(309 days)
No
The device description and performance studies focus on the biological and material properties of the wound covering, with no mention of AI or ML.
Yes
The device is indicated for the management of various types of wounds, including partial-thickness second-degree burns. This fits the definition of a therapeutic device, as it is used to treat or manage a medical condition.
No
The device is indicated for the management of wounds and is described as a topical wound covering, which are therapeutic functions, not diagnostic.
No
The device description clearly states that InnovaBurn™ is a physical wound covering derived from porcine placental tissue, provided in sheets. This indicates it is a hardware 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 clearly states that InnovaBurn™ is for the "management 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 description details a "topical wound covering" made from porcine placental tissue. This is a physical material applied to a wound, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, stability, sterilization, and usability, which are relevant for a therapeutic device, not an IVD.
Therefore, InnovaBurn™ is a medical device intended for wound management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InnovaBurn™ 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), partial-thickness second degree burns, and draining wounds.
The device is intended for one-time use.
Product codes
KGN
Device Description
InnovaBurn™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaBurn" 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 greater than 5 x 5cm (25cm2) up to 20 x 20cm (400cm2). 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing, including In Vitro Cvtotoxicity. Skin Sensitization. Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute Toxicity, Implantation (1-week, 2-week, and 13-week), In Vitro Bacterial Reverse Mutation, Mouse Lymphoma Assay, Sub-Chronic Systemic Toxicity, and Material-Mediated Pyrogenicity was conducted on InnovaMatrix® (K193552). All test results were acceptable. Clinical immunogenicity testing, including Human Repeat Insult Patch Testing and Human Skin Prick Testing, was conducted on InnovaMatrix® (K193552). All results were acceptable. Viral inactivation testing was performed on InnovaMatrix® (K193552), and results were acceptable. Compositional testing, including collagen analysis, elastin, hyaluronic acid, laminin, fibronectin, nucleic acid, and sulfated glycosaminoglycans analyses, and cell debris testing was performed on InnovaMatrix® (K193552). All results were acceptable. Heavy metal residual 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)] was conducted on InnovaMatrix® (K193552), and all results were acceptable. Due to the identical nature of the device composition, the biocompatibility testing, clinical immunogenicity testing, viral inactivation testing, compositional testing, and heavy metals residual testing completed on InnovaMatrix® (K193552) were leveraged to support the subject device InnovaBurn™.
The following testing was conducted in support of InnovaBurn™:
- Biological Risk Assessment and Toxicological Evaluation
- Transportation Testing
- Packaging Stability
- Product Stability
- Sterilization Validation Testing
- Endotoxin
- Physician Usability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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September 29, 2022
Triad Life Sciences, Inc. Donna Best Chief Operating Officer 1770 Moriah Woods Blvd. Suite 18 Memphis. Tennessee 38117
Re: K213716 Trade/Device Name: InnovaBurn™ Regulatory Class: Unclassified Product Code: KGN Dated: December 16, 2021 Received: December 17, 2021
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
1
K213716 - Donna Best
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 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 mediation-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.
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
2
Indications for Use
510(k) Number (if known) K213716
Device Name InnovaBurn™
Indications for Use (Describe)
InnovaBurn™ 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), partial-thickness second degree burns, 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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3
510(k) Summarv – K213716
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 Registration Number: 3017660750
Contact Person: Donna Best Phone: 901-333-6000 Email: dbest(@triadls.com
2. DEVICE
Name of Device: InnovaBurn™ 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: Cytal® Wound Matrix 3-Layer (K192725)
4. DEVICE DESCRIPTION
Description
InnovaBurn™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound covering. InnovaBurn" 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 greater than 5 x 5cm (25cm2) up to 20 x 20cm (400cm2). They are provided as single-use, sterile wound coverings.
4
510(k) Summarv – K213716
5. INDICATION FOR USE
InnovaBurn™ 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, and skin tears), partialthickness second-degree burns and draining wounds. The device is intended for one-time use.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
InnovaBurn™ is a decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. Triad processes the tissue into the ECM topical wound coverings. InnovaBurn" 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 sizes.
Table 1 provides a summary comparison between the subject, predicate, and reference devices.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | K213716 | K193552 | K192725 |
| Applicant | Triad Life Sciences, Inc. | Triad Life Sciences, Inc. | ACell, Inc. |
| Device Name | InnovaBurn™ | InnovaMatrix® | Cytal® Wound Matrix |
| 3-Layer | |||
| Regulation/Class | Unclassified Collagen Wound | ||
| Dressing | Unclassified Collagen | ||
| Wound Dressing | Unclassified Collagen | ||
| Wound Dressing | |||
| Product Code | KGN | KGN | KGN |
| Prescription or | |||
| OTC? | Prescription | Prescription | Prescription |
| Indications for Use | InnovaBurn™ 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, | |||
| and skin tears) partial thickness | |||
| second-degree burns and | |||
| draining wounds. | Same, except indications | ||
| included second-degree | |||
| burns and not partial | |||
| thickness second-degree | |||
| burns. | Same, except | ||
| indications included | |||
| second-degree burns | |||
| and not partial | |||
| thickness second- | |||
| degree burns. | |||
| Design | Single layer extracellular | ||
| matrix, Porcine Placenta | Same | Multi-Layer | |
| extracellular matrix, | |||
| Porcine Urinary | |||
| Bladder Matrix | |||
| (UBM) |
Table 1: Device Comparison Table
5
510(k) Summarv – K213716
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Sizes | Greater than 5 x 5 cm (25 cm2) to | ||
| 20 x 20 cm (400 cm2) | 1 x 1 cm (1 cm2) to | ||
| 5 x 5 cm (25 cm2) | 16 cm x 25 cm (400 cm2) & | ||
| 16 cm x 35 cm (560 cm2) | |||
| Single Use? | Yes | Same | Same |
| Sterile | E-Beam-sterilized | Same | Same |
Overall, the difference in technological characteristics of the subject and predicate device, i.e., the addition of sizes, does not raise any questions of safety and effectiveness.
7. PERFORMANCE DATA
The subject device, InnovaBurn™, is comprised of identical materials and is processed and sterilized using identical methods as the predicate device, InnovaMatrix® (K193552).
Biocompatibility testing. including In Vitro Cvtotoxicity. Skin Sensitization. Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute Toxicity, Implantation (1-week, 2-week, and 13-week), In Vitro Bacterial Reverse Mutation, Mouse Lymphoma Assay, Sub-Chronic Systemic Toxicity, and Material-Mediated Pyrogenicity was conducted on InnovaMatrix® (K193552). All test results were acceptable. Clinical immunogenicity testing, including Human Repeat Insult Patch Testing and Human Skin Prick Testing, was conducted on InnovaMatrix® (K193552). All results were acceptable. Viral inactivation testing was performed on InnovaMatrix® (K193552), and results were acceptable. Compositional testing, including collagen analysis, elastin, hyaluronic acid, laminin, fibronectin, nucleic acid, and sulfated glycosaminoglycan analyses, and cell debris testing was performed on InnovaMatrix® (K193552). All results were acceptable. Heavy metal residual 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)] was conducted on InnovaMatrix® (K193552), and all results were acceptable. Due to the identical nature of the device composition, the biocompatibility testing, clinical immunogenicity testing, viral inactivation testing, compositional testing, and heavy metals residual testing completed on InnovaMatrix® (K193552) were leveraged to support the subject device InnovaBurn™.
The following testing was conducted in support of InnovaBurn™:
- Biological Risk Assessment and Toxicological Evaluation ●
- Transportation Testing ●
- Packaging Stability ●
- Product Stability
- Sterilization Validation Testing ●
- Endotoxin ●
- Physician Usability .
6
8. CONCLUSIONS
InnovaBurn™ has the identical indications for use as the predicate device InnovaMatrix®. The technical characteristics are the same as the technological characteristics of the predicate wound dressing. The only modification for the subject device is the addition of larger sizes to the predicate device. The sizes of the subject device are withing the size ranges of the reference device, Cytal® Wound Matrix 3-Layer. The reference device has the same indications for use as the subject device. The predicate, reference, and subject devices are porcine-derived, decellularized dressings that are comprised primarily of collagen and are intended for the management of wounds. Based on the indications for use, technological characteristics, and performance test results, InnovaBurn" is substantially equivalent to the predicate device InnovaMatrix® (K193552).