SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM

K022567 · Acuson Corp. · IYN · Aug 13, 2002 · Radiology

Device Facts

• Record ID: K022567
• Device Name: SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Acuson Corp.
• Product Code: IYN · Radiology
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) 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. The AcuNav diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

Device Story

Sequoia Signature II is a mobile, software-controlled diagnostic ultrasound system. It acquires primary or secondary harmonic ultrasound echo data via various transducers. Modes include B-mode, M-mode, Pulsed (PW) Doppler, Continuous (CW) wave Doppler, color Doppler, Power Amplitude Doppler, Harmonic Imaging, and 3D imaging. Data is processed and displayed on a CRT monitor. The system includes analysis packages for anatomical measurements to assist clinical diagnosis. The AcuNav catheter enables intra-cardiac/intra-luminal visualization. Used in clinical settings by healthcare professionals. Benefits include non-invasive visualization of internal structures and blood flow to support diagnostic decision-making.

Clinical Evidence

Bench testing only. The system complies with safety and performance standards including UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 (acoustic output), AIUM/NEMA UD-3 (thermal/mechanical indices), and ISO 10993 (biocompatibility). No clinical trial data provided.

Technological Characteristics

Mobile, software-controlled ultrasound system. Features CRT display, thermal/mechanical index on-screen display. Transducers include various models (e.g., 4C1, 5C2, AcuNav). Connectivity includes standard ultrasound interfaces. Biocompatibility per ISO 10993. Safety standards: UL 2601-1, CSA C22.2 No. 601-1, IEC 1157, EN 60601-1 series.

Indications for Use

Indicated for fetal, abdominal, intraoperative, pediatric, small organ, neonatal/adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, and musculoskeletal ultrasound imaging. AcuNav catheter indicated for right-heart intra-cardiac and intra-luminal visualization of anatomy, physiology, and other devices.

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

• Model 3001 system (K935595/S1)
• K973767
• K992580
• K992631
• K002807
• K991805
• K002470

Submission Summary (Full Text)

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Acuson Corporation

### 510(k) SUMMARY

# Sequoia Diagnostic Ultrasound System Signature II

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 By: 1.

Acuson Corporation 1220 Charleston Road PO Box 7393 Mt. View, California 94039-7393

Contact Person Mr. Jerrv W. Tsutsumi Regulatory Affairs Department Phone: [phone] [phone] Fax:

### Date Prepared

26 June 2002

#### 2. Proprietary Name:

Sequoia Diagnostic Ultrasound System Signature II

### Common/ Usual Name:

Diagnostic Ultrasound System with Accessories

## Classification Name:

| 21 CFR 892.1550 | | |
|------------------------------------------|--------------|---------------------|
| Ultrasonic Pulsed Doppler Imaging System | FR# 892.1550 | Product Code 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | FR# 892.1560 | Product Code 90-IYO |
| Diagnostic Ultrasound Transducer | FR# 892.1570 | Product Code 90-ITX |
| Diagnostic Intravascular Catheter | FR# 870.1200 | Product Code 90-DQO |

#### Predicate Device: 3.

K935595/S1 (3/2/1995) cleared as Model 3001 system, marketed as the Sequoia diagnostic ultrasound system with subsequent modifications.

#### 4. Device Description:

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, color Doppler mode, Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

The Sequoia system has been designed to meet the following product safety standards:

- I UL 2601-1, Safety Requirements for Medical Equipment
- CSA C22.2 No. 601-1. Safety Requirements for Medical Equipment I
- . AIUM/NEMA UD-2. 1998. Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 에 AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 93/42/EEC Medical Devices Directive
- l Safety and EMC Requirements for Medical Equipment
- EN 60601-1

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- l EN 60601-1-1
- I EN 60601-1-2
- IEC 1157 Declaration of Acoustic Power l
- ISO 10993 Biocompatibility 트

#### 5. Intended Uses:

The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculoskeletal (Superficial and Conventional) 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.

The AcuNay diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

#### Technological Comparison to Predicate Device: 6.

The Sequoia is substantially equivalent to Model 3001, K935595/S1/S1, and to products that are already cleared for USA distribution with the following 510(k) premarket notification numbers K973767, K992580, K992631, K002807, K991805, and K002470. All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations.

## End of 510(k) Summary

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

Acuson Corporation % Mr. Mark Job Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K022567

Trade Name: Sequoia® Diagnostic Ultrasound System Signature II Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: August 1, 2002 Received: August 2, 2002

Dear Mr. Job:

We have reviewed your Section 510(k) premarket 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 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). 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, labeline, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Sequoia® Diagnostic Ultrasound System Signature II, as described in your premarket notification:

Transducer Model Number

4C1 5C2

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| Page 2 | Mr. Job | |
|--------|---------|--|
| | | |

| 6C2 |
|-----------------|
| 8C4 |
| EC10c5 |
| EV8C4 |
| 6L3 |
| AcuNav (IC10V5) |
| 8L5 |
| 8L5T |
| 13L5SP |
| 15L8 |
| 15L8w |
| V5M TEE |
| V7M TEE |
| V7B TEE |
| Sirius |
| 3V2c |
| 4V1 |
| 4V2 |
| 5V2c |
| 7V3c |
| 8V5 |
| 10V4 |
| AUX CW |

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 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.

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 (OS) 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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Page 3 - Mr. Job

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free 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 Rodrigo C. Perez at [phone].

Sincerely yours.

David G. Lyron

in

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

Enclosure(s)

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Acuson Corporation

Sequoia Diagnostic Ultrasound System Signature II the state of the state of the states and 510(k) Submission

Page 1 of 1

510(k) Number (if known): KO YO S67

Sequoia Diagnostic Ultrasound System Signature II Device Name:

Indications for Use:

The Sequoia system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult and pediatric), Trans-esophageal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (Superficial and Conventional) 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.

The AcuNav diagnostic ultrasound catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart - for use in the right heart only.

(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)

or

Over-the-Counter-Use (Optional Format 1-2-96)

David A. Pearson

(Division Sign-Off) Division of Reproductive, Abo and Radiological Device 510(k) Numbe