(464 days)
No
The device description and performance studies focus on the material properties and biological effects of the wound dressing, with no mention of AI/ML algorithms or data processing.
Yes
The device is indicated for wound management, which is a therapeutic purpose.
No
The device, InnovaMatrix PD, is described as a wound dressing in particulate form intended for the management and covering of wounds, not for diagnosis.
No
The device description clearly states it is a powder manufactured from porcine placental tissue, indicating it is a physical material, 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 from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a wound dressing in particulate form, applied directly to the wound. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on non-clinical tests related to the safety and physical properties of the wound dressing (sterilization, shelf-life, biocompatibility, etc.), not on diagnostic accuracy or performance metrics like sensitivity or specificity.
Therefore, InnovaMatrix PD is a therapeutic medical device intended for wound management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
InnovaMatrix PD 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 (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), draining wounds, and partial-thickness burns
The device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
InnovaMatrix® PD is a powder manufactured from the decellularized extracellular matrix (ECM) derived from porcine placental tissue harvested according to Good Manufacturing Practices. Further treatment and final sterilization vield a particulate device prepared for the management of wounds. The particulate is meant to be deployed by the user to manage wounds of the types outlined in the Indications for Use of the device.
InnovaMatrix® PD is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans.
The wound dressing is provided in a particulate form as a single-use, sterile wound covering.
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)
The following testing was performed to mitigate any risk posed by the additional processing steps and change to the final particulate form from the InnovaMatrix reference device:
- Sterilization Validation Testing
- Shelf-Life Testing
- Packaging
- Product
- Transportation (Packaging Performance) Testing
- Endotoxin
- Physician Usability Testing
- Particle Size Analysis
- Residual Moisture
- Water Absorption
- Chemical Characterization and Toxicity Risk Assessment
- Heavy Metals and Elemental Impurities
- Biocompatibility Testing:
- Cytotoxicity
- Intracutaneous Reactivity/Irritation
Acute Systemic Toxicity - Sensitization
- Implantation
- Material-Mediated Pyrogenicity
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2022
Donna Best Chief Operating Officer 1770 Moriah Woods Blvd. Suite 18 Memphis, Tennessee 38117
Re: K211902
Trade/Device Name: InnovaMatrix PD Regulatory Class: Unclassified Product Code: KGN Dated: March 15, 2022 Received: March 15, 2022
Dear Donna Best:
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,
For Julie Morabito, Ph.D. 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
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Indications for Use
510(k) Number (if known) K211902
Device Name
InnovaMatrix PD
Indications for Use (Describe)
InnovaMatrix PD 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 (donor sites/grafts, post Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, and skin tears), draining wounds, and partial-thickness burns
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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Traditional 510(k) Summary - K211902
In accordance with 21 CFR Part 807.87(h) and 21 CFR 807.92, the 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: Donna Best Phone: (901) 333-6000 Email: dbest@triadls.com
Prepared By: Donna Best Date Prepared: September 19, 2022
2. DEVICE
Name of Device: InnovaMatrix® PD Common Name: Collagen Wound Dressing Classification Regulation/Class: Unclassified Product Code: KGN Panel: General and Plastic Surgery
3. PREDICATE AND REFERENCE DEVICE
Predicate Device: Cook® ECM Powder (K152033) Reference Device: InnovaMatrix® (K193552)
4. DEVICE DESCRIPTION
Description
InnovaMatrix® PD is a powder manufactured from the decellularized extracellular matrix (ECM) derived from porcine placental tissue harvested according to Good Manufacturing Practices. Further treatment and final sterilization vield a particulate device prepared for the management of wounds. The particulate is meant to be deployed by the user to manage wounds of the types outlined in the Indications for Use of the device.
InnovaMatrix® PD is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans.
The wound dressing is provided in a particulate form as a single-use, sterile wound covering.
4
Traditional 510(k) Summary - K211902
5. INDICATION FOR USE
InnovaMatrix® PD is indicated for the management of wounds including: partial- and fullthickness 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, and skin tears), draining wounds and partial-thickness burns. The device is intended for one-time use.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Similar to the predicate Cook® ECM Powder, InnovaMatrix® PD is an extracellular matrix (ECM) topical wound covering in particulate form, derived from porcine material. The biodeqradable wound powder provides a protective cover to the wound.
The predicate Cook® ECM Powder (K152033) is an animal-sourced wound dressing that is derived from porcine small intestinal submucosa (SIS). The porcine SIS, and the resulting wound dressing, is comprised of primarily Types I, III, IV and VI collagen (constituents of the extracellular matrix). The device is intended for use in the management of wounds. Cook® ECM Powder is terminally sterilized in its packaging, applied dry, and becomes hydrated and moist during use. The Cook® ECM Powder is provided in particulate form with particles of ≤1000 µm.
Similar to the predicate Cook® ECM Powder, InnovaMatrix® PD is also composed primarily of collagen. InnovaMatrix® PD is chemically identical to the InnovaMatrix® reference device and differs only in physical form (particulate versus sheet). The device is intended for use in the management of wounds. InnovaMatrix® PD is terminally sterilized in its packaging, applied dry, and becomes hydrated and moist during use.
Overall, the differences in technological characteristics between the subject, predicate, and reference devices do not raise any different questions of safety and effectiveness.
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| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| InnovaMatrix® PD | Cook® ECM Powder | InnovaMatrix® | |
| Particulate Form | Particulate Form | Sheet Form | |
| 510(k) Clearance: | 510(k) Clearance: | 510(k) Clearance: | |
| K211902 | K152033 | K193552 | |
| Product Code | KGN | KGN | KGN |
| Classification | Dressing, Wound, | Dressing, Wound, | Dressing, Wound, |
| Collagen | Collagen | Collagen | |
| Intended Use | Wound Management | Wound Management | Wound Management |
| including: partial- | including: partial- and | including: partial- and | |
| and full-thickness | full-thickness | full-thickness | |
| wounds, pressure | wounds, pressure | wounds, pressure | |
| ulcers, venous | ulcers, venous ulcers, | ulcers, venous ulcers, | |
| ulcers, diabetic | diabetic ulcers, | diabetic ulcers, | |
| ulcers, chronic | chronic vascular | chronic vascular | |
| vascular ulcers, | ulcers, | ulcers, | |
| tunneled/undermined | tunneled/undermined | tunneled/undermined | |
| wounds, surgical | wounds, surgical | wounds, surgical | |
| wounds (donor | wounds (donor | wounds (donor | |
| sites/grafts, post- | sites/grafts, post- | sites/grafts, post- | |
| Mohs surgery, post- | Mohs surgery, post- | Mohs surgery, post- | |
| laser surgery, | laser surgery, | laser surgery, | |
| podiatric, wound | podiatric, wound | podiatric, wound | |
| dehiscence), trauma | dehiscence), trauma | dehiscence), trauma | |
| wounds (abrasions, | wounds (abrasions, | wounds (abrasions, | |
| lacerations, and skin | lacerations, second- | lacerations, second- | |
| tears), draining | degree burns and | degree burns and | |
| wounds and partial- | skin tears) and | skin tears) and | |
| thickness burns | draining wounds | draining wounds | |
| Material | Porcine Placenta | Porcine Small | |
| Intestinal Submucosa | |||
| (ટાટ) | Porcine Placenta | ||
| Material Type | Collagen, | Collagen, | Collagen, |
| Extracellular Matrix | Extracellular Matrix | Extracellular Matrix | |
| Use | Single use | Single use | Single use |
| Subject Device | |||
| InnovaMatrix® PD |
Particulate Form
510(k) Clearance:
K211902 | Predicate Device
Cook® ECM Powder
Particulate Form
510(k) Clearance:
K152033 | Reference Device
InnovaMatrix®
Sheet Form
510(k) Clearance:
K193552 |
| Sterilization | E-Beam Irradiation | Ethylene Oxide | E-Beam Irradiation |
| Sizes | Particles ≤ 1000 μm | Particles ≤ 1000 μm | 1cm x 1cm to 5cm x
5cm |
| Additional
Feature(s) | Mass offering up to ≤
200 mg | Mass offering up to ≤
1000 mg | Solid Sheet, 4
sheets/application |
Summary of Technological Characteristics
6
Traditional 510(k) Summary - K211902
7. PERFORMANCE DATA
Summary of the Non-Clinical Tests:
The following testing was performed to mitigate any risk posed by the additional processing steps and change to the final particulate form from the InnovaMatrix reference device:
- Sterilization Validation Testing ●
- Shelf-Life Testing ●
- o Packaging
- o Product
- Transportation (Packaging Performance) Testing ●
- Endotoxin ●
- Physician Usability Testing ●
- Particle Size Analysis
- Residual Moisture
- Water Absorption
- Chemical Characterization and Toxicity Risk Assessment ●
- Heavy Metals and Elemental Impurities ●
- Biocompatibility Testing: ●
- o Cytotoxicity
- o Intracutaneous Reactivity/Irritation
- Acute Systemic Toxicity о
- Sensitization O
- Implantation O
- Material-Mediated Pyrogenicity O
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8. CONCLUSIONS
InnovaMatrix® PD has the same intended use as the predicate device Cook® ECM Powder. The technological characteristics are fundamentally similar to the predicate wound dressing, and chemically the same as the InnovaMatrix® reference device. All devices are porcine-derived, decellularized dressings that are comprised primarily of collagen. The dressings are intended for the management of wounds. Based on the indications for use, technological characteristics, and non-clinical test results, InnovaMatrix™ PD is substantially equivalent to the predicate device Cook® ECM Powder (K152033).