(113 days)
Not Found
No
The summary describes a collagen-based wound dressing and its performance characteristics, with no mention of AI or ML technology.
Yes
The device is a wound dressing intended for the local management of various types of exuding wounds, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a wound dressing for the local management of wounds, not for diagnosing conditions.
No
The device description clearly states it is a "decellularized, equine pericardial implant," which is a physical, collagen-based wound dressing, not software.
Based on the provided text, the Pegasus Biologics DermADAPT™ Wound Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "local management of moderately to heavy exuding wounds." This describes a therapeutic or wound care application, not a diagnostic test performed in vitro (outside the body) on biological samples to determine the presence of a disease or condition.
- Device Description: The description details a collagen-based wound dressing, which is a physical material applied to a wound. This is consistent with a medical device for wound management, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information about a patient's health status.
Therefore, the Pegasus Biologics DermADAPT™ Wound Dressing is a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pegasus Biologics DermADAPT™ Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, ●
- Draining wounds, .
- Pressure sores/ulcers, ●
- . Venous ulcers.
- Chronic vascular ulcers,
- Diabetic ulcers, ●
- . Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
- . Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)
Product codes
KGN
Device Description
The Pegasus Biologics DermADAPT™ Wound Dressing is a decellularized, equine pericardial implant that has been crosslinked and passed USP Sterility testing. The product is non-pyrogenic and supplied for single use only. The product must be rinsed prior to use following the procedure described in the IFU.
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 testing and in vitro bench testing has been conducted to evaluate the biological safety and biomechanical performance characteristics of the DermADAPT™ Wound Dressing. Biocompatibility test results indicate that the device satisfies all biocompatibility requirements. Biomechanical test results indicate that the dressing satisfies performance requirements for a wound dressing.
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 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
K061494
page 1 of 2
510(K) SUMMARY
SUBMITTER INFORMATION
| A. | Company Name: | Pegasus Biologics, Inc. | SEP 21 2006 |
|---|---|---|---|
| B. | Company Address: | 6 Jenner, Suite 150 | |
| Irvine, CA 92618 | |||
| C. | Company Phone: | (949) 502-3240 | |
| D. | Company Facsimile: | (949) 502-3241 | |
| E | Contact Person: | Pamela Misajon | |
| Vice President, RA/CA | |||
| pmisajon@pegasusbio.com |
DEVICE IDENTIFICATION
| A. | Device Trade Name: | DermADAPT™ Wound Dressing |
|---|---|---|
| B. | Common Name: | Dressing, Wound, Collagen |
| C. | Classification Name(s): | Unclassified |
| D. | Device Code: | KGN |
IDENTIFICATION OF PREDICATE DEVICES
The DermADAPTTM Wound Dressing is substantially equivalent to many commercially available collagen-based wound dressings. Two specific predicate devices are BIOPAD® (Euroresearch S.R.L.) cleared under Premarket Notification Number K040283 and Stimulen™ Collagen (Southwest Technologies, Inc.) cleared under Premarket Notification Number K030774.
DEVICE DESCRIPTION
The Pegasus Biologics DermADAPT™ Wound Dressing is a decellularized, equine pericardial implant that has been crosslinked and passed USP Sterility testing. The product is non-pyrogenic and supplied for single use only. The product must be rinsed prior to use following the procedure described in the IFU.
1
K061494
page 2 of a
INDICATIONS FOR USE
The Pegasus Biologics DermADAPT™ Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, ●
- Draining wounds, .
- Pressure sores/ulcers, ●
- . Venous ulcers.
- Chronic vascular ulcers,
- Diabetic ulcers, ●
- . Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
- . Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)
TECHNOLOGICAL CHARACTERISTICS
The components of the DermADAPT™ Wound Dressing are similar in basic materials. design, construction and performance to the predicate devices. The device consists primarily of Type 1 collagen that has been decellularized, crosslinked, and passes USP sterility testing, and is provided in dimensions appropriate for covering and protecting surface wounds.
BIOCOMPATIBILITY AND PERFORMANCE TESTING
Biocompatibility testing and in vitro bench testing has been conducted to evaluate the biological safety and biomechanical performance characteristics of the DermADAPT™ Wound Dressing. Biocompatibility test results indicate that the device satisfies all biocompatibility requirements. Biomechanical test results indicate that the dressing satisfies performance requirements for a wound dressing.
STERILITY
DermADAPT™ is subjected to 14 day USP sterility testing and USP endotoxin testing prior to release.
CONCLUSIONS DRAWN FROM STUDIES
The results of testing demonstrate that DermADAPT™ Wound Dressing is substantially equivalent to the predicate devices in design, function, source of substrate materials and indications for use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2006
Pegasus Biologics, Inc. % Ms. Pamela Misajon Vice President, RA/CA 6 Jenner, Suite 150 Irvine, California 92618
Re: K061494
Trade/Device Name: DermADAPT™ Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: September 11, 2006 Received: September 13, 2006
Dear Ms. Misajon:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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
3
Page 2 - Ms. Pamela Misajon
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/cdrl/industry/support/index.html.
Sincerely yours,
Mark A. Milken
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
K061494 510(k) Number:
Device Name: DermADAPTTM Wound Dressing
Indications for Use ......
The Pegasus Biologics DermADAPT™ Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- . Draining wounds,
- Pressure sores/ulcers, ●
- Venous ulcers, .
- Chronic vascular ulcers, .
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), .
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)
Prescription Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
Page ______ of ______510(k) Number K061491
Confidential