(28 days)
Not Found
No
The device description and intended use focus on the material properties and application of a collagen-based wound dressing. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as a "collagen-based wound dressing for the local management of moderately to heavy exuding wounds," which directly indicates its use for treating medical conditions.
No
The device description indicates it is a wound dressing used for the local management of wounds, which is a therapeutic function, not a diagnostic one. It does not mention any capability to identify or assess the nature of a disease or condition.
No
The device description clearly states it is a physical, collagen-based wound dressing made from decellularized equine pericardium, which is a hardware component.
Based on the provided information, the Pegasus Biologics Unite™ Biomatrix is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "collagen-based wound dressing for the local management of moderately to heavy exuding wounds." This describes a device applied directly to the body for therapeutic purposes, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details the material (decellularized, equine pericardium), processing (crosslinked, sterilized), and preparation (rinsing prior to use). This aligns with a topical wound care product.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), providing diagnostic results, or being used in a laboratory setting for diagnostic purposes.
Therefore, the Pegasus Biologics Unite™ Biomatrix is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pegasus Biologics Unite™ Biomatrix 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 (comma separated list FDA assigned to the subject device)
KGN
Device Description
The Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
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
Prescription Use
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)
Supplier qualification activities, receiving controls, and design verification testing demonstrate that the Unite™ Biomatrix device is equivalent to the predicate device in terms of design, performance and intended use.
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
JUN 2 0 2007
510(K) SUMMARY
SUBMITTER INFORMATION 11.1
| A. | Company Name: | Pegasus Biologics, Inc. |
|---|---|---|
| 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 11.2
| A. | Device Trade Name: | Unite™ Biomatrix |
|---|---|---|
| B. | Common Name: | Dressing, Wound, Collagen |
| C. | Classification Name(s): | Unclassified |
| D. | Classification Regulation: | Unclassified |
| E. | Regulatory Class: | Unclassified |
| F. | Product Code: | KGN |
| G. | Advisory Panel: | General and Plastic Surgery |
11.3 IDENTIFICATION OF PREDICATE DEVICE
The Unite™ Biomatrix is substantially equivalent to the DermADAPT™ Wound Dressing manufactured by Pegasus Biologics, Inc. and cleared for commercial distribution under 510(k) K061494.
11.4 DEVICE DESCRIPTION
The Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
1
INDICATIONS FOR USE 11.5
The Pegasus Biologics Unite™ Biomatrix 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)
SUBSTANTIAL EQUIVALENCE 11.6
Supplier qualification activities, receiving controls, and design verification testing demonstrate that the Unite™ Biomatrix device is equivalent to the predicate device in terms of design, performance and intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pegasus Biologics, Inc. % Ms. Pamela Misajon Vice President, RA/CA 6 Jenner, Suite 105 Irvine, California 92618
JUN 2 0 2007
Re: K071425
Trade/Device Name: Unite™ Biomatrix Regulatory Class: Unclassified Product Code: KGN Dated: May 15, 2007 Received: May 23, 2007
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 (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. 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/cdrh/industry/support/index.html .
Sincerely yours,
Mark N. Molkerson
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
510(k) Number (if known):
Unite™ Biomatrix Device Name:
Indications for Use:
The Pegasus Biologics Unite™ Biomatrix 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 | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | L071428 |
|---|---|
| --------------- | --------- |
Pegasus Biologics, Inc. Confidential