IVA (MXA II SOFTWARE OPTION)

K060111 · Hologic, Inc. · KGI · Apr 24, 2006 · Radiology

Device Facts

• Record ID: K060111
• Device Name: IVA (MXA II SOFTWARE OPTION)
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

IVA scans are intended for the visualization or quantitative assessment of vertebral bone deformities. IVA also allows the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.

Device Story

IVA (MXA-II) is a software option for X-ray bone densitometers; processes X-ray images to visualize or quantify vertebral bone deformities and abdominal aortic calcification. Used in clinical settings by healthcare professionals; output assists in identifying potential cardiovascular disease associations via aortic calcification visualization. Device provides diagnostic information to clinicians to support clinical decision-making regarding bone health and cardiovascular risk assessment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance specifications consistent with predicate devices.

Technological Characteristics

Software option for X-ray bone densitometers (21 CFR 892.1170). Operates as an image processing module for visualization and quantitative assessment of bone and vascular calcification. No changes to hardware or performance specifications from predicate versions.

Indications for Use

Indicated for patients requiring visualization or quantitative assessment of vertebral bone deformities and visualization of abdominal aortic calcification.

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

• Hologic Vertebral Morphometry Software Option (K941362)
• Hologic Vertebral Morphometry Software II Option (K992775)
• Toshiba KXO-80G x-ray generator (K945668)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

## APR 2 4 2006

Modified Indication for Use for IVA

| Submitter: | Hologic, Inc. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 35 Crosby Drive<br>Bedford, MA 01730 |
| Contact Person: | Jeanette Schier-Pugsley, Regulatory Affairs Manager |
| Phone Number: | [phone] |
| Fax: | [phone] |
| Date of Submission: | January 13, 2006 |
| Device Trade Name: | IVA (MXA -II) software option for the X-Ray bone<br>densitometers. |
| Device Common Name: | X-Ray Bone Densitometer |
| Device Classification: | Bone Densitometer<br>21 CFR 892.1170 |
| Predicate Devices: | Hologic Vertebral Morphometry Software Option (K941362)<br>Hologic Vertebral Morphometry Software II Option (K992775)<br>General use x-ray systems (e.g., Toshiba KXO-80G x-ray<br>generator; K945668) |
| Device Description and<br>Intended Use: | IVA scans are intended for the visualization or quantitative<br>assessment of vertebral bone deformities. IVA also allows the<br>visualization of abdominal aortic calcification, and, if present,<br>clinical correlation may be advised since abdominal aortic<br>calcification may be associated with cardiovascular disease. |
| Substantial Equivalence: | No changes to the manner in which the MXA or MXA-II<br>software operates will be made for the modification to the<br>intended use, nor will any changes be made in the device's<br>performance specifications. The modified intended use<br>statement of the presently commercialized Hologic MXA-II<br>software option is substantially equivalent to those of the<br>MXA-II and MXA software options (K992775 and K941362, |

{1}------------------------------------------------

respectively), and that of general diagnostic x-ray systems, such as the Toshiba KXO-80G x-ray generator (K945668). such as the Toshiba IRTS be be submission support the new claim.

:

:

.

Image /page/1/Picture/3 description: The image shows a sequence of numbers, specifically '000092'. The numbers are printed in a clear, sans-serif font, and they appear to be part of a larger numerical sequence or identifier. The digits are evenly spaced and easily readable, suggesting they are from a digital display or a well-printed document.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem that resembles an eagle or bird-like figure with three stylized wing segments. The emblem is black, and the text is also in black.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 2 4 2006

Ms. Jeanette Schier-Pugsley, RAC Regulatory Affairs Manager Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K060111

Trade/Device Name: IVA (MXA II Software Option) Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: April 3, 2006 Received: April 4, 2006

Dear Ms. Schier-Pugsley:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906 - 2006" at the top and "FDA" in large, bold letters in the center. Below the FDA letters, the word "Centennial" is written in a cursive font. The logo is surrounded by text that reads "Dedicated to Compliance, Protection, and the Norms of Public". The bottom of the image shows the words "ting Public" in a cursive font.

{3}------------------------------------------------

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.

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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

{4}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): K060111

Device Name: _ IVA (MXA II Software Option)_

Indications for Use:

IVA scans are intended for the visualization or quantitative assessment of vertebral bone I v I seats are intended the visualization of abdominal aortic calcification, and, if present, clinical correlation may be advised since abdominal aortic calcification may be associated with cardiovascular disease.

## (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) | |

Nancy Burton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 060111 510(k) Number .

000089