(28 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 and spine, i.e., posterolateral spine fusion procedures with appropriate stabilizing hardware) 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 sponges or paste (hydrated powder discs), which are manufactured from calcium phosphate and Type I bovine dermal collagen. CopiOs® devices are gamma-sterilized for single use and supplied in 1cc. 5cc and 10cc volumes.
The provided text is a 510(k) summary for the CopiOs® Bone Void Filler. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria as might be seen for a new drug or a novel device with a very different mechanism of action.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the submission states:
Acceptance Criteria/Study Information:
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Substantial Equivalence: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The document explicitly states:
- "CopiOs® Bone Void Filler Sponge & Paste is substantially equivalent to the legally marketed predicate device, CopiOs® Bone Void Filler Sponge & Paste (K071237) having identical device designs, materials, processing, intended use and fundamental scientific technology."
- The predicate devices mentioned are K071237 (CopiOs Bone Void Filler Sponge & Paste) and K033679 (CopiOs™ Bone Void Filler).
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Non-Clinical Testing:
- The document mentions that "CopiOs® Bone Void Filler Sponge & Paste have previously undergone non-clinical testing, including animal study, biocompatibility, migration resistance, pH, hydration and handling characteristics."
- This testing "provides reasonable assurance of safety and effectiveness for its intended use."
In summary, the 510(k) process for this device did not involve the types of studies typically associated with "acceptance criteria" for performance metrics in the way a diagnostic algorithm or a novel therapeutic might. Instead, the focus was on demonstrating that the new device is as safe and effective as a previously cleared device through substantial equivalence and supporting non-clinical data.
§ 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.