K Number

Device Name

TERATECH MODEL 10V5 SMART PROBE

Manufacturer

TERATECH CORP.

Date Cleared

2004-04-14

(13 days)

Product Code

ITX

Regulation Number

892.1570

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

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K97367, K991805

Reference Devices

K992505, K012191, K010883, K030191

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no information about training or test sets, which are typical for AI/ML devices.

Therapeutic

No.
The intended use explicitly states "diagnostic ultrasound imaging or fluid flow analysis," which indicates a diagnostic rather than a therapeutic purpose.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The TERATECH Model 10V5 Smart Probe is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "Smart Probe" intended for use with a "portable ultrasound imaging system," indicating it is a hardware component (a probe) and not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the TERATECH Model 10V5 Smart Probe is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states "diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device used on the human body for imaging and analysis, not a device used to test samples taken from the human body (which is the definition of an IVD).
Device Description: It's described as a "portable ultrasound imaging system". Ultrasound imaging is a non-invasive diagnostic technique performed directly on the patient.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components associated with in vitro diagnostics.

Therefore, the TERATECH Model 10V5 Smart Probe is a medical device used for in vivo diagnostic imaging, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes (comma separated list FDA assigned to the subject device)

90 ITX

Device Description

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (Thyroid, Breast, Testes, etc.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic), Intra-luminal, Cardiac Adult, Cardiac Pediatric, Trans-esoph. (Cardiac), Peripheral vessel

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K992505, K012191, K010883, K030191

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.

Summary

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,
Regulatory Affairs Consultant |

-----------------	--------------------------------------------------------------------

Telephone: 206-780-7945

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
(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

Kojovic
Snezana

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

| Probe
Description
(Frequency /
Elements) | Array
Type | Pitch
(mm) | Elevation
Width
(mm) | Geometric
Focus
(mm) | Azimuth
Radius
(mm) | Azimuth
Length
(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.

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);

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.

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

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

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
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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,
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
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

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
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
Fetal
Imaging
& 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,
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
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