(176 days)
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe any characteristics typically associated with AI/ML development (training/test sets, performance metrics like AUC).
No.
The device is used for diagnostic purposes (e.g., estimation of bone mineral density, fracture risk, vertebral deformity assessment, body composition analysis, visualization of abdominal aortic calcifications), not for treating a condition.
Yes
This device is indicated for the estimation of bone mineral density (BMD), comparison to reference values, estimation of fracture risk, and vertebral deformity assessment, all of which are diagnostic functions used for identifying or characterizing health conditions.
No
The device is described as a "Software option for Bone Densitometers," implying it is a software component that integrates with existing hardware (Hologic QDR® X-Ray Bone Densitometers) rather than a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The APEX for QDR X-Ray Bone Densitometers uses X-rays to measure bone mineral density and perform other analyses directly on the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes measurements and assessments performed in vivo (on a living organism), not in vitro (in a lab setting).
Therefore, this device falls under the category of a medical device that performs measurements and analyses directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The APEX for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a detabase of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic ODR® X-Ray Bone Densitometers.
IVA scans are intended for the visualization or quantitative assessment of vertebral body deformities. IVA also allows the visualization of abdominal aortic calcifications and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.
Product codes
90 KGI
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
G. 510(k) - SUMMARY
MAR 2 8 2008
Manufacturing Establishment and Contact Information G.1
Manufacturer Name and Address: G.1.1
Hologic, Inc. 35 Crosby Drive Bedford, MA 01730
G.1.2 Establishment Registration Number:
1221300
G.1.3 Name, Title, and Telephone Number of Contact:
Bryan Cowell, RAC Regulatory Affairs Specialist Phone: (781) 999-7300, ex. 7085 Fax : (781) 280-0614 bcowell(@hologic.com
G.2 Device Identification
G.2.1 Device Trade Name:
APEX 2.0 Software for QDR X-Ray Bone Densitometers
G.2.2 Common / Usual Name:
Software option for Bone Densitometers
Proposed Intended Use: G.2.3
The APEX for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a detabase of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic ODR® X-Ray Bone Densitometers.
IVA scans are intended for the visualization or quantitative assessment of vertebral body deformities. IVA also allows the visualization of abdominal aortic calcifications and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.
Device Classification G.3
G.3.1 Classification:
Class II
1
G.3.2 Classification Name and Rule
Bone Densitometer: 21 CFR 892.1170
-
G.3.3 Classification Panel
Radiology -
G.3.4 Product Code
90 KGI
G.3.5 Predicate Device(s)
- . 510(k) No.: K023398 Trade Name: Discovery Package for Hologic QDR X-Ray Bone Densitometers November 8, 2002 SE Date: Manufacturer: Hologic, Inc.
G.4 Conclusion
Based on the information provided in this 510(k) submission, the Hologic APEX 2.0 Software for QDR X-Ray Bone Densitometers is substantially equivalent to the presently marketed Discovery Package for Hologic QDR X-Ray Bone Densitometers (K023398). No new safety or efficacy questions are raised with the APEX 2.0 Software.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Bryan Cowell Regulatory Affairs Specialist Hologic, Incorporated 35 Crosby Drive BEDFORD MA 01730
MAR 2 8 2008
Re: K072847
Trade/Device Name: APEX 2.0 Software for QDR® X-Ray Bone Densitometers Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometers Regulatory Class: II Product Code: KGI Dated: December 27, 2007 Received: December 28, 2007
Dear Mr. Cowell:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a stylized font. The logo is surrounded by a dotted border.
3
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.
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 one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 the reporting 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 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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number (if known): K072847
Device Name: APEX 2.0 Software for QDR. X-Ray Bone Densitometers
Indication for Use:
The APEX for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.
IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number.