TERATECH MODEL 10V5 SMART PROBE

K040840 · Teratech Corp. · ITX · Apr 14, 2004 · Radiology

Device Facts

• Record ID: K040840
• Device Name: TERATECH MODEL 10V5 SMART PROBE
• Applicant: Teratech Corp.
• Product Code: ITX · Radiology
• Decision Date: Apr 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The TERATECH Model 10V5 Smart Probe 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 TERATECH Model 10V5 Smart Probe is a diagnostic ultrasound transducer designed for use with the Terason Model 2000 portable ultrasound system. It functions as a phased array probe (7 MHz, 128 elements) to capture ultrasound signals from the human body. The system processes these signals to generate real-time diagnostic images and fluid flow analysis, which are displayed to the clinician. The device is operated by healthcare professionals in hospitals, clinics, and military field settings. The output assists clinicians in diagnostic imaging and procedural guidance (e.g., needle placement, biopsies). The probe's portability and integration with the Model 2000 system facilitate point-of-care diagnostics.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on identical design and materials to the predicate device.

Technological Characteristics

Phased array transducer; 7 MHz frequency; 128 elements; 0.110 mm pitch; 6.0 mm elevation width; 36.5 mm geometric focus; 14.1 mm azimuth length. Designed for use with Terason Model 2000 portable ultrasound system.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in clinical applications including intra-operative (specialized and neuro), pediatric, and cardiac (adult and pediatric) settings. Includes ultrasound guidance for needle/catheter placement, cryosurgery, brachytherapy, amniocentesis, and infertility monitoring. Used in hospital, clinic, and military field settings.

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

• Acuson 10V4 Sequoia Ultrasound System and Harmonic Imaging (K97367)
• Acuson Aspen Ultrasound System (K991805)

Submission Summary (Full Text)

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# APR 1 4 2004

Kotto sto
Finge 12

## 510(k) Summary for TERATECH Model 10V5 Smart Probe

#### 1. SPONSOR

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

| Contact Person: | Charles F. Hottinger, Ph.D., RAC,<br>Regulatory Affairs Consultant |
|-----------------|--------------------------------------------------------------------|
|-----------------|--------------------------------------------------------------------|

Telephone: [phone]

Date Prepared: March 8, 2004

#### DEVICE NAME 2.

| Proprietary Name: | TERATECH Model 10V5 Smart Probe |
|----------------------|---------------------------------------------------------------|
| Common/Usual Name: | Diagnostic Ultrasound Transducer |
| Classification Name: | Diagnostic Ultrasound Transducer<br>(21 CFR 892.1570, 90-ITX) |

#### 3. PREDICATE DEVICES

Acuson 10V4 Sequoia™ Ultrasound System and Harmonic Imaging (K97367) Acuson Aspen™ Ultrasound System (K991805)

#### 4. INTENDED USE

The TERATECH Model 10V5 Smart Probe 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 DESCRIPTION 5.

The TERATECHModel 10V5 Smart Probe is intended for use with the Model TERATECH 2000 , a portable ultrasound imaging system. Technical

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specifications for the Model 10V5 Smart Probe with the Model 2000 are as follows:

| Probe<br>Description<br>(Frequency /<br>Elements) | Array<br>Type | Pitch<br>(mm) | Elevation<br>Width<br>(mm) | Geometric<br>Focus<br>(mm) | Azimuth<br>Radius<br>(mm) | Azimuth<br>Length<br>(mm) |
|---------------------------------------------------|---------------|---------------|----------------------------|----------------------------|---------------------------|---------------------------|
| 7 Mhz /128 | Phased | 0.110 | 6.0 | 36.5 | Flat | 14.1 |

#### 7. BASIS FOR SUBSTANTIAL EQUIVALENCE

The TERATECH Model 10V5 Smart Probe is substantially equivalent to the Acuson 10V4, which is currently in commercial distribution in the United States. The TERATECH Model 10V5 Smart Probe is identical in design and materials to the Acuson 10V4; when operated with the TERATECH Model 2000 portable imaging system, the Model 10V5 has intended uses and a mode of operation which are a subset of those of the predicate.

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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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

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

Re: K040840

Trade Name: Model 10V5 Smart Probe Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: Class II Product Code: 90 ITX Dated: March 29, 2004 Received: April 1, 2004

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 Model 10V5 Smart Probe, as described in your premarket notification:

## Transducer Model Number

## 10V5 Smart Probe

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);

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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]. 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 A. Lyons

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

Enclosure

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## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

| System: | Terason Model 2000 Portable 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 | Fetald | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Abdominald: | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Intra-operative (Spec.)d,e | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Intra-operative (Neuro) | N | N | N | | N | N | N |
| | Laparoscopic | | | | | | | |
| | Pediatricd: | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Neonatal Cephalicd: | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Adult Cephalicd: | P1,4 | P2,4 | P2,4 | | 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.)h: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Musculo-skel. (Superfic)i: | P2,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P1 | P2 | P2 | | P2 | P2 | P2 |
| | Cardiac Pediatric | P1 | P2 | P2 | | P2 | P2 | P2 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vesselj: | 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 Dopler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

8+M; B+PWD; B+CD; 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 "Includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development. " Includes guidance of amilocentesis, infertility monitoring of follicle development.

Additional Comments: P : uses previously cleared under K992505 with 3 MHz Model L3 (Linear); P: uses previously cleared under K012191; P: uses previously cleared under K010883 (c.need); previously cleared under K030191

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)

David G. Larson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K040840

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| System: | Terason Model 2000 Portable Ultrasound System | | | | | | | |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------|------|------|-----|----------------|-----------------|--------|
| Transducer: | 10V5 | | | | | | | |
| 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 | Fetaln | | | | | | | |
| | Abdominalo: | | | | | | | |
| | Intra-operative (Spec.)a | P1,4 | P4 | P4 | | P4 | P4 | P4 |
| | Intra-operative (Neuro) | N | N | N | | N | N | N |
| | Laparoscopic | | | | | | | |
| | Pediatricc: | P1,4 | P2,4 | P2,4 | | P2,4 | P2,4 | P2,4 |
| | Small Organ (Thyroid,<br>Breast, Testes, etc.)d: | | | | | | | |
| | Neonatal Cephalicc: | | | | | | | |
| | Adult Cephalicc: | | | | | | | |
| | Trans-rectalf: | | | | | | | |
| | Trans-vaginalp: | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.)g: | | | | | | | |
| | Musculo-skel. (Superfic)g: | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | P1 | P2 | P2 | | P2 | P2 | P2 |
| | Cardiac Pediatric | P1 | P2 | P2 | | P2 | P2 | P2 |
| | Trans-esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessele: | | | | | | | |
| | Other (Specify) | | | | | | | |

## DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

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.

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

° Harmonic Imaging (HI)

· 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.

Additional Comments: P': uses previously cleared under K992505 with 3 MHz Model L3 (Linear); P: uses previously cleared under K012191; P2: uses previously cleared under K010883; P": uses previously cleared under K030191

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)

David H. Ingram

(Division Sign-Off) Division of Reproductive, A and Radiological Devi 510(k) Number