(137 days)
Not Found
No
The description focuses on standard SXA technology and calculations (BMC, Area, BMD, T-Score, Z-Score) based on WHO criteria, with no mention of AI or ML algorithms for image processing, data analysis, or risk assessment beyond these established methods.
No.
The device is described as an aid to physicians in determining fracture risk and providing bone density assessments, not for treating or rehabilitating a condition.
Yes
The device aids physicians in determining fracture risk and disease diagnosis by providing bone density estimates and T-Scores for assessing conditions like low bone mass and osteoporosis.
No
The device description explicitly states it is an "X-Ray Bone Densitometer" and uses "SXA pencil beam technology" to scan the heel, indicating it is a hardware device that performs physical measurements.
Based on the provided information, the Norland OsteoAnalyzerTM Model SXA 3000TM X-Ray Bone Densitometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SXA 3000TM directly scans the patient's heel using X-rays. It does not analyze blood, urine, tissue samples, or any other specimen taken from the body.
- The device's function is to measure bone density in vivo (within the living body). This is a form of medical imaging and measurement, not laboratory testing of a specimen.
- The intended use describes aiding physicians in determining fracture risk based on in vivo measurements. This aligns with the function of a medical imaging or measurement device, not an IVD.
Therefore, the SXA 3000TM is a medical device used for in vivo bone density assessment, not an IVD.
N/A
Intended Use / Indications for Use
The bone density estimates from the SXA 3000TM can be used as an aid to physicians in determining fracture risk, based on their comparison to estimates for people without bone related disease, who have the same gender and ethnic background as the patient.
Product codes (comma separated list FDA assigned to the subject device)
90KGI
Device Description
The Norland OsteoAnalyzerTM Model SXA 3000TM X-Ray Bone Densitometer (SXA 3000TM) can be used whenever it is desirable to do a bone assessment of the os calcis (heel). Bone assessments are of interest in many medical disciplines such as nephrology, endocrinology, rheumatology, gynecology, etc. The SXA 3000TM scans the heel using the industry standard SXA pencil beam technology and provides BMC, Area, BMD, T-Score, and Z-Score values. A scan takes about three minutes and the patient dose is less than 1.5 mRem.
The SXA 3000TM provides fracture risk assessment based on the World Health Organization (WHO) criteria for relating the bone density test to fracture risk assessment and disease diagnosis. In general, this assessment states that patients with T-Scores from +1 to -1 are considered to be normal; T-Scores from -1 to -2.5 are considered to have low bone mass and an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic with a high risk of fracture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
os calcis (heel)
Indicated Patient Age Range
Not Found
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
FAX 9205638626 14:51 ~02/24/98
NORLAND ADMIN.
Image /page/0/Picture/2 description: The image shows a series of characters that appear to be handwritten. The characters include the letter 'K', the number '9', the letter 'f', the letter 'o', the number '2', and the number '8'. The characters are written in a dark color, possibly black ink, against a light background. The handwriting style is somewhat rough, with varying stroke thicknesses.
February 1998
Fracture Risk Capability for SXA 3000704 - Supplement 1
JUN 1 2 1998
: 上一篇:
510k Summary as required by 807.92(c) for Fracture Risk Assessment Capability for the Norland SXA 3000TM Bone Densitometer
Prepared February 1998
| Submitted by: | Norland Corporation
W6340 Hackbarth Road
Fort Atkinson, WI 53538
Reg. # 2124648
Tel: 920-563-8456
Fax: 920-563-8626 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Terry Schwalenberg
Director Regulatory Affairs
920-563-8456 x229 |
| Device Trade Name: | Fracture Risk Assessment Capability
for the Norland SXA 3000TM Bone Densitometer |
| Common Name: | Fracture Risk Assessment for a single energy x-ray (SXA) bone
densitometer |
| Classification: | Bone Densitometer, (21 CFR 892.1170), product code 90KGI; Class II |
| Predicate Devices: | Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104)
Norland Medical Systems, Inc., Fort Atkinson, WI |
| Description of
Device: | The Norland OsteoAnalyzerTM Model SXA 3000TM X-Ray Bone
Densitometer (SXA 3000TM) can be used whenever it is desirable to do a
bone assessment of the os calcis (heel). Bone assessments are of interest in
many medical disciplines such as nephrology, endocrinology,
rheumatology, gynecology, etc. The SXA 3000TM scans the heel using the
industry standard SXA pencil beam technology and provides BMC, Area,
BMD, T-Score, and Z-Score values. A scan takes about three minutes and
the patient dose is less than 1.5 mRem. |
| | The SXA 3000TM provides fracture risk assessment based on the World
Health Organization (WHO) criteria for relating the bone density test to
fracture risk assessment and disease diagnosis. In general, this assessment
states that patients with T-Scores from +1 to -1 are considered to be |
1
BURL AT THE MONE
normal; T-Scores from -1 to -2.5 are considered to have low bone mass and an increased risk of fracture; and T-Scores below -2.5 are considered to be osteoporotic with a high risk of fracture.
Safety and Effectiveness: This Fracture Risk Assessment Capability for the SXA 3000™ is comparable to fracture risk assessment capabilities in use with other boms 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 consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN | 2 1998
Terry Schwalenberg Director Regulatory Affairs Norland Systems, Inc. W6340 Hackbarth Road Fort Atkinson, WI 53538
Re:
· Fracture risk capabililty for the Norland SXA 3000 Bone Densitometer Dated: April 16, 1998 Received: April 20, 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 Federal 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 (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 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 vitro 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/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
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
Enclosure
3
Fracture Risk Capability for SXA 3000TM - Supplement 1
INDICATIONS FOR USE STATEMENT
510(K) Number (if known): K980289
Device Name: Fracture Risk Assessment capability for the Norland SXA 3000™ Bone Densitometer
Indications For Use:
The bone density estimates from the SXA 3000™ can be used as an aid to physicians in determining fracture risk, based on their comparison to estimates for people without bone related disease, who have the same gender and ethnic background as the patient.
(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 Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devi
510(k) Number