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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TERATECH Model 10V5 Smart Probe, based on the provided document:

This 510(k) summary does not contain acceptance criteria in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. Instead, the device's acceptance is based on its substantial equivalence to existing predicate devices.

The "study" that proves the device meets the acceptance criteria is the comparison to predicate devices to demonstrate substantial equivalence.

Here's the information extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Key elements for Substantial Equivalence Determination)	Reported Device Performance (Characteristics of TERATECH Model 10V5 Smart Probe)
Design and Materials: Identical or substantially similar to predicate device.	Identical in design and materials to the Acuson 10V4.
Intended Use: Subset of or equivalent to predicate device's intended uses.	Intended uses and mode of operation are a subset of those of the predicate (Acuson 10V4 and Acuson Aspen Ultrasound Systems). The document lists specific clinical applications and modes of operation that are "previously cleared by FDA" (P) under various K-numbers, indicating they align with existing clearances for the predicate or similar devices. The 10V5 Smart Probe is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body (e.g., Fetal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel).
Technological Characteristics: Equivalent to predicate device.	Operates with the TERATECH Model 2000 portable imaging system. Technical specifications for the 7 Mhz / 128 Phased Array probe are provided (Pitch: 0.110mm, Elevation Width: 6.0mm, Geometric Focus: 36.5mm, Azimuth Radius: Flat, Azimuth Length: 14.1mm). Implicitly, these characteristics are considered equivalent or not raising new questions of safety and effectiveness compared to the predicate.
Acoustic Output: Within safe and effective levels (post-clearance report required).	A post-clearance special report is required to contain complete information, including acoustic output measurements based on production line devices. If these values are unacceptable, the 510(k) clearance may not apply.
Safety and Effectiveness: Does not raise new questions of safety or effectiveness.	The FDA's determination of substantial equivalence implies that the device does not raise new questions of safety or effectiveness compared to the predicate devices.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a test set or data provenance in terms of clinical study participants or imaging datasets. The "test" for substantial equivalence primarily relies on a comparative analysis of device specifications, intended uses, and modes of operation against legally marketed predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) for a diagnostic ultrasound transducer, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. It's a hardware component (transducer) for an ultrasound system, inherently requiring a human operator.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the established safety and effectiveness of the predicate devices (Acuson 10V4 Sequoia™ Ultrasound System and Harmonic Imaging, Acuson Aspen™ Ultrasound System, and other previously cleared devices referenced by K-numbers for specific clinical applications). The new device is deemed acceptable because it performs equivalently or is a subset of these already approved devices.

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set for machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set is involved.

Summary

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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,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

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Kojovic
Snezana

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

ProbeDescription(Frequency /Elements)	ArrayType	Pitch(mm)	ElevationWidth(mm)	GeometricFocus(mm)	AzimuthRadius(mm)	AzimuthLength(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 (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

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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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& 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)
PeripheralVessel	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(Track I Only)	Specific(Tracks I & III)	B	M	PWD	CWD	ColorDoppa	Comb.Modesb	Otherc
Ophthalmic	Ophthalmic
FetalImaging& 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)
PeripheralVessel	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

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.