ACHILLES

K103633 · Ge Medical Systems China Co., Ltd. · MUA · May 11, 2011 · Radiology

Device Facts

• Record ID: K103633
• Device Name: ACHILLES
• Applicant: Ge Medical Systems China Co., Ltd.
• Product Code: MUA · Radiology
• Decision Date: May 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1180
• Device Class: Class 2

Intended Use

The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip. Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment. The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Device Story

Achilles EXPII is a bone sonometer measuring ultrasound variables of the os calcis (heel bone). It calculates a 'Stiffness Index' to estimate osteoporotic fracture risk, providing results comparable to BMD measurements from X-ray absorptiometry. Used by clinicians to assist in osteoporosis diagnosis and skeletal assessment, the device output (Stiffness Index and t-scores) is interpreted by physicians alongside other clinical risk factors. The device is suitable for monitoring bone changes over time due to its precision. It operates on the same fundamental scientific technology as the predicate Achilles Express Ultrasonometer.

Clinical Evidence

Clinical study GE3120 evaluated the precision of the Achilles EXPII and compared its results to the Achilles Express. Results demonstrated equivalence in vivo, with a high linear correlation (R=0.97) between Stiffness Index values obtained from both devices. No significant differences in Stiffness values were observed.

Technological Characteristics

Bone sonometer utilizing ultrasound transmission through the os calcis. Measures ultrasound variables to derive a Stiffness Index. Complies with voluntary standards for safety and performance. System development included module verification, system integration, and simulated use validation.

Indications for Use

Indicated for postmenopausal women to assess risk of osteoporotic fracture and assist physicians in the diagnosis of osteoporosis via measurement of the os calcis.

Regulatory Classification

Identification

A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers.” See § 892.1(e) for the availability of this guidance document.

Predicate Devices

• Achilles Express Ultrasonometer (P970040/S001)

Submission Summary (Full Text)

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# K103633

# MAY 1 1 2011

Image /page/0/Picture/2 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 black and white.

GE Healthcare 510(k) Premarket Notification Submission

# 510(k) Summary

| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December, 10th, 2010 |
| Submitter: | GE Healthcare (GE Medical Systems (China) Co., Ltd)<br>No.19, Changjiang Road,<br>Wuxi National Hi-Tech Development Zone, Jiangsu, China |
| Primary Contact Person: | Chris Paulik<br>Regulatory Affairs Leader<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Dave Blonski<br>RA Director<br>GE Healthcare<br>Phone: [phone] |
| | Fax: [phone] |
| Device: Trade Name: | Achilles |
| Common/Usual Name: | Achilles EXPII |
| Classification Names: | 21CFR892.1180, Class II |
| Product Code: | MUA |
| Predicate Device: | P970040/S001 Achilles Express Ultrasonometer |
| Device Description: | Achilles EXPII measures ultrasound variables of the os calcis to<br>provide a clinical measure called Stiffness Index. The Stiffness<br>Index indicates risk of osteoporotic fracture in postmenopausal<br>women comparable to bone mineral density (BMD) as measured<br>by X-ray absorptiometry at the spine or hip. |
| Intended Use: | Detail descriptions are included in section 11.<br>The Achilles ultrasonometer measures ultrasound variables of the<br>os calcis to provide a clinical measure called Stiffness Index. The<br>Stiffness Index indicates risk of osteoporotic fracture in<br>postmenopausal women comparable to bone mineral density<br>(BMD) as measured by X-ray absorptiometry at the spine or hip. |
| | Stiffness index results expressed as t-scores are used to assist the<br>physicians in the diagnosis of osteoporosis in the same way as are<br>t-scores or obtained by x-ray absorpiometry. Either the stiffness<br>index t-score or x-ray absorptiometry t-score can be utilized by a |

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular border. The letters and the border are black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.

# GE Healthcare 510(k) Premarket Notification Submission

physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

The Achilles EXPII employs the same fundamental scientific Technology: technology as its predicate(s).

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The Achilles EXPII Bone sonometer and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- Risk Analysis .
- Requirements Reviews
- Design Reviews
- . Testing on unit level (Module verification)
- Integration testing (System verification) .
- . Performance testing (Verification)
- Safety testing (Verification) .
- Simulated use testing (Validation) .

#### Summary of Clinical Tests:

A clinical study GE3120 was performed to determine the precision of the Achilles EXPII Bone sonometer and the correlation of the results for the Achilles EXPII and the Achilles Express. See section 20 of this premarket submission.

Stiffness Index results obtained from the Achilles EXPII was shown to be equivalent to those obtained by the Achilles Express in vivo. Linear regression of Stiffness Index values from the two devices demonstrated high correlation (R=0.97)

Comparison of Stiffness values demonstrated no significant differences.

See section 20 of this premarket submission.

Conclusion: GE Healthcare considers the Achilles EXPII to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Chris Paulik Regulatory Affairs Leader GE Medical Systems China Co., Ltd. No. 19 Changhiang Road National Hi-Tech Dev. Zone Wuxi, Jiangsu 214028 CHINA

MAY 1 1 2011

Re: K103633

Trade/Device Name: Achilles EXPII Bone Sonometer Regulation Number: 21 CFR 892.1180 Regulation Name: Bone sonometer Regulatory Class: II Product Code: MUA Dated: December 10.2010 Received: March 3, 2011

#### Dear Mr. Paulik:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: Achilles EXPII Bone Sonometer

Indications for Use:

The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mue Spate

Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K103633

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