(575 days)
No
The description focuses on the material composition and intended use of wound dressings, with no mention of AI or ML capabilities.
Yes
The device, L-Mesitran dressings, is indicated for treating various acute and chronic wounds, including burns, ulcers, and post-operative wounds, which falls under therapeutic use for wound healing.
No
The device description and intended use clearly state that L-Mesitran dressings are wound dressings used for treating and managing wounds, not for diagnosing medical conditions.
No
The device description clearly states that the devices are "hydro-active hydrogel wound dressings containing honey" and "hydro-active hydrogel coated wound dressing containing honey on an open weave polyester net," indicating they are physical dressings, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for treating various types of wounds. This is a topical application for wound management, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is described as a hydro-active hydrogel wound dressing containing honey. This aligns with a wound care product, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device falls under the category of wound care products, which are typically regulated as medical devices but not as IVDs.
N/A
Intended Use / Indications for Use
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 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.
L-Mesitran Active Dressings are indicated for treating minor burns, superficial cuts, lacerations and abrasions, and other small wounds.
Product codes
FRO
Device Description
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.
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
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, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility study and performance test results demonstrate that L-Mesitran Dressings are non-irritating, non-sensitizing and non-toxic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
page 1 of 2
Section 5: 510(k) Summary
The assigned 510(k) number is: K053613
| Company: | Theo Manufacturing BV
Bredestraat 33A
Maastricht NL-6211 HB
The Netherlands
Telephone: 31 43 325 1773
Fax: 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-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. |
| Intended Use: | L-Mesitran Hydro and 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. Maintains a moist wound
healing environment. This moist environment supports
optimal wound healing. |
1
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).
2
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.
3
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
4
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
5
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