(193 days)
The Kensey Nash P1076 Collagen Dental Membrane is indicated for:
- Simultaneous use of GBR-membrane and implants.
- Augmentation around implants placed in immediate extraction sites.
- Augmentation around implants placed in delayed extraction sockets.
- Localized ridge augmentation for later implantation.
- Alveolar ridge reconstruction for prosthetic treatment.
- Filling of bone defects after root resection, cystectomy, removal of retained teeth.
- Guided bone regeneration in dehiscence defects.
- Guided tissue regeneration procedures in periodontal defects
The Kensey Nash (KN) P1076 Collagen Dental Membrane is a translucent, resorbable, rectangular collagen membrane sheet derived from bovine tissue. The KN P1076 Collagen Dental Membrane is intended for single-use and is sterilized by Ethylene Oxide.
The provided text is a 510(k) summary for the Kensey Nash P1076 Collagen Dental Membrane, a medical device submission to the FDA. It does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert qualifications, or study methodologies typically associated with proving a device meets specific performance criteria.
The document primarily focuses on:
- Device Description: What the Kensey Nash P1076 Collagen Dental Membrane is (translucent, resorbable, rectangular collagen membrane sheet from bovine tissue, single-use, sterilized by Ethylene Oxide).
- Intended Use/Indications For Use: The specific dental procedures for which the membrane is intended (e.g., GBR with implants, augmentation around implants, localized ridge augmentation, filling bone defects, guided bone and tissue regeneration).
- Predicate Devices: Kensey Nash compares its device to Geistlich Pharma AG's Bio-Gide (K050466) and Collagen Matrix, Inc.'s Collagen Dental Membrane - Conformable II (K062881).
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document states: "Performance Testing has confirmed that the Kensey Nash P1076 Collagen Dental Membrane is substantially equivalent to the predicate devices with regard to materials, intended use, and technological characteristics, pursuant to section 510(k)."
Key Missing Information:
The document claims that "Performance Testing has confirmed...substantial equivalence" but does not provide any details about this performance testing. Therefore, I cannot extract the information required to answer your prompt, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance for a test set.
- Number/qualifications of experts, adjudication methods for ground truth.
- Results of any Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set or how its ground truth was established.
Conclusion:
Based solely on the provided text, it is impossible to describe the acceptance criteria and the study that proves the device meets them because these specifics are not detailed in the 510(k) summary provided. The summary asserts that performance testing was done to demonstrate substantial equivalence, but it does not present the results or methodology of that testing.
§ 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.