(140 days)
Not Found
No
The summary describes a wound dressing with antimicrobial properties and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes.
The device is a wound dressing intended for the management of various types of wounds, which is a therapeutic purpose. It also acts as an effective barrier to resist microbial colonization and reduce microbes, contributing to the healing process.
No
Explanation: The device, FortaDerm™ Antimicrobial PHMB Wound Dressing, is described as a wound dressing intended for management of wounds and to act as a barrier against microbial colonization. Its description focuses on its physical properties and intended use in wound care, not on diagnosing any medical conditions.
No
The device description clearly states it is a wound dressing made of physical materials (collagen and PHMB) and is supplied in sheet form, indicating it is a physical medical device, 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 states the device is for the "management of wounds" and acts as a "barrier to resist microbial colonization." This describes a therapeutic or protective function applied directly to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "wound dressing" made of collagen and PHMB, which is a physical material applied to a wound. This is consistent with a medical device used for wound care, 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.
Therefore, the FortaDerm™ Antimicrobial PHMB Wound Dressing is a medical device used for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDerm™ Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
The device is intended for one-time use.
Product codes
FRO
Device Description
FortaDerm™ Antimicrobial PHMB Wound Dressing consists of two layers, crosslinked sheet of fenestrated sheet of porcine intestinal collagen coated with 0.1 % Polyhexamethylene Biguanide hydrochloride (PHMB). FortaDerm Wound Dressing is supplied dry in sheet form in sizes ranging from 4 x 4 cm to 12 x 36 cm. The device is packaged in sterile, sealed single pouches.
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)
FortaDerm™ Antimicrobial PHMB Wound Dressing was subjected to a number of tests to assess biocompatibility and performance. The device passed the requirements of all tests.
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
K051647 page
NOV - 8 2005
510(K) SUMMARY
Submitted by:
Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021
Contact
Patrick R. Bilbo Telephone: (781) 401-1155 Facsimile: --------------------------------------------------------------------------------------------(781) 575-1570
October 21, 2005 Date:
Device:
| Trade Name: | FortaDerm™ Antimicrobial PHMB Wound
Dressing coated with 0.1% Polyhexamethylene
Biguanide Hydrochloride (PHMB) |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Topical Wound Dressing, Wound Management
Biomaterial |
| Classification Name: | Dressing, Wound (KMF) |
| Classification: | Unclassified |
Predicate Devices:
The relevant predicate devices are FortaDerm™ (PuraPly™) Wound Dressing (K011026) manufactured by Organogenesis, Inc. and Xcell Antimicrobial Cellulose Wound Dressing (K024054) manufactured by Xylos Corporation.
Statement of Substantial Equivalence:
The FortaDerm™ Antimicrobial PHMB Wound Dressing is similar with respect to intended use, technological characteristics, materials and physical construction to the predicate devices in terms of section 510(k) equivalency.
Intended Use:
The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDerm™ Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound
1
K051647 page 2/2
dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
The device is intended for one-time use.
Device Description:
FortaDerm™ Antimicrobial PHMB Wound Dressing consists of two layers, crosslinked sheet of fenestrated sheet of porcine intestinal collagen coated with 0.1 % Polyhexamethylene Biguanide hydrochloride (PHMB). FortaDerm Wound Dressing is supplied dry in sheet form in sizes ranging from 4 x 4 cm to 12 x 36 cm. The device is packaged in sterile, sealed single pouches.
Performance Data:
FortaDerm™ Antimicrobial PHMB Wound Dressing was subjected to a number of tests to assess biocompatibility and performance. The device passed the requirements of all tests.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2005
Patrick R. Bilbo, Vice President Regulatory and Clinical Affairs Organogenesis, Inc. 150 Dan Road Canton, Massachusetts 02021
Re: K051647
Trade/Device Name: FortaDerm™ Antimicrobial PHMB Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 21, 2005 Received: October 25, 2005
Dear Mr. Bilbo:
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 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); good manufacturing practice requirements 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- Patrick R. Bilbo, Vice President
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/industry/support/index.html
Sincerely yours,
Barbara boehup
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KOSIC47
Device Name: FortaDerm™ Antimicrobial PHMB Wound Dressing
Indications for Use:
The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within FortaDerm™ the dressing and reduce microbes penetrating through the dressing. Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
The device is intended for one-time use.
Prescription Use
(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)
bare buem Pageof
(Division St Division of General, Restorative, and Neurological Devices
510(k) Number K051647
(Posted November 13, 2003)