(207 days)
No
The summary describes a hydrocolloid wound dressing with antibacterial properties. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties, wound healing, and antibacterial efficacy, not algorithmic performance.
Yes
The device (hydrocolloid dressing with sequestered hydrogen peroxide) is intended to treat and manage various types of wounds, including burns, surgical wounds, pressure ulcers, and cuts, by creating a moist wound environment, acting as a barrier to bacteria, and protecting the wound.
No
The device is a hydrocolloid dressing intended for wound care, which acts as a barrier and creates a moist environment for healing, rather than diagnosing a condition.
No
The device description clearly details a physical hydrocolloid dressing with specific material compositions and physical properties, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The Stay Fresh Hydrocolloid dressing is a wound dressing. Its primary function is to cover and protect wounds, absorb exudate, create a moist healing environment, and act as a barrier to bacterial penetration. It does this through physical and chemical properties (hydrocolloid material, sequestered hydrogen peroxide).
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body in vitro. It interacts directly with the wound surface.
- Intended Use: The intended use clearly describes its application as a dressing for various types of wounds, not for diagnostic testing of bodily fluids or tissues.
Therefore, the Stay Fresh Hydrocolloid dressing falls under the category of a wound care device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions, lacerations.
OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.
Product codes
FRO
Device Description
Sarasota Medical Products hydrocolloid dressing adhesive formulations are composed of naturally occurring substances that turn into a gel when they come into contact with wound fluid. Superabsorbent particles are embedded in an inert polymer matrix that provides the desired level of cohesiveness required to prevent leaving any residue in the wound. The outer most layer of the dressing is covered by a polyurethane film that reinforces the dressing's barrier properties and helps to reduce friction on clothing, bedding, and opposing extremities. When placed over a wound, these dressings create a moist environment. This environment has been shown to help to facilitate the removal of debris and protect the wound against bacteria and other external contaminants.
The Stay Fresh Hydrocolloid includes sequestered hydrogen peroxide (0.2 to 0.35% by weight). The sequestered hydrogen peroxide is an effective and safe antibacterial agent that protects the dressing. The role of antibacterial agents in wound dressings is: 1) to reduce the incidence of bacterial colonization within the dressing and 2) to provide a potential barrier to bacterial entry into the wound. The Stay Fresh Hydrocolloid is effective in controlling growth of bacteria commonly found to populate dressings. The outer thermoplastic layer is effective at providing a physical barrier to bacterial entry into the wound.
The Stay Fresh Hydrocolloid dressing will be supplied sterile. Sterilization will be achieved by gamma radiation at 25 Kgy in accordance with ISO 11137 and ISO 14385.
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
Rx: Under the supervision of a healthcare professional
OTC: 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: Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization), Wound Healing Study (Porcine model), Physical Testing & Inspection (Physical inspection, Tack, Absorbance, Hydrogen peroxide concentration, Final product packaging and inspection), Antibacterial Efficacy Testing (Efficacy testing, Minimum Effective Concentration determination), Bacterial Barrier Testing
Sample Size: Not Found (for specific studies)
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key Results: The Stay Fresh Hydrocolloid dressing has been subjected to testing to assess the biocompatibility, as well as the physical and antibacterial performance of the device, to establish its safety and efficacy. Clinical testing was not performed. Non-clinical testing demonstrates substantially equivalent safety and efficacy as compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 27, 2015
Sarasota Medical Products Dr. Walter Leise, III CEO/President 1451 Sarasota Center Boulevard Sarasota, Florida 34240
Re: K151186
Trade/Device Name: Stay Fresh Hydrocolloid Regulatory Class: Unclassified Product Code: FRO Dated: October 30, 2015 Received: November 2, 2015
Dear Dr. Leise:
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
2
Indications for Use
510(k) Number (if known) K151186
Device Name Stay Fresh Hydrocolloid
Indications for Use (Describe)
Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions,
OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K151186: 510(K) SUMMARY FOR SARASOTA MEDICAL PRODUCTS STAY FRESH HYDROCOLLOID
1. SUBMITTER/510(K) OWNER
Sarasota Medical Products, Inc. 1451 Sarasota Center Blvd, Sarasota, Fl. 34240 Phone 941-377-1451 Fax 941-377-1450
| Contact Person: | Dr. Walter Leise, III
CEO/President |
|-----------------|----------------------------------------|
| Phone: | (941) 377-1451 Ext. 222 |
Date Prepared: October 30, 2015
2. DEVICE NAME
| Proprietary Name: | Stay Fresh Hydrocolloid |
|---|---|
| Common/Usual Name: | Hydrocolloid Dressing |
| Product Code: | FRO |
| Classification Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
3. PREDICATE/REFERENCE DEVICES
| Primary Predicate Device | K050032 & K081274 Euromed SureSkin Silver Wound
Dressings and SureSkin Silver Bandage |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices | Sarasota Medical Products' Fortaderm MTMA Hydrocolloid
K121898, Quick-Med Technologies, Inc. Stay Fresh Skin Fold
Management Textile
K083113 ACTICOAT FLEX 7 Dressing |
4. DEVICE DESCRIPTION
Device Identification:
Sarasota Medical Products hydrocolloid dressing adhesive formulations are composed of naturally occurring substances that turn into a gel when they come into contact with wound fluid. Superabsorbent particles are embedded in an inert polymer matrix that provides the desired level of cohesiveness required to prevent leaving any residue in the wound.
4
The outer most layer of the dressing is covered by a polyurethane film that reinforces the dressing's barrier properties and helps to reduce friction on clothing, bedding, and opposing extremities. When placed over a wound, these dressings create a moist environment. This environment has been shown to help to facilitate the removal of debris and protect the wound against bacteria and other external contaminants.
| SKU | Description | Color | Size | Quantity |
|---|---|---|---|---|
| 170405010504 | Rectangle/Std | Off-white | 2" x 4" | 20 per box |
| 170505010504 | Rectangle/Std | Off-white | 2" x 6" | 10 per box |
| 170605010503 | Rectangle/Thin | Off-white | 2" x 8" | 10 per box |
| 170605010504 | Rectangle/Std | Off-white | 2" x 8" | 10 per box |
| 170205010504 | Square/Thin | Off-white | 2" x 2" | 20 per box |
| 170105010504 | Square/Std | Off-white | 4" x 4" | 10 per box |
| 170105010503 | Square/Thin | Off-white | 4" x 4" | 10 per box |
| 170305010504 | Square/Std | Off-white | 6" x 6" | 10 per box |
| 170305010503 | Square/Thin | Off-white | 6" x 6" | 10 per box |
| 170705010504 | Oval/Std | Off-white | 4" x 6" | 10 per box |
| 170805010503 | Oval Spot/Thin | Off-white | 1 3/4" x 1 1/2" | 8 per box |
| 170905010503 | Small finger & toe/Thin | Off-white | 3/4" x 2 3/4" | 8 per box |
| 171005010503 | Small Rectangle/Thin | Off-white | 3/4" x 1 5/8" | 6 per box |
| 171105010503 | Large finger & toe/Thin | Off-white | 1 1/4" x 2 3/4" | 10 per box |
| 171405010503 | Small Rectangle/Thin | Off-white | 1 1/4" x 2 3/4" | 6 per box |
| 171205010503 | Oval Spot 2/Thin | Off-white | 1 5/8" x 2 3/4" | 6 per box |
| 171305010503 | Knee & Elbow | Off-white | 3" x 3" | 4 per box |
Shapes and Dimensions of Stay Fresh Hydrocolloid Dressings
Device Characteristics:
. The Stay Fresh Hydrocolloid includes sequestered hydrogen peroxide (0.2 to 0.35% by weight). The sequestered hydrogen peroxide is an effective and safe antibacterial agent that protects the dressing. The role of antibacterial agents in wound dressings is: 1) to reduce the incidence of bacterial colonization within the dressing and 2) to provide a potential barrier to bacterial entry into the wound. The Stay Fresh Hydrocolloid is effective in controlling growth of bacteria commonly found to populate dressings. The outer thermoplastic layer is effective at providing a physical barrier to bacterial entry into the wound.
The Stay Fresh Hydrocolloid dressing will be supplied sterile. Sterilization will be achieved by gamma radiation at 25 Kgy in accordance with ISO 11137 and ISO 14385.
5
Brief Description of Device:
The Stay Fresh Hydrocolloid includes sequestered hydrogen peroxide (0.2 to 0.35% by weight). The sequestered hydrogen peroxide is an effective and safe antibacterial agent that protects the dressing. The Stay Fresh Hydrocolloid is effective in controlling growth of bacteria commonly found to populate dressings. The outer thermoplastic layer is effective at providing a physical barrier to bacterial entry into the wound.
5. INTENDED USE
Rx: Under the supervision of a healthcare professional, the Stay Fresh Hydrocolloid dressing is intended for use as a primary dressing for exuding wounds that acts as a barrier to bacterial penetration, for use on first and second degree burns, surgical wounds, pressure ulcers, dermal ulcers, as well as minor cuts, abrasions, lacerations.
OTC: The Stay Fresh Hydrocolloid dressing acts as a barrier to bacterial penetration and is indicated for first aid to cover minor cuts, minor abrasions, and minor lacerations.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The purpose of this 510(k) is to obtain clearance to market the Stay Fresh Hydrocolloid dressing as a wound dressing.
The Stay Fresh Hydrocolloid is substantially equivalent to the predicate devices with respect to design, material composition, device characteristics and intended use.
We have chosen Euromed's SureSkin Silver dressing as our primary predicate device. Specifically, these are the SureSkin III with Silver Wound Dressing (K050032 for Rx) and SureSkin Silver Bandage (K081274 for OTC) The SureSkin dressings are composed of a hydrocolloid material and silver, which are in contact with the wound, and an occlusive polyurethane backing. Hydrocolloid wound dressings are composed of very similar components. including CMC, in different ratios to attain the desired tack, wear-time, and absorbance of the final dressing. These slight differences in formulation do not affect the safety or effectiveness of the final device.
The key difference between the technological characteristics of the proposed and predicate devices is the antibacterial agent used to protect the dressings from bacterial contamination. The primary predicate and reference devices contain silver, while the proposed device contains sequestered hydrogen peroxide. The data presented in this submission substantiates the safety and efficacy of the proposed product to overcome any concern regarding the technological differences of the proposed and predicate devices in support of a substantial equivalence decision.
We have chosen Sarasota Medical Products' Fortaderm MTMA (Moderate Tack/Medium Absorption) non-antibacterial hydrocolloid as a reference device. The Fortaderm MTMA adhesive dressing is an occlusive dressing whose material composition is identical to the Stay Fresh Hydrocolloid, with the same design, physical properties and intended use. Both dressings are intended to cover a wound and to provide or support a moist wound environment. The
6
components used to produce the dressings are identical, so physical properties, including tack. wear-time, and absorbance of the final dressings are equivalent.
The key difference between the proposed device and this reference device is the inclusion of sequestered hydrogen peroxide (0.2 to 0.35% by weight) in the proposed device. The sequestered hydrogen peroxide is a safe and effective antibacterial agent that protects the dressing from bacterial contamination.
An additional secondary reference device, Smith & Nephew's Acticoat Flex 7 (K083113) was chosen as an equivalent device that was available to be used in a comparative porcine wound healing study. The Acticoat device is a highly conformable dressing that contains nanocrystalline silver, which provides a microbial barrier for up to 7 days.
A third reference device has been chosen for its technological similarity to the proposed dressing. The OMT Stay Fresh Skin Fold Management Textile, cleared under K121898, uses the same active antibacterial agent, hydrogen peroxide, to achieve its intended use of reducing bacterial populations in the substrate.
The proposed device has the same intended use as the primary predicate device as they are both intended to cover a wound and to provide or support a moist wound environment. Data is presented in this submission to substantiate both the safety and efficacy equivalence of the proposed and predicate devices.
7. PERFORMANCE TESTING
The Stay Fresh Hydrocolloid dressing has been subjected to testing to assess the biocompatibility, as well as the physical and antibacterial performance of the device, to establish its safety and efficacy. Specifically, the following tests have been performed to support the 510(k) submission:
Biocompatibility Testing
Cytotoxicity (Agar Diffusion Direct Contact Method) Irritation (Primary Skin Irritation) Sensitization (Buehler Test)
Wound Healing Study
Porcine wound healing model Full and partial thickness wounds, evaluated for 14 and 6 days respectively Includes comparison to predicate and reference devices
Physical Testing & Inspection
Physical inspection (dispersion, lamination, weight, and thickness) Tack (probe tack, 90° peel, and rolling ball) Absorbance (@ 4 hr and @ 24 hr) Hydrogen peroxide concentration (permanganate titration) Final product packaging and inspection
7
Antibacterial Efficacy Testing
Efficacy testing (QMT 03-2013 - modified ASTM E2180-01) Minimum Effective Concentration (MEC) determination
Bacterial Barrier Testing Barrier Test Protocol
CLINICAL TESTING 8.
Clinical testing was not performed to support the 510(k) for the Stay Fresh Hydrocolloid dressing. Non-clinical testing demonstrates substantially equivalent safety and efficacy as compared to the predicate device.