LUNAR IDXA

K052581 · Ge Medical Systems Ultrasound and Primary Care Dia · KGI · Oct 20, 2005 · Radiology

Device Facts

• Record ID: K052581
• Device Name: LUNAR IDXA
• Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
• Product Code: KGI · Radiology
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1170
• Device Class: Class 2

Indications for Use

The Lunar iDXA Bone Densitometer provides an estimate of bone mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.

Device Story

Lunar iDXA is a general-purpose X-ray bone densitometer. System includes a scan table with X-ray source generation, digital X-ray detection, and processing hardware; user interface consists of a computer workstation and color monitor. Device captures X-ray data to estimate bone mineral density, fat mass, and lean tissue mass. Operated by clinical staff in a medical setting. Output is displayed on a monitor for physician review; used to compare patient values against reference populations to assist in clinical assessment. Modification from predicate provides improved image resolution and accommodates larger patients.

Clinical Evidence

No clinical trials were required. Evidence consists of bench testing for electrical and mechanical safety, and a 40-person in vivo study to verify that design specifications for accuracy and precision were met.

Technological Characteristics

General-purpose X-ray bone densitometer. Components: scan table with X-ray source and digital detector, computer workstation, color monitor. Conforms to medical device safety standards. Design and development per 21 CFR 820 and ISO 13485.

Indications for Use

Indicated for patients requiring estimation of bone mineral density and fat and lean tissue mass for comparison against reference populations 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

• Prodigy bone densitometer (K915535, K982267, K983564, K000826, K001756, K001812, K011917, K023554)

Submission Summary (Full Text)

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0C1 2 0 2005

Special 510(k) Premarket Notification GE Medical Systems Lunar - Lunar iDXA Bone Densitometer September 19th, 2005

## Attachment B 510 (k) Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white and appears to be a vintage or slightly worn version.

GE Healthcare

#### Section a):

- GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC division of Submitter: 1. General Electric Company GE Medical Sustems Lunar (business name) 726 Heartland Trail Madison, WI 53717
- James P. Raskob Contact Person: Safety and Requlatory Engineering Manager Telephone: [phone]; Fax: [phone] September 19th , 2005 Date Prepared:
- Lunar iDXA bone densitometer Bone Densitometer, 71 CFR 892.1170, 90-KGI Device Name: 2.
- 3. Marketed Device: Prodigy bone densitometer: K915535 K982267 K983564 K000826 K001756 K001812 K011917 K023554 currently in commercial distribution.
- 4. Device Description: The Lunar iDXA bone densitometer is a full featured general purpose x-ray bone densitometer system. It consists of a scan table that provides x-ray source generation, digital x-ray detection and processing. The user interface includes a computer workstation and a color monitor display. This modification will provide users with improved image resolution and ease of use with patients of larger size.
- Indications for Use: The Lunar iDXA Bone Densitometer provides an estimate of bone mineral ഹ് density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.
- 6. Comparison with Predicate Device: The Lunar iDXA is of a comparable type and substantially equivalent to the current Prodigy bone densitometer. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has the some intended uses and basic operating modes as the predicate device.

#### Section b):

- Non-clinical Tests: The device has been evaluated for electrical and mechanical safety, and 1. has been found to conform with applicable medical device safety standards. In vitro precision and accuracy values were computed through a series of tests on phantoms and were within design specifications.

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Special 510(k) Premarket Notification GE Medical Systems Lunar – Lunar iDXA Bone Densitometer September 19th, 2005

- 2. Clinical Tests: No clinical tests were required to establish safety or effectiveness, however a 40 ennical reste.
person in vivo study was done to verify that the design specifications of accuracy and precision were met.
- 3. Conclusion: Intended uses and other key features are consistent with previously cleared bone densitometer. The design and development process of the manufacturer conforms with 21 CFR 820 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance was verified through independent evaluation with ongoing factory surveillance. The Lunar iDXA bone densitometer is substantially equivalent to currently marketed devices. No new safety and effectiveness questions are raised with the Lunar iDXA bone densitometer.

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Special 510(k) Premarket Notification GE Medical Systems Lunar – Lunar iDXA Bone Densitometer September 19th, 2005

## Attachment C Truthful and Accurate Statement

### PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(j)))

I certify that, in my capacity as of Safety and Regulatory Engineering Manager for GE r ecring that, in The best of my knowledge, that all data and information r icalcul Systems Land, I Donorbfication are truthful and accurate and that no material fact has been omitted.

Date:

James P. Raskob

510(k) number:

* Must be signed by a responsible person of the firm required to submit the premarket notification (e.g., not a consultant for the 510(k) submitter).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes above a wavy line, representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 0 2005

Mr. James P. Raskob Safety & Regulatory Engineering Manager GE Medical Systems Lunar GE Healthcare 726 Heartland Trail MADISON WI 53717

Re.: K052581

Trade/Device Name: Lunar iDXA Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: II Product Code: KGI Dated: September 19, 2005 Received: September 20, 2005

Dear Mr. Raskob:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leve determined the device is substantially equivalent (for the indications for use stated in above and nave deceminerarketed 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 reay 20. 1770. the chance 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 do not require approval of a provisions of the Act. The general controls provisions of the Act device, subject to the generation, 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 n your de rice is chassilied (boo as a chards. Existing major regulations affecting your Apployal), It may oc stoped to sterral Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I TNA 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 r caerial and outs including, but not limited to registration and listing (21 CFR Part 807): labeling (21 CHR 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your and premarket notification. The PDA inding of succeantial of a lowice 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 device of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Thisoransing of your responsibilities under the Act from the 807.97). You may obtain other general information on your its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Lunar iDXA Bone Densitometer provides an estimate of bonc mineral density and fat and lean tissue mass. The values can then be compared to a reference population at the sole discretion of the physician.

X___ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use -----------(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Sypum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices Radologiour Book (2052581

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