OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

K992775 · Hologic, Inc. · KGI · Oct 1, 1999 · Radiology

Device Facts

• Record ID: K992775
• Device Name: OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Oct 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The intended use of the MXA-II Software Option for the Hologic X-Ray Bone Densitometers is to allow the visual or quantitative assessment of vertebral body deformities.

Device Story

MXA-II is a software option for Hologic QDR X-Ray Bone Densitometers. It utilizes existing imaging protocols and acquisition software identical to the Hologic Vertebral Morphometry program. The device processes X-ray scan data to enable clinicians to perform either visual or quantitative assessments of vertebral body deformities. Used in clinical settings by trained operators, the software provides tools for evaluating spinal morphology. The output assists healthcare providers in identifying vertebral deformities, supporting clinical decision-making regarding bone health and potential fracture risk.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software option for Hologic QDR X-Ray Bone Densitometers. Operates as an add-on to existing densitometry acquisition hardware. Provides quantitative and visual assessment tools for vertebral morphology.

Indications for Use

Indicated for the visual or quantitative assessment of vertebral body deformities in patients undergoing X-ray bone densitometry.

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
• LUNAR Spine Morphometry Software Option
• Radiographic identification of Vertebral Deformities
• CT Scout views

Submission Summary (Full Text)

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1 1999

OCT

## વું વ MXA-II Software Option 510(k) Premarket Notification

## 510(K) SUMMARY

MXA-II software option for the X-Ray Bone Densitometers

| Submitter Name: | Hologic, Incorporated |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 35 Crosby Drive<br>Bedford, MA 01730 |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | August 17, 1999 |
| Device Trade Name: | Hologic® QDR® X-Ray Bone Densitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Devices: | Hologic Vertebral Morphometry Software Option<br>LUNAR Spine Morphometry Software Option<br>Radiographic identification of Vertebral Deformities<br>CT Scout views |
| Device Description: | The imaging protocols and acquisition software of the MXA-II<br>software option are the same as the Hologic Vertebral<br>Morphometry software program. Using the MXA-II option, the<br>patient would be scanned as under the currently distributed<br>vertebral morphometry option. In the MXA-II option, however,<br>the vertebral deformities can be evaluated either quantitatively<br>or visually. |
| Intended Use: | The product is a software option for the Hologic x-ray bone<br>densitometers, allowing the visual or quantitative assessment of<br>vertebral body deformities |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

001 1 1999

Nandini Murthy, RAC Regulatory Scientist Hologic, Inc. 35 Crosby Drive Bedford, MA 01730-1401 RE;

K992775

MXA-II Software Dated: August 17, 1999 Received: August 18, 1999 Regulatory Class: II 221 CFR 892.1170/Procode: 90 KGI

Dear Ms. Murthy:

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 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 redassified 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 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 895. A substantially equivalent defermination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 531 through 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Qther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Dan Detist

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

ਸੀ। Enclosure

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510(k) Number (if known): _

Device Name:

Indications For Use:

The intended use of the MXA-II Software Option for the Hologic X-Ray Bone Densitometers is to allow the visual or quantitative assessment of vertebral body deformities.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Javid A. Sygm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)