(265 days)
Not Found
No
The device description focuses on the material composition and physical properties of a bone void filler, with no mention of software, algorithms, or any terms related to AI/ML.
No.
The device is a bone void filler that facilitates new bone growth, which is a structural or restorative function rather than a therapeutic one (treating a disease or condition).
No
A-GRIX Resorbable Bone Void Filler is used to fill bony voids and acts as a scaffold for new bone growth. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical product composed of calcium sulfate hemihydrate powder and granules, intended to be mixed into a paste or putty for filling bone voids. It is a resorbable bone void filler, not a software application.
Based on the provided information, the A-GRIX Resorbable Bone Void Filler is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural function performed in vivo (within the body).
- Device Description: The device is a material (calcium sulfate) that is mixed and applied directly to a surgical site within the patient's body.
- 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 compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The A-GRIX Resorbable Bone Void Filler is a medical device used inside the body for structural support and bone regeneration.
N/A
Intended Use / Indications for Use
A-GRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The A-GRIX Resorbable Bone Void Filler contains 1 bottle of solid phase and 1 bottle of mixing solution. The solid phase is composed of high purity medical grade calcium sulfate hemihydrate fine powder and different size calcium sulfate granules. Because of the special treated granules, the dissolving of A-GRIX Resorbable Bone Void Filler would be longer than other products and closer to the new bone formation. Besides, the different granule size could make it be easy to be filled into the bony defect. When mixed according to the directions, A-GRIX forms the biodegradable, biocompatible and radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. A-GRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.
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)
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)
The device conforms to applicable standards includes ISO 10993 series : Biological evaluation of medical devices , ASTM F2224-03 : Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants & ANSVAAMI/ISO 11137 Sterilization of Health Care Products -Radiation Sterilization.
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
K09/688
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | AG DIGITAL Technology Corp. |
|---|---|
| Address: | 11F, No. 15, Chi-nan Rd., Sec.1, Taipei (10051), TAIWAN |
| Phone: | + 886-2-23575864 |
| Fax: | + 886-2-23575845 |
| Contact: | Frank Chou / manager MAR - 2 2010 |
| 2. Device Name : | |
|---|---|
| Trade Name: | A-GRIX Resorbable Bone Void Filler |
| Common Name: | Bone Void Filler |
| Classification name | filler, bone void, calcium compound |
-
- DEVICE CLASS
A-GRIX Resorbable Bone Void Filler have been classified as Regulatory Class: II
- DEVICE CLASS
Product Code: MQV Panel : Orthopedic Regulation Number: 21CFR 888.3045
-
- Predicate Device:
The predicate device is the
- Predicate Device:
· Osteo-G bone void filler (K031319) marketed by ASPINE USA, INC.
-
- Device Description: The A-GRIX Resorbable Bone Void Filler contains 1 bottle of solid phase and 1 bottle of mixing solution. The solid phase is composed of high purity medical grade calcium sulfate hemihydrate fine powder and different size calcium sulfate granules.
Because of the special treated granules, the dissolving of A-GRIX Resorbable Bone Void Filler would be longer than other products and closer to the new bone formation. Besides, the different granule size could make it be easy to be filled into the bony defect. When mixed according to the directions, A-GRIX forms the biodegradable, biocompatible and
- Device Description: The A-GRIX Resorbable Bone Void Filler contains 1 bottle of solid phase and 1 bottle of mixing solution. The solid phase is composed of high purity medical grade calcium sulfate hemihydrate fine powder and different size calcium sulfate granules.
| Product: A-GRIX Resorbable Bone Void Filler | ||
|---|---|---|
| Page 1 of 2 | Section 4 - 510(k) Summary | REV. (A) |
1
radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site.
A-GRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.
A-GRIX Resorbable Bone Void Filler is indicated to fill 6. Intended Use: bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
- Performance The device conforms to applicable standards includes ISO 10993 series : Biological evaluation of medical devices , ASTM Summary: F2224-03 : Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants & ANSVAAMI/ISO 11137 Sterilization of Health Care Products -Radiation Sterilization.
8. Conclusions:
The A-GRIX Resorbable Bone Void Filler has the same intended use and technological characteristics as the Osteo-G bone void filler (K031319) marketed by ASPINE USA, INC.. Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the A-GRIX Resorbable Bone Void Filler is substantially equivalent to the predicate devices.
Product: A-GRIX Resorbable Bone Void Filler Page 2 of 2 Section 4 - 510(k) Summary REV. (A)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AG Digital Technology Corporation % Harvest Consulting Corporation (USA) Ms. Jennifer Reich Senior Consultant 2904 North Boldt Drive Flagstaff, Arizona 86001
MAR - 2 2010
Re: K091688
Trade/Device Name: A-GRIX Resorbable Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 5, 2010 Received: February 12, 2010
Dear Ms. Reich:
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. Iisting 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 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
3
Page 2 - Ms. Jennifer Reich
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: A-GRIX Resorbable Bone Void Filler AG DIGITAL Technology Corp.
Indications For Use:
A-GRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number