APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM

K072826 · Toshiba America Medical Systems, In.C · ITX · Oct 24, 2007 · Radiology

Device Facts

• Record ID: K072826
• Device Name: APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: ITX · Radiology
• Decision Date: Oct 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Aplio ARTIDA is intended to be used to display cardiac images.

Device Story

Mobile diagnostic ultrasound system; employs sector array transducers (2.5-3.0 MHz). Inputs: ultrasonic pulses; outputs: cardiac images (2D, 3D/4D, Doppler). Operated by clinicians in clinical settings. Transforms acoustic echoes into visual cardiac representations; supports real-time 3D/4D volume tissue acquisition. Output used by physicians for cardiac assessment and clinical decision-making. Benefits: non-invasive visualization of cardiac structures and function.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 standards for acoustic output and safety.

Technological Characteristics

Mobile ultrasound system; sector array transducers (PST-30BT, PST-25PX). Frequency range 2.5-3.0 MHz. Track 3 device. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, AIUM-NEMA UD2, AIUM-NEMA UD3.

Indications for Use

Indicated for cardiac imaging (adult and pediatric) using B-mode, THI, M-mode, Color Doppler, PW/CW Doppler, and Realtime 3D/4D volume tissue scan acquisition.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Toshiba SSA-790A Aplio XG Diagnostic Ultrasound (k063130)
• GE Medical Systems Vivid7 Diagnostic Ultrasound system (k060542)

Submission Summary (Full Text)

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KD72826

### 0CT 2 4 2007 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|--------------------------|-------------------------------------------------------|
| Address: | PO Box 2068, 2441 Michelle Drive Tustin, CA 92781-206 |
| Contact: | Paul Biggins, Director of Regulatory Affairs |
| Telephone No.: | [phone] |
| Device Proprietary Name: | SSH-880A, Aplio ARTIDA Version 1.00 |
| Common Name: | Diagnostic Ultrasound System |

### Classification:

Regulatory Class: II Review Category: Tier II

Ultrasonic Pulsed Doppler Imaging System - Product Code: 90-IYN [Fed.Reg.No .: ,892.1550] Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed.Reg.No .: ,892.1560] Diagnostic Ultrasonic Transducer - Product Code: 90-ITX [Fed.Reg.No .: 892.1570]

## Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

- 1. Toshiba SSA-790A Aplio XG Diagnostic Ultrasound; 510(k) control number k063130.
- 2. GE Medical Systems Vivid7 Diagnostic Ultrasound system; 510(k) control number k060542.

# Device Description:

The Aplio ARTIDA Ultrasound System is a mobile system. This system is a Track 3 device that employs sector array with a frequency range of approximately 2.5 MHz to 3.0 MHz.

## Intended Use:

The Aplio ARTIDA is intended to be used to display cardiac images.

### Safety Considerations:

This device is designed and manufactured in conjunction with the Quality System Regulation, IEC 60601-1 (applicable portions), IEC 60601-1-2 (applicable portion), IEC60601-2-37 (applicable portions), and the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound systems and the AIUM-NEMA UD3 Output Display Standard.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 4 2007

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K072826

Trade/Device Name: APLIO ARTIDA Diagnostic Ultrasound System Model SSH-880A version 1.0 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: October 2, 2007 Received: October 3, 2007

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, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the APLIO ARTIDA Diagnostic Ultrasound System Model SSH-880A version 1.0, as described in your premarket notification:

### Transducer Model Number

| PST-30BT |
|----------|
| PST-25PX |

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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 (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 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.

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]. 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

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If you have any questions regarding the content of this letter, please contact Lauren Hefner at [phone].

Sincerely yours,

forú hthang

Jr. 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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# Diagnostic Ultrasound Indications For Use Form

Transducer System_X SSH-880A Version 1.00 Model 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|------------------------|---------------|
| Clinical<br>Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify)* | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>(Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac[1] | N | N | N | N | | | | N | N | | | | N |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:

| [1] Cardiac is Adult and Pediatric. |
|---------------------------------------------------------------------------------------|
| [*] Combined modes are : B/M; B/PWD; BDF/PWD; BDF/MDF;<br>BDF/MDF/PWD2D/CWD; BDF/CWD; |
| [*] RT3D is Realtime 3D/4D volume tissue scan acquisition. |

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

Prescription Use (Per 21 CFR 801.109)11

Aoyn M. Wh

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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# Diagnostic Ultrasound Indications For Use Form

System Transducer X Model PST-30SBT 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|------------------------|---------------|
| Clinical<br>Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify)* | RT3D<br>Mode* |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative<br>(Specify) | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac1 | N | N | N | N | | | | N | N | | | | N |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | | | |
| Superficial | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | |

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

Additional Comments:

| [1] Cardiac is Adult and Pediatric. |
|------------------------------------------------------------|
| [*] Combined modes are : B/M; B/PWD; BDF/PWD; BDF/MDF; |
| BDF/MDF/PWD2D/CWD; BDF/CWD; |
| [*] RT3D is Realtime 3D/4D volume tissue scan acquisition. |

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

Prescription Use (Per 21 CFR 801.109)

Jorgi M. Whaz

(Division Sign-Off) Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

{6}------------------------------------------------

# Diagnostic Ultrasound Indications For Use Form

Transducer X System PST-25PX Model 510(k) Number(s)

| | Mode of Operation | | | | | | | | | | | | | |
|----------------------------------|-------------------|-----|---|------------------|-------|-----------------|-----|----|----|-----------|------------------------|------------------------|---------------|---|
| Clinical<br>Application | B | THI | M | Color<br>Doppler | Power | Dynamic<br>Flow | TDI | PW | CW | CHI<br>2D | CHI<br>Dynamic<br>Flow | Combined<br>(Specify)* | RT3D<br>Mode* | |
| Ophthalmic | | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | | |
| Intraoperative<br>(Specify) | | | | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | | |
| Cardiac [1] | N | N | | | | | | | | | | | | N |
| Transesophageal | | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | | | | |

N= new indication: P = Previously Cleared by FDA E Added under Appendix E (ITE)

N= new indication; P = Previously Cleared by FDA; E = Added under Appendix E (LTF)

#### Additional Comments:

| [1] Cardiac is Adult and Pediatric. |
|------------------------------------------------------------|
| [*] Combined modes are: None |
| [*] RT3D is Realtime 3D/4D volume tissue scan acquisition. |

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

Prescription Use (Per 21 CFR 801.109)

Aomi m. Whang

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number