(140 days)
Not Found
No
The description focuses on calculating standard statistical scores (T-scores and Z-scores) based on a reference dataset, which is a traditional statistical method, not AI/ML. There are no mentions of AI, ML, deep learning, or training/test sets.
No
The device provides a context for clinical interpretation of BMD estimates, calculates scores, and is an accessory to a bone mineral densitometer. It does not directly treat or diagnose a disease.
No
The device is an accessory that provides reference data for calculating T-scores and Z-scores based on existing BMD estimates. It aids in the interpretation of data but does not directly diagnose a condition or initiate a new diagnostic process. The physician's discretion is highlighted for interpreting the parameters, implying the device provides supportive information rather than a definitive diagnosis.
No
The device is described as an "accessory" to a "Bone Mineral Densitometer," which is a hardware device. While the accessory itself might be software, its function is directly tied to and dependent on the hardware device. The description does not indicate it is a standalone software product.
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 description clearly states that this device is an "accessory to the CTXA Hip Bone Mineral Densitometer." It uses reference data to calculate T-scores and Z-scores based on BMD estimates obtained from the densitometer.
- No Sample Analysis: There is no mention of analyzing any biological samples from the patient. The device operates on data derived from a medical imaging procedure (bone mineral densitometry).
- Clinical Interpretation Context: Its intended use is to provide "a context for the clinical interpretation of a patient's proximal femur BMD estimates," which is a post-imaging analysis and comparison to reference data, not a diagnostic test performed on a biological sample.
Therefore, this device falls under the category of a medical device used for analysis and interpretation of imaging data, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the CTXA Hip Extence Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician.
The intended use of the CTXA Hip Extence Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. T-scores are calculated relative to a US normal female Caucasian reference population age 20-39 years, and Z-scores are calculated relative to a US normal female Caucasian reference population age 20-79 years. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician.
Product codes (comma separated list FDA assigned to the subject device)
90 KGI
Device Description
The CTXA Hip Extenced Reference Data is an accessory to the CTXA Hip Bone Mineral Densitometer. The CTXA Hip Extended Reference Data is used within the CTXA Hip module to calculate T-scores and percent young normal for any patient, and Z-scores for patients age 20-80 for BMD estimates made using the CTXA Hip module.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
Indicated Patient Age Range
T-scores are calculated relative to a US normal female Caucasian reference population age 20-39 years, and Z-scores are calculated relative to a US normal female Caucasian reference population age 20-79 years.
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
BMD estimates obtained with CTXA Hip with Extended Reference Data accessory are identical to BMD estimates obtained with the predicate CTXA Hip. T-scores calculated with CTXA Hip with Extended Reference Data accessory are slightly less negative than those calculated with CTXA Hip, approximately 0.1-0.2 Tscore units. This difference is not significant clinically.
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
KO3O33O
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
| Contact Information: | Christopher E. Cann, Ph.D.
CEO and Director of Research and Development
Mindways Software, Inc
282 Second St., 4th Floor
San Francisco, CA 94105
Phone: 415-247-9932
Fax: 415-247-9931
Email: chris@gct.com |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | January 30, 2003 |
| Device/Trade Name: | CTXA Hip Extended Reference Data |
| Common/Usual Name: | Bone Mineral Densitometer |
| Classification Name: | Bone Densitometer, 21 CFR 892.1170, Class II |
| | Predicate Devices: |
K002113: CTXA Hip Bone Mineral Densitometer
Device Description
The CTXA Hip Extenced Reference Data is an accessory to the CTXA Hip Bone Mineral Densitometer. The CTXA Hip Extended Reference Data is used within the CTXA Hip module to calculate T-scores and percent young normal for any patient, and Z-scores for patients age 20-80 for BMD estimates made using the CTXA Hip module.
Intended Use
The intended use of the CTXA Hip Extence Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician.
Summary of Technological Characteristics and Comparison with Predicate Devices
The predicate K002113 CTXA Hip Bone Mineral Densitometer Module (CTXA Hip) provides estimates of bone mineral content (BMC) and bone mineral density (BMD) values similar to those obtained from DXA devices. These BMD estimates from the predicate device are compared to a reference database of age 20-39 US Caucasian females to calculate T-scores and percent young normal for patient BMD estimates and Z-scores for patient BMD estimates for ages 20-39. The current CTXA Hip Extence Data is an accessory to CTXA Hip that also is used to calculate T-scores and percent young normal, and also is used to calculate Z-scores for ages 20-80. The CTXA Hip BMD estimates referenced to the CTXA Hip Extence Data reference population are used as an aid to the physician in identifying patients with low bone mineral density and as an aid in determining a patient's fracture risk.
1
Summary of Clinical Performance Data
BMD estimates obtained with CTXA Hip with Extended Reference Data accessory are identical to BMD estimates obtained with the predicate CTXA Hip. T-scores calculated with CTXA Hip with Extended Reference Data accessory are slightly less negative than those calculated with CTXA Hip, approximately 0.1-0.2 Tscore units. This difference is not significant clinically.
Conclusions
The CTXA Hip Extended Reference Data is substantially equivalent to the listed predicate device. The clinical interpretation of BMD estimates made with CTXA Hip Extence Data is comparable to that associated with the predicate device.
Cth Rm
Signature
Christopher Cann Printed Name
CEO and Director of Research and Development Title
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Christopher E. Cann, Ph.D. CEO and Director of Research Mindways Software, Inc. 282 Second Street, Fourth Floor SAN FRANCISO CA 94105
Re: K030330
JUN 2 0 2003
Trade/Device Name: CTXA Hip Extended Reference Data Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: 90 KGI Dated: May 16, 2003 Received: May 19, 2003
Dear Dr. Cann:
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. Drug. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Page
510(k) NUMBER (IF FINNI.)
CTXA HIP EXTENDED REFERENCE DATA DEVICE NAME :
INDICATIONS FOR USE:
The intended use of the CTXA Hip Extence Data accessory for the CTXA Hip Bone Mineral Densitometry module is to provide a context for the clinical interpretation of a patient's proximal femur BMD estimates. T-scores are calculated relative to a US normal female Caucasian reference population age 20-39 years, and Z-scores are calculated relative to a US normal female Caucasian reference population age 20-79 years. The use of a reference data set and the interpretation of parameters derived by the CTXA Hip module when comparing patient-specific BMD estimates to the installed and selected reference data set is at the discretion of the physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
David h. Lyman