HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS

K061561 · Hologic, Inc. · KGI · Jul 28, 2006 · Radiology

Device Facts

• Record ID: K061561
• Device Name: HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
• Applicant: Hologic, Inc.
• Product Code: KGI · Radiology
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Intended Use

The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

Device Story

Software option for Hologic QDR X-Ray Bone Densitometers; utilizes existing DXA scan data as input. Transforms bone mineral mass distribution data into structural hip properties; calculates cross-sectional area (CSA), cross-sectional moment of inertia (CSMI), section modulus (Z), and buckling ratio. Used in clinical settings by physicians to assess hip bone structure. Output provides quantitative estimates to assist clinical decision-making regarding bone health and fracture risk assessment.

Clinical Evidence

No clinical data provided; substantial equivalence supported by scientific literature and bench testing.

Technological Characteristics

Software-only option for existing DXA hardware. Performs geometric and structural calculations based on bone mineral mass distribution. Operates on Hologic QDR X-Ray Bone Densitometer platforms.

Indications for Use

Indicated for use by physicians to estimate hip structural properties (CSA, CSMI, Z, Buckling Ratio) using data from conventional DXA scans.

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

• Discovery Package for QDR Densitometers (K023398)
• Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers (K011917)

Submission Summary (Full Text)

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K061561

JUL 2 8 2006

# Section G 510(k) Summary

000081

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# H. 510(k) Summary

#### Manufacturing Establishment and Contact Information H.1

### H.1.1 Manufacturer Name and Address:

Hologic, Inc. 35 Crosby Drive Bedford, MA 01730

### H.1.2 Establishment Registration Number:

1221300

### H.1.3 Name, Title, and Telephone Number of Contact:

Jeanette Schier-Pugsley Regulatory Affairs Manager Phone: [phone], ex. 7406 Fax: [phone] [e-mail]

#### Device Identification H.2

### H.2.1 Device Trade Name:

Hip Structural Analysis (HSA) Software Option for the Hologic QDR X-Ray Bone Densitometers.

### H.2.2 Common / Usual Name:

Software option for Bone Densitometers

### H.2.3 Intended Use:

The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

#### Device Classification H.3

### H.3.1 Classification:

Class II

### H.3.2 Classification Name and Rule

Bone Densitometer: 21 CFR 892.1170

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### H.3.3 Classification Panel

Radiology

### H.3.4 Product Code

90 KGI

### H.3.5 Predicate Devices

. 510(k) No.: K023398 Trade Name: Discovery Package for QDR Densitometers SE Date: November 8, 2002 Manufacturer: Hologic, Inc.

- . 510(k) No .: K011917
Advanced Hip Assessment (AHA) Software for GE Prodigy x-Trade Name: ray bone densitometers.

August 3, 2001 SE Date:

Manufacturer: GE Lunar Corporation

#### H.4 Conclusion:

Based on the scientific literature and testing supplied in the 510(k) submission, the Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers is substantially equivalent to the presently marketed Discovery Package for QDR Densitometers software (K023398) and the Advanced Hip Assessment (AHA) Software for GE Prodigy x-ray bone densitometers (K011917). No new safety and efficacy questions are raised with the HSA Software Option.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

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

Re: K061561

Trade/Device Name: Hip Structure Analysis (HAS) Software Option for QDR X-Ray Bone Densitometers

Regulation Number: 21 CFR 892.1170 Regulation Name: Bone densitometer Regulatory Class: II Product Code: KGI Dated: June 2, 2006 Received: June 5, 2006

Dear Ms. 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.

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Protecting and Promoting Public Health

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Page 2 -

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 | |

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 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 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): 061561

Hip Structural Analysis (HSA) Software Option for QDR X-Ray Bone Device Name: Densitometers

The Hip Structural Analysis (HSA) Option for QDR X-Ray Bone Densitometers uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at specific cross sections of the hip and allows the physician to estimate structural properties of the hip, such as CSA, CSMI, Z and Buckling Ratio.

### (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 Bradon
(Division Sign-Off)

Division of Reproductive. Abdo and Radiological Device >10(k) Number

000010