(59 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with AI/ML in medical imaging (like training/test sets, performance metrics related to algorithmic output).
No
The device is described as a bone densitometer used for measuring bone loss or gain and identifying bone delistionied (likely a typo for 'depletion' or 'loss'), which are diagnostic functions, not therapeutic.
Yes
The device is indicated for "early detection of bone loss" and "measuring bone loss or gain with time for monitoring osteoporosis," which directly classifies it as a diagnostic device.
No
The device description explicitly states "QCT Bone Densitometer (QCT 5000 and QCT 3000)", which are hardware devices used for QCT imaging. While software is undoubtedly involved in processing the QCT data, the device itself is a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device, a QCT Bone Densitometer, uses imaging (QCT) to measure bone density directly within the patient's body. It does not analyze samples taken from the body.
Therefore, it falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
QCT bone densitometry is indicated for patients with suspected loss of bone to identify QCT bone delistionied I is meetar of the highly responsive spinal trabecular bone is indicated for early detection of bone loss. QCT is useful for measuring bone loss or gain with time for monitoring osteoporsis QCT Is useful for mousaning other collect to increased fracture risk by WHO criteria.
Product codes
90 KGI
Device Description
QCT Bone Densitometer (QCT 5000 and QCT 3000)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
spinal trabecular bone
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/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 image of an abstract symbol that resembles a person with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP . 3 1999
Ben Arnold, Ph.D. Image Analysis, Inc. 1380 Burkesville Street Columbia, KY 42728
Dear Dr. Arnold:
Re: K992246
QCT Bone Mineral Analysis Software Dated: June 14, 1999 Received: August 5, 1999 Requlatory Class: II (two) Product Code: 90 KGI 21 CFR 892.1170
We have reviewed your Section 510(k) 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 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). 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 III (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 Requlations, 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 verily 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, please note the requlation 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/dsma/dsmamain.html".
Sincerely yours,
[signature]
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K992246
Device Name:QCT Bone Densitometer (QCT 5000 and QCT 3000)
Indications For Usc:
QCT bone densitometry is indicated for patients with suspected loss of bone to identify QCT bone delistionied I is meetar of the highly responsive spinal trabecular bone is indicated for early detection of bone loss.
QCT is useful for measuring bone loss or gain with time for monitoring osteoporsis QCT Is useful for mousaning other collect to increased fracture risk by WHO criteria.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Sypman
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological De
Radiological H
K992246
510(k) Number
OR
Prescription Use (Pcr 21 CFR 801.109) Over-The-Counter Use_
(Optional Format 1-2-96)