(62 days)
Norland-Cameron Model 178 Bone Mineral Analyzer
Not Found
No
The description explicitly states the assessment is based on the patient's T-score value using pre-defined WHO categories, which is a rule-based approach, not AI/ML. There are no mentions of AI, ML, training data, or performance studies indicative of AI/ML.
No
The device aids in assessment and diagnosis by providing fracture risk assessment based on bone mineral density, but it does not treat or cure any condition.
Yes
The device is described as aiding the physician in assessing fracture risk from bone density examination results and uses the patient's T-score to provide an assessment of relative fracture risk, which falls under the definition of a diagnostic device as it helps identify a health condition or risk.
No
The device is described as a "software accessory" to a bone densitometer system (LUNAR DPX Series), which is a hardware device. While the Fracture Risk option itself is software, its function is directly tied to and dependent on the output of the hardware bone densitometer. It does not operate as a standalone software 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: This device is a software option for a bone densitometer. It uses the results of a bone density scan (a measurement taken in vivo on the patient's body) to assess fracture risk. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's used with a bone densitometer system to assess fracture risk based on T-score values. This is an assessment based on a physical measurement, not a laboratory test on a biological sample.
Therefore, while it's a medical device used in diagnosis and risk assessment, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Fracture Risk option is used with the LUNAR DPX Series of bone densitometer systems. 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 DPX Series is restricted to prescription use only. The operator's manual for the DPX 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 DPX Series poses no new safety or efficacy concerns.
Product codes (comma separated list FDA assigned to the subject device)
90 KGI
Device Description
The Fracture Risk Option for DPX Series Bone Densitometers provides fracture risk assessment based on patient's bone mineral density T-score.
The Fracture Risk option for DPX Series is a software accessory to aid the physician in assessing fracture risk from the results of a DPX Series 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.
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
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 (pre amendment)
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.
0
Image /page/0/Picture/1 description: The image shows the word "LUNAR" in bold, black letters. The font is sans-serif and appears to be a blocky, slightly rounded style. The letters are closely spaced, creating a solid visual impact.
MADISON, WI 53713 313 W. BELTLINE HIGHWAY
(608) 274-2663
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
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 DPX Series Bone Densitometers |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | Norland-Cameron Model 178 Bone Mineral Analyzer (pre amendment) |
DESCRIPTION OF THE DEVICE: 9.1
The Fracture Risk Option for DPX Series Bone Densitometers provides fracture risk assessment based on patient's bone mineral density T-score.
9.2 SUMMARY OF TECHNICAL CHARACTERISTICS
The Fracture Risk option for DPX Series is a software accessory to aid the physician in assessing fracture risk from the results of a DPX Series 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.
1
9.3 CONCLUSION
The Fracture Risk option for the DPX series bone densitometers 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 DPX Series bone densitometers.
Signed
Kenneth D. Buroker Name
Director, Regulatory Affairs Title
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central design.
Re:
Public Health Service
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
Fracture Risk Assessment Option for DPX Series 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 provisious 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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, 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,
William Yip
Lillian Yin, Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE FORM 3.0
- 510(k) Number (if known) _ 1983271 .
- Device Name: Fracture Risk option for DPX Series Bone Densitometers .
- . Indications for use:
The Fracture Risk option is used with the LUNAR DPX Series of bone densitometer systems. 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 DPX Series is restricted to prescription use only. The operator's manual for the DPX 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 DPX Series 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
(Optional Format 1-2-96)
Urnid A. Seppman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D
510(k) Number K983271