(1029 days)
CollaDental barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.
CollaDental Barrier is a nonfriable, resorbable membrane made of purified type I collagen derived from pig skin using standardized controlled manufacturing process. The collagen is obtained from veterinary certified pigs and purified to avoid its antigenicity. The manufacturing process complies with the standards for virus inactivation. The CollaDental Barrier has been tested for purity using standard purity testing procedures, sterlized by gamma irradiation and for single use only. It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site.
The provided text describes a 510(k) submission for a medical device called CollaDental Barrier. This submission focuses on establishing substantial equivalence to already approved predicate devices, rather than presenting a de novo study with acceptance criteria and performance data in the typical sense of an AI/algorithm-based device.
Therefore, many of the requested criteria for an AI or algorithm study (like sample size for test sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission because the device is a physical product (a resorbable collagen membrane for dental use) and not an AI or algorithm.
The core of this 510(k) is demonstrating that the CollaDental Barrier is as safe and effective as existing, legally marketed devices, primarily through comparison of:
- Intended use: Identical or very similar to predicates.
- Technological characteristics: Similar materials (purified type I collagen from pig skin), manufacturing process (purified, gamma irradiated), and physical properties (flexible, conforms to defects).
- Biocompatibility: Demonstrated through standard ISO 10993 Part 1 testing.
Here's an analysis based on the provided document, highlighting what is (and isn't) present:
Device Name: CollaDental Barrier
Device Type: Resorbable collagen membrane (physical medical device, not an AI/algorithm)
1. Table of Acceptance Criteria and Reported Device Performance
This type of specific table with quantitative metrics (e.g., accuracy, sensitivity, specificity) is not applicable here because this is a 510(k) for a physical medical device, not an AI algorithm. The "acceptance criteria" for a 510(k) revolve around establishing substantial equivalence, primarily by demonstrating similar intended use, technological characteristics, and safety/performance profiles to predicate devices through biocompatibility testing and material characterization, rather than an AI performance study.
What is reported as "performance" for a physical device like this:
- Biocompatibility: "CollaDental Barrier has been demonstrated to be safe. To support the biocompatibility of this product, safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices. All test results from tests conducted on CollaDental Barrier are taken together as a whole, CollaDental Barrier have been demonstrated to be a safe device in accordance with ISO 10993-1." (Section 9)
- Physical Properties: "It is flexible and conforms to the contours of the defect site. When moistened with water, saline, serum or blood, the device is flexible and conforms to the contours of the defect site." (Section 6)
- Material: "nonfriable, resorbable membrane made of purified type I collagen derived from pig skin" (Section 6)
- Sterilization: "sterilized by gamma irradiation" (Section 6)
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable for an AI test set. The regulatory pathway is not for an AI.
- For the biocompatibility testing (ISO 10993-1), the document doesn't specify the sample size of materials or animals/cells used in those tests, nor the exact provenance of that data, only that the tests were conducted.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. Ground truth in the context of expert consensus for AI model validation is not relevant for this physical device's 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. There is no "test set" in the context of an AI algorithm requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, not applicable. This type of study is for evaluating human-AI interaction in diagnostic/interpretive tasks, which is not relevant for a physical dental membrane.
6. If a Standalone (Algorithm Only) Performance Was Done
- No, not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Ground truth concept is different for a physical medical device. For a physical device like CollaDental Barrier, "ground truth" would be established through:
- Biocompatibility Standards: Adherence to ISO 10993-1, which involves standardized biological tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation). The "truth" is whether the material elicits a satisfactory biological response.
- Material Characterization: Chemical composition, physical properties (e.g., tensile strength, degradation rate), and sterility testing, validated against established scientific methods and specifications.
- Clinical Literature/Predicate Device Performance: The "truth" of its intended use and general performance largely derives from the known safety and efficacy of the predicate collagen membranes.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of an AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" or AI ground truth establishment for this device.
Summary of the "Study" and "Acceptance" for this 510(k) Submission:
The "study" conducted for CollaDental Barrier (K100695) is primarily a demonstration of substantial equivalence to existing predicate devices (BioMend Extend absorbable collagen membrane (K992216) and BIO-GIDE® (K042197)).
The "acceptance" is based on the FDA's regulatory determination that:
- The device's intended use is substantially equivalent: "augmented around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth."
- Its technological characteristics are substantially equivalent (purified Type I collagen from pig skin, non-friable, resorbable, gamma sterilized, flexible, conforms to defects).
- Its safety has been demonstrated through standard biocompatibility testing according to ISO 10993 Part 1. This is the primary "proof" of the device's safety profile against established biological criteria.
The FDA's letter (K100695) confirms this determination, stating, "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... You may, therefore, market the device."
In essence, this 510(k) relies on a comparison to well-understood and already approved predicate devices, supported by standard material and biocompatibility testing, rather than a de novo clinical trial or an AI performance study with the specified metrics.
§ 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.