(29 days)
CopiOs™ Bone Void Filler, in combination with autologous blood products such as bone marrow, is intended for use only for filling bone voids or gaps of the skeletal system (i.e. extremities, pelvis, spine) that are not intrinsic to the stability of the bone structure. These voids may be a result of trauma or creation by surgeon. CopiOs Bone Void Filler is intended to be gently packed into the void or gap and will resorb during the course of the healing process.
CopiOs™ Bone Void Fillers are resorbable rectangular sponges or powder discs manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOsTM Paste, a compressed powder disc, forms a paste when mixed with autologous blood products using the supplied spatula. CopiOs™ devices are gamma-sterilized for single use and supplied in 1cc, 5cc and 10cc volumes.
The provided 510(k) summary for K071237, CopiOs™ Bone Void Filler, does not contain detailed acceptance criteria or a comprehensive study report with the requested information. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No explicit criteria mentioned, but assumed to meet ISO 10993 standards for medical devices. | "CopiOs™ Paste has undergone non-clinical testing, including biocompatibility..." |
| Migration Resistance | No explicit criteria mentioned. | "non-clinical testing, including... migration resistance" |
| pH | No explicit criteria mentioned. | "non-clinical testing, including... pH" |
| Hydration Characteristics | No explicit criteria mentioned. | "non-clinical testing, including... hydration" |
| Handling Characteristics | No explicit criteria mentioned, but likely relates to ease of mixing and packing. | "non-clinical testing, including... handling characteristics" |
| Safety and Effectiveness | Reasonable assurance of safety and effectiveness for intended use, as per substantial equivalence. | "Testing provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device." |
Missing Information:
- Specific numerical or qualitative targets for each acceptance criterion (e.g., pH range, migration limits, specific mechanical properties related to handling).
- Quantitative results or detailed qualitative descriptions of the device's performance against these criteria. The document only lists the types of tests performed, not the results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "non-clinical testing" was performed but does not provide details on the number of samples used for each test (e.g., number of specimens for biocompatibility, number of paste samples for pH testing).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Non-clinical testing typically refers to laboratory-based evaluations, so it wouldn't be retrospective/prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided. This device is not an AI/diagnostic device that would require expert-established ground truth for a test set. The non-clinical testing for this bone void filler would involve laboratory analyses and physical/chemical characterization, not expert interpretation of results in the way a diagnostic algorithm does.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC study was not done. This device is a medical implant (bone void filler), not a diagnostic imaging or AI-assisted system that would typically undergo an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- No, a standalone performance study was not done. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- This information is not applicable in the typical sense of AI/diagnostic devices. For non-clinical testing, "ground truth" would be established by validated analytical methods (e.g., pH meter readings, material composition analysis, cell culture assays for biocompatibility). The document does not specify the methods or "ground truth" for individual tests.
8. The Sample Size for the Training Set
- This information is not applicable. This device is a physical medical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable for the same reason as point 8.
Summary of Device and Evidence:
The Kensey Nash Corporation's CopiOs™ Bone Void Filler (K071237) is a resorbable bone void filler made from calcium phosphate and Type I bovine dermal collagen, intended to fill bone voids in the skeletal system.
The company demonstrated substantial equivalence to its predicate device (K033679 - CopiOs™ Bone Void Filler (Sponge)) rather than conducting a standalone clinical effectiveness study with defined acceptance criteria for clinical outcomes. The justification for substantial equivalence relies on:
- Non-Clinical Testing: The submission states that CopiOs™ Paste underwent non-clinical testing for:
- Biocompatibility
- Migration resistance
- pH
- Hydration characteristics
- Handling characteristics
- Conclusion: This testing "provides reasonable assurance of safety and effectiveness for its intended use and supports a determination of substantial equivalence to the predicate device." The submission emphasizes that the new device (CopiOs™ Paste) is "substantially equivalent to the legally marketed predicate device, CopiOs™ Sponge with regard to materials, processing, intended use and fundamental scientific technology."
The provided documentation does not include specific, quantitative acceptance criteria or detailed results from the non-clinical tests. Instead, it relies on the broader concept of substantial equivalence, asserting that the new device performs comparably to a previously cleared predicate device, and the non-clinical tests confirmed its safety and basic functional properties.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.