TERATECH, MODEL 2000 IMAGING IMAGING

K992505 · Teratech Corp. · IYO · Nov 10, 1999 · Radiology

Device Facts

• Record ID: K992505
• Device Name: TERATECH, MODEL 2000 IMAGING IMAGING
• Applicant: Teratech Corp.
• Product Code: IYO · Radiology
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TERATECH Model 2000 is intended for abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fetal imaging. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: [Table indicates B-Mode operation for Fetal, Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Cardiac, and Peripheral Vascular applications]. Intended for use in military field settings in addition to hospital/clinic settings.

Device Story

Portable ultrasound imaging system; consists of laptop computer and 3 MHz linear array ultrasonic probe. Inputs: ultrasonic echoes from patient tissue. Processing: B-Mode (grayscale) imaging; image processing includes gamma correction, dynamic range adjustment, and speckle noise reduction. Outputs: 2D grayscale images displayed on 14.1" LCD; S-VHS/VGA video output. Used in hospitals, clinics, and military field settings by trained clinicians. Output allows visualization of internal structures for diagnostic assessment; aids clinical decision-making by providing real-time anatomical imaging in portable environments.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Portable laptop-based ultrasound system; 3 MHz linear array transducer. Frequencies: 2-4 MHz. Frame rate: 15-30 fps. 128 lines per frame. 256 gray shades. Power: 115 VAC, <20 W consumption. Dimensions: 12.2" x 10" x 2". Weight: 12 lb. Connectivity: S-VHS and VGA output.

Indications for Use

Indicated for diagnostic ultrasound imaging (B-Mode) in fetal, abdominal, pediatric, neonatal cephalic, adult cephalic, cardiac, and peripheral vascular applications. Intended for use in hospital, clinic, and military field settings.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• ATL High-Definition Imaging UltraMark-9 (K903603)
• B&K 3535 (K914945)
• Tetrad 2300 E/U (K946277)

Submission Summary (Full Text)

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

K992505

# 510(k) Summary for TERATECH Model 2000 Imaging System

#### 1. SPONSOR

Teratech Corporation 223 Middlesex Turnpike Burlington, MA 01803

| Contact Person: | Alice Chiang, President |
|-----------------|-------------------------|
| Telephone: | 781-270-4143 |

July 26, 1999 Date Prepared:

#### 2. DEVICE NAME

| Proprietary Name: | TERATECH Model 2000 Imaging System |
|----------------------|-----------------------------------------------------------------|
| Common/Usual Name: | Diagnostic Ultrasound Imaging System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) |
| | Diagnostic Ultrasound Transducer (21 CFR 892.1570, 90-ITX) |

#### 3. PREDICATE DEVICES

ATL High-Definition Imaging UltraMark-9 (K903603) B&K 3535 (K914945) Tetrad 2300 E/U (K946277)

#### 4. INTENDED USE

The TERATECH Model 2000 is intended for abdominal, pelvic, cardiac, peripheral vascular, neurovascular, and fetal imaging.

#### ട്. DEVICE DESCRIPTION

The TERATECH Model 2000 is a portable ultrasound imaging system with grayscale or brightness (B-Mode) imaging. The Model 2000 consists of a laptop computer and a 3 MHz linear array ultrasonic probe. Technical specifications for the Model 2000 are as follows:

7/26/99

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

| System frequencies: | 2-4 MHz |
|------------------------------------------|-------------------------------------------------------------|
| Frame rate: | 15-30 fps (imaging only) |
| Number of ultrasound lines<br>per frame: | 128 |
| Fields of view: | 2-27 cm |
| Mode of Operation: | 2D imaging |
| Image display: | Rectangular and trapezoidal |
| Video: | S-VHS Output, External VGA Monitor |
| LCD size: | 14.1" |
| Gray shades: | 256 |
| Image magnification: | 1X-4X, probe dependent |
| Image presentation: | black/white, left/right, up/down |
| Image processing: | gamma correction, dynamic range, speckle noise<br>reduction |
| Input power: | 115 VAC, A/C adapter rated @ 60 W |
| Power consumption: | <20 W |
| Leakage current: | 50 μA max |
| Primary breakdown voltage: | 2500 V AC min |
| Size: | Width: 12.2"<br>Height: 10"<br>Depth: 2" |
| Weight: | 12 lb (laptop and probe) |

#### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The TERATECH Model 2000 is substantially equivalent to other diagnostic ultrasound devices currently in commercial distribution in the United States. Examples of these devices are the ATL High-Definition Imaging UltraMark-9 (K903603), the B & K 3535 (K914945), and the Tetrad 2300 E/U (K946277). The Model 2000 has the same intended uses as each of these predicates and offers similar operating features. The main differences between the Model 2000 and the predicate devices are the compact size and low power consumption of the Model 2000.

7/26/99

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 1898

Teratech Corporation Sheila Hemeon-Heyer Senior Staff Consultant c/o Medical Device Consultants, Inc. 49 North Plain Street North Attleboro, MA 02740

K992505 Re: Teratech Model 2000 Imaging System Dated: September 29, 1999 Received: September 30, 1999 Requlatory Class: II 21 CFR 892.1560/Procode: 90 IYO

Dear Ms. Hemeon-Heyer:

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 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 provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, qood manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Teratech Model 2000 Imaging System, as described in your premarket notification:

### Transducer Model Number

L3 (3 MHz Linear Array)

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 regulations 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 Failure to comply with the GMP regulation may result in assumptions. In addition, the Food and Drug Administration (FDA) may regulatory action. 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.

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

## Page 2 - Sheila Hemeon-Heyer

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. Tt 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 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 internat 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].

and

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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

# Dlagnostic Ultrasound Indications for Use Form Teratech Model 2000 Imaging System

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

| | 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 | | N | | | | | | | | | |
| Abdominal | | N | | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | | | | | | | | | |
| Small Organ(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | N | | | | | | | | | |
| Adult Cephalic | | N | | | | | | | | | |
| Cardiac | | N | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

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

For use with 3 MHz Model L3 Transducer. Additional Comments: Intended for use 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 CDRH, Office of Device Evaluation

Prescription Use (Per CFR 801.108)

..

Emil A. Severson

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

a comments paparticipal

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

... . ...:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

. . . . . .

## Diagnostic Ultrasound Indications for Use Form 3 MHz Model L3 Transducer for Teratech Model 2000 Imaging System

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

| | 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 | | N | | | | | | | | |
| Abdominal | | N | | | | | | | | |
| Intraoperative (Specify) | | | | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | N | | | | | | | | |
| Small Organ(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | N | | | | | | | | |
| Adult Cephalic | | N | | | | | | | | |
| Cardiac | | N | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

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

Intended for use in military field settings in addition to hospital/clinic Additional Comments: settings.

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

Prescription Use (Per CFR 801.108)

David A. Kyman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

: 上