PEDIATRIC REFERENCE DATABASE

K041266 · Hologic, Inc. · KGI · Aug 11, 2004 · Radiology

Device Facts

• Record ID: K041266
• Device Name: PEDIATRIC REFERENCE DATABASE
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Aug 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone Densitometers. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.

Device Story

Pediatric Reference Database is a software extension for Hologic QDR Series X-Ray Bone Densitometers. It inputs patient BMD measurements obtained via dual-energy X-ray absorptiometry (DXA) and compares them against a reference database of male, white American children aged 3-20 years. The software calculates Z-scores (standard deviations from the mean) and percent-of-mean values, displaying results graphically with markers for patient age and BMD. Used in clinical settings by physicians to assess pediatric bone health. Output assists clinicians in evaluating bone density relative to age, sex, and ethnicity-matched populations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software option for Hologic QDR Series X-Ray Bone Densitometers. Utilizes existing DXA hardware for data acquisition. Provides age-matched reference values for children aged 3-20 years. Operates as an integrated software module within the QDR system.

Indications for Use

Indicated for use in determining bone mineral density (BMD) in children aged 3-20 years. Used as a comparative tool at physician discretion.

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

• Lunar Pediatric Reference Data (K001812)
• Expanded.LUNAR Reference Data (K964307)
• NHANES Reference Data for QDR (K963363)
• Hologic® Discovery Package for QDR (K023398)
• Hologic® QDR Explorer X-Ray Bone Densitometer (K033224)
• ODR 4500 X-Ray Bone Densitometer (K943505)

Submission Summary (Full Text)

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

Hologic®, Inc. May 10, 2004

AUG 1 1 2004

Hologie Reference Database 510(k) Premarket Notification

## Section F.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## 510(k) Summary of Safety and Effectiveness:

## Pediatric Reference Database

K04H266

| Submitter: | Hologic, Inc. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 35 Crosby Drive<br>Bedford, MA 01730 |
| Contact Person: | Richard L. Follett, V.P., Regulatory Affairs and Quality Assurance |
| Phone Number: | [phone] |
| Fax: | [phone] |
| Date Prepared: | May 7, 2004 |
| Device Trade<br>Name: | Pediatric Reference Database |
| Device Common<br>Name: | BoneDensitometer |
| Device Classification<br>Name: | Bone Densitometer<br>21 CFR 892.1170 |
| Predicate Devices: | Lunar Pediatric Reference Data (K001812)<br>Expanded.LUNAR Reference Data (K964307)<br>NHANES Reference Data for QDR (K963363)<br>Hologic® Discovery Package for QDR (K023398)<br>Hologic® QDR Explorer X-Ray Bone Densitometer (K033224)<br>ODR 4500 X-Ray Bone Densitometer (K943505) |

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

Hologic®. Inc. May 10, 2004

Hologic Reference Database 510(k) Premarket Notification

#### Device Description:

The Pediatric Reference Database is a software option which simply extends the existing, commercially available reference databases' ability to generate a Z-score for younger subjects.

The Pediatric Reference Database for the Hologic QDR Series X-Ray Bone Densitometers provides AP I lie rediance Reference Batalensitometry reference data for male, white American children. The Spine, This and "Hotel in conjunction with previously existing software in the QDR Series I culaine relevelos band is results to sex, ethnicity and age-matched values. The reference Densitometers while realigate of bone densitometry reference values to include age 3-20 years of age. database is used to exparison of Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values.

Patient results for each analysis region can be compared to reference values both graphically and I uncility to vach allery of the age dependent reference Bone Mineral Density (BMD) values quantitution of + or the sex and ethnicity of the patient are generated with a marker placed at the position corresponding to the estimated patient BMD and age. Deviation "scores," are computed, quantifying (in eorroponants to are estation units) the difference between the patient's estimated BMD and the mean population standated (Z-score) reference data. In addition, the patient BMD is expressed in percent of the age matched mean in percent of the pediatric mean.

#### Intended Use:

The Pediatric Reference Database is a software option used with Hologic QDR Series X-Ray Bone The roundters. The software expands the range of bone densitometry reference data to include ages 3-20 years of age. The software provides a comparison of measured Bone Mineral Density (BMD) measurements obtained by dual energy x-ray absorptiometry to a database of BMD reference values in children. These data may be used for comparative purposes at the discretion of the physician.

#### Conclusion:

••

The Pediatric Reference Database is substantially equivalent to currently marketed software. No new safety and effectiveness questions are raised with the inclusion of these expanded reference values.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. 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

# AUG 1 1 2004

Ms. Anastasia C. Randall Senior Regulatory Affairs Specialist HOLOGIC, Inc. 35 Crosby Drive BEDFORD MA 01730

Re: K041266

Trade/Device Name: Pediatric Reference Database Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: 90 KGI Dated: July 13, 2004 Received: July 14, 2004

Dear Ms. Randall:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bection b 10(t) personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosare) to regary the Medical Device Amendments, or to econimer of they 2011-11-11 11:47 pm accordance with the provisions of the Federal Food, DNA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetion (110.) that be neview, subject to the general controls provisions of the Act. The r ou may, therefore, mains 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 may or subject to sales advanced 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 that I DA has made a ceretre and regulations administered by other Federal agencies. You must comply or any I coolar started and 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.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ocgin hanteling of substantial equivalence of your device to a legally premarket notification. The PDA miding of dassification 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 If you desire specific advice for your dones to the following numbers, based on the regulation number at the top of the letter:

| 8xx. Ixxx | [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 Adultionaly, for questions on the promote the regulation entitled, "Misbranding Office of Comphanos at (2017 97 1000 (21 CFR Part 807.97) you may obtain. Other general by Ference to premarket notified to the Act may be obtained from the Division of Small information on your responsional and Consumer Assistance at its toll-free number [phone] or 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Hologic®, Inc. May 10, 2004

Section D.

Indications for Use Statement

510(k) Number (if known): _KOU 1266

Device Name: _Pediatric Reference Database

Indications for Use:

The Pediatric Reference Database is a software option used with Hologic QDR Series X-1
1 The Pediatic Reference Database is a soltware openabase is for use in determining Z-Ray Bone Delishometers: The Pears at the discretion of the physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional Format 1)

Vaind C. Syper

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K044 266