(472 days)
NovoGen Wound Matrix 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, single use device intended for use in local management of cutaneous wounds. It is manufactured from bovine type I collagen and 45S5 bioactive glass. When hydrated with wound exudate or sterile water, this product transforms into a soft conforming layer which is naturally incorporated into the wound over time.
The provided text describes the NovoGen Wound Matrix, a medical device, and its substantial equivalence determination by the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance).
Instead, it outlines the device's characteristics, its comparison to a predicate device, and a summary of non-clinical performance testing. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety and performance testing.
Here's a breakdown of the information provided, formatted to address your request as much as possible, with explicit notes where the requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Since there are no explicitly stated numerical acceptance criteria or thresholds in the document, this table will reflect the types of performance tests conducted and their qualitative results as stated in the submission.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Absorption Capacity (demonstrates appropriate fluid handling) | Testing performed. (Specific values or ranges not provided, but implies satisfactory performance given the conclusion of substantial equivalence). |
| Compression Recovery (demonstrates material integrity/shape retention) | Testing performed. (Specific values or ranges not provided). |
| Degradation Potential via Collagenase (demonstrates appropriate bio-resorption) | Testing performed. (Specific values or rates not provided). |
| Hydration Time (demonstrates proper hydration characteristics) | Testing performed. (Specific values or ranges not provided). |
| Tensile Strength (demonstrates mechanical integrity) | Testing performed. (Specific values or ranges not provided). |
| Viral Inactivation (demonstrates safety from viral contaminants) | Testing performed. (Specific methods or quantitative reduction not provided, but implies successful inactivation). |
| Wound Healing Performance (demonstrates effectiveness in promoting wound healing) | A full-thickness porcine wound healing study found equivalent wound healing performance for the NovoGen Wound Matrix when compared to the primary predicate device and untreated control sites. |
| Biocompatibility (demonstrates non-toxic, non-irritating, non-sensitizing properties) | Found to be biocompatible for its intended use when tested in compliance with ISO 10993-1. Cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, subacute systemic toxicity, implantation, genotoxicity, and endotoxin endpoints were addressed via testing. Chronic toxicity and carcinogenicity were addressed via a toxicological risk assessment. The Human Repeat Insult Patch Test (HRIPT) found no potential for eliciting dermal irritation or inducing sensitization. |
| Sterilization (demonstrates sterility assurance) | Gamma, 10^-6 SAL. (Implies successful sterilization). |
| Non-Pyrogenic (demonstrates absence of fever-inducing substances) | Yes. (Implies successful testing). |
2. Sample size used for the test set and the data provenance
- Porcine Wound Healing Study: "A full thickness porcine wound healing study" - Sample size (number of animals or wounds) is not specified. Data provenance is animal study (porcine).
- Biocompatibility (ISO 10993-1): Sample size not specified. Provenance is in vitro and in vivo (e.g., animal tests for systemic toxicity, implantation).
- Human Repeat Insult Patch Test (HRIPT): "Based on the test population who completed the study" - Sample size (number of human subjects) is not specified. Provenance is prospective human study. Specific country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not provided in the document. The studies performed (animal, biocompatibility, HRIPT) would typically involve trained personnel, but the specific number and qualifications of "experts" to establish a ground truth in the sense of clinical interpretation are not mentioned, as these are primarily laboratory and animal studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The studies described are not of a diagnostic nature requiring expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is a wound matrix, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical wound matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Porcine Wound Healing Study: The "ground truth" for wound healing would be based on direct observation and measurement of wound closure, tissue regeneration, and potentially histopathology in the porcine model. It's compared to a predicate device and untreated controls for equivalence.
- Biocompatibility Studies: Ground truth is established by standardized laboratory test results against established safety thresholds (e.g., cell viability in cytotoxicity, immune response in sensitization, absence of fever in pyrogenicity).
- HRIPT: Ground truth is clinical observation of skin reactions (irritation/sensitization) in human subjects.
8. The sample size for the training set
This is not applicable as the device is not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/machine learning algorithm.
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June 09, 2023
Novabone Products, LLC % Linda Braddon CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K220498
Trade/Device Name: NovoGen Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: May 9, 2023 Received: May 10, 2023
Dear Linda Braddon:
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
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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,
| Tek N. | Digitally signed byTek N. Lamichhane |
|---|---|
| Lamichhan -s | |
| e-S | Date: 2023.06.0909:54:23 -04'00' |
For Julie A. 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) K220498
Device Name NovoGen Wound Matrix
Indications for Use (Describe)
NovoGen Wound Matrix 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-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
| 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 K220498
NovoGen Wound Matrix
| Date Prepared | June 9, 2023 | Trait | NovaBone Products, LLCNovaGen Wound Matrix(Subject Device) | Primary PredicateMesynthes LtdEndoform Dermal Template |
|---|---|---|---|---|
| Sponsor | NovaBone Products, LLC13510 NW US Highway 441Alachua, FL 32615 | 510(k) number | K220498 | K092096 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com | Regulation | Unclassified | Unclassified |
| Trade Name | NovoGen Wound Matrix | Product | KGN | KGN |
| Common Name | Collagen Wound Matrix | Classification | ||
| Code - Classification | KGNUnclassified | Common Name | Collagen Wound Dressing | Collagen Wound Dressing |
| Primary Predicate | K092096 Mesynthes Endoform Dermal Template | IndicationsforUse | NovoGen Wound Matrix is indicatedfor the management of woundsincluding:• Partial and full-thickness wounds• Pressure ulcers• Venous ulcers• Diabetic ulcers• Chronic vascular ulcers• Tunneled/undermined wounds• Surgical wounds (donor sites/grafts,post-Moh's surgery, post-lasersurgery, podiatric, wounddehiscence)• Trauma wounds (abrasions,lacerations, partial thickness burns,and skin tears)• Draining wounds | Endoform is supplied sterile and isintended for single use in the treatmentof thefollowing wounds:• Partial and full-thickness wounds• Pressure ulcers• Venous ulcers• Diabetic ulcers• Chronic vascular ulcers• Tunneled/undermined wounds• Surgical wounds (donor sites/grafts,post-Moh's surgery, post-lasersurgery, podiatric, wounddehiscence)• Trauma wounds (abrasions,lacerations, second-degree burns,and skin tears)• Draining wounds |
| Reference Devices | K110368 NovaBone Putty - Bioactive Synthetic Bone GraftK112428 NovaBone Dental Morsels - Bioactive Synthetic Bone GraftK141207 NovaBone Bioactive Strip | CompositionofMaterial | Bovine CollagenBioactive GlassCitric Acid | Ovinecollagen |
| Device Description | NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, singleuse device intended for use in local management of cutaneous wounds. It ismanufactured from bovine type I collagen and 45S5 bioactive glass. Whenhydrated with wound exudate or sterile water, this product transforms into asoft conforming layer which is naturally incorporated into the wound overtime. | StructuralReinforcementMaterial | Bioactive Glass (Same materialasreference device K141207) | Not applicable |
| Indications for UseStatement | NovoGen Wound Matrix is indicated for the management of woundsincluding:● Partial and full-thickness wounds● Pressure ulcers● Venous ulcers● Diabetic ulcers● Chronic vascular ulcers● Tunneled/undermined wounds● Surgical wounds (donor sites/grafts, post-Moh's surgery, post-lasersurgery, podiatric, wound dehiscence)● Trauma wounds (abrasions, lacerations, partial thickness burns, andskin tears) | PrimaryFunction | Wound Dressing | Wound Dressing |
| Absorbable | Yes | Not Stated, but websites say it willdissolve into the wound | ||
| Size(s) | Range of sizes from 26cm² to 130cm²:• 2" x 2" (5.1cm x 5.1cm)• 2" x 3" (5.1cm x 7.6cm)• 3" x 3" (7.6cm x 7.6cm)• 4" x 5" (10.2cm x 12.7cm) | Range of sizes from 9cm² to 400cm² |
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Comparison of Technological Characteristics
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| Trait | NovaBone Products, LLCNovaGen Wound Matrix(Subject Device) | Primary PredicateMesynthes LtdEndoform Dermal TemplateK092096 |
|---|---|---|
| Fluid Absorbency | Yes | Not stated |
| Moist Environment | Maintains a moist wound environment | Not stated |
| Perforated | No | Perforated and Non-Perforated |
| Layers | One Layer | One or Two Layers |
| Customizable | Yes, trim to size | Yes, trim to size |
| Sterilization | Gamma, 10-6 SAL | Ethylene Oxide, 10-6 SAL |
| Packaging | Single peel packs | Not stated |
| Biocompatibility | Biocompatible | Biocompatible |
| Single Use | Yes | Yes |
| Reapplication | As needed | Every 5 to 7 days as needed |
| Non-Pyrogenic | Yes | Not specified |
Technological Characteristics
NovoGen Wound Matrix is supplied terminally sterile barrier packaging configuration. NovoGen Wound Matrix is a scaffold and is similar to other wound matrices with respect to its design. The subject device is composed of bovine collagen with Bioglass® 4555 added as additional structural reinforcement.
There are no significant technological differences between the subject and predicate device. The subject device uses similar materials, is of a similar size and thickness, has similar design properties, and has the same intended use as the primary and additional predicates and reference devices. The presentation of the device in single vs dual peel packaging configuration does not create new risks for safety or effectiveness. The subject device uses the same packaging configuration as cleared in reference device K110368 NovaBone Putty - Bioactive Synthetic Bone Graft and uses the same sterilization process as cleared in reference device K112428 NovaBone Dental Morsels - Bioactive Synthetic Bone Graft.
Non-Clinical Performance Testing Summary
Performance testing for the NovaBone NovoGen Wound Matrix includes:
- Absorption Capacity
- Compression Recovery ●
- Degradation Potential via Collagenase ●
- Hydration Time
- Tensile Strength ●
- Viral Inactivation ●
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A full thickness porcine wound healing study found equivalent wound healing performance for the NovaBone NovoGen Wound Matrix when compared to the primary predicate device and untreated control sites.
The NovaBone NovoGen Wound Matrix was found to be biocompatible for its intended use when tested in compliance with ISO 10993-1. Cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, subacute systemic toxicity, implantation, genotoxicity, and endotoxin endpoints were addressed via testing while chronic toxicity and carcinogenicity were addressed via a toxicological risk assessment.
A Human Repeat Insult Patch Test (HRIPT) was performed to determine the potential of the test material to elicit dermal irritation and/or induce sensitization following repeated patch applications in human subjects. The Induction Phase of the study is designed to assess the potential of the subject device to elicit an irritation reaction, whereas the Challenge Phase of the study is designed to assess the potential of the subject device to elicit a sensitization response.
Based on the test population who completed the study, NovoGen Wound Matrix did not demonstrate a potential for eliciting dermal irritation or inducing sensitization.
Conclusions
Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.
N/A