(290 days)
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- Covering of implants placed in immediate extraction sockets;
- Covering of implants placed in delayed extraction sockets;
- Covering of bone defects after root resection and removal of retained teeth; and
- Guided tissue regeneration procedures in periodontal and recession defects.
The subject device is an acellular resorbable fish dermal matrix, intended for use in periodontal surgical procedures to aid in soft tissue and bone regeneration. It is obtained from cod fish skin by a standardized controlled manufacturing process, and supplied in terminally sterile peel-pouch packaging in the following solid sizes:
- 15mm x 20mm
- 20mm x 30mm
- . 30mm x 40mm
It is biocompatible, non-cross linked, and therefore resorbable, strong, flexible, and supports fixation by sutures and pins.
This document is a 510(k) Premarket Notification from the FDA regarding the Kerecis® Oral device. It details the device's characteristics, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence.
Based on the provided text, the device itself (Kerecis® Oral) is a biological material (acellular resorbable fish dermal matrix) used for various oral surgical procedures to aid in soft tissue and bone regeneration. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing and animal studies performed to demonstrate that the Kerecis® Oral device is substantially equivalent to existing predicate devices, thereby clearing it for market.
Here's an analysis of the provided information to answer your questions:
1. Table of acceptance criteria and the reported device performance
The document doesn't present a single, explicit "acceptance criteria" table with pass/fail thresholds for the entire device in the way a software or AI model might have. Instead, it outlines a series of tests performed on the material properties and functional characteristics of the Kerecis® Oral device and compares them to predicate devices. The "acceptance" is implied by demonstrating substantial equivalence.
Here's a table summarizing the comparison and performance points, where "acceptance" means demonstrating substantial equivalence or meeting/exceeding predicate device performance:
| Feature/Test | Acceptance Criteria (Implied: Substantial Equivalence to Predicate/Reference) | Reported Device Performance (Kerecis® Oral) |
|---|---|---|
| Technological Characteristics | ||
| Device Name | N/A (Identification) | Kerecis Oral |
| Regulation | 21 CFR 872.3930 (Bone Grafting Material) | 21 CFR 872.3930 (Same Regulation as Predicate) |
| Device Class | Class II | Class II (Same Class as Predicate) |
| Product Code | NPL | NPL (Same Product Code as Predicate) |
| Device Classification | Barrier, Animal Source, Intraoral | Barrier, Animal Source, Intraoral (Same Classification as Predicate) |
| Intended Use | Includes elements of predicate and reference devices, supported by performance testing. | Covers localized gingival augmentation, implant covering (immediate and delayed), bone defect covering, GTR. |
| Animal Origin Material | Similar origin to reference device (fish) or acceptable alternative to predicate (porcine). | Fish: skin tissue, single layer sheet (Same animal species as reference) |
| Biocompatibility | Yes (demonstrated per ISO 10993 series) | Yes (Biocompatibility testing performed per ISO 10993 series standards) |
| Non-Pyrogenic | Yes (demonstrated safe per ISO 10993 series) | Yes (Materials-mediated pyrogenicity safe per ISO 10993 series standard) |
| Tensile Strength | Comparable to predicate device (4.6 MPa for predicate) | 14.3 MPa (Meets/Exceeds tensile strength value of the predicate device per ASTM D638) |
| Resorbable | Yes | Yes (All devices are resorbable per comparative performance data) |
| Sizes | Equivalent to predicate/reference sizes (15x20mm, 20x30mm, 30x40mm) | 15x20mm, 20x30mm, 30x40mm (Equivalent sizes by dimensional analysis) |
| Sterilization | Traditional Sterilization Methods (EO or Gamma) | Ethylene Oxide (Traditional Sterilization Methods per ISO 11135 and ISO 11737-1. EO residual testing per ISO 10993-7) |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 (Equivalent SAL per ISO 11137 and ISO 11737) |
| Shelf Life | 3 years | 3 years (Equivalent shelf life per ASTM F1980 and Q5C (R2)[ICH]) |
| Mode of Action | Fixation | Fixation (Equivalent mode of action per ANSI/AAMI/ISO 7198 and ASTM F-1839-08) |
| Performance Testing - Bench | ||
| Morphology Observation (H&E, SEM) | Rich in collagen, porous, favoring cellular infiltration, preserved collagen structure. | Rich in collagen and porous, favoring cellular infiltration. SEM shows equivalent preserved collagen structure. |
| Cellular Ingrowth Comparison (Fibroblast) | Favorable cellular infiltration after 14 days. | Favorable cellular infiltration of fibroblasts after 14 days. |
| Heavy Metal Analysis | Acceptable limits per ICH guidelines (Q3D Elemental Impurities). | Limits of Cd, Pb, As, Hg acceptable under ICH guidelines. |
| Dimensional Validation | Quality limits for capability index > 1.33. | All tested parameters met or exceeded the set goal (>1.33) on three lots. |
| Stability in Simulated Physiological Env. | Structurally stable compared to predicate, dissolves slower at neutral pH. | Structurally more stable than predicate, dissolved slower than predicate at neutral pH 7. |
| Suture Pull-Out Strength | Meets or exceeds predicate with >95% confidence. | Meets or exceeds predicate with >95% confidence (Consistent with ANSI/AAMI/ISO 7198). |
| Pin Pull-Out Strength | Exceeds predicate with >95% confidence. | Exceeds predicate with >95% confidence (Consistent with ASTM F-1839-08). |
| Compression (Peak-Load, Load-at-Break, etc.) | Meet or exceed predicate with >95% confidence. | Meet or exceed predicate with >95% confidence (Consistent with ASTM-F-1306). |
| User Evaluation (Cutting and Shaping) | Favorable usability, substantially equivalent to predicate. | Favorable usability, substantially equivalent to predicate for cutting and shaping (via questionnaire). |
| Packaging | Compliant with ISO 11607-series, ASTM F88 and ASTM F1886. | Compliant. |
| Animal Origin and Viral Inactivation | Compliant with ISO 22422 series. | Compliant. |
| Performance Testing - Animal | ||
| New Bone Formation, Xenograft Resorption, Soft Tissue Infiltration | No qualitative or significant differences compared to predicate. | No noticeable or significant differences between the two membranes at any time point (Histologic and micro-CT volumetric analysis). |
2. Sample sizes used for the test set and the data provenance
- Bench Testing: The specific sample sizes for each bench test (e.g., number of samples for tensile strength, compression, dimensional validation) are not explicitly stated in the provided text. It mentions "representative product samples" and "three lots" for dimensional validation. The provenance is implied to be laboratory testing of the manufactured Kerecis® Oral device.
- Animal Testing: The sample size for the animal study is a "canine (beagle bilateral mandibular bony defect model)." This implies multiple beagle dogs, but the exact number is not specified. The study was conducted in AAALC accredited facilities in compliance with GLP (Good Laboratory Practices) 21 CFR §58, suggesting a controlled, prospective study. The location (country) is not specified, but GLP compliance implies a rigorous study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the animal study, the evaluation involved "gross pathology and histological, and quantitative micro-CT volumetric analysis." This type of analysis would typically be performed by veterinary pathologists and possibly radiologists/imaging specialists. However, the number and specific qualifications of these experts are not mentioned in the text.
- For the user evaluation of cutting and shaping, it was done "using a questionnaire." This implies that "ground truth" was established by user feedback, not by experts in the context of diagnostic accuracy. The number and qualifications of these users are not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None explicitly mentioned. For the animal studies, "no qualitative or significant differences was observed" suggests direct comparison by the evaluators rather than an explicit adjudication process among multiple independent reviewers, though this is not definitively stated. For the bench tests, the data itself (e.g., tensile strength, dimensional measurements) would be objective, not typically requiring adjudication.
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
- No, an MRMC comparative effectiveness study was not done. This product is a biological medical device (a tissue graft), not a diagnostic AI device that assists human readers. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. The "performance" assessment is based on its material properties and biological interaction in an in vitro and in vivo (animal) setting, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For Bench Testing: The "ground truth" is defined by objective material property measurements (e.g., tensile strength in MPa, dimensional measurements in mm, pH and conductivity values) and established international standards (e.g., ISO, ASTM, ICH).
- For Animal Testing: The "ground truth" was established through histologic and micro-CT volumetric analysis of animal tissues collected at different time points post-surgery. This involves pathological assessment (histology) and quantitative imaging analysis (micro-CT) to assess bone formation, xenograft resorption, and soft tissue infiltration. While the specific experts aren't named, this is a form of expert assessment of biological outcomes.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. As a physical device, there is no "training set" or "ground truth for the training set."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Kerecis Gudmundur Sigurjonsson CEO Eyrargata 2 Isafjordur, 400 Iceland
9/30/22
Re: K213904
Trade/Device Name: Kerecis® Oral Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: September 6, 2022 Received: September 7, 2022
Dear Gudmundur Sigurjonsson:
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.
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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 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 medical devices and radiation-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.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213904
Device Name
Kerecis® Oral
Indications for Use (Describe)
- · Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- · Covering of implants placed in immediate extraction sockets;
- · Covering of implants placed in delayed extraction sockets;
- · Covering of bone defects after root resection and removal of retained teeth; and
- · Guided tissue regeneration procedures in periodontal and recession defects.
| 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) |
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Ke
510(k) Summary
Traditional Premarket Notification Submission (510(k)) Summary) Prepared in accordance with 21 CFR § 807.92
1. Submitter Information
| Sponsor Name: | Kerecis Limited |
|---|---|
| Sponsor Address: | Eyrargata 2 – PO Box 151, 400 Isafjordur, Iceland |
| Sponsor Telephone: | +011 354-419-8000 |
| Establishment Registration: | 301060025 |
| Primary Contact Person: | Gudmundur Fertram Sigurjonsson |
| Contact Title: | Founder, Chairman, President & CEO |
| Email Direct: | gfs@kerecis.com |
| Secondary Contact Person: | Daniel L. Mooradian, Ph.D. |
| Contact Title: | Senior VP for Research & Development |
| Email Direct: | dmooradan@kerecis.com |
| Additional Contact Person: | Jennifer Michelle Chambers, MPA, PMP, RAC |
| Contact Title: | Senior Regulatory Specialist |
| Email Direct: | jchambers@kerecis.com |
| Date Summary Prepared: | September 30, 2022 |
2. Device Information
| Trade Name (Proprietary): | Kerecis® Oral |
|---|---|
| Common (Usual): | Intraoral Surgical Graft |
| Classification Name: | Barrier, Animal Source, Intraoral |
| Device Classification: | Class II, 21 CFR § 872.3930 |
| FDA Device Code: | NPL |
3. Predicate Device and Reference Devices
Predicate Device Company Name: Ed. Geistlich Söhne Ag für Chemische Industrie MUCOGRAFT® Collagen Matrix Device Name (proprietary): K073711 Device 510(k):
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Reference Device Company Name: Device Name (proprietary): Device 510(k):
Kerecis Kerecis Gingiva Graft K192612
4. Device Description
The subject device is an acellular resorbable fish dermal matrix, intended for use in periodontal surgical procedures to aid in soft tissue and bone regeneration. It is obtained from cod fish skin by a standardized controlled manufacturing process, and supplied in terminally sterile peel-pouch packaging in the following solid sizes:
- 15mm x 20mm
- 20mm x 30mm
- . 30mm x 40mm
It is biocompatible, non-cross linked, and therefore resorbable, strong, flexible, and supports fixation by sutures and pins.
5. Intended Use
The subject device is indicated for:
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- . Covering of implants placed in immediate extraction sockets;
- Covering of implants placed in delayed extraction sockets;
- Covering of bone defects after root resection and removal of retained teeth; and
- Guided tissue regeneration procedures in periodontal and recession defects.
6. Technological Characteristics and Substantial Equivalence
Comparison with the predicate device (K073711), and the reference device (K192612), demonstrate that it is substantially equivalent with regards to: intended use, materials, design, and operational principle.
See Table 6.1. Kerecis Oral is comparison with predicate and reference devices.
Table 6.1. Kerecis Oral is comparison with predicate and reference devices.
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| SubjectDevice | PredicateDevice | ReferenceDevice | Discussion | |
|---|---|---|---|---|
| Device Name | Kerecis Oral | GeistlichMUCOGRAFTCollagenMatrix | KerecisGingiva Graft | N/A |
| 510(k) | TBD | K073711 | K192612 | N/A |
| Regulation | 21 CFR 872.3930 | 21 CFR 872.3930 | 21 CFR 872.3930 | Same regulation |
| Device Class | II | II | II | Same device class |
| Product Code | NPL | NPL | NPL | Same product code |
| DeviceClassification | Barrier, AnimalSource, Intraoral | Barrier, AnimalSource, Intraoral | Barrier, AnimalSource, Intraoral | Same device classification |
| Intended Use | indicated for:Localizedgingivalaugmentationto increasekeratinizedtissue (KT)around teethor implants;-Covering ofimplantsplaced inimmediateextractionsockets;-Covering ofimplantsplaced indelayedextractionsockets; | indicated for:-Simultaneoususe of GBR-membrane andimplants-Covering ofimplantsplaced inimmediateextractionsockets;-Covering ofimplantsplaced indelayedextractionsockets;-Localized ridgeaugmentation | indicated for:-Localizedgingivalaugmentationto increasekeratinizedtissue (KT)around teethor implants. | Intended use includeselements of the predicate andreference devices, supported byperformance testing in canines,intended to demonstrateequivalence in the oralenvironment |
| -Covering ofbone defectsafter rootresection andremoval ofretained teeth;-Guided tissueregenerationprocedures inperiodontaland recessiondefects. | for laterimplantation;-Alveolar ridgereconstructionfor prosthetictreatment;-Covering ofbone defectsafter rootresection,cystectomy,removal ofretained teeth;-Guided boneregeneration indehiscencedefects; and-Guided tissueregenerationprocedures inperiodontaland recessiondefects. | |||
| Animal OriginMaterial | Fish: skintissue, singlelayer sheet | Porcine: skinand connectivetissue, doublelayer sheet | Fish: skintissue, singlelayer sheet | Same animal species asreference |
| Biocompatibility | Yes | Yes | Yes | Biocompatibility testingperformed per ISO 10993 seriesstandards |
| NON-Pyrogenic | Yes | Yes | Yes | Materials-mediatedpyrogenicity safe per ISO 10993series standard |
| Tensile Strength | 14.3 MPa | 4.6 MPa | 14.3 MPa | Meets tensile strength value ofthe predicate device per ASTMD638 |
| Resorbable | Yes | Yes | Yes | All devices are resorbable percomparative performance data |
| Sizes | 15x20 mm | 15x20 mm | 15x20 mm | Equivalent sizes by dimensionalanalysis |
| 20x30 mm | 20x30 mm | 20x30 mm | ||
| 30x40 mm | 30x40 mm | 30x40 mm | ||
| Sterilization | Ethylene Oxide | GammaIrradiation | Ethylene Oxide | Traditional Sterilization Methodsper ISO 11135 and ISO 11737-1.EO residual testing perISO 10993-7 |
| SterilityAssurance Level | 10-6 | 10-6 | 10-6 | Equivalent SAL per ISO 11137and ISO 11737 |
| Shelf Life | 3 years | 3 years | 3 years | Equivalent shelf life per ASTMF1980 and Q5C (R2)[ICH] |
| Mode of Action | Fixation | Fixation | Fixation | Equivalent mode of action perANSI/AAMI/ISO 7198 and ASTMF-1839-08 |
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7.
Performance Testing - BenchBench testing was performed following FDA guidance,
"Preparation of a Premarket Notification Application for a Surgical Mesh" (1999). The following performance studies were conducted on representative product samples to verify that material properties remain unchanged and support substantial equivalence:
7.1 Morphology Observation
The subject device and the predicate device are based on the collagen rich animal tissue, piscine and porcine, respectively. Based on H&E staining, both materials are rich in collagen and porous, therefore favoring cellular infiltration. Scanning Electron Microscope (SEM) shows equivalent preserved collagen structure of the animal origin tissues used for both devices. Cross section of both devices showed that the porous surfaces in the skin derived collagen structure of both materials allows tissue adherence and promotes tissue regeneration by favoring cellular ingrowth when applied to soft tissue defect areas.
7.2. Cellular ingrowth comparison
Both materials were tested for cellular ingrowth capability by fibroblast seeding onto the materials in vitro cellular modes. Both materials showed favorable cellular infiltration of fibroblasts after 14 days
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which is a key component for tissue augmentation and re-epithelization of defected keratin tissue in the oral cavity.
7.3. Tensile Strength
The tensile strength of the subject device was determined to be comparable to the predicate device measured by ultimate tensile strength.
7.4. Heavy Metal Analysis
A heavy metal analysis was evaluated to show that the limits of cadmium (Cd), lead (Pb), arsenic (As) and mercury (Hg) contained within the subject device were acceptable under the ICH guidelines: Q3D Elemental Impurities-Guidance for Industry.
7.5. Dimensional Validation
Manufacturing dimensional validation was performed on three lots of the subject device where its dimension and thickness were tested. Kerecis has set the quality limits for a capability index to be > 1.33. All tested parameters met or exceeded the set goal.
7.6. Stability in a simulated physiological environment
A stability test was done in a simulated physiological oral environment (artificial saliva buffer) to investigate the dissolution of both material over time and to compare the effects that the products have on the pH levels and conductivity of the buffer over 24 hours. The subject device is structurally more stable than the predicate device since it dissolved slower than the predicate device at neutral pH 7.
7.7. Suture Pull-Out Strength
Consistent with recognized standard ANSI/AAMI/ISO 7198, The suture pull-out strength of the subject device meets or exceeds that of the predicate with a confidence of greater than 95%. The products are equivalent.
7.8. Pin Pull-Out Strength
Consistent with recognized standard ASTM F-1839-08, The pin pull-out strength of the subject device exceeds that of the predicate at a confidence level of greater than 95%. The products are equivalent.
7.9. Compression
In accordance with ASTM-F-1306, "Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates", the mechanical test for compressive strength was measured for the subject and predicate device. The compressive Peak-Load, Load-at-Break, Probe Penetrationat-Break, and Energy-to-Break of the subject device meet or exceed those of the predicate device, with a confidence of greater than 95%. The products are equivalent.
7.10. User Evaluation of Device for Cutting and Shaping
The subject device was evaluated in comparison to the predicate for use in the oral environment using a questionnaire. The results showed favorable usability that was substantially equivalent to the predicate for cutting and shaping the device for use as a dental barrier membrane.
7.11.Biocompatibility, Sterilization, Shelf-life and Animal origin.
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Testing from the applicant's own predicate device (K190528 and K153364) was used to s substantial equivalence.
Biocompatibility per ISO 10993 series
- · Cytotoxicity
- Sensitization
- Irritation or Intracutaneous reactivity
- · Acute systemic toxicity
- · Subacute/sub-chronic toxicity
- · Genotoxicity
- Implantation
- Materials-Mediated Pyrogenicity
- Chronic Toxicity
- Carcinogenicity
• Sterilization validation per ISO 11737-1, Ethylene Oxide residual test following ISO 10993-7
• Endotoxin validation (<20 EU/device) of sterilization method per LAL turbidimetric kinetic method following ISO 10993-11
- Shelf life per ASTM F1980 and Q5C (R2)[ICH] using accelerated and real-time aged samples
- Packaging per ISO 11607-series, ASTM F88 and ASTM F1886
- Animal Origin and Viral inactivation per ISO 22422 series
The performance data demonstrates that the subject device is substantially equivalent to the predicate device.
8. Performance Testing - Animal
Comparative performance testing in an animal canine (beagle bilateral mandibular bony defect model was used to support equivalence with the predicate device for the stated indications for use. On the 30, 60 and 90 day post-surgery, animal tissues were evaluated for gross pathology and histological, and quantitative micro-CT volumetric analysis of new bone (%) and xenograft (%).
In a side-by-side comparison between the Test (Subject device) and Control (Predicate device), no qualitative or significant differences was observed for new bone formation, xenograft membrane resorption kinetics and soft tissue infiltration. Histologic and micro-CT volumetric analysis revealed no noticeable or significant differences between the two membranes at any time point.
Soft tissue endpoints were part of the applicant's previous canine testing as described in the reference device application K192612.
Studies were performed in AAALC accredited facilities in compliance with the applicable requirements of Good Laboratory Practices (GLP) 21 CFR §58.
9. Performance Testing - Clinical
No human clinical trials were performed in support of this submission.
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10. Conclusion
The data provided within this submission support substantial equivalence of the subject device to the predicate device with regards to intended use, materials, design, and technological characteristics, including principles of operation, performance characteristics, and device safety. For use in oral surgical applications, Kerecis Oral is substantially equivalent to the predicate device.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.