(306 days)
InnovaMatrix™ 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, seconddegree burns and skin tears) and draining wounds.
The device is intended for one-time use.
InnovaMatrix™ 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™ is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans.
The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes ranging from 1 x 1cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.
The provided text is a 510(k) summary for the InnovaMatrix™ device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria as would be required for a novel device or a PMA.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the way a clinical trial for a new diagnostic algorithm or treatment efficacy would. Specifically, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a "test set" in the context of an AI/diagnostic algorithm study.
- Information about expert ground truth establishment (number of experts, qualifications, adjudication method).
- Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
- Standalone performance data for an algorithm.
- Specific "ground truth" types (pathology, outcomes data) for clinical efficacy.
- Training set sample size or how ground truth was established for a training set.
Instead, the study presented in this document is a substantial equivalence demonstration based on:
- Biocompatibility Testing: Evaluating the safety profile of InnovaMatrix™ with various in vitro and in vivo tests (cytotoxicity, skin sensitization, intracutaneous reactivity, acute/subacute/subchronic systemic toxicity, implantation, genotoxicity, material-mediated pyrogenicity). The conclusion drawn is that the biocompatibility profile is comparable to the predicate device.
- Laboratory Testing: Analysis of the physical and chemical properties of the device (cell debris, collagen/elastin/etc. analysis, endotoxin, residual moisture, water absorption, tensile strength, viral inactivation, shelf life, heavy metals). These tests aim to characterize the material and ensure it meets relevant standards.
- Clinical Testing (Human Repeat Insult Patch Testing and Skin Prick Testing): These are safety tests to assess allergic/irritant potential, not efficacy studies.
- Human Repeat Insult Patch Testing: 58 subjects completed, no reactions.
- Skin Prick Testing: 23 subjects completed, 22 showed no reactions, 1 had a low-grade positive reaction that resolved.
Key takeaway: The provided information is about demonstrating the safety and similar technological characteristics of a wound dressing to an existing device, not about proving performance against specific acceptance criteria in a study format typically associated with AI or diagnostic device performance evaluation.
If this were a study proving the device meets acceptance criteria for a diagnostic AI, the structure and content would be vastly different, focusing on metrics like sensitivity, specificity, AUC, human-AI collaboration impact, etc.
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October 21, 2020
Triad Life Sciences, Inc. % Stephen Rhodes Principal Streamline Regulatory 3502 Dundee Driveway Chevy Chase, Maryland 20815
Re: K193552
Trade/Device Name: InnovaMatrix™ Regulatory Class: Unclassified Product Code: KGN Dated: September 24, 2020 Received: September 24, 2020
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) 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) K193552
Device Name InnovaMatrix™M
Indications for Use (Describe)
InnovaMatrix™ 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, seconddegree burns and skin tears) and draining wounds.
The device is intended for one-time use.
| 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) |
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In accordance with 21 CFR 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
Contact Person: Russell I. Olsen Phone: 901-333-6000 Email: rolsen@triadls.com
Prepared By: Stephen P. Rhodes, Streamline Regulatory stephen.rhodes@streamlineregulatory.com Date Prepared: October 21, 2020
2. DEVICE
Name of Device: InnovaMatrix™ Common Name: Collagen Wound Dressing Classification Regulation/Class: Unclassified Product Code: KGN Panel: General and Plastic Surgery
3. PREDICATE DEVICE
Predicate Device: Oasis Wound Matrix (K061711)
4. DEVICE DESCRIPTION
Description
InnovaMatrix™ 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™ is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans.
The wound dressing is provided in sheets that are approximately 40-100 microns thick in sizes ranging from 1 x 1cm to 5 x 5cm. They are provided as single-use, sterile wound coverings.
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5. INDICATION FOR USE
InnovaMatrix™ 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
InnovaMatrix™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound coverings. InnovaMatrixTM is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and sulfated glycosaminoglycans. The biodegradable wound matrix provides a protective cover to the wound.
The predicate Oasis Wound Matrix is an ECM topical wound covering derived from porcine small intestinal submucosal tissue. The predicate ECM is composed of collagen, elastin, laminin, fibronectin, hyaluronic acid and glycosaminoglycans. Like the subject device, the collagenglycosaminoglycan biodegradable matrix provides a protective cover to the wound.
Overall, the differences in technological characteristics of the subject and predicate device do not raise any different questions of safety and effectiveness.
7. PERFORMANCE DATA
The following GLP compliant, biocompatibility studies were conducted to evaluate the safety of the InnovaMatrix™:
Biocompatibility Testing
- In Vitro Cytotoxicity ●
- Skin Sensitization (Maximization Method) ●
- Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Subacute Toxicity
- Implantation: 1-week, 2-week, 4-week and 13-week
- In Vitro Bacterial Reverse Mutation (AMES) ●
- Mouse Lymphoma Assay
- Sub-Chronic Systemic Toxicity ●
- . Material-Mediated Pyrogenicity
The biocompatibility testing showed the comparable safety profile of InnovaMatrix™ and the predicate.
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Per FDA guidance on shelf life, sterilization, and devices containing animal-derived material, the following laboratory and clinical studies were also conducted:
Laboratory Testing
- Cell Debris ●
- Collagen Analysis
- Elastin, hyaluronic acid, laminin, fibronectin, nucleic acid and sulfated glycosaminoglycan ● analysis
- Endotoxin
- Residual Moisture ●
- Water Absorption ●
- Ultimate Tensile Strength and Tensile Modulus ●
- Viral Inactivation
- Expiration Dating / Shelf Life for Two Month Shelf Life
- Heavy Metals Residuals Testing per FDA Q3D(R1) Elemental Impurities Guidance for Industry (March 2020), including Class 1 Elements; Class 2A Elements; and Applicable Class 3 Elements [Li (lithium). Sb (antimony), and Cu (copper)]
Clinical Testing
- Human Repeat Insult Patch Testing
- Human Skin Prick Testing ●
Human Repeat Insult Patch Testing and Skin Prick Testing was performed. 58 subjects completed the Human Repeat Insult Patch Testing with no reactions. 23 subjects completed the Skin Prick Testing with 22 subjects exhibiting no reactions. One of the 23 subjects had a low-grade positive reaction at the 15 minute timepoint which resolved to no reaction at the 6 hour and 24-48 hour timepoints.
CONCLUSIONS 8.
InnovaMatrix™ has the identical indications for use as the predicate device. The technical characteristics are similar to the technological characteristics of the predicate wound dressing. Both devices are 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™ is substantially equivalent to the predicate device (K061711).
N/A