(126 days)
Not Found
No
The description focuses on standard DXA technology, comparison to pre-defined reference sets, and calculation of T-scores and fracture risk based on established WHO criteria. There is no mention of AI or ML algorithms being used for image processing, data analysis, or risk assessment.
No
The device aids in diagnosis and risk assessment of osteoporosis and fractures, it does not provide treatment or therapy.
Yes
The device aids physicians in diagnosing and managing osteoporosis, and in determining fracture risk, which are diagnostic activities.
No
The device description explicitly states that the Norland Apollo™ Bone Densitometer (Apollo™) "scans the os calcis (heel) using the industry standard DXA pencil beam technology". This indicates the device includes hardware components (the scanner and DXA technology) in addition to any software used for data processing and analysis.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Apollo™ Function: The Apollo™ Bone Densitometer uses dual energy x-ray (DXA) to scan the os calcis (heel) directly on the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to estimate bone density and aid physicians in diagnosing and managing osteoporosis and determining fracture risk based on these direct measurements.
Therefore, the Apollo™ is a medical device that performs a diagnostic function in vivo (on the living body), not in vitro (in a test tube or other artificial environment).
N/A
Intended Use / Indications for Use
The bone density estimates from the Apollo. can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo. can be used as an aid to physicians in determining fracture risk.
Product codes (comma separated list FDA assigned to the subject device)
90KGI
Device Description
The Norland Apollo. Bone Densitometer (Apollo.) scans the os calcis (heel) using the industry standard DXA pencil beam technology to assess bone density. A water bath is not required and the scan takes less than 30 seconds. Patient dose is less than 0.5 mRem and scatter radiation is less than 0.1 mRem/hour at 3 feet.
Two reference sets are provided, one for female Caucasians and one for male Caucasians. These reference data sets allow comparison of Apollo. BMD scan results to healthy young adults aged 20 to 42. The results of the comparison is given in terms of T-Score (the number of standard deviations from the healthy young adult value), % Young Reference (the percentage relative to the healthy young adult value), and in graphical form.
The Apollo. Reference Population capability also includes Fracture Risk assessment based on the World Health Organization (WHO) criteria. In general, this means that patients with T- Scores from +1 to -1 are considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Bone
DXA pencil beam technology
Anatomical Site
os calcis (heel)
Indicated Patient Age Range
The bone density estimates from the Apollo. can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis.
healthy young adults aged 20 to 42.
Intended User / Care Setting
physicians
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.
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
MAY 2 0 1998
. .
510k Summary as required by 807.92(c) for Reference Population Capability for the Norland Apollo™ Bone Densitometer
Prepared April 1998
| Submitted by: | Norland Medical Systems
W6340 Hackbarth Road
Fort Atkinson, WI 53538
Reg. # 2124648
920-563-8456 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Terry Schwalenberg
Director Regulatory Affairs |
| Device Trade Name: | Reference Population for young normal Caucasian men and women for the
Norland Apollo™ X-Ray Bone Densitometer |
| Common Name: | Reference Population for dual energy x-ray (DXA) bone densitometer |
| Classification: | Bone densitometer, (21 CFR 892.1170), product code 90KGI; Class II |
| Predicate Devices: | Reference Population for pDEXA™ Bone Densitometer (K931996)
Norland Corporation, Fort Atkinson, WI |
| | Fracture Risk Assessment for pDEXA™ Bone Densitometer (K973104)
Norland Medical Systems, Inc., Fort Atkinson, WI |
| Description of
Device: | The Norland Apollo™ Bone Densitometer (Apollo™) scans the os calcis
(heel) using the industry standard DXA pencil beam technology to assess
bone density. A water bath is not required and the scan takes less than 30
seconds. Patient dose is less than 0.5 mRem and scatter radiation is less
than 0.1 mRem/hour at 3 feet. |
| | Two reference sets are provided, one for female Caucasians and one for
male Caucasians. These reference data sets allow comparison of Apollo™
BMD scan results to healthy young adults aged 20 to 42. The results of the
comparison is given in terms of T-Score (the number of standard
deviations from the healthy young adult value), % Young Reference (the
percentage relative to the healthy young adult value), and in graphical
form. |
| | The Apollo™ Reference Population capability also includes Fracture Risk
assessment based on the World Health Organization (WHO) criteria. In
general, this means that patients with T- Scores from +1 to -1 are |
1
considered to be normal; with T-Scores from -1 to -2.5 are considered to have low bone mass and have an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture.
Other reference data sets will be available in the future.
Safety and Effectiveness: The Reference Population capability for the Apollo™ is comparable to reference population capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised with this capability.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing snakes or streams.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Terry Schwalenberg Director Regulatory Affairs Norland Medical Systems, Inc. W6340 Hackbarth Road Fort Atkinson, WI 53538
Re:
K980125 Norland Apollo™ X-Ray Bone Densitometer Dated: April 15, 1998 Received: April 17, 1998 Regulatory class: II 21 CFR 892.1170/Procode: 90 KGI
Dear Mr. Schwalenberg:
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 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 II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral 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 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 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 vito 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/cdrh/dsmaldsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
15 April 98
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K980125
Device Name: Reference Population and Fracture Risk capability for the Norland Apollo TM Bone Densitometer
Indications For Use:
The bone density estimates from the Apollo™ can be compared to estimates of young normal Caucasian men and women, and as an aid to physicians in diagnosing and managing osteoporosis. The bone density estimates from the Apollo™ can be used as an aid to physicians in determining fracture risk.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / OR Over-The-Counter-Use__
(Per 21 CFR 810.109)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devj
510(k) Number