(133 days)
Not Found
No
The document describes a bone void filler material and its intended use, with no mention of AI or ML technology in its description, intended use, or performance studies.
Yes
The device is a bone void filler intended to facilitate bone healing, which is a therapeutic function.
No
Explanation: The device, GRAFTYS®BCP, is a bone void filler intended for use in the skeletal system. Its function is to fill voids or gaps caused by trauma or surgery and to be replaced by bone during healing, not to diagnose medical conditions.
No
The device description clearly states that GRAFTYS®BCP is a physical, sterile, single-use bioresorbable bone void filling substitute made of calcium phosphate ceramic, available in various physical forms (granules, sticks, cylinders, wedges). This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that GRAFTYS®BCP is a "bone void filler for voids or gaps of the skeletal system... caused by trauma or surgery". This describes a device that is implanted or placed within the body to aid in bone healing.
- Device Description: The description details a "sterile single use bioresorbable bone void filling substitute" made of calcium phosphate ceramic. This further reinforces its use as an implantable material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples. GRAFTYS®BCP is used within the body to fill bone voids.
N/A
Intended Use / Indications for Use
GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.
GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
GRAFTYS®BCP can be used with autograft as a bone graft extender.
In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies
Product codes
MQV
Device Description
GRAFTYS®BCP is a sterile single use bioresorbable bone void filling substitute.
GRAFTYS®BCP is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate.
Following placement in the bony voids or gap, GRAFTYS®BCP resorbs and is replaced with bone during the healing process.
GRAFTYS®BCP is available in the form of granules, sticks, cylinders and wedges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities, spine and pelvis), femoral or tibial osteotomies
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro tests, performed according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device; Guidance for Industry and FDA June 2, 2003, support the substantial equivalence between GRAFTYS®BCP and the predicate 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.
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Image /page/0/Picture/0 description: The image contains a large, bold letter 'G' in black. The letter is stylized with a thick stroke and a slightly curved shape. To the right of the 'G', there is a faded, textured area that appears to be part of the original image or background.
K07306 4
MAR 1 1 2008
Graftys
GRAFTYS®BCP Resorbable Bone Void Filler 510(k) Summary
Prepared: October 15th, 2007
1. Submitter Information
| Name : | GRAFTYS |
|---|---|
| Address : | Eiffel Park – Bât D |
| 415, rue Claude Nicolas Ledoux- | |
| 13 854 AIX EN PROVENCE Cedex 3 | |
| FRANCE | |
| Telephone: | + 33 (0) 4 42 60 30 00 |
| Facsimile: | + 33 (0) 4 42 60 30 11 |
| Contact: | Anthony LE NAOUR - Regulatory Manager |
Name of Device 2.
| Trade Name: | GRAFTYS®BCP |
|---|---|
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification | Resorbable calcium salt bone void filler device (CFR 888.3045 ; Product |
| name: | Code : MQV) |
3. Legally Marketed Predicate Device
| Predicate | MBCP ™ - Resorbable calcium salt bone void filler device [K051774] |
|---|---|
| VITOSS- Resorbable calcium salt bone void filler [K994337] |
4. Device Description
GRAFTYS®BCP is a sterile single use bioresorbable bone void filling substitute.
GRAFTYS®BCP is a microporous and macroporous two-phase calcium phosphate ceramic made of 60% Hydroxyapatite and 40% beta-tricalcium phosphate.
Following placement in the bony voids or gap, GRAFTYS®BCP resorbs and is replaced with bone during the healing process.
GRAFTYS®BCP is available in the form of granules, sticks, cylinders and wedges.
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Image /page/1/Picture/0 description: The image shows the word "Graftys" in a serif font. Above the word is a large letter "G" in a handwritten style. To the right of the "G" is a small, faded graphic that is difficult to discern.
5. Intended Use
GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.
GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
GRAFTYS®BCP can be used with autograft as a bone graft extender.
In addition when used with appropriate opening osteotomy system devices, plates and screws, GRFATYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies
6. Technological characteristics
GRAFTYS®BCP and the predicate device MBCP have the same technological characteristics and are osteoconductive scaffold for bone ingrowth. Both are sterile single use devices made of 60% Hydroxyapatite/40% β-Tricalcium Phosphate and have a similar porous structure (total volume ratio of 70%). As the predicate VITOSS, the interconnection between the pores is ensured by mesoporosity. GRAFTYS®BCP and predicates are provided sterile for single-use.
7. Non clinical performance data
In vitro tests, performed according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device; Guidance for Industry and FDA June 2, 2003, support the substantial equivalence between GRAFTYS®BCP and the predicate device.
8. Conclusion
GRAFTYS®BCP is claimed to be substantially equivalent in term of safety and effectiveness to the predicate devices as a non structural osteoconductive bone void filler for osseous defect.
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Image /page/2/Picture/12 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Graftys % Mr. Anthony Le Naour 415 Rue Charles Nicolas Ledoux Eiffel Park Bat D Aix En Provence France 13854
MAR 1 1 2008
K073064 Re:
Trade/Device Name: GRAFTYS®BCP -- Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 28, 2008 Received: February 1, 2008
Dear Mr. Le Naour:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 may be subject 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Anthony Le Naour
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Mulhusan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073064
Device Name:
GRAFTYS®BCP - Resorbable Bone Void Filler
Indications For use:
GRAFTYS®BCP is intended for use as a bone void filler for voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure.
GRAFTYS BCP has limited initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
GRAFTYS®BCP can be used with autograft as a bone graft extender.
In addition when used with appropriate opening osteotomy system devices, plates and screws, GRAFTYS®BCP is intended to be used as a bone void filler in femoral or tibial osteotomies
Prescription Use X (Part 21 CFR 801 Subpart D)
l
Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Niel Rl Jule formxm
Division of General, Restorat and Neurological Devices
510(k) Number K073064
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