(267 days)
CollOvine™ Wound Dressing is indicated for the management of exuding wounds including:
- full-thickness & partial-thickness wounds
- pressure ulcers
- venous ulcers
- ulcers caused by mixed vascular etiologies
- diabetic ulcers
- superficial second-degree burns
- donor sites and other bleeding surface wounds
- abrasions
- traumatic wounds healing by secondary intention
- dehisced surgical incisions
CollOvine Wound Dressing is a sterile advanced wound care device composed of medical grade ovine collagen. CollOvine Wound Dressing is soft, absorbent, and readily conforms to the wound bed. CollOvine Wound Dressing is available in multiple sizes; 1"x1", 2"x2" and 4"x4". CollOvine wound dressing is intended to maintain the moist microenvironment. CollOvine Wound Dressing is a primary wound dressing that can be cut with sterile scissors to ensure good contact with the wound bed. CollOvine Wound Dressing should be used with suitable non-occlusive absorbent secondary dressing and secured with standard non-irritating fixations such as medical grade tape or semi-occlusive dressing as appropriate. CollOvine Wound Dressing is a primary dressing, to maintain the required moist wound bed environment. CollOvine Wound Dressing is soft and pliable. The ovine collagen for CollOvine Wound dressing is obtained from sheep in compliance with ISO22442, including controls of animal tissue sourcing, collection, storage and viral inactivation.
The provided FDA 510(k) clearance letter for the CollOvine™ Wound Dressing does not contain any information about acceptance criteria or a study that proves the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (Fibracol Plus Collagen wound dressing with Alginate) based on non-clinical testing in a side-by-side comparison.
Therefore, I cannot fulfill your request for the specific details you've asked for, as they are not present in the provided text.
Here is a breakdown of what is contained in the document related to testing, and why it doesn't align with your request for acceptance criteria and a study proving device performance:
1. A table of acceptance criteria and the reported device performance
- Not present. The document lists the Indications for Use for both the CollOvine Wound Dressing and the predicate device, showing they are identical. It also presents a "Technological Comparison" table that details attributes like classification, product code, regulatory class, indications for use, manufacturer, material, origin, device characteristics, biocompatibility, reusability, and sterilization method. This table focuses on comparing attributes rather than defining performance acceptance criteria or reporting specific performance metrics against those criteria. The “Device Characteristics” for both are simply listed as “Collagen” and “Collagen with 10% calcium alginate” respectively, which is a material description, not a performance metric.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. The document describes non-clinical biocompatibility testing (Acute systemic toxicity, Primary skin irritation, Dermal sensitization, Pyrogenicity, Subacute Systemic toxicity, Subcutaneous implant, In vitro Cytotoxicity, Chemical Characterization, Toxicological Risk assessment). For these tests, sample sizes and data provenance are not provided. These are generally standard biological safety tests, not clinical performance studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not present. This information is typically relevant for studies involving human assessment or interpretation (e.g., radiology AI devices). This is not applicable to the non-clinical biocompatibility and physiochemical testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. Adjudication methods are typically used in clinical studies where expert consensus is needed. This is not mentioned for the non-clinical tests.
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
- Not present. An MRMC study is a type of clinical study, often used for diagnostic devices involving human interpretation (like AI in radiology). The document describes a wound dressing, and the testing conducted is non-clinical.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This concept is specific to AI or software-as-a-medical-device (SaMD). The CollOvine Wound Dressing is a physical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not present. For the non-clinical biocompatibility tests, "ground truth" would be established by the results of standardized biological assays comparing the device's effects to known safety profiles or controls. For pH and absorbency tests, the "ground truth" is the measured physical property itself, compared to the predicate. No expert consensus or pathology is mentioned.
8. The sample size for the training set
- Not present. Training sets are relevant for AI/machine learning models. This is a physical wound dressing device.
9. How the ground truth for the training set was established
- Not present. As above, not relevant for this type of device.
Summary of what the document does provide regarding testing:
- Study Objective (Implied): To demonstrate substantial equivalence to the predicate device (Fibracol Plus Collagen wound dressing with Alginate, K982597) through non-clinical testing.
- Tests Performed:
- Biocompatibility testing in compliance with ISO 10993 Part 1 Biological Evaluation of Medical Devices, including:
- Acute systemic toxicity (in mice)
- Primary skin irritation (in rabbits)
- Dermal sensitization (in Guinea pigs)
- Pyrogenicity (in rabbits)
- Subacute Systemic toxicity (in rats; 30 days intraperitoneal route)
- Subcutaneous implant (in rats, 1-week and 4-weeks)
- In vitro Cytotoxicity (Direct cell contact)
- Chemical Characterization
- Toxicological Risk assessment
- pH and absorbency testing (results stated as "found to be similar to that of the primary predicate Fibracol Plus wound dressing").
- Biocompatibility testing in compliance with ISO 10993 Part 1 Biological Evaluation of Medical Devices, including:
- Conclusion: Based on the non-clinical testing, CollOvine wound dressing is substantially equivalent to the predicate device.
In essence, the document serves as a regulatory clearance (510(k)) based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical, benchtop, and biocompatibility studies, rather than a clinical performance study with predefined acceptance criteria for patient outcomes.
FDA 510(k) Clearance Letter - CollOvine™ Wound Dressing
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 20, 2025
OviGenex LLC
Thomas Hyland
COO/GM
2630 Homestead Place
Rancho Dominguez, California 90220
Re: K242985
Trade/Device Name: CollOvine™ Wound Dressing
Regulatory Class: Unclassified
Product Code: KGN
Dated: May 20, 2025
Received: May 20, 2025
Dear Thomas Hyland:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K242985 - Thomas Hyland Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
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K242985 - Thomas Hyland Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D.
Assistant Director
DHT4B: Division of Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242985
Device Name: CollOvine™ Wound Dressing
Indications for Use (Describe)
CollOvine™ Wound Dressing is indicated for the management of exuding wounds including:
- full-thickness & partial-thickness wounds
- pressure ulcers
- venous ulcers
- ulcers caused by mixed vascular etiologies
- diabetic ulcers
- superficial second-degree burns
- donor sites and other bleeding surface wounds
- abrasions
- traumatic wounds healing by secondary intention
- dehisced surgical incisions
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number"
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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K242985
Page 1 of 5
510(k) Summary
1. DATE PREPARED
20th June 2025
2. SUBMITTER
OviGenex LLC
2630 Homestead Place
Rancho Dominguez,
California 90220
3. CONTACT PERSON
Thomas Hyland
CEO
Cell (+44) 7984432366
+1 562-297-0310 (Phone)
+1 310-635-5503 (Fax)
4. DEVICE NAME
Classification Name: Wound Dressing with animal derived materials
Common/Usual Name: Wound dressing
Primary Predicate device: K982597 – Fibracol Plus Collagen wound dressing with Alginate
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K242985
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5. DEVICE CLASSIFICATION
Product Code/Classification Number: KGN
Regulatory Class: Unclassified
6. INDICATIONS FOR USE
CollOvine Wound Dressing is designed for use with adults only, and for the management of exuding wounds including:
- full-thickness & partial-thickness wounds
- pressure ulcers
- venous ulcers
- ulcers caused by mixed vascular etiologies
- diabetic ulcers
- superficial second-degree burns
- donor sites and other bleeding surface wounds
- abrasions
- traumatic wounds healing by secondary intention
- dehisced surgical incisions
Precautions:
CollOvine Wound Dressing should only be used under the direct supervision of a wound care professional. When visible signs of infection are present then CollOvine Wound Dressing should not be used and an appropriate course of treatment for infections should be followed. Stop using immediately if an allergic reaction is suspected
Contraindications:
CollOvine Wound Dressings are not indicated for deep second-degree, or third-degree burns, wounds with active vasculitis, pregnant or breast-feeding women, or children, or for patients with known sensitivity to collagen or lanolin.
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K242985
Page 3 of 5
CollOvine wound dressing indications for use are the same as the primary predicate FIBRACOL Plus collagen wound dressing with alginate.
Indications for Use
| CollOvine wound dressing K242985 | Fibracol Plus collagen wound dressing with alginate K982597 |
|---|---|
| • full-thickness & partial-thickness wounds | • full-thickness & partial-thickness wounds |
| • pressure ulcers | • pressure ulcers |
| • venous ulcers | • venous ulcers |
| • ulcers caused by mixed vascular etiologies | • ulcers caused by mixed vascular etiologies |
| • diabetic ulcers | • diabetic ulcers |
| • superficial second-degree burns | • superficial second-degree burns |
| • donor sites and other bleeding surface wounds | • donor sites and other bleeding surface wounds |
| • abrasions | • abrasions |
| • traumatic wounds healing by secondary intention | • traumatic wounds healing by secondary intention |
| • dehisced surgical incisions | • dehisced surgical incisions |
7. DEVICE DESCRIPTION
CollOvine Wound Dressing is a sterile advanced wound care device composed of medical grade ovine collagen. CollOvine Wound Dressing is soft, absorbent, and readily conforms to the wound bed.
CollOvine Wound Dressing is available in multiple sizes; 1"x1", 2"x2" and 4"x4".
CollOvine wound dressing is intended to maintain the moist microenvironment. CollOvine Wound Dressing is a primary wound dressing that can be cut with sterile scissors to ensure good contact with the wound bed.
CollOvine Wound Dressing should be used with suitable non-occlusive absorbent secondary dressing and secured with standard non-irritating fixations such as medical grade tape or semi-occlusive dressing as appropriate.
CollOvine Wound Dressing is a primary dressing, to maintain the required moist wound bed environment. CollOvine Wound Dressing is soft and pliable.
The ovine collagen for CollOvine Wound dressing is obtained from sheep in compliance with ISO22442, including controls of animal tissue sourcing, collection, storage and viral inactivation.
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K242985
Page 4 of 5
8. TECHNOLOGICAL COMPARISON
| Attribute | CollOvine | Fibracol Plus |
|---|---|---|
| 510(k) Number | K242985 | K982597 |
| Classification | Wound Dressing with animal derived material | Wound Dressing with animal derived material |
| Product Code | KGN | KGN |
| Regulatory Class | Unclassified | Unclassified |
| Indications for use | CollOvine Wound Dressing is indicated for the management of exuding wounds including: Full-thickness & partial-thickness wounds; pressure ulcers; venous ulcers; ulcers caused by mixed vascular etiologies; diabetic ulcers; superficial second-degree burns; donor sites and other bleeding surface wounds; abrasions; traumatic wounds healing by secondary intention; dehisced surgical incisions. | Fibracol Plus Dressing is indicated for the management of exuding wounds including: Full thickness & partial thickness wounds; pressure ulcers venous ulcers; ulcers caused by mixed vascular etiologies; diabetic ulcers; second- degree burns; donor sites and other bleeding surface wounds; abrasions; traumatic wounds healing by secondary intention; dehisced surgical incisions. |
| Manufacturer | OviGenex LLC. | Johnson & Johnson Medical, Inc. |
| Material | Collagen | Collagen with 10% calcium alginate. |
| Origin | Ovine hide | Bovine hide |
| Device Characteristics | Collagen | Collagen with 10% calcium alginate. |
| Biocompatible | Yes, ISO 10993-1 | Yes, ISO 10993-1 |
| Reusable | Single Use Device | Single Use Device |
| Sterilization Method | Gamma irradiation | Not publicly available |
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K242985
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9. NON CLINICAL / CLINICAL SUMMARY and CONCLUSIONS
CollOvine Wound dressing was tested for biocompatibility in compliance with ISO 10993 Part 1 B
The following safety testing was conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices to support the biocompatibility of this product.
- Acute systemic toxicity (in mice)
- Primary skin irritation (in rabbits)
- Dermal sensitization (in Guinea pigs)
- Pyrogenicity (in rabbits)
- Subacute Systemic toxicity (in rats; 30 days intraperitoneal route)
- Subcutaneous implant (in rats, 1-week and 4-weeks)
- In vitro Cytotoxicity (Direct cell contact)
- Chemical Characterization
- Toxicological Risk assessment
pH and absorbency of CollOvine wound dressing was tested and found to be similar to that of the primary predicate Fibracol Plus wound dressing.
In conclusion, CollOvine wound dressing is substantially equivalent to the predicate device.
N/A