(55 days)
No
The device uses established algorithms (FRAX, SIRI UWE % Fat charts based on NIH and Tanita work) and calculations (BMI) based on inputted data and existing scan results. There is no indication of learning or adaptive capabilities characteristic of AI/ML.
No
The device provides information for healthcare professionals to manage diseases or conditions, but it explicitly states that it "does not diagnose disease or recommend treatment." Therefore, it is not a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states that "This option does not diagnose disease or recommend treatment" for both the Ten-Year Fracture Risk Option and the SIRI Table Option. The "Device Description" states that it provides "additional information to the medical professional as they diagnose and treat bone related and body fat related diseases and conditions," indicating a supportive rather than a primary diagnostic role.
No
The device is described as "software options for the Norland DXA Bone Densitometers," indicating it is an add-on to existing hardware (DXA bone densitometers) and not a standalone software 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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a software option for a DXA bone densitometer. It uses data already acquired by the DXA scan (femoral neck T-Score, SIRI UWE % Fat value) and patient-provided information (clinical risk factors, height, weight) to calculate risk estimations and plot values on charts.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It processes data generated by another medical device (the DXA scanner) and patient input.
- Intended Use: The intended use is to provide additional information to healthcare professionals to assist in managing conditions. It explicitly states that it "does not diagnose disease or recommend treatment."
While the information provided by the software is used in a clinical context to inform healthcare decisions, the device itself does not perform an in vitro diagnostic test. It's a data processing and presentation tool that utilizes results from a diagnostic imaging modality (DXA).
N/A
Intended Use / Indications for Use
The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's len-year risk of a hip fracture and/or a major osteoporodic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.
The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This ontion also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.
Product codes (comma separated list FDA assigned to the subject device)
KGI
Device Description
The Ten-Year Fracture Risk Option and the SIRI Table Option for the Norland DXA Bone Densitometers are software options that use presently provided scan results and related industry standards to provide additional information to the medical professional as they diagnose and treat bone related and body fat related diseases and conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DXA
Anatomical Site
Femoral neck (for fracture risk); Whole body (for body fat)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professional / 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
Previously acquired data from 150 patients was used by the new software to generate their Ten-Year Probability of a hip fracture and of a Major Osteoporotic Fracture. These values were then compared to the values given by the charts on the FRAX website for the same demographics. The results correlated well and a linear regression analysis was carried out on the resulting data.
Previously acquired data from 150 patients was used by the new software to generate their bone exam report, to verify the proper chart was included in the report, and to verify the SIRK UWE % Fatu value was properly plotted on the chart.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
Ten-Year Fracture Risk:
The chart values in the software were compared to the values in the charts on the FRAX website, by a person different from the one who entered the data. The clinical risk factors and the low, woderate, and high significance assigned to them, were verified to be the same as the FRAX publication.
Previously acquired data from 150 patients was used by the new software to generate their Ten-Year Probability of a hip fracture and of a Major Osteoporotic Fracture. These values were then compared to the values given by the charts on the FRAX website for the same demographics. The results correlated well and a linear regression analysis was carried out on the resulting data.
SIRI Table Option:
Previously acquired data from 150 patients was used by the new software to generate their bone exam report, to verify the proper chart was included in the report, and to verify the SIRK UWE % Fatu value was properly plotted on the chart.
Clinical Tests:
Clinical testing was not required for either of these options to establish safety or effectiveness, because they do not cause changes to the scanning or analysis processes. Instead, they just use the values presently generated to produce their results. However, proper operation of both options with real patient data was tested, using sets of clinical data available from Norland customers. See bench testing above. However, no subjects were scanned solely to test these new options.
Test Conclusions:
Testing confirms the performance of the Ten-Year Fracture Risk Option and the SIRI Table Option is consistent with the indications for use; and that these options are substantially equivalent to currently marketed devices with respect to safety and efficacy.
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo for Norland, a CooperSurgical Company. The word "NORLAND" is written in large, bold, black letters. Below the word "NORLAND" is the text "a CooperSurgical Company".
09132 W(6340 Hackbarth Road / Fort Aikinson, W1-53538 (920) 563-9504 / Fax (920) 563-8626
510(k) Summary
prepared in accordance with 21 CFR Part 807.92(c) April 2009
JUN 29 2009
ું જ
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- Name Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers
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- Manufacturer Norland, a CooperSurgical Company W6340 Hackbarth Road Fort Atkinson, WI, 53538 Establishment Registration #2124648
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- Owner Cooper Surgical Inc. 95 Corporate Drive Trumbull, CT, 06611 Establishment Registration #1216677
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- Contact Person Mr. Tom Williams VP RA/Business Assurance
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- Trade Name Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers
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- Common Name Ten-Year Fracture Risk and SIRI Table Options
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- Classification DXA Bone Densitometer, 90 KGI, Class II, Section 892.1170
- Predicate Device Comparison 8.
Ten-Year Fracture Risk Option
K080711, Hologic 10-year Fracture Risk Questionnaire Option.
The Norland Ten-Year Fracture Risk Option is substantially equivalent to the Hologic 10-year Fracture Risk Option. Both use the World Health organization (WHO) Fracture Risk Assessment algorithm (FRAX) to estimate the patient's risk of hip fracture and major osteoporotic fracture. No new safety or efficacy questions are raised.
SIRI Table Option
K071570. GE Lunar Body Composition Software Ontion.
K014009 - Tanita Body Composition Analyzer
The Norland SIRI Table Option for the Norland DXA Bone Densitometers is substantially equivalent to the GE Lunar Body Composition Software Option. Both use DXA technology to determine % Body Fat, and both plot this value against the gender and age matched Body Fat Charts to indicate if the patient is Underfat, Healthy, Overfat, or Obese. Further, both use similar technology and have similar intended uses. The SIRI Table Option is also comparable to the
1
510(k) Summary
prepared in accordance with 21 CFR Part 807 92(c) January 2009
Tanita Body Composition Analyzer because it uses the relationship between % body fat and the classifications (Underfat to Obese), that was developed by Tanita and used in their analyzer. No new safety or efficacy questions are raised.
ರು. Device Description
The Ten-Year Fracture Risk Option and the SIRI Table Option for the Norland DXA Bone Densitometers are software options that use presently provided scan results and related industry standards to provide additional information to the medical professional as they diagnose and treat bone related and body fat related diseases and conditions.
10. Intended Use
The Ten-Year Fracture Risk Option uses the femoral neck T-Score results of the Norland DXA bone densitometer, along with the results of a Clinical Risk Factor questionnaire, to determine the patient's risk of incurring a hip fracture or a major osteoporotic fracture in the next ten years. This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.
The SIRI Table Option uses the SIRI UWE % Fat results of the Norland DXA bone densitometer to classify the patient as Underfat, Healthy, Overfat, or Obese, based on the industry standard Body. Fat Charts developed by Tanita from the work done by D. Galligher. It also calculates the industry standard BMI based on the patient height and weight information entered by the operator. This information is useful to health care professionals as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.
11. Technological Characteristics
These options do not affect the technology of the Norland bone densitometers. No physical changes are required and the scanning and analysis functions are not impacted. They only require software modifications to add their additional features.
12. Non-Clinical Tests
/
Ten-Year Fracture Risk:
The chart values in the software were compared to the values in the charts on the FRAX website, by a person different from the one who entered the data. The clinical risk factors and the low, woderate, and high significance assigned to them, were verified to be the same as the FRAX publication.
Previously acquired data from 150 patients was used by the new software to generate their Ten-Year Probability of a hip fracture and of a Major Osteoporotic Fracture. These values were then compared to the values given by the charts on the FRAX website for the same demographics. The results correlated well and a linear regression analysis was carried out on the resulting data.
SIRI Table Option.
Previously acquired data from 150 patients was used by the new software to generate their bone exam report, to verify the proper chart was included in the report, and to verify the SIRK UWE % Fatu value was properly plotted on the chart.
2
・
510(k) Summary
prepared in accordance with 21 CFR Part 807.92(c) January 2009
13. Clinical Tests
Clinical testing was not required for cither of these options to establish safety or effectiveness. because they do not cause changes to the scanning or analysis processes. Instead, they just use the values presently generated to produce their results.
However, proper operation of both options with real patient data was tested, using sets of clinical data available from Norland customers. See bench testing above. However, no subjects were scanned solely to test these new options.
14. Test Conclusions
Testing confirms the performance of the Ten-Year Fracture Risk Option and the SIRI Table Option is consistent with the indications for use; and that these options are substantially equivalent to currently marketed devices with respect to safety and efficacy.
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- Other Pertinent Information (None)
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three stripes representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 29 2009
Mr. Thomas G. Williams VP RA/Business Assurance CooperSurgical, Inc. 95 Corporate Drive TRUMBULL CT 06611
Re: K091325
Trade/Device Name: Ten-Year Fracture Risk and SIRI Table Option for Norland DXA Bone Densitometer
Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: April 30, 2009 Received: May 5, 2009
Dear Mr. Williams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrls/indr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KC91325
Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Device Name: Densitometers
Indications for Use: .
Ten-Year Fracture Risk Option
The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's len-year risk of a hip fracture and/or a major osteoporodic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.
SIRI Table Option
The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This ontion also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.
Prescription Use YES AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Center for Devices and Radiological Health / CDRH
Hath Pluma
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number