HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER

K033224 · Hologic, Inc. · KGI · Nov 5, 2003 · Radiology

Device Facts

• Record ID: K033224
• Device Name: HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Nov 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Indications for Use

The Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periproshtetic BMD.

Device Story

Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer; utilizes switched pulse dual-energy x-ray tube (100/140 kV) and 54-channel detector array (CdWO4 scintillators/silicon diodes) to measure bone mineral content and density. Operated by clinicians in clinical settings; uses laser positioning for patient alignment. System processes scan data to produce BMD/BMC measurements, fracture risk estimates, and body composition analysis. Output allows healthcare providers to assess bone health and fracture risk, aiding clinical decision-making for osteoporosis management. Device is a modification of the QDR-3000 platform, featuring updated Windows XP-based software and hardware components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Fan beam X-ray bone densitometer; switched pulse dual-energy X-ray tube (100/140 kV, tungsten target); 54-channel detector array (CdWO4 scintillators/silicon diodes); laser positioning diode (<1mW); Windows XP-based operating system; PC hardware (>1.5 GHz, 256 MB RAM). Complies with 21 CFR 1020.30(k) for leakage radiation.

Indications for Use

Indicated for patients requiring bone mineral content (BMC) and bone mineral density (BMD) assessment, fracture risk estimation, body composition analysis, and periprosthetic BMD measurement.

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 QDR-3000 X-Ray Bone Densitometer (K943505)
• Hologic Discovery Package for QDR X-Ray Bone Densitometers (K023398)

Submission Summary (Full Text)

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K033224

Hologic, Inc. October 3, 2003 Hologic QDR Explorer X-Ray Bone Densitometer SPECIAL 510(k) Premarket Notification

Section E

510(k) Summary

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## E. 510(k) Summary

## E.1 Company Identification

Hologic, Inc. 35 Crosby Drive Bedford. MA 01730 781-999-7300

#### E.2 Contact Information

Daniel F. Phelan Senior Regulatory Affairs Specialist

## E.3 Date of Submission

October 3, 2003

### E.4 Device Identification

Proprietary Name Classification Name: Common/Usual Name Requlation Number: Product Code: Classification Classification Panel

Hologic QDR Explorer X-Ray Bone Densitometer Bone Densitometer Bone Densitometer 21 CFR 892.1170 90 KGI 11 Radiology

### E.5 Predicate Device Information

- K943505 Hologic QDR-3000 X-Ray Bone Densitometer
- Hologic Discovery Package for QDR X-Ray Bone Densitometers K023398

#### E.6 Device Description and Intended Use

The Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periproshtetic BMD.

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Hologic, Inc.
October 3, 2003

# Hologic QDR Explorer X-Ray Bone Densitometer SPECIAL 510(k) Premarket Notification

KT333222

## E.7 Substantial Equivalence

| | QDR-3000 | QDR Explorer |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K943505 | |
| System Footprint | 3.02m (119 in) L x 1.50m (59 in) W x<br>1.42m (56 in) H +/- 25mm (1 in). | Same |
| System Weight | 320 kg (720 lb) | 327 kg (729 lb) |
| System Power Requirements | 100V (23A), 120V (18A), and 230V<br>(9A) models available | Same |
| X-Ray Tube | Switched pulse dual-energy x-ray tube<br>operating at 100 kV and 140 kV. 2.5<br>mA average at 25% duty cycle.<br>Tungsten target | Same. |
| Detector Array | 64 multichannel detector consisting of<br>CdWO4 scintillators coupled to silicon<br>diodes | 54 multichannel detector consisting of<br>CdWO4 scintillators coupled to silicon<br>diodes |
| X-Ray Source-to-Image-Detector<br>Distance | 1070 mm (42 in) +/- 8 mm (0.315 in) | 883.4 mm (34.8 in) +/- 8 mm (0.315 in) |
| X-Ray Source-to-Patient Distance | 424 mm (16.7 in) +/- 6 mm (0.236 in) | Same |
| Collimation | Aperture with 1.0 mm slit. | Same |
| Laser Positioning Device | Laser diode < 1mW cross hair with<br>emergency mechanical shutter. | Same |
| Leakage Radiation | The QDR-3000 meets the<br>requirements of 21 CFR 1020.30(k) for<br>leakage from the x-ray source. | The QDR Explorer meets the<br>requirements of 21 CFR 1020.30(k) for<br>leakage from the x-ray source |
| Scatter Radiation | 10μGy/hr at 1m from the examination<br>table (Nominal) | Same |
| Scan Time | 15 seconds - 407 seconds, depending<br>on scan mode | 62 seconds - 403 seconds, depending<br>on scan mode |
| Scan Sites | Lumbar spine (L1, L2, L3, L4),<br>Proximal femur (hip), Forearm (radius<br>and ulna), Whole body | Same |
| Software Operating System | Hologic Eagle Software Windows 98-<br>Based Operating System (K992677) | Hologic Discovery Software Package<br>Windows XP-Based Operating System<br>(K023398) |
| PC Hardware Requirements | > 1.0 GHz processor<br>> 256 MB RAM<br>> 20 GB hard disk<br>3.5" 1.44 MB diskette drive<br>17" monitor (CRT)<br>120 MB SuperDisk drive<br>CD-ROM drive<br>16 MB video card<br>Standard keyboard and mouse | > 1.5 GHz processor<br>Same<br>Same<br>Same<br>17" monitor (CRT or LCD)<br>CD/RW drive<br>N/A<br>Same<br>Same |
| BMC Measurement | Standard | Same |
| BMD Measurement | Standard | Same |
| Fracture Risk Estimation (K983028) | Standard | Same |
| Reference Databases (K963363) | Standard | Same |
| Body Composition Analysis (K961787) | Optional | Same |
| Periprosthetic BMD Measurement<br>(K002711) | Optional | Same |

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2003

Mr. Daniel F. Phelan Senior Regulatory Affairs Specialist Hologic, Inc. 35 Crosby Drive BEDFORD MA 01730-1401

Re: K033224 Trade/Device Name: Hologic ODR X-Ray Bone Densitometer Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: 90 KGI Dated: October 3, 2003 Received: October 6, 2003

Dear Mr. Phelan:

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 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.

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 (OS) 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 vours.

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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## A.2 Indications for Use Statement

510(k) Number (if known): K033224

Device Name: Hologic QDR Explorer X-Ray Bone Densitometer

Indications for Use:

The Hologic QDR Explorer is a fan beam X-Ray Bone Densitometer indicated for (1) the measurement of bone mineral content (BMC) and the estimation of bone mineral density (BMD), (2) comparison of measurements to reference databases, (3) the estimation of fracture risk, (4) body composition analysis, and (5) measurement of periprosthetic BMD

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional Format 1)

Nancy C Brogdon

(Division Sign-Division of Reproductive and Radiological Devic 510(k) Number