SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING

K980557 · Siemens Medical Solutions USA, Inc. · IYN · Apr 24, 1998 · Radiology

Device Facts

• Record ID: K980557
• Device Name: SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: IYN · Radiology
• Decision Date: Apr 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Device Story

Mobile, software-controlled diagnostic ultrasound system; acquires ultrasound data via transducers; displays images in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler, and Continuous (CW) Doppler; provides on-screen thermal and mechanical indices. Used in clinical settings by healthcare professionals for anatomical measurements and diagnostic analysis. Output viewed on CRT display; assists clinicians in diagnosis of various body structures and fluid flow. Superficial musculoskeletal imaging added via 7.5L40 linear array transducer.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mobile diagnostic ultrasound system; software-controlled; CRT display; supports multiple imaging modes (B, M, PW, CW, Color Doppler). Complies with UL 2601, CSA 22.2 No. 601-1, and AIUM/NEMA standards for thermal/mechanical indices. Includes 7.5L40 linear array transducer.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including general radiology, abdominal, intraoperative, small parts, transcranial, OB/GYN, pelvic, neonatal/adult cephalic, urology, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Siemens SONOLINE Elegra Ultrasound System (K945072)

Submission Summary (Full Text)

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# 510(K) SUMMARY

(k98055)

APR 2 4 1998

SONOLINE Elegra Diagnostic Ultrasound system

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

### Submitted Bv: 1.

Siemens Medical Systems, Inc., Ultrasound Group 22010 S.E. 51st Street Issaquah. WA 98027-7002

Contact Person: Steve Hesler Manager of Regulatory Affairs [phone]

Date Prepared: February 6, 1998

- 2. Proprietary Name: SONOLINE Elegra Advanced SONOLINE Élegra
Common/ Usual Name: Diagnostic Ultrasound System with Accessories

Classification Name: Ultrasonic Pulsed Doppler Imaging System (Product Code 90 IYN, 21 CFR 892.1550)

#### 3. Predicate Device:

Siemens SONOLINE Elegra Ultrasound System (K945072), 11/21/95

### 4. Device Description:

The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for themal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode. M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Dopper Mode, or in a combination of modes, on a CRT display.

The ®SONOLINE ELEGRA, has been designed to meet the following product safety standards:

- UL 2601. Safety Requirements for Medical Equipment .
- . CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment
- . Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment. AIUM/NEMA. 1992.
- . 93/42/EEC Medical Devices Directive EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment

### 5. Intended Uses:

The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial,

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OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

### 6. Technological Comparison to Predicate Device:

SONOLINE Elegra is a previously cleared device. The purpose of this submission is to receive clearance for the indication of Superficial Musculoskeletal imaging. This indication is equivalent to the small parts imaging indication for which the system is already cleared.

# End of 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 4 1998

Steve C. Hesler Siemens Medical Systems, Inc.
22010 S.E. 51st St. 98029-7002 Issaquah, WA

K980557 Re: Sonoline® Elegra Diagnostic Ultrasonic System Dated: February 12, 1998 Received: February 13, 1998 Regulatory class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 892.1560/Procode: 90 IYO 90 ITX 21 CFR 892.1570/Procode:

Dear Mr. Hesler:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls The general controls provisions of the Act include provisions Act (Act). requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducer intended for the Superficial Musculoskeletal application with the Sonoline® Elegra Diagnostic Ultrasonic System, as described in your premarket notification:

## Transducer Model Number

## 7.5L40 Linear Array Transducer

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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## Page 2 - Steve C. Hesler

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 Therefore, your product labeling must be consistent with FDA's CFR, Part 812. position on this use.

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR Other general information on your responsibilities under the Act may 807 97) . be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D. at [phone].

Sincerely yours,

David A. Sejerson
for Lillian Yin, Ph.D.

Lillian Yin, PH.D.--Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health ...

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## Addition of Superficial Musculoskeletal Application to SONOLINE® Elegra 510(k) Submission

## Ultrasound Device Indications Statement

## 510 (k) Number (if known)

### 7.5L40 Linear Array Transducer Device Name :

Diagnostic ultrasound imaging or fluid flow analysis of the human body as Intended Use: follows:

Mode of Operation

| Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
|-------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | P | P | P | | P | P | | BMDC (P) | | |
| Intraoperative<br>(Specify) | | P | P | P | | P | P | | BMDC (P) | | |
| Pediatric | | P | P | P | | P | P | | BMDC (P) | | |
| Small Organ<br>(Specify) | | P | P | P | | P | P | | BMDC (P) | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophage | | | | | | | | | | | |
| al | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral<br>vessel | | P | P | P | | P | P | | BMDC (P) | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-<br>skeletal | | P | P | P | | P | P | | BMDC (P) | | |
| Conventional | | | | | | | | | | | |
| Musculo-<br>skeletal<br>Superficial | | N | N | N | | N | N | | BMDC (N) | | |
| Other (specify) | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under Appendix E Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

510(k) Number

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Image /page/5/Picture/0 description: The image shows the text 'K 980557'. The text is written in a handwritten style. The numbers are all connected and the 'K' is separated from the numbers.

Siemens Medical Systems, Inc. Ultrasound Group

Addition of Superficial Musculoskeletal Application to SONOLINE® Elegra 510(k) Submission

# Ultrasound Device Indications Statement

510 (k) Number (if known)

SONOLINE Elegra Device Name :

Intended Use:

SONOLINE Elegra
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation

| Mode of Operation | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
|-------------------------------------------------------------------------------------------------------|----------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Abdominal | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Intraoperative<br>(Specify) | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Pediatric | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Small Organ<br>(Specify) | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Neonatal<br>Cephalic | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Adult Cephalic | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Cardiac | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Transesophage<br>al | | | | | | | | | | | | |
| Transrectal | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Transvaginal | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral<br>vessel | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-<br>skeletal<br>Conventional | | P | P | P | P | P | P | P | | BMDC (P) | | |
| Musculo-<br>skeletal<br>Superficial | | N | N | N | | N | N | | | BMDC (N) | | |
| Other (specify) | | | | | | | | | | | | |
| N = new indication; P = previously cleared by FDA; E = added under Appendix E<br>Additional Comments: | | | | | | | | | | | | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Seysam

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number