(277 days)
K88 4625B, K93 5454
Not Found
No
The summary describes standard bone densitometry software that performs calculations based on acquired data, without mentioning any AI/ML specific terms or methodologies.
No
The device is used to acquire and estimate body composition properties like BMD, Lean Tissue Mass, and Fat Tissue Mass, but it does not treat or prevent any condition.
Yes
The device estimates BMD, Lean Tissue Mass, and Fat Tissue Mass, which are clinical measurements used in diagnosing various health conditions (e.g., osteoporosis, sarcopenia, obesity). Its restriction to prescription use further indicates its medical diagnostic purpose.
No
The device is described as "accessory software option for estimation" and is used "with the EXPERT-XL® bone densitometer system." This indicates it is software that functions in conjunction with a specific hardware device (the bone densitometer), rather than being a standalone software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The description clearly states that the EXPERT-XL® Total Body Acquisition and Analysis Software is used with a bone densitometer system to acquire and estimate measurements directly from the patient's body (Total Body and sub-regions). It does not involve the analysis of blood, urine, tissue samples, or any other specimen taken from the body.
- The input is a bone densitometer. This is an imaging modality that interacts directly with the patient, not a method for analyzing a biological sample.
- The outputs are estimations of BMD, Lean Tissue Mass, and Fat Tissue Mass. These are physical measurements derived from the bone densitometer scan, not the results of analyzing a biological specimen.
The device is a medical device used for diagnostic purposes (estimating body composition), but it falls under the category of in vivo diagnostics, as it interacts directly with the living body.
N/A
Intended Use / Indications for Use
EXPERT-XL® Total Body Acquisition and Analysis Software is used with the EXPERT-XL® bone densitometer system. This software acquires and estimates BMD, Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions.
The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only. The operator's manual for the EXPERT-XL 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 EXPERT-XL Total Body Acquisition and Analysis software requires a 3 minute exposure, with an exposure dose of 3 mrem. This software option is substantially equivalent to the DPX Total Body software and poses no new safety or efficacy concerns.
Product codes
90 KPS
Device Description
The EXPERT-XL Total Body Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD in g/cm), Lean Tissue Mass (g), and Fat Tissue Mass (g) for the Total Body and sub-regions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Total Body and sub-regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Prescription Use Only
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
The Total Body BMD estimations correlate highly (r=0.97) with corresponding regions estimated with the DPX series of products which already has 510(k) clearance. The Lean and Fat Tissue Mass estimations also correlate highly (r=0.95). The average short term precision (%CV) is 0.4% for BMD, 3.1 % for lean tissue mass, and 4.8% for fat tissue mass which is also comparable to that shown on the DPX series.
Key Metrics
%CV: 0.4% for BMD, 3.1 % for lean tissue mass, and 4.8% for fat tissue mass.
Correlation to predicate: BMD r=0.97, Lean and Fat Tissue Mass r=0.95.
Predicate Device(s)
K88 4625B, K93 5454
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
OCT - 3 1997
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(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: | December 20, 1996 |
| Device/Trade Name: | EXPERT-XL Total Body Acquisition and Analysis |
| Software | |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer |
| 21CFR 892.1170 | |
| Predicate Device: | K88 4625B Total Body Software for Lunar DPX Series |
| K93 5454 Tissue Quantitation for DPX Series | |
DESCRIPTION OF THE DEVICE: 9.1
The EXPERT-XL Total Body Acquisition and Analysis Software is an accessory software option for estimation of Bone Mineral Density (BMD in g/cm), Lean Tissue Mass (g), and Fat Tissue Mass (g) for the Total Body and sub-regions.
SUMMARY OF TECHNICAL CHARACTERISTICS 9.2
Scans of the Total Body on the EXPERT-XL densitometer take approximately 3 minutes. The Total Body BMD estimations correlate highly (r=0.97) with corresponding regions estimated with the DPX series of products which already has 510(k) clearance. The Lean and Fat Tissue Mass estimations also correlate highly (r=0.95). The average short term precision (%CV) is 0.4% for BMD, 3.1 % for lean tissue mass, and 4.8% for fat tissue mass which is also comparable to that shown on the DPX series. The radiation exposure of 5 mrem is higher than that for the DPX series densitometers but remains low compared to the maximum permissible dose for the total body.
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CONCLUSION 9.3
The results from the EXPERT-XL Total Body Acquisition and Analysis Software are The results from the EAT ENT ALL Foto Foto similar precision. No new safety and effectiveness Comparable to the DI A results RPPERT-XL Total Body software accessory.
Kunsell Bunk
Signed
Kenneth D. Buroker Name :
Director, Regulatory Affairs .j Title
Summary of Safety, Effectiveness Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a stylized image of three human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 3 1997
Richard B. Mazess, Ph.D. President Lunar Corporation 313 W. Beltine Highway Madison, WI 53713
Re:
Expert-XL Total Body Acquisition and Analysis Software Dated: July 16, 1997 Received: July 17, 1997 Regulatory class: II 21 CFR 892.1170/Procode: 90 KPS
Dear Dr. Mazess:
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 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, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 requirement, as set forth in the Quality 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 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 marked 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 question 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/cdrh/dsmamain.html".
Sincerely yours,
W. Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATION FOR USE FORM 3.0
Page 1 of 1
510(k) Number (if known) K965226
Device Name: EXPERT-XL Total Body Acquisition and Analysis Software
Indications for use:
ట
EXPERT-XL® Total Body Acquisition and Analysis Software is used with the EXPERT-XL® bone densitometer system. This software acquires and estimates BMD, Lean Tissue Mass, and Fat Tissue Mass for the Total Body and sub-regions.
The use of the EXPERT-XL® Total Body Acquisition and Analysis Software is restricted to prescription use only. The operator's manual for the EXPERT-XL 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 EXPERT-XL Total Body Acquisition and Analysis software requires a 3 minute exposure, with an exposure dose of 3 mrem. This software option is substantially equivalent to the DPX Total Body software and 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)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K965226 |
|---|---|
| --------------- | --------- |
OR
Over-the-Counter Use(Optional Format 1-2-96)
CONFIDENTIAL
Prescription Use (Per 21 CRF 801.109)
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