(575 days)
L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds. L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree burns and fistulae. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
L-Mesitran Active dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
L-Mesitran dressings are indicated for acute and chronic superficial wounds such as: bruises, tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings. It should not be used on its own as a covering for dirty infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
L-Mesitran Hydro, L-Mesitran Border, and L-Mesitran Active are hydro-active hydrogel wound dressings containing honey. L-Mesitran Net is a hydro-active hydrogel coated wound dressing containing honey on an open weave polyester net.
Here's an analysis of the provided text regarding the acceptance criteria and study for the L-Mesitran® Dressing Family:
Based on the provided 510(k) Summary, it's important to note that this submission is for a wound care dressing, which typically relies on biocompatibility and performance testing rather than the kind of AI/machine learning performance assessment described in the prompt's questions (e.g., sensitivity, specificity, reader studies, etc.). The 510(k) pathway focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, many of the questions related to AI/ML performance metrics, ground truth, expert opinions for image interpretation, and reader studies are not applicable to this type of device and submission.
Here's the information that can be extracted from the provided text, addressed within the context of hardware/material device submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-irritating | L-Mesitran Dressings are non-irritating. |
| Non-sensitizing | L-Mesitran Dressings are non-sensitizing. |
| Non-toxic | L-Mesitran Dressings are non-toxic. |
| Substantially equivalent in function and intended use to predicate | The L-Mesitran Dressing Family is substantially equivalent in function and intended use to Elasto-gel Dressings (#K872165). |
| Maintain a moist wound healing environment | Maintains a moist wound healing environment. This moist environment supports optimal wound healing. |
| Intended Use as described | Specific indications for use are described for L-Mesitran Hydro, Border, Active, and Net. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the biocompatibility or performance tests.
- Data Provenance: Not specified. Standard biocompatibility tests are generally conducted by certified laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a wound dressing, not an AI/imaging device requiring expert interpretation for ground truth establishment. Biocompatibility and performance tests follow established laboratory protocols and standards, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for discrepancies in expert interpretations (e.g., radiology reads). This does not apply to biocompatibility or physical performance testing of a wound dressing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, this was not done. MRMC studies are specific to AI/imaging devices involving human reader performance. This device is a passive wound dressing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical AI sense. For biocompatibility, "ground truth" would equate to established biological safety standards (e.g., ISO 10993 series) and laboratory results conforming to these standards. For performance, it would be the physical and chemical characteristics of the dressing that ensure it functions as intended (e.g., ability to maintain moisture, adhesion properties, non-shedding, etc.) as demonstrated through validated test methods. The text mentions "Biocompatibility study and performance test results," implying these standard tests were performed.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML system and does not have a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML system and does not have a training set.
Summary of Relevant Information:
The core of this 510(k) submission for the L-Mesitran® Dressing Family relies on:
- Biocompatibility Studies: Demonstrating the device is non-irritating, non-sensitizing, and non-toxic. The specific tests (e.g., cytotoxicity, sensitization, irritation) are implied but not detailed.
- Performance Tests: Demonstrating the dressing's ability to maintain a moist wound healing environment and physical integrity.
- Substantial Equivalence: Comparing the device's materials, design, intended use, and performance to a legally marketed predicate device (Southwest Technologies' Elasto-Gel Dressings, #K872165) to show that it is as safe and effective. The conclusion explicitly states substantial equivalence.
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page 1 of 2
Section 5: 510(k) Summary
The assigned 510(k) number is: K053613
| Company: | Theo Manufacturing BVBredestraat 33AMaastricht NL-6211 HBThe NetherlandsTelephone: 31 43 325 1773Fax: 31 43 326 1022 |
|---|---|
| Contact: | Barbara DeBiase |
| Date Prepared: | July 17, 2007 |
| Proprietary Names: | L-Mesitran® Dressing Family· L-Mesitran Hydro· L-Mesitran Border· L-Mesitran Active· L-Mesitran Net |
| Classification Name: | Dressing |
| Common Name: | Wound Dressing |
| Classification Code: | Dressing, Product Code FRO |
| Predicate Device: | Southwest Technologies' Elasto-Gel Dressings, #K872165 |
| Device Description: | L-Mesitran Hydro, L-Mesitran Border, and L-MesitranActive are hydro-active hydrogel wound dressingscontaining honey. L-Mesitran Net is a hydro-activehydrogel coated wound dressing containing honey on anopen weave polyester net. |
| Intended Use: | L-Mesitran Hydro and BorderL-Mesitran Hydro and Border dressings are indicated foracute and chronic superficial wounds such as: bruises, cuts,bedsores, first and second-degree burns and other traumaticwounds, venous and arterial ulcera, diabetes ulcers, donorsites, and post-operative wounds. L-Mesitran Hydro andBorder should not be used as a covering for deep narrowcavities, dirty wounds (these should first be cleansed),third-degree burns and fistulae. Maintains a moist woundhealing environment. This moist environment supportsoptimal wound healing. |
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L-Mesitran Active
L-Mesitran® Active dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
L-Mesitran Net
L-Mesitran dressings are indicated for acute and chronic superficial wounds such as: bruises, tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings. It should not be used on its own as a covering for dirty infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities. Maintains a moist wound healing environment. This moist environment supports optimal wound healing.
Performance Data Biocompatibility study and performance test results demonstrate that L-Mesitran Dressings are non-irritating, non-sensitizing and non-toxic.
Conclusion:
The L-Mesitran Dressing Family is substantially equivalent in function and intended use to Elasto-gel Dressings (#K872165).
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Image /page/2/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 a stylized image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2007
Theo Manufacturing BV % QNet LLC Ms. Barbara DeBiase Project Consultant 1467 vigilante Avenue Suite 405 Bailey, Colorado 80421
Re: K053613
Trade/Device Name: L-Mesitran® Dressing Family Regulatory Class: Unclassified Product Code: FRO Dated: June 20, 2007 Received: June 21, 2007
Dear Ms. DeBiase:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 vour 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); good manufacturing practice requirement; as set 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.
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Page 2 - Ms. Barbara DeBiase
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milikman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
(Page 1 of 2)
510(k) Number (if known): K053613
Device Name: L-Mesitran® Dressing Family
Indications for Use:
L-Mesitran Hydro and L-Mesitran Border
L-Mesitran Hydro and Border dressings are indicated for acute and chronic superficial wounds such as: bruises, cuts, bedsores, first and second-degree burns and other traumatic wounds, venous and arterial ulcera, diabetes ulcers, donor sites, and post-operative wounds.
L-Mesitran Hydro and Border should not be used as a covering for deep narrow cavities, dirty wounds (these should first be cleansed), third-degree burns and fistulae.
L-Mesitran Net
L-Mesitran Net Dressings are indicated for acute and chronic superficial wounds such as: bruises, skin tears, pressure ulcers, venous and arterial ulcera, diabetes ulcers, donor sites, cuts, first and second degree burns, postoperative wounds and other external wounds caused by trauma. L-Mesitran Net is to be used in conjunction with other secondary dressings.
It should not be used on its own as a covering for dirty, infected and heavily exudating wounds (should first be cleansed), third degree burns, or deep narrow cavities.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark A. Mckesson
estorative.
510(k) Number K053613
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Indications for Use
(Page 2 of 2)
510(k) Number (if known): K053613
Device Name: L-Mesitran® Dressing Family
..
Indications for Use:
L-Mesitran Active
L-Mesitran Active Dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark N. Mulkern
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K053613
N/A