is compared with the following Predicate Device in terms of intended use, principle of operation, material, technology, characteristics and performance. K080383, AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing Manufactured by ConvaTec.
The following table shows comparison between proposed device and predicate devices. These data came from commercially product labeling and 510(k) summary.
| Item | Proposed Device | Predicate Device(K080383) |
|---|---|---|
| Product Code | FRO | FRO |
| Class | Unclassified | Unclassified |
| Indication for | ||
| Use | Over-the-Counter Use: | Over-the-Counter Use: |
| Silver Gelling Fiber Dressing may be | ||
| used for the management of: | AQUACEL® Hydrofiber® Wound | |
| Dressing may be used for: | ||
| • Minor abrasions | • Abrasions | |
| • Minor lacerations | • Lacerations | |
| • Minor cuts | • Minor cuts | |
| • Minor scalds and burns | • Minor scalds and burns | |
| Prescription Use: | Prescription Use: | |
| Under the supervision of a healthcare | ||
| professional: | Under the supervision of a healthcare | |
| professional: | ||
| Silver Gelling Fiber Dressing may be | ||
| used for the management of wounds | ||
| as follows: | AQUACEL® Ag Hydrofiber Dressing | |
| may be used for the management of: | ||
| • Partial thickness (second degree) | ||
| burns; | • Wounds as an effective barrier to | |
| bacterial penetration of the dressing as | ||
| this may help reduce infection; | ||
| • Pressure ulcers (partial and full | ||
| thickness); | • Partial thickness (second degree) | |
| burns; | ||
| • Leg ulcers (venous stasis ulcers, | ||
| arterial ulcers and leg ulcers of mixed | ||
| etiology); | • Diabetic foot ulcers, leg ulcers | |
| (venous stasis ulcers, arterial ulcers | ||
| and leg ulcers of mixed etiology) and | ||
| pressure ulcers/sores (partial & full | ||
| thickness); | ||
| • 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; |
| Table 1 Comparison of Intended use, Design and Technological Characteristics | |||||||
|---|---|---|---|---|---|---|---|
7
| | • Surgical wounds left to heal by
secondary intention such as dehisced
surgical incisions and donor sites;
• Traumatic wounds | • Surgical wounds that heal by
primary intent such as dermatological
and surgical incisions (e.g., orthopedic
and vascular);
• Traumatic wounds;
• Wounds that are prone to bleeding
such as wounds that have been
mechanically or surgically debrided
and donor sites;
• Oncology wounds with exudate such
as fungoides-cutaneous tumors,
fungating carcinoma, cutaneous
metastasis, Kaposi's sarcoma and
angiosarcoma;
• Management of painful wounds;
• Infected Wounds; |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of | The dressing absorbs wound fluid | The dressing absorbs wound fluid and |
| operation | and creates a soft, conformable gel, | creates a soft, conformable gel, which |
| | which maintains a moist wound | maintains a moist wound environment |
| | environment to support the healing | to support the healing process. Silver |
| | process. Silver ionic present in the | ionic present in the fiber for reducing |
| | fiber for reducing bacteria | bacteria colonization in the dressing. |
| | colonization in the dressing. | |
| Material | Composed of sodium | Composed of sodium |
| components | carboxymethylcellulose and 1.2% | carboxymethylcellulose |
| | ionic silver | (Hydrofiber™) and 1.2% ionic silver |
| | Silver impregnated sodium | Silver impregnated sodium |
| | carboxymethylcellulose fibers | carboxymethylcellulose fibers |
| Technology | needled together to non-woven pad | needled together to non-woven pad |
| | or ribbon | or ribbon |
| Characteristics | • Sterile | • Sterile |
| | • Absorbs exudate (including | • Absorbs exudate (including bacteria) |
| | bacteria) | |
| | • Forms a soft conformable gel | • Forms a soft conformable gel |
| | • The silver in the dressing kills | • The silver in the dressing kills |
| | bacteria held in the dressing | bacteria held in the dressing |
| | • May require a secondary dressing | • May require a secondary dressing |
| | | |
| Antibacterial | 7 days | 7 days |
| Duration | | |
| Single Use | Yes | Yes |
| Sterilization | Radiation | Radiation |
| | | |
| 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)) |
8
The proposed device has same intended use, materials of construction, principle of operation, technology and characteristics to the predicate device.
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.