(420 days)
No
The summary describes a biological graft material and its physical properties and performance in bench, animal, and clinical studies. There is no mention of any computational or algorithmic components, let alone AI/ML.
Yes
The device is used for "localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants," which directly addresses a health condition (gingival defects) and aims to restore normal function (increase keratinized tissue). This aligns with the definition of a therapeutic device.
No
The device, Kerecis Gingiva Graft, is an implantable medical device used for localized gingival augmentation. Its function is to integrate into surrounding tissue and facilitate new host tissue deposition, which is a therapeutic action, not a diagnostic one.
No
The device description explicitly states it is a "fish skin medical device" and details its physical properties and manufacturing process, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants." This describes a surgical procedure to physically augment tissue, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The device is a "fish skin medical device indicated gingiva augmentation." It's a physical material intended to be implanted or integrated into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (blood, tissue, etc.) or provide any diagnostic information. Its function is purely structural and regenerative.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Kerecis Gingiva Graft is indicated for:
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
The subject device is fish skin medical device indicated gingiva augmentation.
The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular sizes:
- 15mm x 20mm
- 20mm x 30mm
- 30mm x 40mm
The subject device becomes completely integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The physical properties of the subject device allow cellular ingrowth for augmentation of keratinized tissue.
The subject device is biocompatible, non-crosslinked, bioresorbable, strong, pliable and supports fixation by sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingiva, oral cavity
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)
7 Performance Testing - Bench
The following performance studies were conducted on representative products to verify that material properties remain unchanged and support the substantial equivalence determination:
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 which is a key component for tissue augmentation and re-epithelization of defected keratinized 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. Stability of Kerecis Gingiva Graft 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 buffer incubated with the two products was stable over time. Incubation of the subject device to the buffer raises the pH slightly, while incubation of the predicate device decreases it slightly. The subject device is structurally more stable than the predicate device since it dissolved slower than the predicate device at neutral pH 7.
7.6. Suture Pull-Out Strength
The suture pull-out strength of the subject device meets or exceeds that of the predicate with a confidence of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.
7.7. Pin Pull-Out Strength
The pin pull-out strength of the subject device exceeds that of the predicate at a confidence level of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.
7.8. Compression
The compressive Peak-Load, Load-at-Break, Probe Penetration-at-Break, and Energy-to-Break of the subject device meet or exceed those of the predicate device, with a confidence of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.
7.9. User Evaluation of Device for Cutting and Shaping
The subject device was evaluated in comparison to the predicate by four dental clinicians for use in the oral environment using a questionnaire to assess: ease of placement, stability over the site, robustness of the device, and satisfaction with handling the device. The questionnaire results showed a favorable usability that was substantially equivalent to the predicate for cutting and shaping the device for use as a dental barrier membrane.
7.10.Biocompatibility, Sterilization, Shelf-life and Animal origin.
Testing from the applicant's own predicate device (K190528 and K153364) were leveraged in support of 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 (
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 13, 2020
Kerecis Limited Gudmundur Sigurjonsson CEO Eyrargata 2 400 Isafjordur ICELAND
Re: K192612
Trade/Device Name: Kerecis Gingiva Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: October 9, 2020 Received: October 13, 2020
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.
1
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 (OS) 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
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192612
Device Name Kerecis Gingiva Graft
Indications for Use (Describe)
Kerecis Gingiva Graft is indicated for:
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.
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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3
510(k) Summary
1 Submitter/510(k) Holder
| Address: | Kerecis Limited
Eyrargata 2
400 Isafjordur
Iceland |
|-----------------|-------------------------------------------------------------|
| Contact Person: | Gudmundur Fertram Sigurjonsson
President and CEO |
| Telephone: | 011 354 562 2601 |
| Date Prepared: | November 12, 2020 |
2 Device Name
| Proprietary Name: | Kerecis Gingiva Graft |
|---|---|
| 510(k) Number: | K192612 |
| Classification Name: | Barrier, animal source, intraoral |
| Classification Product Code: | NPL |
| Regulatory Number: | 872.3930 |
| Class: | II |
3 Predicate Devices
Primary Predicate: MUCOGRAFT® Collagen Matrix (K102531) Reference Devices: Kerecis MariGen Wound Extra (K190528), Kerecis SecureMesh (K153364).
4 Device Description
The subject device is fish skin medical device indicated gingiva augmentation.
The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular sizes:
4
- 15mm x 20mm ●
- 20mm x 30mm
- . 30mm x 40mm
The subject device becomes completely integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The physical properties of the subject device allow cellular ingrowth for augmentation of keratinized tissue.
The subject device is biocompatible, non-crosslinked, bioresorbable, strong, pliable and supports fixation by sutures.
5 Intended Use
Kerecis Gingiva Graft is indicated for:
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.
6 Technological Characteristics and Substantial Equivalence
Comparisons of the subject device with the predicate device (K102531), and the reference devices (K153364 and K 190528), demonstrate that it is substantially equivalent with regards to: intended use, materials, design, and operational principles.
See Table 6.1. Kerecis Gingiva Graft in comparison with predicate and references device
5
Table 6-1 Kerecis Gingiva Graft in comparison with predicate and references devices
| Subject Device | Predicate Device | Discussion | ||
|---|---|---|---|---|
| Device Name | Kerecis Gingiva Graft | Geislich MUCOGRAFT® | ||
| Collagen Matrix | No discussion | |||
| required | ||||
| 510(k) | Subject Device | K102531 | Predicate device | |
| and reference | ||||
| devices are cleared. | ||||
| Regulation | 21 CFR 872.3930 | 21 CFR 872.3930 | Same as predicate | |
| Product Code | NPL | NPL | Same as predicate | |
| Device Classification | Barrier, Animal Source, | |||
| Intraoral | Barrier, Animal Source, | |||
| Intraoral | Same as predicate | |||
| Intended Use | Kerecis Gingiva Graft is a | |||
| biocompatible, sterile | ||||
| collagen membrane | ||||
| intended for augmentation | ||||
| and regeneration of soft | ||||
| tissue in oral surgical | ||||
| settings. | MUCOGRAFT® Collagen | |||
| Matrix is sterile resorbable | ||||
| bilayer extra cellular | ||||
| collagen membrane matrix | ||||
| for soft tissue | ||||
| augmentation, guided | ||||
| tissue regeneration and | ||||
| multiple oral tissue defect | ||||
| regeneration in oral | ||||
| surgical settings. | Subset of the | |||
| intended use of the | ||||
| predicate device. | ||||
| Indications | Localized gingival | |||
| augmentation to increase | ||||
| Keratinized tissue (KT) | ||||
| around teeth and implants. | • Covering of implants | |||
| placed in immediate | ||||
| extraction sockets; | ||||
| • Localized gingival | ||||
| augmentation to | ||||
| increase keratinized | ||||
| tissue (KT) around | ||||
| teeth and implants; | Subset of the | |||
| indications of the | ||||
| predicate device | ||||
| • Alveolar ridge | ||||
| reconstruction for | ||||
| prosthetic treatment | ||||
| • Guided tissue | ||||
| regeneration | ||||
| procedures in | ||||
| recession defects for | ||||
| root coverage | ||||
| • Guided tissue | ||||
| regeneration | ||||
| procedures in | ||||
| recession defects for | ||||
| root coverage. | ||||
| Animal Origin | ||||
| Material | North Atlantic Cod fish: skin | |||
| tissue, single layer sheet | Porcine skin and | |||
| connective tissue, double | ||||
| layer sheet | Different animal | |||
| source, same | ||||
| anatomical tissue | ||||
| Biocompatibility | Yes | Yes | Same as predicate | |
| NON-Pyrogenic | Yes | Yes | Same as predicate | |
| Resorbable | Yes | Yes | Same as predicate | |
| Sizes | 15mm x 20mm | |||
| 20mm x 30mm | ||||
| 30mm x 40mm | 15mm x 20mm | |||
| 20mm x 30mm | ||||
| 30mm x 40mm | Same as predicate | |||
| Sterilization | Ethylene Oxide | Gamma Irradiation | Traditional | |
| Sterilization | ||||
| Method | ||||
| Sterility Assurance | ||||
| Level | 10-6 | 10-6 | Same as predicate | |
| Shelf life | 3 years | 3 years | The shelf life of the | |
| product has been | ||||
| validated |
6
7
7 Performance Testing - Bench
The following performance studies were conducted on representative products to verify that material properties remain unchanged and support the substantial equivalence determination:
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 which is a key component for tissue augmentation and re-epithelization of defected keratinized 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. Stability of Kerecis Gingiva Graft 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 buffer incubated with the two products was stable over time. Incubation of the subject device to the buffer raises the pH slightly, while incubation of the predicate device decreases it slightly. The subject device is structurally more stable than the predicate device since it dissolved slower than the predicate device at neutral pH 7.
7.6. Suture Pull-Out Strength
The suture pull-out strength of the subject device meets or exceeds that of the predicate with a confidence of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.
7.7. Pin Pull-Out Strength
The pin pull-out strength of the subject device exceeds that of the predicate at a confidence level of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.
Kerecis Limited Traditional 510k for Kerecis Gingiva Graft
8
7.8. Compression
The compressive Peak-Load, Load-at-Break, Probe Penetration-at-Break, and Energy-to-Break of the subject device meet or exceed those of the predicate device, with a confidence of greater than 95%. For oral surgery and gingival augmentation, the products are equivalent.
7.9. User Evaluation of Device for Cutting and Shaping
The subject device was evaluated in comparison to the predicate by four dental clinicians for use in the oral environment using a questionnaire to assess: ease of placement, stability over the site, robustness of the device, and satisfaction with handling the device. The questionnaire results showed a favorable usability that was substantially equivalent to the predicate for cutting and shaping the device for use as a dental barrier membrane.
7.10.Biocompatibility, Sterilization, Shelf-life and Animal origin.
Testing from the applicant's own predicate device (K190528 and K153364) were leveraged in support of 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 (