(472 days)
No
The device description and performance studies focus on the material properties and biological interactions of a wound matrix, with no mention of AI or ML technologies.
Yes.
The device is indicated for the management of various types of wounds, which is a therapeutic purpose.
No
The device is described as a 'Wound Matrix' intended for the management of wounds, functioning as an absorbable material that transforms into a soft conforming layer to be incorporated into the wound over time. Its function is to facilitate healing, not to diagnose a condition.
No
The device description clearly states it is a physical product manufactured from bovine type I collagen and 45S5 bioactive glass, intended for local management of cutaneous wounds. It is a physical matrix, not software.
Based on the provided information, the NovoGen Wound Matrix is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of wounds." This involves direct application to the wound for healing purposes.
- Device Description: The description details a material (collagen and bioactive glass) that is applied to the wound and is absorbed over time. This is a therapeutic or wound care device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Performance Studies: The performance studies focus on the physical properties of the material (absorption, degradation, strength) and its effect on wound healing in a porcine model and biocompatibility in humans. These are typical evaluations for a wound care product, not an IVD.
IVD devices are used outside the body to examine specimens obtained from the body to provide information for diagnostic purposes. The NovoGen Wound Matrix is applied to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous wounds
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)
Performance testing for the NovaBone NovoGen Wound Matrix includes:
- Absorption Capacity
- Compression Recovery ●
- Degradation Potential via Collagenase ●
- Hydration Time
- Tensile Strength ●
- Viral Inactivation ●
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.
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.
K092096 Mesynthes Endoform Dermal Template
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.
K110368 NovaBone Putty - Bioactive Synthetic Bone Graft, K112428 NovaBone Dental Morsels - Bioactive Synthetic Bone Graft, K141207 NovaBone Bioactive Strip
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 by
Tek N. Lamichhane |
|--------------|------------------------------------------|
| Lamichhan -s | |
| e-S | Date: 2023.06.09
09:54:23 -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
2
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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3
510(k) SUMMARY K220498
NovoGen Wound Matrix
| Date Prepared | June 9, 2023 | Trait | NovaBone Products, LLC
NovaGen Wound Matrix
(Subject Device) | Primary Predicate
Mesynthes Ltd
Endoform Dermal Template |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | NovaBone Products, LLC
13510 NW US Highway 441
Alachua, FL 32615 | 510(k) number | K220498 | K092096 |
| 510(k) Contact | Secure BioMed Evaluations
Linda Braddon, Ph.D.
7828 Hickory Flat Highway
Suite 120
Woodstock, GA 30188
770-837-2681
Regulatory@SecureBME.com | Regulation | Unclassified | Unclassified |
| Trade Name | NovoGen Wound Matrix | Product | KGN | KGN |
| Common Name | Collagen Wound Matrix | Classification | | |
| Code - Classification | KGN
Unclassified | Common Name | Collagen Wound Dressing | Collagen Wound Dressing |
| Primary Predicate | K092096 Mesynthes Endoform Dermal Template | Indications
for
Use | 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 | Endoform is supplied sterile and is
intended for single use in the treatment
of the
following 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-laser
surgery, podiatric, wound
dehiscence)
• Trauma wounds (abrasions,
lacerations, second-degree burns,
and skin tears)
• Draining wounds |
| Reference Devices | K110368 NovaBone Putty - Bioactive Synthetic Bone Graft
K112428 NovaBone Dental Morsels - Bioactive Synthetic Bone Graft
K141207 NovaBone Bioactive Strip | Composition
of
Material | Bovine Collagen
Bioactive Glass
Citric Acid | Ovine
collagen |
| Device Description | 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. | Structural
Reinforcement
Material | Bioactive Glass (Same material
as
reference device K141207) | Not applicable |
| Indications for Use
Statement | 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) | Primary
Function | Wound Dressing | Wound Dressing |
| Absorbable | Yes | Not Stated, but websites say it will
dissolve 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 | | |
4
Comparison of Technological Characteristics
5
| Trait | NovaBone Products, LLC
NovaGen Wound Matrix
(Subject Device) | Primary Predicate
Mesynthes Ltd
Endoform Dermal Template
K092096 |
|-------------------|--------------------------------------------------------------------|---------------------------------------------------------------------------|
| 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 ●
6
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.