(69 days)
No
The device description and performance studies focus on the material properties and biological interactions of a collagen matrix for wound healing, with no mention of AI or ML technologies.
Yes
The device is described as a "wound care matrix" and its intended use is for "the management of wounds," which directly addresses the healing and treatment of a medical condition.
No
Explanation: The device, Omeza® Collagen Matrix, is intended for the management and healing of wounds by providing a conducive environment for the natural wound healing process, not for diagnosing a condition or disease.
No
The device description clearly states it is a wound care matrix comprised of physical materials (hydrolyzed fish collagen, cod liver oil, plant-derived oils and waxes) and is applied to a wound surface. This indicates a physical medical device, not a software-only one.
Based on the provided information, Omeza® Collagen Matrix is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the management of various types of wounds. This involves direct application to the wound surface to support the healing process.
- Device Description: The device is a wound care matrix applied to the wound surface. It is designed for intimate contact with the wound bed.
- Lack of In Vitro Testing: The description of the device and its intended use does not involve testing samples (like blood, urine, tissue) outside of the body to diagnose, monitor, or determine the state of a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, clinical safety (skin reactions), animal wound healing, and bench testing related to the physical properties and composition of the matrix. These are typical for a wound care product, not an IVD.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment decisions. Omeza® Collagen Matrix is a therapeutic device applied directly to the wound.
N/A
Intended Use / Indications for Use
Omeza® Collagen 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, superficial partial thickness burns, skin tears)
- Draining wounds
The device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Omeza® Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular wound beds to provide a conducive environment for the patient's natural wound healing process.
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
All biocompatibility endpoints required according to ISO 10993-1 and FDA's corresponding 2016 guidance were evaluated with favorable results. Testing was performed in the following categories:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Genotoxicity
- Material-mediated pyrogenicity
Clinical Studies
- Skin Prick Study: The single-center, monadic, one-day study enrolled 25 subjects in the US. The study evaluated Collagen Matrix for the potential of an immediate allergic reaction following a one-day Skin Prick Method Study. The test article, a positive control (1.0 mg/mL histamine base), and a negative control (aqueous negative control) were tested on subjects using the "Allergy Diagnostic Testing: An Updated Practice Parameter" skin prick test method. No immediate allergic reaction to the test product was observed for any subjects. Therefore, no potential allergenicity of the test product was observed under the conditions of this study.
- Human Repeat Insult Patch Test: The study was single site, evaluator-blinded using a within-subject randomization design, and had 58 subjects enrolled in the US. Omeza® Collagen Matrix was evaluated for the potential to cause irritation and sensitization compared to that of a negative control (0.9% aqueous sodium chloride) based on a modified human repeat insult patch test. Under the conditions of this study, the test product showed to be safe for use with no side effects.
Animal Studies
Two wound healing studies were conducted to assess the implantation and the wound healing endpoints of Omeza® Collagen Matrix on porcine wounds.
- Study 1: Compared the subject product to saline. The two products were applied to 10 full-thickness circular wound sites (approximately 3.0 cm in diameter) on four animals, with 14 and 25 day evaluations followed by pathology and independent expert review.
- Study 2: Compared an exaggerated dose of Omeza Collagen Matrix to Hollister Endoform Dermal Template (K092096). Products were applied to 10 full-thickness circular wound sites (approximately 2.0 cm in diameter) on two animals. The final wound evaluation occurred at 24 days, followed by pathology and independent expert review.
Both studies showed no evidence of impairment of wound healing with the use of Omeza® Collagen Matrix, and demonstrated that the subject product was safe and did not trigger adverse biological reactions in the animals.
Additional Testing (Bench)
- Extrusion: Quantified the amount of product a typical user can extrude from a vial.
- Final Product Coverage: Calculated the time required for the product to cover 18 sq. cm in a simulated model.
- Product Characterization under Environmental Conditions: Used Scanning Electron Microscopy (SEM) to image surface morphology at varying magnifications to observe and confirm microscopic and macroscopic stability of the OCM structure.
- Interaction with Wound Exudate: Employed SEM to compare the surface structure/morphology of sterile, dry OCM to OCM immersed in solutions of varying salinity concentrations, simulating moist wound exudate conditions.
- Sterilization/endotoxins: OCM vials are sterilized using a process validated per ANSI/AAMI/ISO 11137-2. Biologic testing for sterilization validation was also performed. Endotoxin testing confirmed an acceptable level of endotoxins in the final product.
- Viral Inactivation: Three viral inactivation studies were performed utilizing a panel of model viruses per ISO 22442 Part 3.
- Shelf Life: OCM meets requirements for a 9-month shelf life, based on product tested at the end of this period passing all finished product specifications.
- Collagen Characterization: Standard ELISA techniques were used to determine the types of collagen in OCM.
- Lot-to-Lot Consistency: Testing of samples from representative lots demonstrated lot-to-lot consistency of all OCM raw materials.
- Cod Liver Oil Identification and Quantification: Fatty Acid Methyl Ester analysis following AOAC 996.06 was conducted on representative lots to quantify the Cod Liver Oil (CLO) in the final product.
- Elastic Modulus: Evaluated rheological properties by analyzing elastic modulus, with results showing consistency across lots.
- Extractables and Leachables: Completed on the OCM primary and secondary packaging system, following ISO 10993 and USP 1663. No extractable compounds were detected in the product primary packaging above the analytical evaluation threshold.
- Final Product Specifications: Analyzed representative samples of final, sterilized OCM for conformance to pre-defined specifications for quantity (%w/w) of collagen, pH, specific gravity, heavy metals, product structure, and bioburden.
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.
SweetBio Apis (K182725)
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.
INTEGRA Flowable Wound Matrix (K072113), Kerecis MariGen Wound Dressing (K132343), Southwest Technologies Stimulen Collagen (K030774)
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
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September 1, 2021
Omeza, LLC % Randy Prebula Partner Hogan Lovells US LLP 555 13th Street NW Washington, District of Columbia 20004
Re: K211972
Trade/Device Name: Omeza Collagen Matrix Regulatory Class: Unclassified Product Code: FRO Dated: June 24, 2021 Received: June 24, 2021
Dear Randy Prebula:
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,
Lixin Liu, PhD Acting 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
510(k) Number (if known)
K211972
Device Name
Omeza® Collagen Matrix
Indications for Use (Describe)
Omeza® Collagen 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, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, superficial thickness burns, skin tears)
- · Draining wounds
The device is intended for one-time use.
Type of Use (Select one or both, as applicable)
Z 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
Omeza® Collagen Matrix
K211972
Submitter's name and address:
Omeza, LLC 25 South Osprey Avenue Sarasota, Florida 34231
Contact person and telephone number:
Thomas Gardner Chief Executive Officer Telephone: 941-780-5274 Email: tgardner@omeza.com
Date Summary was prepared:
August 23, 2021
Product Name:
| Proprietary Name: | Omeza® Collagen Matrix |
|---|---|
| Common Name: | Wound Dressing |
| Device Classification Name: | Dressing, Wound, Drug |
| Regulatory Classification: | Unclassified |
| Product Code: | FRO |
| Predicate Device: | SweetBio Apis (K182725) |
|---|---|
| Reference Devices: | INTEGRATM Flowable Wound Matrix (K072113) |
| Kerecis MariGen Wound Dressing (K132343) | |
| Southwest Technologies Stimulen Collagen (K030774) |
Product Description:
Omeza® Collagen Matrix (OCM) is a wound care matrix comprised of hydrolyzed fish collagen infused with cod liver oil, which acts as an anhydrous skin protectant, and other plant-derived oils and waxes. When applied to a wound surface, the matrix is naturally incorporated into the wound over time. Omeza® Collagen Matrix is designed for intimate contact with both regular wound beds to providea conducive environment for the patient's natural wound healing process.
Intended Use/Indications for Use:
Omeza® Collagen Matrix is indicated for the management of wounds including:
- Partial and full-thickness wounds .
- Pressure ulcers .
- Venous ulcers .
- Diabetic ulcers .
- Chronic vascular ulcers .
4
- Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, superficial partial thickness burns, skin tears)
- Draining wounds
The device is intended for one-time use.
Comparison with the Predicate Device:
Omeza® Collagen Matrix and the predicate device SweetBio Apis (K182725) have the same intended use, namely to manage wounds by providing an animal-derived collagen product that is biodegradable and incorporates into the surrounding tissue during the body's natural wound healing processes. Both supplement the collagen constituent with additional biocompatible materials to achieve a final product that covers and protects the wound, assists in managing wound exudate, and maintains a moist wound environment. Both products are supplied sterile and for single use, and have very similar specific indications for use.
As can be seen from the substantial equivalence table below, the comparison to the predicate device shows no new questions of safety or effectiveness. Both products rely primarily on collagen to achieve the intended use, and based on the function of the additional materials in each product, the intended use of the Omeza Collagen Matrix is the same compared to that of the predicate. Additionally, performance testing data shows that there are no different questions of safety or effectiveness.
| | Omeza® Collagen Matrix
(Subject product) | SweetBio Apis (predicate)
(K182725) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | |
| Product Code | FRO | FRO |
| Indications for Use | 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, superficial partial thickness
burns, and skin tears), draining wounds.
The device is intended for one-time use. | Indicated for use in management
of wounds including: full and
partial thickness wounds,
pressure ulcers (stages I-IV),
venous stasis ulcers, diabetic
ulcers, abrasions, surface
wounds, traumatic wounds
(healing by secondary intention),
donor site wounds, surgical
wounds |
| Rx | Yes | Yes |
| Single use | Yes | Yes |
| Technological Characteristics | | |
| Sizes | Single-use vial of 1.6g (2mL); volume
covers 3cm x 6cm area (18 cm²) | Sheet form, available in sizes 16
x16mm, 25x 25mm, 50 x 50mm |
| Intimate contact
with wound bed | Yes | Yes |
| Technological
Features | Collagen and other components
manufactured to gel-like consistency,
soft at ambient temperature, and applied
topically | Collagen derivative and other
components manufactured to
sheet, softened with saline, and
applied topically |
5
| Collagen Source | Whitefish skin collagen Types I, II, III, IV | Porcine skin collagen derivative(gelatin) |
|---|---|---|
| Collagen product particle size | Collagen particles of ≤1000µm in diameter | Collagen particle derivative (gelatin) |
| Applied hydrated or flowable | Yes | Yes |
| Contains salt when applied | Yes (Sea salt) | Yes (Final product softened with saline before topical application) |
| Additional materials of composition | Cod liver oil, plant-derived oils and waxes, and process aids | Manuka honey and hydroxyapatite |
| Absorbable | Fully absorbable | Fully absorbable |
| Moist environment | Maintains moist wound environment | Maintains moist wound environment |
| Wound protection | Protects the wound tissue | Protects the wound tissue |
| Supplied sterile? | Yes (E-beam) | Yes (Gamma) |
| Shelf life | Shelf stable at room temperature | Shelf stable at room temperature |
| Additional performance testing | Porosity, mechanical, endotoxin, chemical composition, and distribution testing; sterilization validation | Porosity, mechanical, endotoxin, chemical composition, and distribution testing; sterilization validation |
The main differences between the Omeza Collagen Matrix and the predicate are the specific collagen source - Omeza uses whitefish skin-derived collagen and SweetBio Apis uses porcine skin-derived collagen – and the specific identity of the supplements, which serve the same fundamental purpose in enabling each wound dressing to achieve the shared intended use. The key questions of safety of the animal-derived material and effectiveness of achieving the intended use remain the same for both products, and are fully addressed for the Omeza Collagen Matrix through submitted performance testing. They are additionally supported by clearance of the reference devices with the same intended use and similar indications:
- MariGen Wound Dressing (K132343), which is also derived from fish collagen;
- Stimulen® Collagen Gel (K030774) which also contains collagen delivered in a gel-like . consistency; and
- INTEGRA Flowable Wound Matrix (K072113), which is also gel-like. In particular, Omeza® Collagen Matrix and the INTEGRA Flowable Wound Matrix (K072113) manage wounds by providing collagen particles of similar diameter in a gel-like consistency applied topically in a sterile, single-use application. Both products are designed to conform to the wound bed, achieving intimate contact with the surface, and are ultimately incorporated into the wound during the natural healing process.
Performance Data:
The following testing was performed to demonstrate substantial equivalence:
Biocompatibility Testing
All biocompatibility endpoints required according to ISO 10993-1 and FDA's corresponding 2016guidance were evaluated with favorable results. Testing was performed in the following categories:
- . Cytotoxicity
- Sensitization ●
- Irritation
- Acute systemic toxicity ●
- Genotoxicity ●
6
- . Material-mediated pyrogenicity
Clinical Studies
A Skin Prick Study was performed in the US in accordance with Good Clinical Practice Standards. The single-center, monadic, one-day enrolled 25 subjects. The study evaluated Collagen Matrix for the potential of an immediate allergic reaction following a one-day Skin Prick Method Study. The test article, a positive control (1.0 mg/mL histamine base), and a negative control (aqueous negative control) were tested on subjects using the "Allergy Diagnostic Testing: An Updated Practice Parameter" skin prick test method. During this study, no immediate allergic reaction to the test product was observed for any subjects. Therefore, no potential allergenicity of the test product was observedunder the conditions of this study.
A Human Repeat Insult Patch Test was performed in the US to Good Clinical Practice Standards. The study design was based on a modified Human Repeat Insult Patch Test. The study was single site, evaluator-blinded using a within-subject randomization design. The study had (58) subjects enrolled. Omeza® Collagen Matrix was evaluated for the potential to cause irritation and sensitization compared to that of a negative control (0.9% aqueous sodium chloride) based on a modified human repeat insult patch test. Under the conditions of this study, the test product showed to be safe for use with no side effects.
Animal Studies
Two wound healing studies were conducted to assess the implantation and the wound healing endpoints of Omeza® Collagen Matrix on porcine wounds. The first swine study compared the subject product to saline. The two products were applied to 10 full-thickness circular wound sites (approximately 3.0 cm in diameter) on four animals, with 14 and 25 day evaluations followed by pathology and independent expert review. The second swine study compared an exaggerated dose of Omeza Collagen Matrix to Hollister Endoform Dermal Template (K092096), with the products applied to 10 full-thickness circular wound sites (approximately 2.0 cm in diameter) on two animals. The final wound evaluation occurred at 24 days, followed by pathology and independent expert review. Both studies showed no evidence of impairment of wound healing with the use of Omeza® Collagen Matrix, and demonstrated that the subject product was safe and did not trigger adverse biological reactions inthe animals.
Additional Testing (Bench)
- . Extrusion: Omeza performed testing on representative lots to quantify the amount of producta typical user can extrude from a vial.
- Final Product Coverage: The time required for the product to cover 18 sq. cm - target coveragefor one vial - was calculated in a simulated model.
- Product Characterization under Environmental Conditions: Surface morphology of Omeza ● Collagen Matrix was imaged at varying magnifications using Scanning Electron Microscopy (SEM), to observe andconfirm microscopic and macroscopic stability of the OCM structure.
- . Interaction with Wound Exudate: SEM was employed to compare the surface structure/morphology of sterile, dry OCM to OCM immersed in solutions of varying salinity concentrations, simulating moist wound exudate conditions.
- Sterilization/endotoxins: OCM vials are sterilized using a process validated per . ANSI/AAMI/ISO 11137-2. Biologic testing for sterilization validation was also
7
performed. Endotoxin testing confirmed an acceptable level of endotoxins in the final product.
- Viral Inactivation: Three viral inactivation studies were performed on the OCM utilizing a . panel of model viruses per ISO 22442 Part 3 (Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents).
- Shelf Life: OCM meets requirements for a 9-month shelf life, based on product tested at ● theend of this period passing all finished product specifications.
- Collagen Characterization: Standard ELISA techniques were used to determine the types . ofcollagen in OCM.
- Lot-to-Lot Consistency: Testing of samples from representative lots demonstrated lot-to-lot ● consistency of all OCM raw materials.
- Cod Liver Oil Identification and Quantification: Fatty Acid Methyl Ester analysis following AOAC 996.06 was conducted on representative lots to quantify the Cod Liver Oil (CLO) in thefinal product.
- . Elastic Modulus: The product's rheological properties were evaluated by analyzing elastic modulus, with results showing that this feature of the final product is consistent across lots.
- Extractables and Leachables: Extractables testing was completed on the OCM primary ● and secondary packaging system, following ISO 10993 and USP 1663. No extractable compounds were detected in the product primary packaging above the analytical evaluationthreshold.
- Final Product Specifications: Representative samples of final, sterilized OCM were . analyzed for conformance to pre-defined specifications for quantity (%w/w) of collagen, pH, specific gravity, heavy metals, product structure, and bioburden.
Conclusion:
Omeza® Collagen Matrix functions as intended, and is as safe and effective as SweetBio Apis (K182725). As explained above, OCM has the same intended use and similar indications for use, and similar key technological and design characteristics and mechanism of action. The minor differences between the subject and predicate products do not raise different questions of safety or effectiveness, as supported by performance data on the subject product and prior clearance of the reference devices. Thus, Omeza® Collagen Matrix is substantially equivalent with the predicate device.