(74 days)
No
The summary does not mention AI, ML, or related terms, nor does it describe any characteristics typically associated with AI/ML-powered devices like training/test sets or performance metrics like AUC. The description focuses on standard bone densitometry and risk estimation based on established classifications.
No.
The device is for diagnostic and patient management decisions, specifically providing an estimate of fracture risk. It does not actively treat or alleviate a condition.
Yes
The device provides an estimate of fracture risk assessment based on WHO classification, and the physician uses the report to arrive at "diagnostic and patient management decisions." This clearly indicates its role in diagnosis.
No
The device description explicitly states it is an "added feature" to the "Hologic QDR X-Ray Bone Densitometers," which are hardware devices. The software component is integrated with and relies on the hardware for its function.
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 description clearly states that the device is a Bone Densitometer that uses X-Ray technology to measure Bone Mineral Density (BMD). It then uses this BMD data, along with other factors, to estimate fracture risk.
- Sample Type: The device does not analyze samples taken from the body. It directly interacts with the patient's body using X-rays.
- Intended Use: While the intended use involves diagnostic and patient management decisions, the core function is measuring a physical property (BMD) within the body, not analyzing a biological sample.
Therefore, this device falls under the category of a medical imaging device or a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Fracture Risk Option includes the World Health Organization's (WHO) definition of osteoporosis and osteopenia based on the T-score and provides an estimate of Fracture Risk assessment based on WHO classification. The physician uses the Fracture Risk report in conjunction with other risk factors to arrive at diagnostic and patient management decisions.
The intended use of the Hologic Fracture Risk Option includes an added feature of estimation of Fracture Risk from bone mineral density (BMD) using the Hologic QDR® X-Ray Bone Densitometers.
Product codes
90 KGI
Device Description
The Hologic QDR X-Ray Bone Densitometers with the added feature of estimation of Fracture Risk from BMD includes additional reports that provide an estimation of risk of fracture.
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)
NORLAND-CAMERON Bone Mineral Analyzer, Model 178, Norland model pDEXA Bone Densitometer with Fracture Risk Option. (K973104, FDA clearance Jan 29, 1998)
Reference Device(s)
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
§ 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
510(K) SUMMARY
HOLOGIC® QDR® X-Ray Bone Densitometers with an added feature of Estimation of Fracture Risk from BMD*
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 590 Lincoln Street |
| Waltham, MA 02451 | |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (781) 890-2300 |
| Fax Number: | (781) 890-8031 |
| Date Prepared: | August 28, 1998 |
| Device Trade Name: | Hologic® QDR® X-Ray Bone Densitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Devices: | NORLAND-CAMERON Bone Mineral Analyzer, Model 178, |
| Preamendment device. | |
| Norland model pDEXA Bone Densitometer with Fracture Risk | |
| Option. (K973104, FDA clearance Jan 29, 1998) | |
| Device Description: | The Hologic QDR X-Ray Bone Densitometers with the added |
| feature of estimation of Fracture Risk from BMD includes | |
| additional reports that provide an estimation of risk of fracture. | |
| Intended Use: | The intended use of the Fracture Risk Option includes the World |
| Health Organization's (WHO) definition of osteoporosis and | |
| osteopenia based on the T-score and provides an estimate of | |
| Fracture Risk assessment based on WHO classification. The | |
| physician uses the Fracture Risk report in conjunction with other | |
| risk factors to arrive at diagnostic and patient management | |
| decisions. |
- BMD = Bone Mineral Density
0027
NOV 1 3
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1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Nandini Murphy, RAC Regulatory Scientist Hologic, Inc. 590 Lincoln St. Waltham, MA 02154
Re: K983028
Estimation of Fracture Risk from BMD using Hologic QDR x-ray Bone Densitometers Dated: August 28, 1998 Received: August 31, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Ms. Murphy:
We have reviewed your Section 510(s) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, piease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html".
Sincerely yours,
Lillian Yip, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
The intended use of the Hologic Fracture Risk Option includes an added feature of estimation of Fracture Risk from bone mineral density (BMD) using the Hologic QDR® X-Ray Bone Densitometers.
Hind G. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi 305 510(k) Number
Prescription Use
(Per 21 CFR 801.109)