(147 days)
No
The summary describes a bone void filler composed of a mixture of existing materials. There is no mention of any computational analysis, image processing, or learning algorithms.
Yes
The device is described as a bone void filler intended for filling bone defects, which is a therapeutic intervention to aid in bone regeneration.
No
Explanation: The device is described as a bone void filler intended for surgical repair and regeneration, not for diagnosing medical conditions.
No
The device description clearly states it is a mixture of bone void filler granules made of beta-tricalcium phosphate, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bone voids or gaps in the skeletal system. This is a therapeutic and structural application within the body.
- Device Description: The device is a bone void filler material intended for implantation.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are used outside the body to analyze samples (like blood, urine, tissue) to provide diagnostic information. This device is implanted within the body for a structural and regenerative purpose.
N/A
Intended Use / Indications for Use
Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.
Product codes
MQV
Device Description
The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules.
The material should not be packed in dry form; it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities, posterolateral spine, and pelvis)
Indicated Patient Age Range
For patients with bony voids or gaps resulting from surgery, trauma or degenerative processes and which are not intrinsic to the stability of the bony structure.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The only difference between the proposed device and the predicate devices is that the Cerasorb® MIX device is constructed of two forms of previously cleared calcium phosphate salts. This does not affect safety or effectiveness since they are all resorbable and carry out the same function. The safety and biocompatibility testing performed for calcium phosphates (found in K014156 and K040216) and the long history of safe clinical use. Curasan believes that the proposed device has the identical technological characteristics as the predicate devices; therefore, the Cerasorb® MIX device should behave and function exactly as the parent devices and therefore no new testing is required. Testing performed on the proposed device contained in K014156 and K040216 confirmed that the Cerasorb® MIX device meets the applicable requirements of the FDA guidance documents on bone void fillers. Therefore, the differences in material forms between the proposed and predicate devices do not impact the safety or effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary for the Cerasorb® MIX
1. SUBMITTER/510(K) HOLDER
Curasan AG Lindigstrasse 4 63 801 Kleinostheim Germany
··
Dr. Wolf-Dietrich Hübner Contact Person: +49-6027-40900-0 Telephone:
Date Prepared: August 16, 2010
2. DEVICE NAME
| Trade Name: | Cerasorb® MIX |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Name: | Filler, bone void, calcium compound, 21CFR 888.3045, |
| Product Code MQV |
3. PREDICATE DEVICES
.
4. DEVICE DESCRIPTION
The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules.
The material should not be packed in dry form; it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.
1
Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence reads 'K100841'. The characters are written in a simple, slightly irregular style, typical of handwriting. The image is in black and white, with the characters standing out against the background.
5. INTENDED USE
Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Since the Cerasorb® MIX device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216, the technological characteristics are identical to that described in the previously cleared 510(k) premarket notifications. The bone replacement and bone regeneration material Cerasorb® MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000µm and 1000-2000 µm. The mixing ratiò is 1cc to 1cc. Cerasorb® and Cerasorb® M granules.
| | Cerasorb® MIX Device | Predicate Cerasorb Ortho
Granules | Predicate Cerasorb M Ortho
Granules |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Regulatory Status | Proposed | K014156 | K040216 |
| Target population | For patients with bony voids or gaps resulting from surgery, trauma or degenerative
processes and which are not intrinsic to the stability of the bony structure. | | |
| Labeling | Labeling contains same
intended use, contraindications,
warnings, precautions, and
adverse events as predicate. | same | Labeling contains same
intended use, contraindications,
warnings, precautions, and
adverse events as predicate. |
| Performance | Osteoconductive | Osteoconductive | Osteoconductive |
| Sizes | 500 - 2000µm | 50 - 2000µm | 50 µm -8000µm |
| Porosity | >0 to 500 µm | Micropores >0