(265 days)
Not Found
No
The summary describes a bone void filler composed of calcium salt mixture and mixing solution, focusing on its material properties, application method, and function as an osteoconductive scaffold. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is indicated to fill bony voids or gaps of the skeletal system and acts as an osteoconductive scaffold to facilitate new bone growth, thereby providing therapeutic benefit.
No
The device is a resorbable bone void filler used for filling bone defects, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components (bottles of calcium salt mixture and mixing solution) that form a paste or putty, indicating it is a physical medical device, not software-only.
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 the device is used to "fill bony void or gaps of the skeletal system". This is a therapeutic and structural application within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a mixture that forms a paste/putty for filling bone defects and acting as a scaffold for bone growth. This is consistent with a medical device used for treatment or repair, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
A-GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities 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 TE Resorbable Bone Void Filler may be used at an infected site.
Product codes
MQV
Device Description
The A-GRIX TE Resorbable Bone Void Filler consists of 1 bottle of pre-measured surgical grade calcium salt mixture and 1 bottle of mixing solution. When mixed according to the direction, A-GRIX TE forms the biodegradable, biocompatible and radiopaque paste or putty for digitally applying directly or by dispensing into the defect site. Then A-GRIX TE will harden in situ which acts as an osteoconductive scaffold and provides temporary intra-operative support to facilitate new bone growth. 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 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.
Bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
• A-GRIX Resorbable Bone Void Filler (K091688)
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
K121453$_{1/2}$
510(K) SUMMARY
FEB 0 5 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| Date of Prepare: Dec. 8, 2012 | |
|---|---|
| 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 |
| 2. Device Name : | |
| Trade Name: | A-GRIX TE Resorbable Bone Void Filler |
| Common Name: | Bone Void Filler |
| Classification name | filler, bone void, calcium compound |
| 3. DEVICE CLASS | A-GRIX TE Resorbable Bone Void Filler has been |
| classified as | |
| Regulatory Class: II | |
| Product Code: MQV | |
| Panel : Orthopedic | |
| Regulation Number: 21CFR 888.3045 | |
| 4. Predicate Device: | The predicate device is the |
| • A-GRIX Resorbable Bone Void Filler (K091688) | |
| marketed by AG DIGITAL Technology Corp. | |
| 5. Device Description: | The A-GRIX TE Resorbable Bone Void Filler consists of 1 |
| bottle of pre-measured surgical grade calcium salt mixture | |
| and 1 bottle of mixing solution. When mixed according to the | |
| direction, A-GRIX TE forms the biodegradable, biocompatible | |
| and radiopaque paste or putty for digitally applying directly or | |
| by dispensing into the defect site. |
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Product: A-GRIX TE Resorbable Bone Void Filler Section 4 - 510(k) Summary REV. 【B】
1
Then A-GRIX TE will harden in situ which acts as an osteoconductive scaffold and provides temporary intra-operative support to facilitate new bone growth. This product is supplied sterile for single patient use.
A-GRIX TE Resorbable Bone Void Filler is indicated to fill 6. Intended Use: bony void or gaps of the skeletal system (i.e., the extremities 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 TE Resorbable Bone Void Filler may be used at an infected site.
The device conforms to applicable standards includes ISO 7. Performance 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 TE Resorbable Bone Void Filler has the same intended use and technological characteristics as the A-GRIX Resorbable Bone Void Filler (K091688) marketed by AG DIGITAL Technology Corp.. 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 TE Resorbable Bone Void Filler is substantially equivalent to the predicate device.
Product: Page 2 of 2
A-GRIX TE Resorbable Bone Void Filler Section 4 - 510(k) Summary REV. 【B】 2/2
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.
Letter dated: February 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - 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
Re: K121453
Trade/Device Name: A-GRIX TE 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: December 10, 2012 Received: December 14, 2012
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, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Jennifer Reich
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/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.
Mark N. Melkerson
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K121453 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: A-GRIX TE Resorbable Bone Void Fiiller
Indications for Use:
A- GRIX TE Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities 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 TE Resorbable Bone Void Filler may be used at an infected site.
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)
Laurence D. Coyne
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121453
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