(54 days)
No
The device description and performance studies focus on the biological and physical properties of the wound covering, with no mention of AI or ML technologies.
Yes
The device is indicated for the management of wounds and is a topical wound covering, which falls under the category of therapeutic devices for wound healing.
No
The device is described as a "topical wound covering" and a "wound dressing" for the management of wounds, indicating a therapeutic rather than diagnostic purpose. Its composition and form (fenestrated sheets) further support its role in wound care and not in identifying or determining the nature of a disease or condition.
No
The device description clearly states that InnovaMatrix™ FS is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue, provided as physical sheets. This 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 is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is a topical wound covering made from decellularized porcine placental tissue. It is applied directly to the wound. This is a physical barrier and biological scaffold, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing bodily fluids, tissues, or other specimens to provide diagnostic information. The device's function is to support wound healing.
Therefore, InnovaMatrix™ FS is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InnovaMatrix™ FS is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns and skin tears) and draining wounds.
The device is intended for one-time use.
Product codes
KGN
Device Description
InnovaMatrix™ FS is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaMatrix™ FS is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in fenestrated sheets that are approximately 40-100 microns thick in sizes ranging from 2 x 2cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.
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
Verification testing was conducted to confirm that bioburden, endotoxin and water absorption capacity were within the specified values in accordance with the risk assessment. As InnovaMatrix™ FS is comprised of the same materials and undergoes the same manufacturing processing steps with the inclusion of the creations, existing biocompatibility, shelf life, sterilization, human repeat insult patch testing and human skin prick testing for the predicate InnovaMatrix™ remains applicable to InnovaMatrix™ FS. The Design Controls demonstrates that the modified device met the pre-determined acceptance criterion for the verification activity to substantiate the addition of fenestrations to the wound dressing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
April 21, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Triad Life Sciences, Inc. % Stephen Rhodes Regulatory Consultant Streamline Regulatory 3502 Dundee Driveway Chevy Chase, Maryland 20815
Re: K210580
Trade/Device Name: InnovaMatrix FS Regulatory Class: Unclassified Product Code: KGN Dated: February 25, 2021 Received: February 26, 2021
Dear Stephen Rhodes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lixin Liu. Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210580
Device Name InnovaMatrix™ FS
Indications for Use (Describe) InnovaMatrix™ FS is indicated for the management of wounds including:
- · Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- Chronic vascular ulcers
- · Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Mohs surgery, post- laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, second-degree burns and skin tears)
- · Draining wounds
The device is intended for one-time use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - K210580
In accordance with 21 CFR 807.97(h) and 21 CFR 807.92, the Special 510(k) Summary is provided below.
1. SUBMITTER
Triad Life Sciences®, Inc. 1770 Moriah Woods Blvd., Suite 18 Memphis, TN 38117 Registration Number: 3017660750
Contact Person: William J. Willis Phone: (901) 312-7923 Email: bwillis@triadls.com
Prepared By: Stephen P. Rhodes, Streamline Regulatory stephen.rhodes@streamlineregulatory.com Date Prepared: April 21, 2021
2. DEVICE
Name of Device: InnovaMatrix™ FS Common Name: Collagen Wound Dressing Classification Regulation/Class: Unclassified Product Code: KGN Panel: General and Plastic Surgery
3. PREDICATE AND REFERENCE DEVICE
Predicate Device: InnovaMatrix™ (K193552) Reference Device: Oasis® Wound Matrix (K061711)
4. DEVICE DESCRIPTION
Description
InnovaMatrix™ FS is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaMatrix™ FS is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The wound dressing is provided in fenestrated sheets that are approximately 40-100 microns thick in sizes ranging from 2 x 2cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.
4
510(k) Summary - K210580
5. INDICATION FOR USE
InnovaMatrix™ FS is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wounds (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns and skin tears) and draining wounds.
The device is intended for one-time use.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
InnovaMatrix™ FS is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound coverings. InnovaMatrix™ FS is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The biodegradable wound matrix provides a protective cover to the wound.
The only modification made to the device since its previous clearance in K193552 is the addition of fenestrations.
Table 1 provides a summary comparison between the subject and predicate devices.
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | TBD | K193552 |
| Applicant | Triad Life Sciences, Inc. | Triad Life Sciences, Inc. |
| Device Name | InnovaMatrix™ FS | InnovaMatrix™ |
| Regulation/Class | Unclassified Collagen Wound | |
| Dressing | Unclassified Collagen Wound | |
| Dressing | ||
| Product Code | KGN | KGN |
| Prescription or OTC? | Prescription | Prescription |
| Indications for Use | InnovaMatrix™ FS is indicated | |
| for the management of wounds | ||
| including: partial- and full- | ||
| thickness wounds, pressure | ||
| ulcers, venous ulcers, diabetic | ||
| ulcers, chronic vascular ulcers, | ||
| tunneled/undermined wounds, | ||
| surgical wounds (donor | ||
| sites/grafts, post-Mohs surgery, | ||
| post-laser surgery, podiatric, | ||
| wound dehiscence), trauma | ||
| wounds (abrasions, lacerations, | ||
| second-degree burns and skin | ||
| tears) and draining wounds. | same | |
| Design | Single layer, porcine | |
| extracellular matrix from | ||
| placenta (fenestrated) | Single layer, porcine | |
| extracellular matrix from | ||
| placenta | ||
| Sizes | 2 x 2 cm, 4 x 4 cm, 5 x 5 cm | 1 x 1 cm to 5 x 5 cm |
| Thickness | 40-100 microns | same |
| Single Use? | Yes | same |
| Sterile | E-Beam-sterilized | same |
Table 1: Device Comparison Table
5
510(k) Summary - K210580
Overall, the difference in technological characteristics of the subject and predicate device, i.e., the addition of fenestrations, does not raise any different questions of safety and effectiveness.
7. PERFORMANCE DATA
Verification testing was conducted to confirm that bioburden, endotoxin and water absorption capacity were within the specified values in accordance with the risk assessment.
As InnovaMatrix™ FS is comprised of the same materials and undergoes the same manufacturing processing steps with the inclusion of the creations, existing biocompatibility, shelf life, sterilization, human repeat insult patch testing and human skin prick testing for the predicate InnovaMatrix™ remains applicable to InnovaMatrix™ FS.
8. CONCLUSIONS
InnovaMatrix™ FS has the identical indications for use as the predicate device InnovaMatrix™. The technological characteristics are similar to the technological characteristics of the predicate wound dressing. The only modification for the subject device is the addition of fenestrations to the predicate device. The fenestrations of the subject device are features of the reference device, Cook Biotech's OASIS® Wound Matrix. The reference device has the same indications for use as the subject device. Both the predicate and subject devices are placental porcine-derived, decellularized dressings that are comprised primarily of collagen. The dressings are both intended for the management of wounds. Based on the indications for use, technological characteristics, and performance test results, InnovaMatrix™ FS is substantially equivalent to the predicate device InnovaMatrix™ (K193552). In addition, the Design Controls demonstrates that the modified device met the pre-determined acceptance criterion for the verification activity to substantiate the addition of fenestrations to the wound dressing.