(67 days)
No
The description focuses on comparing BMD results to a pre-defined reference population using standard statistical measures (percentage, T-score). There is no mention of AI or ML algorithms being used for analysis, interpretation, or any other function.
No
The device uses a bone densitometer to compare BMD results to a reference population for diagnostic purposes (assessing bone density like T-scores), not to treat a medical condition.
Yes
The device compares the patient's Bone Mineral Density (BMD) to an average young adult reference population and expresses the results as a percentage or T-score, which are diagnostic indicators for bone health.
No
The device description clearly states that the reference BMD values are "incorporated in this submission," implying they are part of a larger system, the "PIXI™," which is a bone densitometer (a hardware device). The submission describes an additional feature for the PIXI™ system, not a standalone software product.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
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 description clearly states that the device (or rather, the feature being described) is a "reference population" used to compare the Bone Mineral Density (BMD) results obtained from a Bone Densitometer (PIXI™) to a reference value. This comparison is done after the BMD measurement has been taken from the patient's body using the densitometer.
- Input Modality: The input modality is a Bone Densitometer, which is an imaging device that measures bone density in vivo (within the living body), not in vitro (outside the living body).
- Anatomical Site: The measurements are taken on the os calcis and forearm, which are parts of the human body.
The device is a feature or software component that utilizes data obtained from an in vivo diagnostic device (the bone densitometer) to provide a comparative analysis. It does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value.
This additional feature is highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers.
The use of the PIXI™ young adult reference population for os calcis and forearm, 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."
Product codes
KGI
Device Description
The reference BMD values incorporated in this submission, provides the ability to compare the BMD result of the PIXI™, to the value of an average young adult, age 20 - 45 years old, of the the BMD result of the FTAT - , to the vatus of an areased as a percentage of young adult, or as a T-Score, defined as number of standard deviations from the young adult value.
Data were collected on normal white young adult men and women, age 20 to 45 years. This data is summarized as shown in Table A.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
os calcis and forearm
Indicated Patient Age Range
20-45 years old
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
The use of reference values with the PIXI™ bone densitometer is comparable to how reference values are utilized on other commercially available bone densitometers.
Key Metrics
Not Found
Predicate Device(s)
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
313 W. BELTLINE HIGHWAY
MADISON, WI 53713
(608) 274-2663
AUG - 8 1997
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: | May 29, 1997 |
| Device/Trade Name: | PIXITM young adult reference population for os calcis and
forearm. |
| Common Name: | Bone Densitometer |
| Classification Name: | Bone Densitometer
21CFR 892.1170 |
| Predicate Device: | Osteon Osteoanalyzer
510 (k) K891582
Norland pDEXA
510 (k) K931996 |
DESCRIPTION OF DEVICE 10.1
The reference BMD values incorporated in this submission, provides the ability to compare the BMD result of the PIXI™, to the value of an average young adult, age 20 - 45 years old, of the the BMD result of the FTAT - , to the vatus of an areased as a percentage of young adult, or as a T-Score, defined as number of standard deviations from the young adult value.
Data were collected on normal white young adult men and women, age 20 to 45 years. This data is summarized as shown in Table A.
1
| Female | Male | |||||
|---|---|---|---|---|---|---|
| Site | n | Mean | SD | n | Mean | SD |
| Os Calcis | 143 | 0.556 | 0.089 | 107 | 0.682 | 0.106 |
| Forearm | 126 | 0.523 | 0.062 | 91 | 0.623 | 0.085 |
Table A
10.2 CONCLUSION
The use of reference values with the PIXI™ bone densitometer is comparable to how reference values are utilized on other commercially available bone densitometers. This feature can be used by the clinician entirely at his/her discretion. No new safety and effectiveness questions are raised with PIXIM young adult reference population for os calcis and forearm.
Signature
Kenneth D. Buroker Printed Name
Director, Regulatory Affairs Title
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 1997
Kenneth D. Buroker Director, Regulatory Affairs Lunar Corporation 313 W. Beltline Highway Madison, WI 53713
Re: K972053
PIXI™ Young Adult Reference Population for OS Calcis and Forearm Dated: May 29, 1997 Received: June 2, 1997. 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 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 III (Premarket Aproval), 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 (QS) 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 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 yitro 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 (30) 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 your
Lillian Yin, Ph.D.
Lilian 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
Enclosure
3
INDICATION FOR USE FORM 4.0
Page 1 of 1
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501(k) Number (if known) K972053
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PIXI™ young adult reference population for os calcis . Device name: and forearm... .. . . . .
Indications For Use: .
The PIXI™ young adult reference population for os calcis and forearm provides the ability to compare the BMD result of the PIXI™ to the value of an average young adult, age 20-45 years old, of the same sex. The results from this comparison are expressed as a percentage of young adults, or as a T-score, defined as a number of standard deviations from the young adult value.
This additional feature is highly comparable to similar features in the Norland pDEXA as well as the Osteon Osteoanalyzer densitometers.
The use of the PIXI™ young adult reference population for os calcis and forearm, 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."
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 | K972053 |
| Prescription Use | X |
| (Per 21 CRF 801.109) | |
| OR | |
| Over-the-Counter Use | __________ |
| (Optional Format 1-2-96) |