(62 days)
Norland-Cameron Model 178 Bone Mineral Analyzer
Not Found
No
The description focuses on using a T-score and WHO categories for risk assessment, which is a standard, non-AI/ML approach. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML models.
No
This device is a software feature that assesses fracture risk based on bone mineral density T-scores and does not actively treat or mitigate a disease or condition. It provides information for diagnosis, not therapy.
Yes
The device is described as providing "assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO)" and "fracture risk assessment based on the patient's bone mineral density T-score," which are diagnostic assessments for a medical condition. It also states "the diagnosis of osteoporosis."
No
The device is described as a "software feature" for a bone densitometer system (LUNAR PIXI), indicating it is an add-on to existing hardware, not 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 such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a software option used with a bone densitometer system. It assesses fracture risk based on the patient's T-score, which is derived from a bone density examination. This is a measurement taken directly from the patient's body using a medical imaging technique (bone densitometry), not a test performed on a sample taken from the body.
- Input: The input is a bone density examination, not a biological sample.
Therefore, this device falls under the category of a medical device used for diagnosis or assessment based on imaging/measurement, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Fracture Risk option is used with the LUNAR PIXI bone densitometer system. This option provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.
The use of the Fracture Risk option for PIXI is restricted to prescription use only. The operator's manual for the PIXI system contains the following statement:
"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
The Fracture Risk option for PIXI poses no new safety or efficacy concerns.
Product codes (comma separated list FDA assigned to the subject device)
KGI
Device Description
The Fracture Risk option for EXPERT-XL is a new software feature, providing fracture risk assessment based on the patient's bone mineral density T-score.
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
Physician / 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): 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.
Norland-Cameron Model 178 Bone Mineral Analyzer
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
§ 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.
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NOV 1 8 1998
Image /page/0/Picture/1 description: The image shows the word "LUNAR" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is horizontally oriented and appears to be a logo or brand name.
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(608) 274-2663
9.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Contact Person: | Kenneth D. Buroker
LUNAR Corporation
313 West Beltline Highway
Madison, WI 53713 |
|----------------------|-------------------------------------------------------------------------------------------|
| Phone: | (608) 288-6460 |
| Fax: | (608) 274-0853 |
| Date: | September 15, 1998 |
| Device/Trade Name: | Fracture Risk option for EXPERT-XL Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
Predicate Device: Norland-Cameron Model 178 Bone Mineral Analyzer (preamendment)
DESCRIPTION OF THE DEVICE: 9.1
The Fracture Risk option for EXPERT-XL is a new software feature, providing fracture risk assessment based on the patient's bone mineral density T-score.
SUMMARY OF TECHNICAL CHARACTERISTICS 9.2
The Fracture Risk option for EXPERT-XL is a software accessory to aid the physician in assessing fracture risk from the results of an EXPERT-XL bone density examination. The Fracture Risk Assessment Feature does not cause any changes to the scan parameters used in the examination, and it does not affect the results produced.
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9.3 CONCLUSION
The Fracture Risk option for EXPERT-XL is substantially equivalent to the Norland-Cameron Model 178 Bone Mineral Analyzer, a pre-amendment device that was used to aid the physician in determining fracture risk. No new safety and effectiveness questions are raised with the Fracture Risk option for the EXPERT-XL bone densitometer.
Signed
Kenneth D. Buroker and the comments of the comments of the country of the country of the country of the country of the country of the country of the country of the country of the country of the Name
Director, Regulatory Affairs ........... Title
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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, serif font. The text is centered in the image. The words are stacked on top of each other.
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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1998
Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 West Beltline Highway Madison, WI 53713
Re: K983262
Fracture Risk Assessment Option for PIXI Bone Densitometer Dated: September 15, 1998 Received: September 17, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Mr. Buroker:
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 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 ecuivaliance compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) 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 classfilication 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 vitto 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 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/cdr/dsmardsmamain.html".
Sincerely yours,
Lillian Yin, 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
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INDICATION FOR USE FORM 3.0
Page 1 of 1
- (983262 510(k) Number (if known) .
- Device Name: Fracture Risk option for PIXI Bone Densitometer .
- Indications for use: .
The Fracture Risk option is used with the LUNAR PIXI bone densitometer system. This option provides an assessment of relative fracture risk based on the patient's T-score value using the categories of fracture risk defined by the World Health Organization (WHO). Physician and patient information is provided to indicate that although bone density is the single most important factor in the assessment of fracture risk and the diagnosis of osteoporosis, the physician should also consider other factors.
The use of the Fracture Risk option for PIXI is restricted to prescription use only. The operator's manual for the PIXI system contains the following statement:
"United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
The Fracture Risk option for PIXI poses no new safety or efficacy concerns.
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
David G. Laymon
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K983262
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