(282 days)
a) Over-The-Counter (OTC) use
The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns
b) Prescription (Rx) use
Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. The L-Mesitran Dressing Family II is intended for the management of the following:
-
Diabetic foot ulcers
-
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
-
Pressure ulcers / sores (partial and full thickness)
-
1st and 2nd degree partial thickness burns
-
Donor sites, and traumatic and surgical wounds
L-Mesitran Soft and Tulle are to be used in conjunction with other secondary dressings.
L-Mesitran® Soft and Tulle are wound dressings for the use on wounds
• L-Mesitran® Soft is a gel that contains: 40% medical grade honey, medical grade hypoallergenic lanolin, propylene glycol, PEG 4000, and vitamins C and E.
• L-Mesitran® Tulle is a non-adherent polyethylene dressing impregnated with the patented L-Mesitran® Soft gel.
This document is a 510(k) Pre-market Notification for the L-Mesitran® Dressing Family II, which includes L-Mesitran® Soft and L-Mesitran® Tulle. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis based on the provided text, focusing on acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide specific quantitative acceptance criteria or a table detailing the device's performance against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and other non-clinical tests, rather than meeting specific performance metrics for wound healing efficacy.
The "performance" demonstrated is that the device is biocompatible and suitable and safe for its intended use. This is concluded based on meeting the specifications of various ISO and pharmacopoeial tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 10993-5, 2009) | Met test specifications (demonstrates non-cytotoxic) |
| Irritation (ISO 10993-10, 2002, as amended 2006) | Met test specifications (demonstrates non-irritating) |
| Sensitization (ISO 10993-10) | Met test specifications (demonstrates non-sensitizing) |
| Preservation/Sterility: | |
| Preservative Efficacy Test (modified Ph.Eur. 5.1.3, USP 51) | Met test specifications (reduction in bioburden at least 4 logs) |
| Bioburden tests (Ph.Eur. 2.6.12: 2.6.13, USP 61;62) | Met test specifications (suitable bioburden levels) |
| Overall Safety and Suitability for Intended Use | Concluded to be safe and suitable based on non-clinical testing results. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of clinical performance data or a specific dataset of wound images/patient data for evaluating an AI (which is not applicable here).
For the non-clinical performance testing:
- Sample size: Not explicitly stated for each test (e.g., number of test articles for cytotoxicity, sensitization). However, the tests referenced (ISO, Ph.Eur., USP) typically specify sample size requirements.
- Data provenance: Not specified by country. These are laboratory-based tests of the device material itself. They are retrospective in the sense that the testing was performed on the manufactured device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This submission concerns a medical device (wound dressing), not an AI/imaging diagnostic device requiring expert interpretation for ground truth. The ground truth for the non-clinical tests is based on objective, standardized laboratory measurements and compliance with international standards.
4. Adjudication Method for the Test Set
Not applicable for a medical device (wound dressing) regulatory submission. Adjudication methods are typically employed in clinical trials or studies involving human interpretation, especially for AI or diagnostic devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of medical device (wound dressing). MRMC studies are typically performed for diagnostic imaging devices to assess the performance of readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no algorithm or AI component to this medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's safety and performance is based on:
- Scientific and regulatory standards: Compliance with ISO 10993 for biocompatibility, European Pharmacopoeia (Ph.Eur.), and United States Pharmacopeia (USP) for preservative efficacy and bioburden.
- Objective laboratory measurements: The tests performed generate quantifiable data that are compared against predefined acceptance criteria outlined in these standards.
8. The Sample Size for the Training Set
Not applicable. There is no AI or algorithm involved that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI, there is no training set or ground truth in that context.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2015
Theo Manufacturing BV Mrs. Monique Gottgens Quality Assurance/Regulatory Affairs Manager Capucijnenstraat 71 Maastricht 6211 RP The Netherlands
Re: K150676 Trade/Device Name: L-Mesitran® Soft and L-Mesitran® Tulle (L-Mesitran Dressing Family II) Regulatory Class: Unclassified Product Code: FRO Dated: November 20, 2015 Received: December 2, 2015
Dear Mrs. Gottgens:
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
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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,
Binita S.Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K150676
Device Name
L-Mesitran® Soft and L-Mesitran® Tulle (L-Mesitran Dressing Family II)
Indications for Use (Describe)
-
a) Over-The-Counter (OTC) use
The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, L-Mesitran Dressing Family II may be used for: -
minor abrasions
-
lacerations
-
minor cuts
-
minor scalds and burns
b) Prescription (Rx) use
Under the supervision of a healthcare professional, The L-Mesitran Dressing Family II - Soft and Tulle provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. The L-Mesitran Dressing Family II is intended for the management of the following:
-
Diabetic foot ulcers
-
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
-
Pressure ulcers / sores (partial and full thickness)
-
1st and 2nd degree partial thickness burns
-
Donor sites, and traumatic and surgical wounds
L-Mesitran Soft and Tulle are to be used in conjunction with other secondary dressings.
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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Image /page/3/Picture/1 description: The image shows the logo for L-Mesitran. The logo consists of a yellow and white circular graphic on the left, followed by the text "L-Mesitran" in a gray, sans-serif font. The "®" symbol is located at the end of the word "Mesitran".
Section 5: 510K SUMMARY
| The assigned 510(k) number is: | K150676 |
|---|---|
| 1. Sponsor | |
| Company: | Theo Manufacturing BVCapucijnenstraat 71Maastricht NL-6211 RPThe NetherlandsTelephone: +31 43 325 1773 |
| Date Prepared: | December 23rd, 2015 |
| 2. Device Name | |
| Proprietary Names: | L-Mesitran® Dressing Family II• L-Mesitran® Soft• L-Mesitran® Tulle |
| Common/Usual Name: | Wound Dressing |
| Classification: | Unclassified |
| Classification Code: | Dressing, Product Code FRO |
| Panel: | General & Plastic Surgery |
| 3. Predicate Devices | |
| #K053613 L-Mesitran® Dressing Family I : L-Mesitran®Hydro, Border, Active and Net | |
| #K101793 Derma Sciences Medihoney Gel Dressings withActive Manuka Honey | |
| 4. Device Description |
L-Mesitran® Soft and Tulle are wound dressings for the use on wounds
• L-Mesitran® Soft is a gel that contains: 40% medical grade honey, medical grade hypoallergenic lanolin, propylene glycol, PEG 4000, and vitamins C and E.
• L-Mesitran® Tulle is a non-adherent polyethylene dressing impregnated with the patented L-Mesitran® Soft gel.
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Image /page/4/Picture/1 description: The image shows the logo for L-Mesitran. The logo features a yellow circle with a white gradient behind it on the left side. To the right of the circle is the text "L-Mesitran" in a sans-serif font. The "R" in "Mesitran" has a circle around it, indicating that it is a registered trademark.
5. Intended use
Indications for Use:
Over-The-Counter (OTC) Use
The L-Mesitran Dressing Family II – Soft and Tulle provide a moist environment conducive to wound healinq and are indicated for light to moderately exudinq wounds. For over the counter use, L-Mesitran Dressing Family II may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns
L-Mesitran Soft is to be used in conjunction with other secondary dressings.
Prescription (Rx) Use
Under the supervision of a healthcare professional, L-Mesitran Soft provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds. L-Mesitran Soft is intended for the management of the following:
- Diabetic foot ulcers
- Leq ulcers (venous stasis ulcers, arterial ulcers and leq ulcers of mixed etioloqy)
- Pressure ulcers / sores (partial and full thickness)
- 1st and 2nd degree partial thickness burns
- Donor sites, and traumatic and surgical wounds.
L-Mesitran Soft is to be used in conjunction with other secondary dressings.
6. Summary of technological characteristics compared to the predicate devices.
The technological characteristics of the L-Mesitran® Dressing Family II with honev, the L-Mesitran® Dressing Family I (Hydro/Border/Active/Net) subject of K053613 and the Medihoney Gel Dressing with Active Manuka Honey subject of K101793, are substantially equivalent in that they are honey containing wound dressings that can be covered with most commonly used secondary dressings. Also, they share same
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Image /page/5/Picture/1 description: The image shows the logo for L-Mesitran. The logo features a yellow circle with a white semi-transparent circle overlapping it on the left side. To the right of the circles is the text "L-Mesitran" in a dark gray sans-serif font, with a registered trademark symbol next to the word.
properties in that they are intended for use as primary wound dressings and prevent the secondary dressing from adhering to the wound bed.
There are no new concerns of safety and effectiveness, therefore, the subject device is substantially equivalent to the predicate devices in this regard.
The difference in honey percentage provides the user with a wider variety of honey dressings and does not represent a significant change in technological characteristics.
The intended use of the L-Mesitran® Dressing Family II and the predicate devices are identical with respect to their intention to provide a moist environment conducive to wound healing.
In addition, both the proposed and predicate devices are intended for both OTC and prescription use.
The L-Mesitran® Dressing Family II and the predicate devices are identical with respect to their indication for management of wounds including partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
The differences in technological characteristics between the predicate devices and L-Mesitran® Dressing Family II are the different auxiliary substances used.
7. Non-clinical performance testing/data
Biocompatibility testing performed demonstrates that the L-Mesitran® Dressing Family II is safe for its intended use. The biocompatibility and performance testing included:
Cytotoxicity: Quantitative MEM-Elution Test – ISO 10993-5, 2009: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity.
irritation: Intracutaneous Injection Test – ISO 10993-10, 2002, Biological evaluation of medical devices – Part 10: Tests for irritation and Delayed-Type Hypersensitivity, as amended 2006.
Sensitization: Guinea Pig Maximization Sensitization Test – ISO 10993-10, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
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Image /page/6/Picture/1 description: The image shows the logo for L-Mesitran. The logo features a yellow circle with a white outline on the left side. To the right of the circle is the text "L-Mesitran" in a bold, sans-serif font. The "®" symbol is located at the end of the word.
Preservative Efficacy Test - modified Ph.Eur. 5.1.3, harmonized with USP 51, modifications: starting inoculum at least 6 logs, reduction in bioburden at least 4 logs, microorganisms: 3 gram positive bacteria, 3 gram negative bacteria, a yeast and a mold, on aged products.
Bioburden tests – Ph.Eur. 2.6.12: 2.6.13, harmonized with USP 61;62.
8. Clinical performance testing
Not applicable.
9. Conclusions
Based on the information provided in this 510(k), Theo Manufacturing BV believes that the proposed L-Mesitran® Dressing Family II (Soft/Tulle) is substantially equivalent in function and intended use to L-Mesitran® Dressing Family I (K053613), the Medihoney Gel Dressing with Active Manuka Honey (K101793). The proposed devices raise no new issues of safety and effectiveness. The non-clinical testing performed demonstrates that the proposed device met all test specifications and is suitable and safe for its intended use.
N/A