(169 days)
K89021
K89021
No
The device description focuses on updated reference values for bone mineral density (BMD) measurements and does not mention any AI or ML components.
No
The device provides reference values for BMD measurements, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as providing "expanded reference BMD values" and is compared to a predicate device that is a "Bone Densitometer." Bone densitometry is a diagnostic imaging technique used to measure bone mineral density, typically to diagnose osteoporosis. Therefore, this device, by providing BMD values and being related to a bone densitometer, serves a diagnostic purpose.
No
The device description focuses on reference values for BMD measurements and their inclusion in an Operator's Manual. It does not describe a software application or program that performs a medical function. The predicate device is a bone densitometer, which is a hardware 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 to detect diseases or other conditions.
- Device Description: The description clearly states that the device provides "expanded reference BMD values" for "BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites." This indicates the device is used to measure bone mineral density directly on the patient's body, not on a sample taken from the body.
- Anatomical Site: The listed anatomical sites are all locations on the human body where bone density is measured directly.
- Input Imaging Modality: While not explicitly stated, bone densitometry typically involves imaging techniques like DXA (Dual-energy X-ray Absorptiometry), which are applied to the patient's body.
- No mention of samples: There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
Therefore, this device is a bone densitometer, which is a medical device used for in-vivo measurement of bone density, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
892.1170
Device Description
The expanded reference BMD values described in the present submission include both male and female data from white adults in the U.S. and northern Europe. These new reference values are for BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites. Male data for lateral spine BMD measurements are not available. The Operator's Manual contains tabulated summaries of these updated reference values and citations to published sources of these materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft
Indicated Patient Age Range
adults
Intended User / Care Setting
clinician
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)
K89021 Modified DPX Bone Densitometer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 1 6 1997
Image /page/0/Picture/2 description: The image shows the word "LUNAR" in bold, black letters. The font is sans-serif and appears to be slightly slanted. The word is presented in a straightforward, simple design.
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: | October 28, 1996 |
| Device/Trade Name: | Expanded Reference Values for |
| DPX Series Bone Densitometer | |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer |
| 21CFR 892.1170 | |
| Predicate Device: | K89021 Modified DPX Bone Densitometer |
DESCRIPTION OF THE DEVICE: 9.1
The expanded reference BMD values described in the present submission include both male and female data from white adults in the U.S. and northern Europe. These new reference values are for BMD measurements taken at the AP Spine, Lateral Spine, Proximal Femur, Total Body and Radius Shaft sites. Male data for lateral spine BMD measurements are not available. The Operator's Manual contains tabulated summaries of these updated reference values and citations to published sources of these materials.
7
1
CONCLUSION 9.3
The expanded reference BMD values incorporated in this submission merely add to the reference value data already established and provided with the DPX series bone densitometers. These data can be used for comparative purposes by the clinician entirely at hisher discretion. No new safety and effectiveness questions are raised with the inclusion of these expanded reference values.
and of the Signed
Kenneth D. Buroker ....... Printed Name
Director, Regulatory Affairs Title