(231 days)
InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is immediate or delayed guided tissue and bone regeneration.
- · in the context of a treatment of fenestration defects
- · in case of dehiscence defects
- · after apicoectomy and resection of retained teeth
- · in extraction sockets after tooth extractions
- · in case of immediate or delayed augmentation around implants in extraction sockets
InterCollagen® Guide is a resorbable collagen membrane, derived from porcine pericardium. InterCollagen® Guide is intended for periodontal and/or dental surgical procedures as a barrier membrane restricting the entry of rapidly proliferating non-osteogenic cells within the bone defect while allowing the ingrowth of slow-growing bone forming cells. The membrane is a bioresorbable barrier which eventually is remodeled and/or incorporated by the host tissue. InterCollagen® Guide is substantially resorbed within 15 weeks after implantation. It is adaptable and easy to handle. It can be trimmed to the desired size and conforms easily when hydrated. The product is terminally sterilized via gamma irradiation.
This FDA 510(k) summary describes the InterCollagen® Guide, a resorbable collagen membrane. The submission seeks to prove substantial equivalence to a predicate device, the Straumann Jason Membrane, rather than demonstrate strict acceptance criteria and performance against those criteria. Therefore, the response will be structured to extract relevant performance claims and the study details provided, even if they don't explicitly fit a "table of acceptance criteria" format with numerical targets.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission seeking substantial equivalence, explicit numerical "acceptance criteria" with defined thresholds are not typically presented in the same way as a de novo or PMA submission. Instead, the focus is on demonstrating similar performance to a legally marketed predicate device. The following table summarizes the key performance aspects that were evaluated and the results presented, which essentially serve as the "reported device performance" against the implicitly accepted standard of the predicate device's performance.
| Performance Aspect | Acceptance Standard (Implicitly based on Predicate Device) | Reported Device Performance (InterCollagen® Guide) |
|---|---|---|
| Biocompatibility | Meets ISO 10993 requirements for medical devices. | Non-mutagenic (Mouse Lymphoma, Ames Test) |
| (General) | Non-sensitizer (Kligman Maximization) | |
| Non-irritant (Intracutaneous irritation) | ||
| Non-cytotoxic (Cytotoxicity L929 Neutral Red uptake) | ||
| Non-toxic (Acute Systemic Toxicity, 90-day Subchronic Toxicity) | ||
| Non-pyrogenic (Pyrogenicity) | ||
| Minimum tissue reaction at 2, 11, and 15 weeks of implantation; no adverse tissue reaction to the host (Local effects after Implantation) | ||
| In Vivo Performance | Performance substantially equivalent to the predicate device (Jason membrane) in a canine model, with similar histological, histomorphometric, and micro-CT outcomes. | Performed in a manner substantially equivalent to the cleared predicate device across pathology, histology, histomorphology, and micro-CT endpoints. |
| Resorption Time | Substantially resorbed by 12 weeks (Predicate device: Straumann Jason Membrane) | Substantially resorbed by 15 weeks |
| Sterility Assurance | Sterility Assurance Level (SAL) of 10^-6 (Predicate device also achieves this) | Achieves a Sterility Assurance Level of 10^-6 (via Irradiation) |
| Viral Inactivation | Meets ISO 22442-3 | Viral inactivation studies performed in accordance with ISO 22442-3 to ensure viral safety. |
| Pyrogenicity (Batch) | Non-pyrogenic (release test) | Each batch tested for endotoxin (LAL test, USP , USP ) as finished product release test. |
| Shelf Life/Stability | Performance testing of packaging system; Selection, qualification, and validation of packaging. | Product and packaging stability determined using real-time aging data; Packaging tested per ASTM D4169, ISO 11607. |
2. Sample size used for the test set and the data provenance
The primary "test set" for performance evaluation was the canine two-wall intrabony defect model.
- Sample Size: Not explicitly stated in terms of the number of animals or defects. The document mentions "End points for pathology, histology, histomorphology and micro-CT were taken after 2, 6, and 13 weeks," implying a longitudinal study.
- Data Provenance: Conducted as an animal study (canine model). The country of origin is not specified in the provided text. The study design was a comparison between the test article (InterCollagen® Guide), a predicate device (Jason membrane), and an empty control. This is a prospective study design for evaluating the device's performance post-implantation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the animal study. Histology, histomorphology, and pathology evaluations are typically conducted by trained veterinary pathologists or researchers specialized in bone regeneration, but specific details are not provided.
4. Adjudication method for the test set
The document does not specify any adjudication method for establishing ground truth in the animal study. Evaluations of pathology, histology, histomorphology, and micro-CT are usually performed by experts, but whether independent reviews or consensus methods were used is not mentioned.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a resorbable collagen membrane for guided bone and tissue regeneration, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not performed. This is a medical device (collagen membrane), not a software or AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal study:
- Pathology: Evaluation of pathological changes in tissues.
- Histology: Microscopic examination of tissue samples.
- Histomorphology: Quantitative analysis of tissue morphology (e.g., bone formation).
- Micro-CT: Three-dimensional imaging for bone volume and structure analysis.
These are considered objective biological and imaging endpoints, typically interpreted by experts, to establish the "ground truth" regarding the device's in-vivo performance and tissue response.
8. The sample size for the training set
This is not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of medical 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.