HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY

K023398 · Hologic, Inc. · KGI · Nov 8, 2002 · Radiology

Device Facts

• Record ID: K023398
• Device Name: HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the Discovery Package for QDR X-Ray Bone Densitometers is the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.

Device Story

Discovery Package is software system for Hologic QDR X-ray bone densitometers; integrates previously cleared features into Microsoft Windows XP environment. Device processes X-ray scan data to estimate bone mineral density (BMD), assess vertebral deformities, analyze body composition, estimate fracture risk, and discriminate bone from prosthetics. Used in clinical settings by trained operators; output provides quantitative data and comparative analysis against reference databases to assist clinicians in diagnosing bone health and fracture risk. Benefits include consolidated software platform for existing Hologic densitometry capabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system for Hologic QDR X-ray bone densitometers. Operates on Microsoft Windows XP platform. Integrates existing algorithms for BMD estimation, vertebral morphometry, fracture risk, and body composition analysis. Connectivity via standard Hologic QDR hardware interfaces.

Indications for Use

Indicated for estimation of bone mineral density (BMD), comparison of scan variables to reference databases, fracture risk estimation, vertebral deformity assessment, body composition analysis, and bone/prosthetic discrimination in patients undergoing Hologic QDR 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

• Windows 98 "Eagle" Software for QDR Densitometers (K992677)
• Assessment of Vertebral Deformities Using QDR Densitometers (K992775)
• Fracture Risk Estimation for QDR Densitometers (K983028)
• Reference Databases (NHANES Software) for QDR Densitometers (K963363)
• Vertebral Morphometry Analysis Software for QDR Densitometers (K941362)
• QDR 4500 X-Ray Bone Densitometer (K943505)
• QDR 2000 X-Ray Bone Densitometer (K913321)
• QDR 1000W X-Ray Bone Densitometer (K894795)
• QDR 1000 X-Ray Bone Densitometer (K883280)
• Pediatric Reference Data for Lunar Bone Densitometer (K001812)

Submission Summary (Full Text)

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

K023398

## Special 510(k) - SUMMARY

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

## Discovery Package for Hologic QDR X-Ray Bone Densitometers

| Submitter Name: | Hologic, Incorporated |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 35 Crosby Drive<br>Bedford, MA 01730 |
| | NOV 8 2002 |
| Contact Person: | Daniel F. Phelan, Senior Regulatory Affairs Specialist |
| Phone Number: | 781-999-7300 |
| Fax Number: | 781-280-0662 |
| Date Prepared: | October 1, 2002 |
| Device Trade Name: | Discovery Package for Hologic QDR X-Ray Bone Densitometers |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Devices: | K992677 Windows 98 "Eagle" Software for QDR Densitometers<br>K992775 Assessment of Vertebral Deformities Using QDR Densitometers<br>K983028 Fracture Risk Estimation for QDR Densitometers<br>K963363 Reference Databases (NHANES Software) for QDR Densitometers<br>K941362 Vertebral Morphometry Analysis Software for QDR Densitometers<br>K943505 QDR 4500 X-Ray Bone Densitometer<br>K913321 QDR 2000 X-Ray Bone Densitometer<br>K894795 QDR 1000W X-Ray Bone Densitometer<br>K883280 QDR 1000 X-Ray Bone Densitometer<br>K001812 Pediatric Reference Data for Lunar Bone Densitometer |
| Device Description: | The Discovery Package for QDR Bone Densitometers is a software system that<br>integrates all of the previously cleared features of prior versions of the QDR<br>Densitometers in a Microsoft Windows XP operating environment. |
| Intended Use: | The intended use of the Discovery Package for QDR X-Ray Bone<br>Densitometers is the estimation of bone mineral density (BMD), comparison of<br>measured variables obtained from a given QDR scan to a database of reference<br>values, the estimation of fracture risk, vertebral deformity assessment, body<br>composition analysis, and discrimination of bone from prosthetics using the<br>Hologic QDR® X-Ray Bone Densitometers. |

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

Image /page/1/Picture/1 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle's head, represented by three curved lines that suggest the bird's beak and head feathers. To the left of the eagle's head, there is a partial inscription of the words "DEPARTMENT OF HEALTH". The text is arranged vertically, following the curve of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 8 2002 NOV

Re: K023398

Mr. Richard L. Follett Vice President, Regulatory Affairs And Quality Assurance HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730

Trade/Device Name: Discovery Package for Hologic QDR X-ray Bone Densitometers Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometers Regulatory Class: II Product Code: 90 KGI Dated: October 1, 2002 Received: October 9, 2002

Dear Mr. Follett:

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.

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

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). Other general information on vour 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. Progdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use Statement

The Discovery Package for QDR X-Ray Bone Densitometers is indicated for the estimation of bone mineral density (BMD), comparison of measured variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics using the Hologic QDR® X-Ray Bone Densitometers.

Prescription Use
(Per 21 CFR 801.109)

David A. Flynn

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