(50 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description and performance studies focus on standard bone densitometry measurements and comparisons to predicate devices.
No
The device is used to estimate Bone Mineral Density (BMD) for diagnostic purposes, not to treat or cure a disease or condition.
Yes
The device "provides an estimate of BMD," which is then "compared to a reference population" to assess bone health, indicating its role in identifying or characterizing a condition.
No
The device is described as a "Bone Densitometer," which is a type of hardware device used to measure bone density. The description and performance studies refer to in vitro and in vivo measurements, which are characteristic of a physical device interacting with a patient. There is no mention of the device being solely software.
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 DPX-RX Bone Densitometer measures bone mineral density directly on the patient's body (in vivo) using a non-invasive method. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as providing an estimate of BMD at specific anatomical sites on the patient.
Therefore, the DPX-RX Bone Densitometer falls under the category of a medical device used for diagnostic purposes, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DPX-RX Bone Densitometer provides an estimate of BMD at the lumbar Spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
The use of the DPX-RX Bone Densitometer is restricted to prescription use only. The operator's manual for the DPX-RX 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."
Product codes
90 KGI
Device Description
The DPX-RX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) of the lumbar spine and the proximal femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine and the proximal femur
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
The BMD estimations in vivo provided by the DPX-RX correlate r>0.98 with the DPX-L. The average BMD values obtained in 50 subjects in vivo were very similar with DPX-L and DPX-RX. The average short-term precision (%CV) in vitro was
§ 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/3 description: The image contains a handwritten string of alphanumeric characters. The string appears to be "K982267". The characters are written in a cursive style, with varying stroke thicknesses. The image is in black and white.
313 W. BELTLINE HIGHWAY MADISON, WI 53713
AUG 25 1998
(608) 274-2663
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 10.0
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: | June 18, 1998 |
| Device/Trade Name: | DPX-RX Bone Densitometer |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | LUNAR DPX-Alpha and DPX-L
510(k) Accession Number K904980
LUNAR EXPERT
510(k) K945526 |
10.1 DESCRIPTION OF THE DEVICE:
The DPX-RX Bone Densitometer provides an estimation of Bone Mineral Density (BMD in g/cm2) of the lumbar spine and the proximal femur.
SUMMARY OF TECHNICAL CHARACTERISTICS 10.2
The DPX-RX Bone Densitometer performs a 30-second scan, with a total skin exposure dose of 2.5 mrem per measurement. The radiation exposure of 2.5 mrem is comparable to the predicate DPX-L, and is ten times lower than predicate fanbeam densitometers such as the EXPERT.
The BMD estimations in vivo provided by the DPX-RX correlate r>0.98 with the DPX-L. The average BMD values obtained in 50 subjects in vivo were very similar with DPX-L and DPX-RX. The average short-term precision (%CV) in vitro was "United States Federal Law restricts this device to the sale, distribution, and use by or on the order of a physician."
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David la heppner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K982267
Prescription Use
(Per 21 CRF 801.109)
್ಕೆ.
OR
Over-the-Counter Use (Optional Format 1-2-96)
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