(119 days)
Not Found
No
The description explicitly states the interpretation is based on established World Health Organization (WHO) criteria and general methods, not on learned patterns or algorithms.
No
The device aids the physician in determining the risk of fracture, not in treating or preventing a condition.
Yes
The device is described as aiding the physician in "determining risk of fracture, risk of bone disease, or treatment effectiveness" and interprets bone density test results based on established criteria (WHO). This directly involves identifying or characterizing symptoms or conditions.
No
The device description explicitly states that the fracture risk assessment capability is added to the screens and printouts of Norland bone densitometers, implying it is integrated with existing hardware. It also interprets results from bone density tests performed by these densitometers, which are hardware devices.
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: This device uses data from an X-ray bone densitometer to estimate bone density and assess fracture risk. It does not analyze biological samples taken from the patient.
- Input Modality: The input is from an X-ray bone densitometer, which is an imaging modality, not a method for analyzing biological samples.
The device processes data obtained from a medical imaging procedure (bone densitometry) to provide information to a physician. This falls under the category of medical devices that aid in diagnosis or treatment planning, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.
Product codes (comma separated list FDA assigned to the subject device)
90KGI
Device Description
This fracture risk assessment capability provides information that aids the physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria 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 with T-Scores below -2.5 are considered to be osteoporotic and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports.
This fracture risk capability does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts. In particular, it does not increase the scanning time, patient dose, or scatter radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Bone Densitometers
Anatomical Site
Not Found
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 (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.
Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104), Norland-Cameron Model 178 Bone Mineral Analyzer (pre-amendment device)
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
February 1998
Fracture Risk Assessment 510(k) - Supplement 1
JUN 12 1998
510k Summary
as required by 807.92(c) for
Fracture Risk Assessment Capability
for Norland X-Ray Bone Densitometers
Prepared February 1998
Norland Medical Systems, Inc. Submitted by: W6340 Hackbarth Road Fort Atkinson, WI 53538 Reg. # 2124648 Contact Person: Mr. Terry Schwalenberg Director Regulatory Affairs 920-563-8456 x229 Fracture Risk Assessment Capability for Norland X-Ray Bone Device Trade Name: Densitometers Common Name: Fracture risk assessment for bone densitometers Classification: Bone densitometer. (21 CFR 892.1170), product code 90KGI: Class II Fracture Risk Assessment for pDEXATM Bone Densitometer (K973104) Predicate Devices: Norland Medical Systems, Inc., Fort Atkinson, WI Fracture Risk Assessment for the Norland-Cameron Model 178 Bone Mineral Analyzer, which is a pre-amendment device. Description of This fracture risk assessment capability provides information that aids the Device: physician in determining risk of fracture, risk of bone disease, or treatment effectiveness. This fracture risk assessment capability interprets the results of the bone density tests performed by Norland bone densitometers in accordance with methods in general use in the medical community. In general they use the bone densitometer values (usually BMD and T-Score) and patient information (usually gender, age, and ethnic background). The interpretation is based on the World Health Organization's (WHO) criteria relating bone density to risk of fracture and diagnosis of osteoporosis. In general, the WHO criteria 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 with T-Scores below -2.5 are considered to be osteoporotic
1
and have a high risk of fracture. This information is presented graphically and as verbiage on the screens and reports.
This fracture risk capability does not require any modifications to the Norland bone densitometers besides adding the fracture risk information to the screens and printouts. In particular, it does not increase the scanning time, patient dose, or scatter radiation.
This Norland Fracture Risk Assessment Capability is comparable to Safety and Effectiveness: fracture risk assessment capabilities in use with other bone densitometers in the industry. No new safety or effectiveness issues are raised.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope.
JUN | 7 1998
Terry Schwalenberg Director Regulatory Affairs Norland Systems, Inc. W6340 Hackbarth Road Fort Atkinson, WI 53538
Re:
Fracture risk capabililty for the Norland Bone Densitometer: Models XR Series, pDEXA Series, Apollo Series, XCT Series and SXA Series 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 III (Premarket Aporoval), 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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/dsma/dsmamain.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
INDICATIONS FOR USE STATEMENT
510(K) Number (if known):
Device Name: Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers.
Indications For Use:
The bone density estimates from Norland X-Ray Bone Densitometers can be used as an aid to the physician in determining risk of fracture.
(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)
David A. Byrom
Page 1-4
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number