TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER

K051334 · Teratech Corp. · IYN · Jun 3, 2005 · Radiology

Device Facts

• Record ID: K051334
• Device Name: TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
• Applicant: Teratech Corp.
• Product Code: IYN · Radiology
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

Device Story

The TERASON Ultrasound System (Models t3000 and Echo) is a diagnostic ultrasound platform providing B-mode, M-mode, PWD, CWD, Color Doppler, and harmonic imaging. It processes ultrasound echoes to generate real-time images and flow analysis. The system features 128 transmit/receive channels (Echo model features 128 receive channels). It supports ECG triggering, tissue Doppler, and LV dyssynchrony assessment (Echo model). Operated by clinicians in hospitals, clinics, or military settings, the system provides visual output for diagnostic assessment and procedural guidance (e.g., needle/catheter placement). The device aids clinical decision-making by providing anatomical and hemodynamic information, potentially improving diagnostic accuracy and procedural safety.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is supported by performance testing and comparison of technical specifications and intended uses to the predicate device.

Technological Characteristics

Diagnostic ultrasound system with 128 transmit/receive channels. Modes: B, M, PWD, CWD, Color Doppler, Harmonic Imaging. Features include ECG trigger, tissue Doppler, and LV dyssynchrony assessment. Connectivity and software architecture are consistent with diagnostic ultrasound standards. Sterilization/biocompatibility requirements apply to transducers.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intra-operative, pediatric, small organ, neonatal/adult cephalic, trans-rectal, trans-vaginal, musculoskeletal, cardiac, and peripheral vessel applications. Includes ultrasound guidance for needle/catheter placement, cryosurgery, brachytherapy, and infertility monitoring. Used in hospital, clinic, and military field settings.

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

• Toshiba Powervision 6000 (K991710)

Submission Summary (Full Text)

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K051334

# 510(k) Summary TERATECH Corporation TERASON™ Ultrasound System with Continuous Wave (CW) Doppler

- 1. SPONSOR
2.

TERATECH Corporation 77-79 Terrace Hall Rd. Burlington, MA 01803

| Contact Person: | Charles F. Hottinger, Ph.D., RAC,<br>Regulatory Affairs Consultant | | | |
|--------------------|--------------------------------------------------------------------|--|--|--|
| Telephone: | 206-780-7945 | | | |
| Date Prepared: | May 11, 2005 | | | |
| DEVICE NAME | | | | |
| Proprietary Name: | TERASON™ Ultrasound System with Continuous<br>Wave (CW) Doppler | | | |
| Common/Usual Name: | Diagnostic Ultrasound System | | | |

- Classification Name: Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)
- 3. PREDICATE DEVICES

Toshiba Powervision 6000 (K991710)

- 4. INTENDED USE
The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this

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submission.

#### 5. DEVICE DESCRIPTION

The TERASON™ Ultrasound System with Continuous Wave (CW) Doppler introduces two new versions of the TERATECH Model 2000 Imaging System.

| | TERATECH | TERASON ™ | TERASON ™ |
|--------------------------------------------|----------|-----------|-----------|
| | 2000 | t3000 | Echo |
| Transmit: Receive<br>Beam forming Channels | 128:64 | 128:64 | 128:128 |
| CW Doppler | No | Yes | Yes |
| ECG Trigger | No | Yes | Yes |
| Tissue Doppler | No | No | Yes |
| LV Dyssynchrony<br>Assessment | No | No | Yes |

#### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The TERASON™ Ultrasound System is substantially equivalentto the Toshiba Powervision 6000, which is currently in commercial distribution in the United States. Since it is identical in modes of operation, and intended for the same clinical applications, as described in this submission.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

JUN 3 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TERATECH Corporation % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K051334

K031334
Trade Name: TERASON Ultrasound System with Continuous Wave Doppler 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: IYN, IYO, and ITX Dated: May 19, 2005 Received: May 23, 2005

## Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Soctor o re(i) proxing 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 merslate collinered pror to May 20, 1978, its classified in accordance with the provisions of the Amendinents, or to devices and Cosmetic Act (Act). You may, therefore, market the device, subject to Federal Food, Drug, and Oosmetic Fee et. The general controls provisions of the Act include the general controls provisions of the Frica - Fift going of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for I mis deternmination of subbanial vith Continuous Wave Doppler, as described in your premarket notification:

Transducer Model Number

4C2 4V2

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (see above) into entrols. Existing major regulations affecting your device. FDA it may be subject to such additional controls: "Listing negation of 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 800 to 100 can be found in the Code of I cuctar Rogalations, Friderice in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substitive with other requirements of the Act
that FDA has made a determination that your device also anaios. You must that FDA has made a delefinination and your arres by other Federal agencies. You must or any Federal statutes and regulations administered by Septiration and listing (21)
comply with all the Act's requirements, including, but not limited on viraments as set comply with all the Act s requirements, mortalians practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god if caplicable, the electronic CFR Part 807); labeling (21 CFA 1 at 601); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicab forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

This determination of substantial equivalence is granted on the prior to shipping of This determination of substantial cquivalence special report. This seport should contain complete the first device, you submit a postclearance spocal reportan ine devices, requested
information, including acoustic output measurements based on production for Masufaqurers information, including accusur output measurements 30, 1997 "Information for Manufacturers" in Appendix G, (enclosed) of the Celler's beptems and Translucers." If the special Seeking Marketing Clearance of Diagnosite United Oritus output greater than approved report is incomplete of contails macceptable values (orgi, accuration of possible 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 The special report should reference are marked 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 I his letter will anow you to begin marketing your device of your device to a legally marketed nothication. The FDA midnig of substantial equivalier of 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 If you desire specific advice ion your act [phone]. Also, please note the regulation entitled, Contact the Office of Compunation at (210FR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-204 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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Page 3 – Mr. Job

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Rat C. Pelly

ﮨﮯ

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

| System: | TERASON™ Ultrasound System | | | | | | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|-------------------|------|------|-----|----------------|-----------------|--------|
| Transducer: | (see comments) | | | | | | | |
| | Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | |
| Clinical Application | | Mode of Operation | | | | | | |
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb.<br>Modesb | Otherc |
| Ophthalmic | Ophthalmic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Fetalh | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Abdominali: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| | Intra-operative (Spec.)j,k | P4 | P4 | P4 | | P4 | P4 | P4 |
| | Intra-operative (Neuro) | P5 | P5 | P5 | | P5 | P5 | P5 |
| | Laparoscopic | P6 | P6 | P6 | | P6 | P6 | P6 |
| | Pediatricd: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| | Small Organ (Thyroid, Breast, Testes, etc.)c,d: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Neonatal Cephalice: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| | Adult Cephalice: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| | Trans-rectalf: | P2,4 | P3,4 | P3,4 | | P3,4 | P3,4 | P3,4 |
| | Trans-vaginalg: | P2,4 | P3,4 | P3,4 | | P3,4 | P3,4 | P3,4 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Musculo-skel. (Superfic)e: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P1 | P2 | P2 | N | P2 | P2 | P2 |
| | Cardiac Pediatric | P1 | P2 | P2 | N | P2 | P2 | P2 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Other (Specify) | | | | | | | |

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

Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

" Molades Oblor Boppicil (OD), B+DPD, B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

* Abdominal organs and peripheral vessel.

I Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

Includes guidance of amniocentesis, infertility monitoring of follicle development. 1

System uses previously cleared under K992505 with 3 MHz Mindel L3 (Linear).

2 System uses previously cleared under K0121919
3 System uses previously cleared under K0121919
3 System uses previously cleared under K012191

3 System uses previously cleared under K010883.

* System uses previously cleared under K010003.
* System uses previously cleared under K030199.

System uses previously cleared under K040840.

System uses previously cleared under K040040.

Includes uses in military field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Ruta Phillips

(Division Sign-Off and Ra 510k) Nur

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| System: | TERASON TM Ultrasound System |
|---------|------------------------------|
|---------|------------------------------|

Transducer: 4C2

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

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|--------------------------------------------------|-------------------|------|------|-----|----------------|-----------------|--------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb.<br>Modesb | Otherc |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetald | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Abdominald: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| | Intra-operative (Spec.)d,e | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricd: | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicd: | | | | | | | |
| | Adult Cephalicd: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalg: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | N1 | N2 | N2 | N | N2 | N2 | N2 |
| | Cardiac Pediatric | N1 | N2 | N2 | N | N2 | N2 | N2 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | Other (Specify) | | | | | | | |

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

' Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

0 B+M; B+PWD; B+CD; B+DPD; B+PD.

° Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

9 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).
3 System uses previously cleared under K992505

2 System uses previously cleared under K012191.

System uses previously cleared under K012103183.

* System uses previously cleared under K030191.

System uses previously cleared under K040840.

· System uses previously cleared under K043278.

Includes uses in military field settings in addition to hospital/clinic settings. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Rach Phillips

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

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TERASON ™ Ultrasound System System:

Transducer: 4V2

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

| Clinical Application | Mode of Operation | | | | | | | |
|-----------------------------|--------------------------------------------------|------|------|------|-----|----------------|----------------|--------|
| General<br>(Track I Only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppa | Comb<br>Modesb | Otherc |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetalh | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Abdominald: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| | Intra-operative (Spec.)a,e | N4 | N4 | N4 | | N4 | N4 | N4 |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| Fetal<br>Imaging<br>& Other | Pediatricc: | P1,4 | P2,4 | P2,4 | N | P2,4 | P2,4 | P2,4 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicc: | P1 | P2 | P2 | N | P2 | P2 | P2 |
| | Adult Cephalicc: | P1 | P2 | P2 | N | P2 | P2 | P2 |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalf: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)d: | | | | | | | |
| | Musculo-skel. (Superfic)d: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P1 | P2 | P2 | N | P2 | P2 | P2 |
| | Cardiac Pediatric | P1 | P2 | P2 | N | P2 | P2 | P2 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesseld: | | | | | | | |
| | Other (Specify) | | | | | | | |

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

Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

B+M; B+PWD; B+CD; B+DPD; B+PD.

°Harmonic Imaging (HI)

4 Includes ultrasound guidance for placement of needles, catheters.

Abdominal organs and peripheral vessel.

Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy

4 Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.

" Includes guidance of amniocentesis, infertility monitoring of follicle development.

System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).
3 System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).

2 System uses previously cleared under K012191.

3 System uses previously cleared under K010883.

"System uses previously cleared under K010003.
* System uses previously cleared under K030191.

System uses previously cleared under K0408441.
* System uses previously cleared under K040844.
* System uses previously cleared under K040830.

* System uses previously cleared under K043278.

Includes uses in military field settings in addition to hospital/clinic settings.

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

Concurrence of Center for Devices and Radiological Health, Office of Device Evaluation Prescription Use (Per 21 CFR 801.109)

Rata Phillips

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