(178 days)
Not Found
No
The description focuses on the material composition and physical properties of a bone void filler, with no mention of AI or ML technologies.
Yes
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process, addressing bony voids or defects. This function directly pertains to therapy—repairing or restoring a damaged or abnormal bodily function.
No
The device is described as a bone void filler that resorbs and is replaced with bone during the healing process. Its function is to fill bony voids or defects, not to diagnose medical conditions or identify diseases.
No
The device description clearly states it is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute, which is a physical material, not software.
Based on the provided information, GRAFTYS® Quickset is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- GRAFTYS® Quickset's Function: GRAFTYS® Quickset is a bone void filler that is implanted into the body to help with bone healing. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for filling bony voids and defects within the skeletal system.
- Device Description: The description details its composition and how it hardens and is resorbed in vivo (within the body).
Therefore, GRAFTYS® Quickset falls under the category of a medical device used for treatment and repair within the body, not for diagnosing conditions using samples taken from the body.
N/A
Intended Use / Indications for Use
GRAFTYS® Quickset is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® Quickset is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
GRAFTYS®QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. Invivo, this apatite which hardens in approximately 2min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®QUICKSET is a sterile single-use product.
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 and 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)
In vitro testing, 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®QUICKSET and the predicate device GRAFTYS®HBS.
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.
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G
Graftys
GRAFTYS® Quickset Resorbable Bone Void Filler 510(k) Summary
APR 2 2 2010
Prepared: October, 14, 2009
1. Submitter Information
| Name : | GRAFTYS |
|---|---|
| Address : | Eiffel Park – Bât D |
| 415, rue Claude Nicolas Ledoux- | |
| 13 854 AIX EN PROVENCE Cedex3 | |
| FRANCE | |
| Telephone: | + 33 (0) 4 42 60 30 00 |
| Facsimile: | + 33 (0) 4 42 60 30 11 |
| Contact: | Anthony LE NAOUR - Regulatory Manager |
2. Name of Device
| Trade Name: | GRAFTYS®QUICKSET |
|---|---|
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification name: | Resorbable calcium salt bone void filler device (CFR 888.3045; Product Code : MQV) |
3. Legally Marketed Predicate Device
Predicates GRAFTYS®HBS - Resorbable calcium salt bone void filler device [K082498]
4. Device Description
GRAFTYS®QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. Invivo, this apatite which hardens in approximately 2min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®QUICKSET is a sterile single-use product.
GRAFTYS - S.A. au capital de 537.037 Euros - Siret 484 024 989 - APE 2120Z Eiffel Park - Bât D - 415, rue Claude Nicolas Ledoux - F-13 854 Aix en Provence Cedex 3, France Tel : +33 (0)4 42 60 30 00 - Fax : + 33 (0)4 42 60 30 11 - contact@graftys.fr www.graftys.com
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Image /page/1/Picture/1 description: The image shows a large, bold letter 'G' on the left side. To the right of the 'G', there is a smaller, less distinct symbol that appears to be the number '5'. The number '5' is partially obscured and has a textured or grainy appearance, contrasting with the solid black 'G'.
Graftys
5. Intended Use
GRAFTYS®QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
6. Technological characteristics
GRAFTYS®QUICKSET and the predicate GRAFTYS®HBS devices have the same intended use, the same principle of operation and very similar technological characteristics. The minor technological differences do not raise any new issues of safety or effectiveness.
7. Non clinical performance data
In vitro testing, 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®QUICKSET and the predicate device GRAFTYS®HBS.
8. Conclusion
GRAFTYS®QUICKSET is claimed to be substantially equivalent in term of safety and effectiveness to the predicate devices GRAFTYS®HBS as a resorbable calcium salt bone void filler device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it, topped by wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
GRAFTYS APR 2 2 2010 % Mr. Anthony Le Naour Regulatory Affairs Manager Eiffel Park – Bât D 415, rue Claude Nicolas Ledoux 13854 AIX EN PROVENCE Cedex3 France
Re: K093343
Trade/Device Name: GRAFTYS® Quickset Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 30, 2010 Received: March 30, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Anthony Le Naour
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Boettner
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification Graftys GRAFTYS®QUICKSET- Resorbable Bone Void Filler
Statement of Indications for Use
510(k) Number (if known): K093343
Device Name:
GRAFTYS® Quickset
Indications For use:
GRAFTYS® Quickset is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® Quickset is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis).These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Division Sign-Off
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093343
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