HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000

K981397 · Toshiba America Medical Systems, In.C · IYN · Jul 31, 1998 · Radiology

Device Facts

• Record ID: K981397
• Device Name: HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: IYN · Radiology
• Decision Date: Jul 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended use remains unchanged from the SSA-380A.

Device Story

The PowerVision 7000 (SSA-380A) is a diagnostic ultrasound system modified to support harmonic imaging and Flash Echo Imaging (FEI). The system transmits at one frequency and receives returning harmonic echoes at a different frequency, based on Rayleigh's theory that bubbles in an ultrasonic field radiate harmonic echoes. The modification involves new/modified circuit boards and software updates to enable two existing transducers (PSK-25AT, PVT-357AT) to process these harmonic signals. Used in clinical settings by trained professionals, the system provides real-time ultrasound images. The output allows clinicians to visualize anatomical structures and blood flow, potentially enhancing diagnostic clarity when used with contrast agents. The modification does not alter acoustic output levels compared to conventional ultrasonography.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and the technological similarity to predicate devices. The FDA required a post-clearance special report containing acoustic output measurements based on production line devices.

Technological Characteristics

Diagnostic ultrasound system; utilizes harmonic imaging (receiving echoes at multiples of the incident frequency). Includes modified circuit boards and software for harmonic processing. Transducers: PSK-25AT, PVT-357AT. Operates under 21 CFR 892.1550 (Ultrasonic Pulsed Doppler) and 892.1570 (Diagnostic Ultrasonic Transducer).

Indications for Use

Indicated for diagnostic ultrasound imaging in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, transesophageal, transrectal, transvaginal, transurethral, and peripheral vascular applications. Includes use with contrast agents for approved indications. 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

• HP Sonos 2500 (K964309)
• ATL Level 10 HDI (K961459)
• Diasonics/Vingmed System 5 (K963315)
• Toshiba SSA-380A PowerVision (K933473 & K943303)

Submission Summary (Full Text)

{0}------------------------------------------------

#### JUL 31 1000

# 510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

KQ81397

| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|-------------------|---------------------------------------------------------|
| Address: | P.O. Box 2068,2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Regulatory Affairs Specialist |
| Telephone No .: | [phone] |

Device Proprietary Name: PowerVision 7000 Ultrasound Imaging System Common Name:

## Classification:

Regulatory Class: П Tier II Review Category: Ultrasonic Pulsed Doppler Imaging System Accessory [Fed.Reg.No .: 892.1550.Pro.Code:90-IYN]

## Identification of Predicate Devices:

Toshiba America Medical Systems believes that the SSA-380A PowerVision 7000 is substantially equivalent to:

- 1) HP Sonos 2500 510(k) K964309 found to be SE on April 22, 1997
- 2) ATL Level 10 HDI 510k) K961459 found to SE on March 26,1997
- 3) Diasonics/Vingmed System 5 510(k) K963315 found to be SE on March 17, 1997
- 4) Toshiba SSA-380A PowerVision 510(k)s K933473 & K943303

#### Device Description:

Functionality: This modification will allow the existing SSA-380A system to transmit at one frequency and receive the returning echo at a different frequency.

Scientific Concept: Rayleigh's theory predicts that a bubble in an ultrasonic field will radiate harmonic echoes that are multiples of the incident beam. This theory also stipulates that the second resonated frequency echoed could possibly be higher that the echoed fundamental frequency. This modification equips the SSA-380A to detect and process those harmonic echoes.

Description of Modification: The modification includes the addition of several new/modified circuit boards and modifications to the software to allow two existing transducers to operate in this manner.

Significant Safety Concerns: None. The FDA is currently evaluating the use of contrast agents for their Safety and Effectiveness. This modification does not change the amount of acoustic output required in conventional ultrasonography. The modification is to provide and existing device with the capability of receiving echoes at a frequency different than the transmitted frequency.

#### Statement of Intended Use:

Intended use remains unchanged from the SSA-380A.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

JUL 31

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paul Bigggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. P.O. Box 2068 2441 Michelle Drive Tustin, CA 92781-2068

Re: K981397 Trade Name: Harmonic Imaging and Flash Echo Imaging Function for the SSA-380A Diagnostic Ultrasound System (PowerVision 7000) Regulatory Class: II/21 CFR 892.1550/21 CFR 892.1570 90 IYN/90 ITX Product Code: Dated: July 1, 1998 Received: July 2, 1998

Dear Mr. Biggins:

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 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 SSA-380A Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

PSK - 25AT PVT - 357AT

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. A 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 regulations.

{2}------------------------------------------------

#### Page 2 - Paul Biggins

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 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 807.97). Other general information on your responsibilities under the Act may 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 Rodrigo C. Perez at [phone].

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{3}------------------------------------------------

## Diagnostic Ultrasound Indications For Use Form

System _X_ Transducer____________________________________________________________________________________________________________________________________________________________________ Model SSA-380A 510(k) Number(s) _K933743, K943303, K964865, K970047

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Tissue<br>Harmonics | Harmonics<br>w/Contrast | FEI |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|-------------------------|-----|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | p | p | p | p | p | p | p | p | * | n | | |
| Abdominal | p | p | p | p | p | p | p | p | * | n | | |
| Intraoperative (Abdominal) | e | e | e | e | e | e | e | e | * | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | p | p | p | p | p | p | p | p | * | n | | |
| Small Organ | p | p | p | p | p | p | p | p | * | | | |
| -Breast | | | | | | | | | | | | |
| -Testicle | | | | | | | | | | | | |
| -Thyroid | | | | | | | | | | | | |
| Neonatal Cephalic | p | p | p | p | p | p | p | p | * | | | |
| Adult Cephalic | p | p | p | p | p | p | p | p | * | | | |
| Cardiac | p | p | p | p | p | p | p | p | * | n | n | n |
| Transesophageal | p | p | p | p | p | p | p | p | * | | | |
| Transrectal | p | p | p | p | p | p | p | p | * | | | |
| Transvaginal | p | p | p | p | p | p | p | p | * | | | |
| Transurethral | p | p | p | p | p | p | p | p | * | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | p | p | p | p | p | p | p | p | * | n | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Superficial | p | p | p | p | p | p | p | p | * | | | |
| Musculo-skeletal Conventional | p | p | p | p | p | p | p | p | * | | | |
| Other (specify) | | | | | | | | | | | | |
| | | | | | | | | | | | | |

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

Additional Comments: Combinations B/M, BDF/MDF, B/PWD, BDF/PWD, B-TDJ,M-TDI

The SSA-380A is ready for use with Contrast Agents for their approved uses.

(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)

Wilkan you

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

Radiological Devices
510(k) Number K981397

{4}------------------------------------------------

# Diagnostic Ultrasound Indications For Use Form

System _____ Transducer 区 Model PSK-25AT 510(k) Number(s) _K933743_

| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Tissue<br>Harmonics | Harmonics<br>w/Contrast | FEI |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|-------------------------|-----|
| Clinical Application | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ | | | | | | | | | | | | |
| -Breast | | | | | | | | | | | | |
| -Testicle | | | | | | | | | | | | |
| -Thyroid | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | p | p | p | p | p | p | p | p | * | n | n | n |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

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

Additional Comments: Combinations BM, BDF/MDF, B/PWD, BDF/PWD, B-TDI,M-TDI

The PSK-25AT is ready for use with Contrast Agents for their approved uses.

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

Prescription Use (Per 21 CFR 801.109)

W.Carlyn

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

510(k) Number K981397

{5}------------------------------------------------

## Diagnostic Ultrasound Indications For Use Form

System Transducer_X Model PVK-357AT 510(k) Number(s) K943303

| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Tissue<br>Harmonics | Harmonics<br>w/Contrast | FEI |
|-------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|---------------------|-------------------------|-----|
| Ophthalmic | | | | | | | | | | | | |
| Fetal | | p | p | p | p | p | p | p | * | n | | |
| Abdominal | | p | p | p | p | p | p | p | * | n | | |
| Intraoperative (Abdominal) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Pediatric | | p | p | p | p | p | p | p | * | n | | |
| Small Organ | | p | p | p | p | p | p | p | * | | | |
| -Breast | | | | | | | | | | | | |
| -Testicle | | | | | | | | | | | | |
| -Thyroid | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Peripheral Vascular | | p | p | p | p | p | p | p | * | n | | |
| Laparoscopic | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | | |

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

Additional Comments: Combinations B/M, BDF/MDF, B/PWD, BDF/PWD, B-TDI,M-TDI

The PVK-357AT is ready for use with Contrast Agents for their approved uses.

(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)

(Division Sign-Off)

and Radiological Dev

510(k) Number

Division of Reproductive, Abdominal, ENT,