(135 days)
Not Found
No
The summary describes a resorbable implant made of calcium salts for filling bone voids. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making. The performance studies focus on substantial equivalence to predicate devices based on non-clinical testing of the material properties.
No
Allogran-R® is a resorbable implant designed to fill bony voids or gaps, acting as a structural filler rather than providing therapeutic treatment for a disease or condition.
No
The device is described as a resorbable implant intended to fill bony voids, and its function involves filling defects, not diagnosing them.
No
The device description clearly states that Allogran-R® is a bioabsorbable device manufactured from calcium salts and supplied in the form of granules or other preformed shapes, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Allogran-R® is a resorbable implant intended to fill bony voids or gaps in the body. This is a therapeutic or structural function, not a diagnostic one.
- Device Description: The description mentions it's manufactured from calcium salts and supplied as granules or preformed shapes, consistent with a bone graft substitute or filler.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. Allogran-R® is used within the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.
Product codes (comma separated list FDA assigned to the subject device)
MVQ
Device Description
Allogran-R® is a bioabsorbable device manufactured from calcium salts and may be supplied in the form of granules or other preformed shapes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony structure (e.g., the extremities, spine or pelvis)
Indicated Patient Age Range
Not Found
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)
Non Clinical Testing
Test data supplied demonstrates that the Allogran-R® is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 2 2006
510(k) SUMMARY
Allogran-R®
- Applicant Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 SNL
- Mr Simon Fitzer Contact Person +44 (0) 1782 338580 Tel: Fax +44 (0) 1782 338599 Email: sf@biocomposites.com
| Classification Name: | Filler, bone void, calcium compound |
|---|---|
| Common/Usual Name: | Filler, bone void, calcium compound |
| Trade/Proprietary Name | Allogran-R® |
| Product Code | MVQ |
Legally Marketed Predicate Devices
| Trade Name | Manufacturer | 510(k) No | |
|---|---|---|---|
| 1 | Vitoss Scaffold | Orthovita | K032409 |
| 2 | βGran | Orthos (UK) Ltd | K041616 |
Device Description
Allogran-R® is a bioabsorbable device manufactured from calcium salts and may be supplied in the form of granules or other preformed shapes.
1
Intended Use / Indications
Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.
Summary of Technology
Allogran-R® has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness.
Non Clinical Testing
Test data supplied demonstrates that the Allogran-R® is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that Allogran-R® is substantially equivalent to the legally marketed predicate devices in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of Allogran-R®
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2006
Biocomposites Ltd. % Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keele Staffordshire United Kingdom ST5 5NL
· Re:-K061311
Trade Name: Allogran-R® Regulation Number: 21 CFR 888.3045 Regulation Name: Filler, Bone Void, Calcium Compound Regulatory Class: Class II Product Code: MQV Dated: September 6, 2006 Received: September 8, 2006
Dear Mr. Fitzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of pror to ria) 2011-07-11 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Ocometier fore, market the device, subject to the general controls provisions of the Act. The r ou may, dierelere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r trate be actived a determination that your device complies with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must or mr) vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cr re rate 077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorni in the quisions of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Simon Fitzer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
APPENDIX I
INDICATIONS FOR USE
510(k) Number (if known): K061311
Allogran-R® Device Name:
Indications For Use:
Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter use (Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
barbare Brielud formin
(Division Sega-Off) (Division of Ceneral Secsiorative, and Neurolagical I
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