(369 days)
K99080
No
The device description focuses on the physical properties and antibacterial activity of a foam dressing, with no mention of AI or ML.
Yes
The device is intended for treating wounds (pressure ulcers, lower extremity ulcers, diabetic ulcers, donor sites) and promotes optimal wound healing, which aligns with the definition of a therapeutic device.
No
The device description indicates it is an "exudate handling system" and a "dressing," which are used for treatment and wound management, not for diagnosing conditions.
No
The device description clearly describes a physical wound dressing made of foam with silver, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the dressing is for treating wounds (pressure ulcers, lower extremity ulcers, diabetic ulcers, donor sites). This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the dressing (exudate handling, antibacterial activity, moist wound environment) and its sterilization process. It does not mention any analysis of biological samples or diagnostic procedures.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dressing does not perform any such function.
N/A
Intended Use / Indications for Use
MedTrade Product's Antiseptic Barrier Silver Foam Dressings should be used under health care professional direction for the following indications: Pressure ulcers Lower extremity ulcers, including: 1. Venous 2. Arterial Mixed etlology 3. Diabetic ulcers Donor sites
Product codes
FRO
Device Description
MedTrade Product's Antiseptic Barrier Silver Foam Dressing is an exudate handling system intended for low to moderate exuding wounds. The antibacterial activity acting in the dressing is supported by laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginose, Staphylococcus aureus & Escherichia coli. The island dressing maintains a moist wound environment, which is conducive to optimal wound healing. During use the absorbent island gently expands as it takes up exudate. During use the lesion size may initially increase. This is normal and to be expected prior to wound granulation
MedTrade Product's Antiseptic Barrier Silver Foam Dressing should be used under health care professional direction for the following indications: Pressure ulcers, Lower extremity uicers, Venous, Arterial, Mixed etlology, Diabetic ulcers, Donor sites.
Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation. 30 Edition (ANS/AAMI/SO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 7
Packaging will consist of a single dressing in either a paper / paper / poly pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.
Biocompatability testing including: Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity and HemocompatibilityHemolysis have been successfully completed per ISO/Tripartite guidelines.
The MedTrade Product's Antiseptic Barrier Silver Foam Dressings are similar in design, composition and function to MedTrade Products Self Adhesive Foam Island Dressings 510(k) #K993627.
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
health care professional direction
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K99080
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DEC - 1 2004
K033732 page 1/2
Safety & Effectiveness: MedTrade Products Antiseptic Barrier Silver Foam Dressing
Classification Name: 79 MGP, 878.4020 Dressing, Wound and Burn, Occlusive
Contact: Jonathan Ranfield - Director, Quality Assurance & Regulatory Affairs
Prepared: October 21, 2003
Description: MedTrade Product's Antiseptic Barrier Silver Foam Dressing is an exudate handling system intended for low to moderate exuding wounds. The antibacterial activity acting in the dressing is supported by laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginose, Staphylococcus aureus & Escherichia coli. The island dressing maintains a moist wound environment, which is conducive to optimal wound healing. During use the absorbent island gently expands as it takes up exudate. During use the lesion size may initially increase. This is normal and to be expected prior to wound granulation
MedTrade Product's Antiseptic Barrier Silver Foam Dressing should be used under health care professional direction for the following indications: Pressure ulcers, Lower extremity uicers, Venous, Arterial, Mixed etlology, Diabetic ulcers, Donor sites.
Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation. 30 Edition (ANS/AAMI/SO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 7
Packaging will consist of a single dressing in either a paper / paper / poly pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.
Biocompatability testing including: Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity and HemocompatibilityHemolysis have been successfully completed per ISO/Tripartite guidelines.
The MedTrade Product's Antiseptic Barrier Silver Foam Dressings are similar in design, composition and function to MedTrade Products Self Adhesive Foam Island Dressings 510(k) #K993627. A table of comparative features may be found below.
1
K033732 page 2/2
| Characteristics | MedTrade Product's
Self Adhesive Foam Island
Dressing | MedTrade Products
Antiseptic Barrier Silver
Foam Dressings |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Hydropolymer Foam Island
Dressing with medical
pressure-sensitive adhesive
coated on one side. | Hydropolymer Foam Island
Dressing with medical
pressure-sensitive adhesive
coated on one side. |
| Backing Foam | Thickness 0.4mm± 10%
Density 350-450 kgs/m3
Tensile Strength >1
kg./25mm width at 0.4mm
Elongation >200% at break | Thickness 0.4mm± 10%
Density 350-450 kgs/m3
Tensile Strength >1
kg./25mm width at 0.4mm
Elongation >200% at break |
| Foam Island | Thickness 3+1mm | Thickness 3+1mm |
| Adhesive Coverage | 100% | 100% |
| Colour | Light Skin Tone | Light Skin Tone |
| Indications For Use | MedTrade Product's
Foam Dressings should be
used under health care
professional direction for the
following indications:
Pressure ulcers
Lower extremity ulcers,
including:
- Venous
- Arterial
- Mixed etlology
Diabetic ulcers
Donor sites | MedTrade Product's
Antiseptic Barrier Silver
Foam Dressings should be
used under health care
professional direction for the
following indications:
Pressure ulcers
Lower extremity ulcers,
including: - Venous
- Arterial
- Mixed etlology
Diabetic ulcers
Donor sites |
| Packaging | Printed Pouch | Printed Pouch |
| Sterilisation Method | Gamma Irradiation | Gamma Irradiation |
COMPARATIVE FEATURES
Additionally, as with Maersk Medical's Arglaes-AB Antiseptic Barrier Dressing K99080 AddRenally, as the macrer Moulea D Arglass AD Antiseptic Rooms Novel
(attached), MedTrade Products Antiseptic Barrier Silver Foam Dressing has been shown to be an
antibacteri
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus features a staff with a snake winding around it, and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2004
Mr. Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs MedTrade Products Ltd Electra House Crewe Business Park, Crewe CW16GL United Kingdom
Re: K033732
K035732
Trade/Device Name: Antiseptic Barrier Silver Foam Dressings Regulatory Class: Unclassified Product Code: FRO Dated: November 1, 2004 Received: November 4, 2004
Dear Mr. Ranfield:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard actual date of the Medical Device Amendments, or to commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Cosment Act (Act) that to not require appent of the general controls provisions of the Act. The r ou may, increrore, market the act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (tional controls. Existing major regulations affecting your device can may be subject to suen additional collisers, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase of actived that I Brinination that your device complies with other requirements of the Act that I Drinas Internations and regulations administered by other Federal agencies. You must or any I odelar statutes and equirements, including, but not limited to: registration and listing (21 Comply with an the Fee orequirements (01); good manufacturing practice requirements as set CI K Fat 6077; adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and qtion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Jonathan Ranfield
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K0 33732
Indications for Use
510(k) Number (if known):_ K033732
Device Name: MedTrade Product's Antiseptic Barrier Silver Foam Dressings
Indications For Use:
MedTrade Product's Antiseptic Barrier Silver Foam Dressings should be used under health care professional direction for the following indications: Pressure ulcers Lower extremity ulcers, including: 1. Venous 2. Arterial Mixed etlology 3. Diabetic ulcers Donor sites
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriame C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K633732