(128 days)
Not Found
No
The 510(k) summary describes a wound dressing with different layers and materials, and the performance studies focus on biocompatibility, antimicrobial effectiveness, sterility, and fluid management. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for the management of various types of wounds, including burns, incisions, ulcers, lacerations, and abrasions, which fall under the scope of therapeutic applications for healing and managing injuries.
No
The device description and intended use indicate it is a wound care dressing used for management of various skin conditions and injuries, not for diagnosing them. It is a therapeutic device.
No
The device description clearly states it is a wound care dressing comprised of multiple physical layers, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers". This describes a therapeutic or wound care application, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a wound dressing with layers designed for moist wound management. This aligns with a topical wound care product, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to manage wounds directly on the body.
N/A
Intended Use / Indications for Use
The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation activities to support the use of the ULTRA Silver Dressings consisted of four main elements:
- Biocompatibility Testing
- Validation of Antimicrobial Effectiveness
- Sterility Validation
- Fluid Management Performance
Testing of the ULTRA Silver Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modification system meets user needs.
No clinical testing was conducted to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
Milliken Healthcare Products, LLC % Dr. Gordon Macfarlane Aptiv Solutions Incorporated 62 Forest Street, Suite 300 Marlborough, Massachusetts 01752
Re: K141603
Trade/Device Name: ULTRA Silver Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 3, 2014 Received: October 6, 2014
Dear Dr. Macfarlane:
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 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
1
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/Resourcesfor You/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) K141603
Device Name ULTRA Silver Dressing
Indications for Use (Describe)
The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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ULTRA SILVER DRESSINGS
510(K) SUMMARY
(per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)
SPONSOR/MANUFACTURER 1.
Milliken Healthcare Products, LLC 920 Milliken Road, M-207 Spartanburg, SC 29303
| Contact Person: | Brian J. Lindsay |
|---|---|
| Telephone: | 864-503-1323 |
Date Prepared: 26 August 2014
Consultant/Contact: Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, MA 01752
Primary Contact: Gordon MacFarlane, PhD, RAC Telephone: 919-873-8962
2. DEVICE NAME
| Trade Name | ULTRA Silver Dressings |
|---|---|
| Common Name | Wound Dressing |
| Classification Name | Dressing, Wound, Drug (Product Code: FRO) |
3. PREDICATE DEVICE
AFM Ultra Ag Dressings (K093188)
4. DEVICE DESCRIPTION
The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric.
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5. INDICATIONS FOR USE
The ULTRA Silver Dressings are indicated for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
SUMMARY OF TECHNICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6. DEVICE
The subject of this Special 510(k) is a modification of the AFM Ultra Ag Dressings that was previously cleared on February 17, 2010 under Premarket Notification Number K093188. There are no changes to the fundamental design and technology characteristics. The only change proposed is a modification of the materials in the non-patient contacting layers of the dressing. This modification includes the absorbent foam material, the high MVTR film layer and the hot-melt adhesive that binds the wound contact layer to the foam layer. No modification is being made to the patient contacting component or to the silver component.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Validation activities to support the use of the ULTRA Silver Dressings consisted of four main elements:
- Biocompatibility Testing ●
- Validation of Antimicrobial Effectiveness
- Sterility Validation ●
- . Fluid Management Performance
Testing of the ULTRA Silver Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modification system meets user needs.
SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE 8.
No clinical testing was conducted to support this submission.
SUMMARY OF OTHER INFORMATION 9.
No other information is available.
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10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed ULTRA Silver Dressings and the predicate AFM Ultra Ag Dressings lead to a conclusion of substantial equivalence between the proposed and predicate device. A side-by-side comparison of the predicate device and the proposed device is provided in the table below.
| Product Characteristics | ULTRA Silver Dressings | AFM Ultra Ag Dressings (K093188) |
|---|---|---|
| Intended Use | Management of Partial- to Full Thickness Acute and Chronic Wounds | Same |
| Fabric Layer (Wound Contact) | Silver coated polyester/nylon/lycra | Same |
| Indications | The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). | The AFM Ultra Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). |
| Antimicrobial Components | Silver sodium hydrogen zirconium phosphate | Same |
| Moisture Management Properties | Yes | Yes |
| Conformable | Yes | Yes |
| Multiple Day Use? | Yes | Yes |
| Thickness | $\ge 4.0 mm$ | $\ge 5.5 mm$ |
| Porous Fabric Layer | Yes | Yes |
| Biocompatible | Yes | Yes |
| Contra-Indications | Known allergy to silver | Same |
| Packaging | Tyvek/Film Medical Pouch | Same |
| Sterilization | Gamma Irradiation (25 kGy) | Same |