(231 days)
Not Found
No
The device description focuses on the material composition and physical structure of wound dressings. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended for use as wound coverings and to provide a moist wound healing environment for various types of wounds, including burns, ulcers, and surgical wounds, which are therapeutic applications.
No
The device is a wound covering and dressing intended to provide a moist wound healing environment. Its function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components (nylon fabric, silicone membrane, gelatin, aloe vera) and their physical properties (slits, configuration), indicating it is a physical wound dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as "wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established." This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a physical wound dressing made of nylon, silicone, gelatin, and aloe vera. It is applied directly to the wound.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- No Mention of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as reagents, calibrators, controls, or analytical procedures performed on biological samples.
The device is a wound dressing intended for direct application to the body for healing purposes, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
PermeaDerm B, CW and Glove are intended for use as wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established.
PermeaDerm B is indicated for partial thickness burn wounds, donor sites and coverage of meshed autograft.
PermeaDerm CW is indicated for partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
PermeaDerm Glove is indicated for debrided partial thickness hand burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
PermeaDerm B, PermeaDerm CW and PermeaDerm Glove are identical in chemical composition and 3D structure. They are all composed of a monofilament nylon knitted fabric (virgin Indachi Nylon Monofilament Yarn 15/1), bonded to a thin slitted silicone membrane (Unrestricted Medical Grade Silicone, Applied Silicone, Dimethyl-Silicone-Elastomer P/N 40000). The nylon side of this dressing is coated with a mixture of hypoallergenic porcine gelatin (Gelita MedellaPro®) and a pure fraction of Aloe vera (Aloecorp Inc. Immuno-10®).
The physical differences in the two configurations (PermeaDerm B versus PermeaDerm CW and PermeaDerm Glove) are in the number and orientations of slits per unit area.
PermeaDerm B contains 2280 parallel slits (0.25" long) per square foot. PermeaDerm CW contains 4,464 slits (0.180" long) per square foot, and the rows of slits are parallel or perpendicular in orientation. PermeaDerm Glove has identical and physical properties of PermeaDerm CW, except it is sewn into a glove configuration.
The slit configuration creates pores when the dressing is stretched. All configurations provide a moist wound healing environment with a slitted silicone/nylon membrane coated with gelatin and aloe vera extract.
The wound dressings are primary dressings, to be used with secondary absorbent cover dressings.
Dressing sizes
PermeaDerm B: 5" x 10", 10" x 15", 15" x 20"; PermeaDerm CW: 2.5" x 5", 5" x 5" PermeaDerm Glove: Range from Pediatric to XXL (designed to fit right or left hands)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (partial thickness burn wounds, donor sites, meshed autograft, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds), hand burns.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
They are prescription use products to be applied by a physician/ health care practitioner.
Environment of Use
The devices are to be used by clinicians in health care facilities.
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: Testing (per table below) demonstrated the PermeaDerm dressings are substantially equivalent in biocompatibility. Final test reports are included in the 510(k).
The table lists studies performed according to ISO 10993: Part 5 (Cytotoxicity: ISO Elution), Part 10 (Maximization Sensitization: Guinea Pig, Intracutaneous: Rabbit), Part 11 (Acute Systemic Toxicity: Mouse, Subacute Systemic Toxicity: Rat), Part 3 (Genotoxicity: Ames: Bacterial Reverse Mutation, Mouse Lymphoma, Mouse Micronucleus), Part 11 (Pyrogenicity: Rabbit (according to USP)).
Sterilization and Shelf Life: Testing of the PermeaDerm dressing, according to ISO 11137-2, was performed to substantiate a 25 kGy E Beam dose, to validate the effectiveness of sterilization to assure a SAL of 10-6.
Real time shelf life testing has established a shelf life of 7 months. Additional testing to extend shelf life is ongoing.
Animal Performance: No additional animal studies were provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/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 a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2016
PermeaDerm, Inc. c/o Aubrey Woodroof, Ph.D., M.B.A. Founder and CEO 2905 Segovia Way Carlsbad, California 92009
Re: K153678
Trade/Device Name: PermeaDerm B, PermeaDerm CW, PermeaDerm Glove Regulatory Class: Unclassified Product Code: FRO Dated: July 11, 2016 Received: July 11, 2016
Dear Dr. Woodroof:
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 devicerelated adverse events) (21 CFR 803); 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
David Krause -S
for 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
2
Indications for Use
510(k) Number (if known) K153678
Device Name PermeaDerm B PermeaDerm CW PermeaDerm Glove
Indications for Use (Describe)
PermeaDerm B, CW and Glove are intended for use as wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established.
PermeaDerm B is indicated for partial thickness burn wounds, donor sites and coverage of meshed autograff.
PermeaDerm CW is indicated for partial thickness wounds, pressure sores, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
PermeaDerm Glove is indicated for debrided partial thickness hand burns.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
1.0 Name, Address, Phone and Fax Number of the Applicant
PermeaDerm. Inc. 2905 Segovia Way Carlsbad, CA 92009 Phone: (760) 271-1589 Fax: (760) 632-7162
2.0 Contact Person
Aubrey Woodroof, PhD, MBA Founder and CEO
3.0 Date Prepared
December 19, 2015; revised July 11, 2016.
4.0 Device Identification
Name: PermeaDerm Trade Names: Permeaderm B, PermeaDerm CW, PermeaDerm Glove Common Name: Wound Dressing, Drug Classification Name: Unclassified Product Code: FRO
6.0 Predicate Devices
| Name | AWBAT Plus | Biobrane | Oasis |
|---|---|---|---|
| 510(k) number | K091863 | K790496 | K061711 |
| Trade Names | AWBAT Plus | Biobrane | Oasis Wound |
| Matrix | |||
| Common Name | Wound Dressing, | ||
| Drug | Wound Dressing, | ||
| Collagen | Wound Dressing, | ||
| Collagen | |||
| Classification Name | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | KGN | KGN |
7.0 Device Description
Composition and Design
PermeaDerm B, PermeaDerm CW and PermeaDerm Glove are identical in chemical composition and 3D structure. They are all composed of a monofilament nylon knitted fabric (virgin Indachi Nylon Monofilament Yarn 15/1), bonded to a thin slitted silicone membrane (Unrestricted Medical Grade Silicone, Applied Silicone, Dimethyl-Silicone-Elastomer P/N 40000). The nylon side of this dressing is coated with a mixture of hypoallergenic porcine gelatin (Gelita MedellaPro®) and a pure fraction of Aloe vera (Aloecorp Inc. Immuno-10®).
The physical differences in the two configurations (PermeaDerm B versus PermeaDerm CW and PermeaDerm Glove) are in the number and orientations of slits per unit area.
4
PermeaDerm B contains 2280 parallel slits (0.25" long) per square foot. PermeaDerm CW contains 4,464 slits (0.180" long) per square foot, and the rows of slits are parallel or perpendicular in orientation. PermeaDerm Glove has identical and physical properties of PermeaDerm CW, except it is sewn into a glove configuration.
The slit configuration creates pores when the dressing is stretched. All configurations provide a moist wound healing environment with a slitted silicone/nylon membrane coated with gelatin and aloe vera extract.
The wound dressings are primary dressings, to be used with secondary absorbent cover dressings.
Dressing sizes
PermeaDerm B: 5" x 10", 10" x 15", 15" x 20"; PermeaDerm CW: 2.5" x 5", 5" x 5" PermeaDerm Glove: Range from Pediatric to XXL (designed to fit right or left hands)
Prescription Use
They are prescription use products to be applied by a physician/ health care practitioner.
Sterilization Information
The wound dressings are provided sterile for single-use only. Sterilization method is electron beam (E Beam) irradiation.
Environment of Use
The devices are to be used by clinicians in health care facilities.
Duration and type of contact
The product is to be in contact with breached skin for prolonged periods of time, thus it is categorized as a permanent contact device (Biocompatibility Contact Duration Category C).
8.0 Intended Use/Indications for Use
PermeaDerm B, CW and Glove are intended for use as wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established.
PermeaDerm B is indicated for partial thickness burn wounds, donor sites and coverage of meshed autograft.
PermeaDerm CW is indicated for partial thickness wounds, pressure sores, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
PermeaDerm Glove is indicated for debrided partial thickness hand burns.
5
Summary of Testing 9.0
Biocompatibility
Testing (per table below) demonstrated the PermeaDerm dressings are substantially equivalent in biocompatibility. Final test reports are included in the 510(k).
| ISO 10993 Reference | Study |
|---|---|
| Part 5 | Cytotoxicity: ISO Elution |
| Part 10 | Maximization Sensitization: Guinea Pig |
| Part 10 | Intracutaneous: Rabbit |
| Part 11 | Acute Systemic Toxicity: Mouse |
| Subacute Systemic Toxicity: Rat | |
| Part 3 | Genotoxicity |
| Ames: Bacterial Reverse Mutation | |
| Mouse Lymphoma | |
| Mouse Micronucleus | |
| Part 11 | Pyrogenicity: Rabbit (according to USP) |
Sterilization and Shelf Life
Testing of the PermeaDerm dressing, according to ISO 11137-2, was performed to substantiate a 25 kGy E Beam dose, to validate the effectiveness of sterilization to assure a SAL of 10-6.
Real time shelf life testing has established a shelf life of 7 months. Additional testing to extend shelf life is ongoing.
Animal Performance
No additional animal studies were provided.
10.0 Comparison of Technological Characteristics with Predicate Devices
The subject and predicate devices are based on the following similar technological elements.
Intended Use
Each predicate and PermeaDerm are primary wound dressings. The specific indications fall under the same intended use, which is to act as a wound covering and provide a moist wound healing environment.
Design
Porosity: PermeaDerm dressings and all predicates except Oasis are designed to be porous.
Flexibility: PermeaDerm dressings and all predicates are designed to be flexible.
Size: The sheet form and sizes are comparable among all devices.
6
The following technical (material composition) differences exist between the subject and predicate devices:
Nylon: All devices except Oasis contain a knitted nylon layer.
Silicone: All except Oasis contain silicone which is bonded to the nylon.
Gelatin: All except Oasis contain porcine gelatin; Oasis is processed porcine small intestine.
Aloe: All except BioBrane and Oasis contain aloe.
11.0 Substantial Equivalence Conclusion
The summary provided herein and the testing included in the 510(k) submission shows the PermeaDerm device has the intended use, same basic design characteristics, and similar material composition to the predicate devices. The minor differences in the specific indications do not change the intended use of the device, and the differences in material composition do not raise new questions of safety and effectiveness.
Therefore, it can be concluded the PermeaDerm devices are substantially equivalent to the noted predicate devices.