(369 days)
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
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. 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.
The provided document is a 510(k) premarket notification for a medical device, specifically an Antiseptic Barrier Silver Foam Dressing. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a new effectiveness study with specific acceptance criteria and performance metrics for the new device.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, expert consensus details, or MRMC comparative effectiveness studies.
Instead, the submission demonstrates equivalence through a comparison of characteristics with a predicate device.
Here's an analysis of the information available in the document in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable in the traditional sense for a 510(k) submission.
- The document provides a "COMPARATIVE FEATURES" table, which lists characteristics of the proposed device and its predicate (MedTrade Product's Self Adhesive Foam Island Dressing, K993627). This table serves to show that the new device's specifications are similar to those of a device already on the market.
- The document mentions "laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginosa, Staphylococcus aureus & Escherichia coli" for the antibacterial activity of the silver in the dressing. This is the closest thing to reported device performance but no specific acceptance criteria (e.g., "X% reduction in bacterial count") or detailed study results are provided within this summary.
| Characteristics | MedTrade Products Antiseptic Barrier Silver Foam Dressing (New Device) | Performance/Comparison |
|---|---|---|
| Composition | Hydropolymer Foam Island Dressing with medical pressure-sensitive adhesive coated on one side. | Similar to predicate |
| Backing Foam | Thickness 0.4mm± 10%, Density 350-450 kgs/m3, Tensile Strength >1 kg./25mm width at 0.4mm, Elongation >200% at break | Similar to predicate |
| Foam Island | Thickness 3+1mm | Similar to predicate |
| Adhesive Coverage | 100% | Similar to predicate |
| Colour | Light Skin Tone | Similar to predicate |
| Indications For Use | Pressure ulcers, Lower extremity ulcers (Venous, Arterial, Mixed etiology), Diabetic ulcers, Donor sites | Similar to predicate |
| Packaging | Printed Pouch | Similar to predicate |
| Sterilisation Method | Gamma Irradiation | Similar to predicate |
| Antibacterial Activity | Supported by laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginosa, Staphylococcus aureus & Escherichia coli. | (Performance demonstrated, but no specific quantitative acceptance criteria or detailed results provided in this summary) |
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. 510(k) submissions demonstrating substantial equivalence typically do not involve new clinical trials with test sets in the same way a PMA submission would. The "test set" here would implicitly be the data supporting the predicate device or the bench testing data (e.g., antibacterial activity), but no sample sizes are given.
- Data Provenance: The antibacterial activity testing is stated as "laboratory testing." No country of origin is specified for this testing. The information on the predicate device's performance is inherent to its prior clearance and presumably from a variety of sources.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable/Not provided. This type of information relates to clinical studies and expert review for establishing ground truth, which is not described as being part of this 510(k) submission.
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No an MRMC study was done. This is a comparison of human reader performance with and without AI assistance, which is irrelevant for a foam dressing device.
6. Standalone (Algorithm Only) Performance Study:
- No standalone study was done. This concept applies to AI algorithms, not a physical medical device like a wound dressing. The antibacterial activity is a "standalone" performance characteristic of the dressing itself, but it's not an algorithm.
7. Type of Ground Truth Used:
- Not explicitly stated in the context of clinical outcomes for the new device.
- For the antibacterial claims, the "ground truth" would be established by standard microbiological methods showing inhibition or reduction of bacterial growth.
- For biocompatibility, the "ground truth" would be the successful completion of ISO/Tripartite guidelines for dermal sensitization, cytotoxicity, acute systemic toxicity, and hemocompatibility/hemolysis.
- For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device (MedTrade Product's Self Adhesive Foam Island Dressing K993627 and Maersk Medical's Arglaes-AB Antiseptic Barrier Dressing K99080).
8. Sample Size for the Training Set:
- Not applicable/Not provided. Training sets are used for machine learning models, which is not relevant to this device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable/Not provided.
In summary, this 510(k) submission relies on demonstrating substantial equivalence to existing devices through a comparison of design, composition, and function, as well as providing general statements about laboratory testing for specific claims (like antibacterial activity and biocompatibility), rather than presenting a new, full-scale clinical trial with detailed acceptance criteria and performance data as might be found in a PMA submission or for AI/diagnostic devices.
{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'sSelf Adhesive Foam IslandDressing | MedTrade ProductsAntiseptic Barrier SilverFoam Dressings |
|---|---|---|
| Composition | Hydropolymer Foam IslandDressing with medicalpressure-sensitive adhesivecoated on one side. | Hydropolymer Foam IslandDressing with medicalpressure-sensitive adhesivecoated on one side. |
| Backing Foam | Thickness 0.4mm± 10%Density 350-450 kgs/m3Tensile Strength >1kg./25mm width at 0.4mmElongation >200% at break | Thickness 0.4mm± 10%Density 350-450 kgs/m3Tensile Strength >1kg./25mm width at 0.4mmElongation >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'sFoam Dressings should beused under health careprofessional direction for thefollowing indications:Pressure ulcersLower extremity ulcers,including:1. Venous2. Arterial3. Mixed etlologyDiabetic ulcersDonor sites | MedTrade Product'sAntiseptic Barrier SilverFoam Dressings should beused under health careprofessional direction for thefollowing indications:Pressure ulcersLower extremity ulcers,including:1. Venous2. Arterial3. Mixed etlologyDiabetic ulcersDonor 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
N/A