LogoFDA 510(k) Search
K Number
K211972
Device Name
Omeza Collagen Matrix
Manufacturer
Omeza, LLC
Date Cleared
2021-09-01

(69 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
K072113,K132343,K030774,K182725
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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, podiatric, wound dehiscence)
  • · Trauma wounds (abrasions, lacerations, superficial thickness burns, skin tears)
  • · Draining wounds
    The device is intended for one-time use.
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 providea conducive environment for the patient's natural wound healing process.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for a medical device called Omeza® Collagen Matrix. It outlines the device's characteristics and how it demonstrates substantial equivalence to a predicate device, SweetBio Apis (K182725).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through performance testing designed to show substantial equivalence to the predicate device, especially in terms of safety and effectiveness. While explicit numerical acceptance criteria for each test are not listed in a table format, the document states that all tests had "favorable results" or showed "no evidence of impairment of wound healing," demonstrating the device met an acceptable standard.

Acceptance Criteria (Implied from Testing)Reported Device Performance
Biocompatibility
CytotoxicityFavorable results
SensitizationFavorable results
IrritationFavorable results
Acute systemic toxicityFavorable results
GenotoxicityFavorable results
Material-mediated pyrogenicityFavorable results
Allergenicity (Skin Prick Study)
No immediate allergic reactionNo immediate allergic reaction observed for any subjects.
Irritation/Sensitization (HRIPT)
Safe for use with no side effectsShowed to be safe for use with no side effects.
Wound Healing (Animal Studies)
No impairment of wound healingNo evidence of impairment of wound healing.
No adverse biological reactionsDid not trigger adverse biological reactions.
Sterilization
Validated per ANSI/AAMI/ISO 11137-2Sterilization process validated per ANSI/AAMI/ISO 11137-2.
Acceptable endotoxin levelEndotoxin testing confirmed an acceptable level.
Viral Inactivation
Validated per ISO 22442 Part 3 (for viruses and TSEs)Three viral inactivation studies utilizing a panel of model viruses per ISO 22442 Part 3 performed.
Shelf Life
9-month shelf lifeMeets requirements for a 9-month shelf life, product passed all finished product specifications.
Product Consistency & Characterization
Consistent product extrusion from vialPerformed testing to quantify amount extruded.
Consistent coverage (18 sq. cm)Time calculated for 18 sq. cm.
Stable surface morphology (SEM)Imaged at varying magnifications to observe and confirm microscopic and macroscopic stability.
Stable interaction with wound exudate (SEM)Compared surface structure of sterile, dry OCM to OCM immersed in solutions of varying salinity.
Consistent collagen typesStandard ELISA techniques used to determine types.
Lot-to-lot consistency of raw materialsTesting demonstrated lot-to-lot consistency.
Consistent CLO quantificationFatty Acid Methyl Ester analysis conducted.
Consistent elastic modulusRheological properties evaluated.
No detectable extractable compounds (packaging)No extractable compounds detected above analytical evaluation threshold.
Conformance to pre-defined final product specifications (quantity, pH, specific gravity, heavy metals, structure, bioburden)Representative samples analyzed for conformance.

Detailed Study Information:

The document primarily describes performance data used to demonstrate "substantial equivalence" to a predicate device, rather than a single, comprehensive "study" with a traditional test set/training set split as one might see for an AI/ML device. The tests are focused on characterizing the device's safety and effectiveness compared to known standards and the predicate.

  1. Sample sizes used for the test set and the data provenance:

    • Skin Prick Study: 25 subjects. Performed in the US, in accordance with Good Clinical Practice Standards (implied prospective).
    • Human Repeat Insult Patch Test (HRIPT): 58 subjects. Performed in the US, to Good Clinical Practice Standards (implied prospective).
    • Animal Studies (Swine Wound Healing):
      • Study 1: 4 animals, 10 full-thickness circular wound sites per animal.
      • Study 2: 2 animals, 10 full-thickness circular wound sites per animal.
      • Provenance: Implied prospective, conducted specifically for this evaluation.
    • Bench Testing: "Representative lots" or "representative samples" were used for various tests. Specific quantities are not provided.

  2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

    • For the Animal Studies, "independent expert review" was conducted for pathology and wound evaluation. The number and specific qualifications (e.g., DACVP for pathology) are not stated, but "independent expert" implies relevant veterinary or pathology expertise.
    • For the Skin Prick Study and HRIPT, clinical evaluation was performed, presumably by trained clinicians, but "experts" in the sense of adjudicators are not explicitly mentioned for establishing "ground truth" on top of the clinical observations. The "evaluator-blinded" design in HRIPT points to a clinical assessor.
    • For Biocompatibility and Bench Testing, "ground truth" is established by laboratory standards and validated methods, implicitly overseen by qualified lab personnel.

  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not explicitly stated for any of the studies in a formal "adjudication" sense.
    • In the Animal Studies, "independent expert review" suggests a form of expert consensus or verification, but the exact method (e.g., multiple experts with a tie-breaker) is not detailed.
    • Clinical studies (Skin Prick, HRIPT) typically involve clinical assessment and data collection by trained personnel, rather than multi-reader adjudication of images or diagnoses.

  4. 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:

    • No MRMC study was performed or described. This document is for a wound dressing, not an AI-assisted diagnostic device. The evaluation focuses on the physical and biological performance of the dressing itself.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This device is a physical wound dressing, not a software algorithm.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Biocompatibility: Ground truth is established by standardized ISO 10993 testing endpoints and criteria.
    • Clinical Studies (Skin Prick, HRIPT): Ground truth is based on direct clinical observation of immediate allergic reactions, irritation, and sensitization markers as per established dermatological study protocols.
    • Animal Studies: Ground truth for wound healing endpoints is established through gross observation, pathology (histopathology), and "independent expert review" of the wounds.
    • Bench Testing: Ground truth is established by validated analytical methods, physical property measurements, and established quality specifications (e.g., ISO, AOAC standards).

  7. The sample size for the training set:

    • Not applicable. This device is not an AI/ML algorithm that requires a training set. The data presented is for performance validation, not algorithm development.

  8. How the ground truth for the training set was established:

    • Not applicable. Since there is no AI/ML algorithm, there is no training set mentioned in this context.

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.

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)

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:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

{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 CodeFROFRO
Indications for UseIndicated for the management ofwounds including: partial and full-thickness wounds, pressure ulcers,venous ulcers, diabetic ulcers, chronicvascular ulcers, tunneled/underminedwounds, surgical wounds (donorsites/grafts, post- Moh's surgery, post-laser surgery, podiatric, wounddehiscence), trauma wounds (abrasions,lacerations, superficial partial thicknessburns, and skin tears), draining wounds.The device is intended for one-time use.Indicated for use in managementof wounds including: full andpartial thickness wounds,pressure ulcers (stages I-IV),venous stasis ulcers, diabeticulcers, abrasions, surfacewounds, traumatic wounds(healing by secondary intention),donor site wounds, surgicalwounds
RxYesYes
Single useYesYes
Technological Characteristics
SizesSingle-use vial of 1.6g (2mL); volumecovers 3cm x 6cm area (18 cm²)Sheet form, available in sizes 16x16mm, 25x 25mm, 50 x 50mm
Intimate contactwith wound bedYesYes
TechnologicalFeaturesCollagen and other componentsmanufactured to gel-like consistency,soft at ambient temperature, and appliedtopicallyCollagen derivative and othercomponents manufactured tosheet, softened with saline, andapplied topically

{5}------------------------------------------------

Collagen SourceWhitefish skin collagen Types I, II, III, IVPorcine skin collagen derivative(gelatin)
Collagen product particle sizeCollagen particles of ≤1000µm in diameterCollagen particle derivative (gelatin)
Applied hydrated or flowableYesYes
Contains salt when appliedYes (Sea salt)Yes (Final product softened with saline before topical application)
Additional materials of compositionCod liver oil, plant-derived oils and waxes, and process aidsManuka honey and hydroxyapatite
AbsorbableFully absorbableFully absorbable
Moist environmentMaintains moist wound environmentMaintains moist wound environment
Wound protectionProtects the wound tissueProtects the wound tissue
Supplied sterile?Yes (E-beam)Yes (Gamma)
Shelf lifeShelf stable at room temperatureShelf stable at room temperature
Additional performance testingPorosity, mechanical, endotoxin, chemical composition, and distribution testing; sterilization validationPorosity, 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.

N/A