CTXA HIP EXTENDED REFERENCE DATA

K030330 · Mindways Software, Inc. · KGI · Jun 20, 2003 · Radiology

Device Facts

• Record ID: K030330
• Device Name: CTXA HIP EXTENDED REFERENCE DATA
• Applicant: Mindways Software, Inc.
• Product Code: KGI · Radiology
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Software as a Medical Device

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. 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.

Device Story

CTXA Hip Extended Reference Data is a software accessory for the CTXA Hip Bone Mineral Densitometer. It functions by applying an expanded reference database to existing BMD estimates generated by the CTXA Hip module. The device transforms patient-specific BMD inputs into comparative T-scores and Z-scores. Used in clinical settings by physicians to interpret bone density data; the output serves as an aid in identifying patients with low bone mineral density and determining fracture risk. The device does not alter the underlying BMD measurement process but provides a broader normative context for clinical decision-making.

Clinical Evidence

Bench testing only. Comparison of BMD estimates and T-scores between the subject device and the predicate CTXA Hip module. Results showed identical BMD estimates and a non-significant difference of 0.1-0.2 T-score units.

Technological Characteristics

Software accessory for CTXA Hip Bone Mineral Densitometer. Operates as a reference database module for calculating T-scores and Z-scores from BMD estimates. No hardware components; software-based calculation.

Indications for Use

Indicated for clinical interpretation of proximal femur bone mineral density (BMD) estimates in patients. Provides T-scores (relative to US Caucasian females age 20-39) and Z-scores (relative to US Caucasian females age 20-79) to aid physicians in identifying low BMD and assessing fracture risk.

Regulatory Classification

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.

Predicate Devices

• CTXA Hip Bone Mineral Densitometer (K002113)

Submission Summary (Full Text)

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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.<br>CEO and Director of Research and Development<br>Mindways Software, Inc<br>282 Second St., 4th Floor<br>San Francisco, CA 94105<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.

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### 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

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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K030330

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