(420 days)
Kerecis Gingiva Graft is indicated for:
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.
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.
The provided text describes the Kerecis Gingiva Graft device, a collagen membrane intended for localized gingival augmentation. This is a 510(k) submission, meaning the device seeks clearance based on its substantial equivalence to a legally marketed predicate device, not necessarily on meeting quantitative acceptance criteria established by the FDA for novel devices.
Therefore, the information typically requested in questions 1 through 9 (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) is not applicable in the context of this 510(k) summary, as it describes a different type of regulatory submission process. The study presented here aims to demonstrate equivalence, not to quantify the device's performance against pre-defined thresholds.
However, I can extract information related to the "study that proves the device meets the acceptance criteria" in the context of proving substantial equivalence to the predicate device.
Here's the relevant information based on the provided text, reinterpreting "acceptance criteria" as "criteria for demonstrating substantial equivalence" for this 510(k) submission:
1. A table of (Substantial Equivalence) Criteria and the Reported Device Performance:
The document establishes substantial equivalence by comparing the Kerecis Gingiva Graft (subject device) to the MUCOGRAFT® Collagen Matrix (predicate device) and other reference devices across various characteristics and performance tests. Rather than explicit "acceptance criteria" with numerical thresholds, the "performance" is the demonstration of comparability or superiority to the predicate device.
| Characteristic / Performance Element | Substantial Equivalence Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as, or subset of, predicate device. | "Subset of the intended use of the predicate device." (Kerecis: "a biocompatible, sterile collagen membrane intended for augmentation and regeneration of soft tissue in oral surgical settings." Predicate: includes broader indications like "guided tissue regeneration and multiple oral tissue defect regeneration in oral surgical settings.") |
| Indications for Use | Same as, or subset of, predicate device. | "Subset of the indications of the predicate device." (Kerecis: "Localized gingival augmentation to increase Keratinized tissue (KT) around teeth and implants." Predicate: includes this, plus "Covering of implants placed in immediate extraction sockets," "Alveolar ridge reconstruction for prosthetic treatment," and other GTR procedures.) |
| Regulation, Product Code, Class | Same as predicate. | "Same as predicate." (21 CFR 872.3930, NPL, Class II) |
| Biocompatibility | Meets ISO 10993 series standards. Comparable to predicate. | "Yes" (Same as predicate). Leveraged testing from applicant's own predicate devices (K190528 and K153364) for Cytotoxicity, Sensitization, Irritation, Acute/Subacute/Sub-chronic/Chronic Toxicity, Genotoxicity, Implantation, Materials-Mediated Pyrogenicity, Carcinogenicity. |
| NON-Pyrogenic | Yes. | "Yes" (Same as predicate). 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.