(464 days)
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.
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 yield 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.
This document is a 510(k) Summary for the InnovaMatrix PD device, a collagen wound dressing. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence to a legally marketed device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving the device meets them:
Crucially, this document (a 510(k) Summary) focuses on demonstrating "substantial equivalence" of a new medical device to a legally marketed predicate device. This process typically relies heavily on comparing technological characteristics and non-clinical performance data to show the new device is as safe and effective as the predicate.
It does NOT describe a study with "acceptance criteria" for a device's performance in a clinical setting in the way you've outlined (e.g., diagnostic accuracy metrics like sensitivity, specificity, or human reader improvement with AI assistance). These types of detailed performance studies are commonly seen for diagnostic devices or AI/ML-driven software, not typically for wound dressings demonstrating substantial equivalence.
Therefore, I cannot provide all the requested information as it is not contained within this type of regulatory submission. However, I can extract what is present and clarify what is absent.
Based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies acceptance criteria by performing specific non-clinical tests and concluding that the device is "substantially equivalent" to predicate devices. However, explicit numerical performance targets (e.g., "Device must achieve X sensitivity") are not stated. The "performance data" section lists the types of tests performed to mitigate risks, not specific performance metrics against pre-defined criteria.
- Reported Device Performance: Instead of explicit performance metrics, the document reports that the conducted tests support the conclusion of substantial equivalence. For example, Biocompatibility Testing was performed, and the implication is that the results were acceptable.
Table (Inferred based on non-clinical testing performed):
| Test Category | Implied Acceptance / Purpose | Reported Performance (Qualitative from text) |
|---|---|---|
| Sterilization Validation Testing | To ensure sterility and validate the E-Beam process. | Performed to mitigate risk from processing steps. (Assumed successful to support clearance) |
| Shelf-Life Testing (Packaging, Product) | To demonstrate stability and integrity over shelf life. | Performed to mitigate risk. (Assumed successful) |
| Transportation (Packaging Performance) | To ensure product integrity during transport. | Performed. (Assumed successful) |
| Endotoxin | To ensure endotoxin levels are within safe limits. | Performed. (Assumed acceptable levels) |
| Physician Usability Testing | To assess the ease and safety of use by physicians. | Performed. (Assumed positive feedback/no significant issues) |
| Particle Size Analysis | To confirm the particulate form meets specifications. | Confirmed particles ≤ 1000 µm as specified in comparison table. |
| Residual Moisture | To ensure appropriate moisture content for stability/performance. | Performed. (Assumed within acceptable range) |
| Water Absorption | To confirm expected hydration properties. | Performed. (Assumed to behave as expected, becoming hydrated and moist during use as per predicate) |
| Chemical Characterization & Toxicity Risk Assessment | To confirm composition and assess potential toxicity. | Performed. Confirmed as "chemically identical" to reference device (InnovaMatrix®). (Assumed safe) |
| Heavy Metals and Elemental Impurities | To ensure levels are below harmful thresholds. | Performed. (Assumed acceptable levels) |
| Biocompatibility Testing (Cytotoxicity, Intracutaneous, Acute Systemic Toxicity, Sensitization, Implantation, Material-Mediated Pyrogenicity) | To ensure the device is biologically safe when interacting with the body. | Performed. (Assumed to pass all relevant ISO 10993 requirements for contact duration/type) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified. The document does not mention the country of origin of data or whether it was retrospective/prospective. This is typical for non-clinical lab testing.
3. Number of Experts and Qualifications for Ground Truth
- This concept does not apply to this type of submission. "Ground truth" established by experts (e.g., radiologists for image analysis) is applicable to studies of diagnostic accuracy or AI performance where expert interpretation is the reference standard. This document focuses on material properties, manufacturing controls, and physical/chemical performance of a wound dressing. "Physician Usability Testing" involved physicians, but their role was to assess usability, not to establish a "ground truth" for a performance metric.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are for reconciling differences in expert interpretations, which is not relevant to the non-clinical testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study for Human Readers
- Not applicable. This device is a wound dressing, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, MRMC studies evaluating human reader performance with/without AI assistance are not relevant or performed for this product.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a physical wound dressing, not an algorithm or software.
7. Type of Ground Truth Used
- Not applicable in the conventional sense of clinical ground truth. The "ground truth" for the non-clinical tests performed is typically defined by established laboratory standards, specifications, and regulatory requirements (e.g., ISO standards for biocompatibility, USP for endotoxins, validated test methods for particle size).
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How Ground Truth for Training Set Was Established
- Not applicable.
Summary of what the document does provide regarding "acceptance":
The document effectively describes the regulatory acceptance process for a medical device through the 510(k) pathway, which primarily involves demonstrating substantial equivalence to an existing predicate device. The "acceptance criteria" here are that the new device (InnovaMatrix PD) must be as safe and effective as the predicate device (Cook® ECM Powder), despite minor differences in technological characteristics (e.g., raw material source, sterilization method, form factor).
The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing listed in Section 7. These tests were performed to address any potential risks introduced by changes from the predicate or reference devices. The successful completion of these tests, combined with the comparison of technological characteristics, forms the basis for the FDA's determination of substantial equivalence and subsequent market clearance. The "proof" is the FDA's clearance letter itself, stating they "have determined the device is substantially equivalent."
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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
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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.
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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 SmallIntestinal Submucosa(ટાટ) | Porcine Placenta |
| Material Type | Collagen, | Collagen, | Collagen, |
| Extracellular Matrix | Extracellular Matrix | Extracellular Matrix | |
| Use | Single use | Single use | Single use |
| Subject DeviceInnovaMatrix® PDParticulate Form510(k) Clearance:K211902 | Predicate DeviceCook® ECM PowderParticulate Form510(k) Clearance:K152033 | Reference DeviceInnovaMatrix®Sheet Form510(k) Clearance:K193552 | |
| Sterilization | E-Beam Irradiation | Ethylene Oxide | E-Beam Irradiation |
| Sizes | Particles ≤ 1000 μm | Particles ≤ 1000 μm | 1cm x 1cm to 5cm x5cm |
| AdditionalFeature(s) | Mass offering up to ≤200 mg | Mass offering up to ≤1000 mg | Solid Sheet, 4sheets/application |
Summary of Technological Characteristics
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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).
N/A