Predicate Devices

K140773, K071134, K112953, K132304, K070792, K110482, K082098

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ultrasound image processing and does not mention any AI or ML techniques.

Therapeutic

No
The device is an ultrasound system intended for evaluation by imaging or fluid flow analysis, which are diagnostic purposes, not therapeutic.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body," which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "general purpose Ultrasound System" and details hardware components such as a proprietary ultrasound engine, single-board computer, FireWire connection, screen, battery, power supply, and transducer connector. It also mentions physical dimensions and weight. This clearly indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Terason uSmart3300 is an ultrasound system. It uses sound waves to create images of internal structures of the human body. It does not analyze biological specimens.
Intended Use: The intended use clearly states it's for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This is an in-vivo (within the living body) diagnostic method, not in-vitro.

Therefore, the Terason uSmart3300 is a medical imaging device, specifically an ultrasound system, and not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.

Product codes

IYN, IYO, ITX

Device Description

This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the host single-board computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.

The Terason™ uSmart3300 ultrasound weighs approximately 14.6 pounds and has a 15.6" backlit screen. The system dimensions (10"(H) x 14.5"(W) x 2.5"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the unit) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for battery charging). The ultrasound transducer connector is identical to that used in the Terason™ uSmart3300 predicate device. Optional accessories include a cart and printer.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified physician

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)

Non Clinical Tests: Tested for compliance to the following standards:

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety.
IEC60950-1 Information Technology Equipment Safety Part 1: General Requirements
IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. (Specific transducer models tested include 8TE3, 12L5A Ophthalmic, 15L4 Ophthalmic, 9MC3, PDOF)
IEC60601-1-2:2007 / EN60601-1-2:2007 Electromagnetic Compatibility, Harmonic Current Emissions (Specific transducer models tested include 8TE3 Transducer and Terason uSmart3300 Cart with 3 port MUX)
NEMA UD 3 Acoustic Output Display
Biocompatibility Tests, ISO 10993 Part 5 and Part 10 (Biocompatibility reports for all transducers).

Key Results:

The 9MC3 uses the same acoustic array materials as the predicate (8MC3) device and therefore has the same acoustic characteristics. Acoustic testing was performed per the IEC60601-2-37 standard. The 9MC3 consists of the same patient contact material as the predicate device, and biocompatibility tests were run.
There are no differences between the 8TE3 device and its predicate device (Philips(Oldelft) S7-3t). Acoustic output and device settings were evaluated in an acoustic tank.
There are no differences between the PDOF device and its predicate device (Aloka ProSound-C3 UST-T109). The transducer CWD performance was evaluated in an acoustic tank.
The 15L4 uses the same acoustic array as the predicate device (Sonosite Edge L25x) and therefore has the same acoustic characteristics. Acoustic testing for ophthalmic use was performed per the IEC60601-2-37 standard. The 15L4 transducer consists of the same patient contact materials as the predicate device.
The 12L5A uses the same acoustic array as the predicate device (Sonosite Edge L25x) and therefore has the same acoustic characteristics. Acoustic testing for ophthalmic use was performed per the IEC60601-2-37 standard. The 12L5A transducer consists of the same patient contact materials as the predicate device.

Conclusion: The uSmart3300 ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate devices.

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

Not Found

Predicate Device(s)

K140773, K071134, K112953, K132304, K070792, K110482, K082098

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

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

Summary

0

Image /page/0/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 a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 20, 2015

TERATECH CORPORATION C/O MARK JOB 1394 25TH STREET, NW BUFFALO MN 55313

Re: K150148

Trade/Device Name: Terason uSmart3300 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 22, 2015 Received: January 23, 2015

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041

1

Page 2-Mr. Job

or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K150148

Device Name

Terason uSmart3300 Ultrasound System

Indications for Use (Describe)

The Teratech Corporation Terason uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Number (if known):

Device Name:	Terason uSmart3300 Ultrasound System
--------------	--------------------------------------

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	Color	Comb.	Other
(Track I Only)	(Tracks I & III)					Doppa	Modesb
Ophthalmic	Ophthalmic	N	N	N		N	N	N
	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominala:	P1	p1	P1		P1	p1	P1
	Intra-operative (Spec.)d,e	P1	P1	P1		P1	P1	P1
	Intra-operative (Neuro)
	Laparoscopic
Fetal	Pediatric®:	P1	P1	P1		P1	P1	P1
Imaqinq
& Other	Small Organ (Thyroid, Breast,
Testes, etc.)ª:	P1	p1	P1		P1	P1	P1
	Neonatal Cephalice:	P1	P1	P1	p2	P1	P1	P1
	Adult Cephalica:	P1	P1	P1	p2	P1	P1	P1
	Trans-rectal*:	P1	P1	P1		P1	P1	P1
	Trans-vaginal9:	P1	P1	P1		P1	P1	P1
	Trans-urethral
	Trans-esoph. (non-Card.)	N	N	N		N	N	N
	Musculo-skel. (Convent.)d:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic)d:	P1	P1	P1		P1	P1	P1
	Intra-luminal
	Other (Specify)
	Cardiac Adult	P1	P1	P1	P1	P1	P1	P1
Cardiac	Cardiac Pediatric	P1	P1	P1	p2	P1	P1	P1
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N
	Other (Specify)
Peripheral	Peripheral vesseld:	P1	p1	P1	N	P1	P1	P1
Vessel	Other (Specify)

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

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

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

° Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic and peripheral vessel.

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

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

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

Additional Comments: P1: uses previously cleared under K140773

P2: uses previously cleared under K051334 Prescription Use _x AND/OR -Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)

Page 2 of 13

4

510(k) Number (if known): _________

Device Name: Terason uSmart3300 - 9MC3 Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh	N	N	N		N	N	N
	Abdominald:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatricd:	N	N	N		N	N	N
	Small Organ (Thyroid, Breast,
Testes, etc.)d:	N	N	N		N	N	N
	Neonatal Cephalicd:	N	N	N		N	N	N
	Adult Cephalicd:	N	N	N		N	N	N
	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	N	N		N	N	N	N
	Cardiac Pediatric	N	N		N	N	N	N
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:	N	N	N	N	N	N	N
	Other (Specify)

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

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

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

° Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic and peripheral vessel.

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

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

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k)_

Page 3 of 13

5

510(k) Number (if known):

Device Name: Terason uSmart3300 - 8TE3 Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh
	Abdominald:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatricd:
	Small Organ (Thyroid, Breast,
Testes, etc.)d:
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)	N	N	N	N	N	N	N
	Musculo-skel. (Convent.)d:
	Musculo-skel. (Superfic)d:
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)	N	N	N	N	N	N	N
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Prescription Use ___x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 4 of 13

6

510(k) Number (if known):

Device Name: Terason uSmart3300 – PDOF Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
	Ophthalmic
Fetal
Imaging
& Other	Fetalh
	Abdominald:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:
	Small Organ (Thyroid, 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				N
	Cardiac Pediatric				N
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 5 of 13

7

510(k) Number (if known):

Device Name: Terason uSmart3300 - 15L4 Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic	N	N	N		N	N	N
	Fetalh
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal	Pediatricd:	P1	P1	P1		P1	P1	P1
Imaging	Small Organ (Thyroid, Breast,	P1	P1	P1		P1	P1	P1
& Other	Testes, etc.)d:
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic)d:	P1	P1	P1		P1	P1	P1
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
Vessel	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K140773

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 6 of 13

8

510(k) Number (if known):

Device Name: Terason uSmart3300 – 12L5A Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic	N	N	N		N	N	N
	Fetalh
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,
Testes, etc.)d:	P1	P1	P1		P1	P1	P1
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic)d:	P1	P1	P1		P1	P1	P1
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)

Peripheral
Vessel	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K140773

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 7 of 13

9

510(k) Number (if known):

Device Name: Terason uSmart3300 - 4V2A Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,
Testes, etc.)d:
	Neonatal Cephalicd:	P1	P1	P1		P1	P1	P1
	Adult Cephalicd:	P1	P1	P1		P1	P1	P1
	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	P1	P1	P1	P1	P1	P1	P1
	Cardiac Pediatric	P1	P1	P1		P1	P1	P1
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K112953

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 8 of 13

10

510(k) Number (if known):

Device Name: Terason uSmart3300 - 5C2A Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, 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 Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K112953

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 9 of 13

11

510(k) Number (if known):

Device Name: Terason uSmart3300 – 8EC4A Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominald:
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:
	Small Organ (Thyroid, Breast,
Testes, etc.)d:
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:	P1	P1	P1		P1	P1	P1
	Trans-vaginalg:	P1	P1	P1		P1	P1	P1
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:
	Musculo-skel. (Superfic)d:
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K112953

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 10 of 13

12

510(k) Number (if known):

Device Name: Terason uSmart3300 -8L2 Transducer

Indications For Use: Diagnostic ultrasound imaging system 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
Doppaa	Comb.
Modesb	Otherc
Ophthalmic	Ophthalmic
	Fetalh
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,
Testes, etc.)d:
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic) d:	P1	P1	P1		P1	P1	P1
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K140773

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 11 of 13

13

510(k) Number (if known):

Device Name: Terason uSmart3300 -8V3A Transducer

Indications For Use: Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation						Otherc
General
(Track I Only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppaa	Comb.
Modesb
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetalh	P1	P1	P1		P1	P1	P1
	Abdominald:	P1	P1	P1		P1	P1	P1
	Intra-operative (Spec.)d,e
	Intra-operative (Neuro)
	Laparoscopic
	Pediatricd:	P1	P1	P1		P1	P1	P1
	Small Organ (Thyroid, Breast,
Testes, etc.)d:
	Neonatal Cephalicd:	P1	P1	P1		P1	P1	P1
	Adult Cephalicd:	P1	P1	P1		P1	P1	P1
	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	P1	P1	P1	P1	P1	P1	P1
	Cardiac Pediatric	P1	P1	P1	P1	P1	P1	P1
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K140773

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 12 of 13

14

510(k) Number (if known):

Device Name: Terason uSmart3300-16HL7 Transducer

Indications For Use: Diagnostic ultrasound imaging system 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.
Modes	Other
Ophthalmic	Ophthalmic
	Fetalh
	Abdominald:
	Intra-operative (Spec.)d,e	P1	P1	P1		P1	P1	P1
	Intra-operative (Neuro)
	Laparoscopic
Fetal
Imaging
& Other	Pediatricd:
	Small Organ (Thyroid, Breast,
Testes, etc.)d:	P1	P1	P1		P1	P1	P1
	Neonatal Cephalicd:
	Adult Cephalicd:
	Trans-rectalf:
	Trans-vaginalg:
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:	P1	P1	P1		P1	P1	P1
	Musculo-skel. (Superfic)d:	P1	P1	P1		P1	P1	P1
	Intra-luminal
	Other (Specify)
	Cardiac Adult
Cardiac	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:	P1	P1	P1		P1	P1	P1
	Other (Specify)

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

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

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

º Harmonic Imaging (HI)

d Includes ultrasound guidance for placement of needles, catheters.

e Abdominal, thoracic 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.

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

Additional Comments: P1: uses previously cleared under K110020

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k)_

Page 13 of 13

15

510(k) Summary

Teratech Corporation

Terason™ uSmart3300 Ultrasound System

1. Sponsor:

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

Contact Person: Ben Chiampa, Quality Assurance and Regulatory Affairs Telephone: 781-270-4143

Date Prepared: January 20, 2015

2. Device Name

Terason™ uSmart3300 Ultrasound System Proprietary Name: Common / Usual Name: Diagnostic Ultrasound System Classification Name: Diagnostic Ultrasound Transducer

Ultrasonic Pulsed Doppler Imaging System (21 CFR 892.1550, 90-IYN) Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX)

3. Predicate Devices

Terason uSmart3300 Ultrasound System (K140773, K071134), Terason t3000 8MC3 transducer (K112953), Philips iE33 S7-3t TE transducer (K132304, K070792), Aloka ProSound-C3 UST-T109 PDOF transducer (K110482) and Sonosite Edge L25x transducer (K082098).

4. Device Description

This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These

16

data are then transferred to the host single-board computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.

The Terason™ uSmart3300 ultrasound weighs approximately 14.6 pounds and has a 15.6" backlit screen. The system dimensions (10"(H) x 14.5"(W) x 2.5"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the unit) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for battery charging). The ultrasound transducer connector is identical to that used in the Terason™ uSmart3300 predicate device. Optional accessories include a cart and printer.

5. Intended Use

The Teratech Corporation Terason™ uSmart3300 is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal, Abdominal, Intraoperative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (noncardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.

6. Technology Characteristics

The design and construction of the Terason™ uSmart3300 ultrasound system is identical to the Terason™ uSmart3300 predicate system. This system utilizes a single-board computer running Windows 7 to execute the ultrasound application and a custom designed engine for control of the acoustic array and processing of the return echoes. For the uSmart3300, the engine is housed in a compartment that is attached to the base of the chassis.

The similarities and differences between the Terason™ uSmart3300 (current filing) and the predicate Terason uSmart3300 Ultrasound System (K140773) include the following:

. The engines are the identical with no modifications. As in the predicate device, the custom beamformer chip provides the processing of the return ultrasound echoes to support wide bandwidth signals and provide enhanced resolution across the entire image field.

17

The ultrasound application software has been modified to support 3 new transducers (9MC3, 8TE3, PDOF) and the new Ophthalmic indication for use (with the 15L4 and 12L5A transducers). The predicate devices that provide identical Ophthalmic indications for use are: K071134 (system) and K082098 (transducer).
Transducers: The Terason uSmart3300 will support 3 new transducers and the new Ophthalmic indication for use (IFU). (The Terason uSmart3300 has been previously cleared with eight transducers in K140773). The new transducers and associated predicate devices include:
. 9MC3: Predicate device 8MC3 cleared in 510k submission K112953
. 8TE3: Predicate device Philips(Oldelft) S7-3t previously cleared in 510k submissions K132304 and K070792
PDOF: Predicate device Aloka ProSound-C3 UST-T109 previously clear in 510k submission K110482
. 15L4: Ophthalmic IFU predicate device Sonosite Edge L25x previously cleared in 510k submission K082098
12L5A: Ophthalmic IFU predicate device Sonosite Edge L25x previously cleared in 510k submission K082098.

The following provides additional details of the 5 transducers presented in this submission.

. 9MC3: Identical indications for use to the predicate transducer 8MC3. Different frequency range but the shape of the transducer is identical when compared to the predicate. Same manufacturer, same acoustic array and patient contact materials as the predicate 8MC3 transducer.
8TE3: Identical indications for use to the predicate trans-esophageal (TE) . probe Philips(Oldelft) S7-3t. Similar frequency range and probe shape when compared to the predicate. Same original manufacturer (Oldelft), same acoustic array and patient contact materials as the predicate Philips S7-3t TE probe.
PDOF: Identical indications for use to the predicate PDOF Aloka ProSound-C3 UST-T109 transducer. Identical frequency range and probe shape when compared to the predicate. Same original manufacturer (Sound Technology), same acoustic array and patient contact materials as the predicate Aloka UST-T109 transducer.
. 15L4: Similar Ophthalmic indication for use, frequency settings, and shape of transducer head as the predicate Sonosite Edge L25x transducer. Different manufacturer (Vermon). Similar acoustic array and patient contact materials.
12L5A: Similar Ophthalmic indication for use, frequency settings, and shape . of transducer head as the predicate Sonosite Edge L25x transducer. Different manufacturer (Apex). Similar acoustic array and patient contact materials.

18

7. Table of Similarities and Differences Compared to the Predicate Devices

New Transducers: 9MC3, 8TE3, PDOF

New Indication for Use (IFU): Ophthamology for 15L4 and 12L5A transducers Previously Cleared Transducers (K140773): 8EC4A, 16HL7, and 15L4, 12L5A, 5C2A, 4V2A, 8V3A, and 8L2

Terason uSmart3300 Ultrasound System

	Subject Device Model	Comparable Predicate Device
	Terason uSmart3300	Terason uSmart3300
K140773	Sonosite Maxx
K071134
	(This Submission)
Intended Use	Diagnostic Ultrasound
imaging or fluid flow analysis
of the human body	Diagnostic Ultrasound
imaging or fluid flow analysis
of the human body	Diagnostic Ultrasound
imaging or fluid flow analysis
of the human body
Indication for Use	Ophthalmic, Fetal,
Abdominal, Intra-operative
(Spec. and Neuro.), Pediatrics,
Small Organ (Thyroid, Breast,
Testes); Neonatal and Adult
Cephalic, Trans-rectal, Trans-
vaginal, Trans-esophageal
(non-Cardiac and Cardiac),
Musculo-skeletal
(Conventional and
Superficial); Cardiac (Adult &
Pediatric), Peripheral Vascular	Fetal, Abdominal, Intra-
operative (Spec. and Neuro.),
Pediatrics, Small Organ
(Thyroid, Breast, Testes),
Neonatal and Adult Cephalic,
Trans-rectal, Trans-vaginal,
Musculo-skel. (Conventional
and Superficial), Cardiac
(Adult and Pediatric),
Peripheral Vascular	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, Musculo-skel.
(Convent.), Musculo-skel.
(Superficial), Cardiac Adult,
Cardiac Pediatric,Trans-
esophageal (Cardiac),
Peripheral vessel
Transducer Types	Linear Array
Curved Array
Phased Array
Endocavity - curved array
Hockey Stick - Linear
PDOF
Trans-esophageal	Linear Array
Curved Array
Phased Array
Endocavity - curved array	Linear Array
Curved Array
Phased Array
Endocavity - curved array
Hockey Stick - Linear
Transesophageal
Acoustic Output and FDA
Limits	Display Features for High
Outputs	Display Features for High
Outputs	Display Features for High
Outputs
Global Maximum
Outputs/Worst Case Setting	ISPTA.3: 652.9 mW/cm² (4V2A)
TI Type: TIB (4V2A)
TI Value: 5.64 (4V2A)	ISPTA.3: 652.9 mW/cm² (4V2A)
TI Type: TIB (4V2A)
TI Value: 5.64 (4V2A)	N/A

19

| | MI: 1.78 (8EC4A)
IPA.3@MI Max: 1029 W/cm²
(15L4) | MI: 1.78 (8EC4A)
IPA.3@MI Max: 1029 W/cm²
(15L4) | MI: 1.78 (8EC4A)
IPA.3@MI Max: 1029 W/cm²
(15L4) | | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Modes of Operation | B-Mode Grayscale Imaging
Tissue Harmonic Imaging
M-Mode (motion)
Anatomical M-Mode
Color M-Mode
Color Power Doppler
Velocity Color Doppler
Duplex/Triplex – Doppler
imaging
Pulsed Wave (PW) Doppler
TeraVision II Postprocessing | B-Mode Grayscale Imaging
Tissue Harmonic Imaging
M-Mode (motion)
Anatomical M-Mode
Color M-Mode
Color Power Doppler
Velocity Color Doppler
Duplex/Triplex – Doppler
imaging
Pulsed Wave (PW) Doppler
TeraVision II Postprocessing | B-Mode Grayscale Imaging
Tissue Harmonic Imaging
M-Mode (motion)
Anatomical M-Mode
Color M-Mode
Color Power Doppler
Velocity Color Doppler
Duplex/Triplex – Doppler
imaging
Pulsed Wave (PW) Doppler | | |
| PW Doppler | Available for all transducers
Triplex Mode
B-Mode and PW Doppler
High PRF | Available for all transducers
Triplex Mode
B-Mode and PW Doppler
High PRF | Available for all transducers
Triplex Mode
B-Mode and PW Doppler
High PRF | | |
| Transducer Frequency | 2.0—15.0 MHz | 2.0—15.0 MHz | 2.0 – 15.0 MHz (est.) | | |
| #Transmit Channels | 128 Channels | 128 Channels | 128 Channels | | |
| # Receive Channels | 128 Channels | 128 Channels | 128 Channels | | |
| Acoustic Output
Measurement Standard | NEMA UD 2-2004
NEMA UD 3-2004 | NEMA UD 2-2004
NEMA UD 3-2004 | NEMA UD 2-2004
NEMA UD 3-2004 | | |
| DICOM | DICOM 3.0 Structured
Reporting, Worklist - Image
Viewer | DICOM 3.0 Structured
Reporting, Worklist - Image
Viewer | DICOM supported | | |
| Product Safety Certification | IEC60601-1
IEC60601-1-2
IEC60601-1-6
IEC60601-2-37 | IEC60601-1
IEC60601-1-2
IEC60601-1-6
IEC60601-2-37 | IEC60601-1
IEC60601-1-2
IEC60601-1-4
IEC60601-2-37 | | |
| EMC | IEC60601-1-2
CISPR11 Class B | IEC60601-1-2
CISPR11 Class B | IEC60601-1-2
CISPR11 Class B | | |
| System
Characteristics | board computer over a
FireWire (aka IEEE 1394) | uSmart3300:
Integrated single-board
computer
Weighs 14.6 lbs (6.62 Kg)
15.6" backlit touch screen.
System dimensions (15.58"(H) x 15.29"(W) x 3.5"(D)).
A Lithium-Polymer battery
(integrated into the tablet)
provides 2 hours of
continuous ultrasound
scanning
Medical-grade power supply
Data transferred to the single-
board computer over a | board computer over a
FireWire (aka IEEE 1394) | uSmart3300:
Integrated single-board
computer
Weighs 14.6 lbs (6.62 Kg)
15.6" backlit touch screen.
System dimensions (15.58"(H) x 15.29"(W) x 3.5"(D)).
A Lithium-Polymer battery
(integrated into the tablet)
provides 2 hours of
continuous ultrasound
scanning
Medical-grade power supply
Data transferred to the single-
board computer over a | Sonosite Maxx:
Information available on the
corporate web site:
http://www.sonosite.com. |

20

Three transducers have been added to the Terason uSmart3300 in this submission: 9MC3, 8TE3 and PDOF. A new indication for use (IFU) that is included in this submission is for Ophthalmic use with the 15L4 transducer.

9MC3 Transducer

| Key Features | Subject Device Model
Terason 9MC3 Transducer | Comparable Predicate
Device
Terason 8MC3 Transducer | Same or Different |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K112953 | n/a |
| Indications for Use | The transducer is intended
to be used with a
conventional ultrasound
system (Terason
uSmart3300) to image fetal,
pediatric, small organs,
cephalic (neonatal and
adult), cardiac and
peripheral vessels. | The transducer is intended
to be used with a
conventional ultrasound
system (Terason t3000) to
image fetal, pediatric, small
organs, cephalic (neonatal
and adult), cardiac and
peripheral vessels. | Same. The proposed
transducer and the predicate
transducer have the identical
claim of imaging similar
regions in the human body. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same.
Regarding Safety: Same.
Effectiveness: Both arrays |
| Acoustic Array Style: | Micro Curved Array | Micro Curved Array | allow focused transmission
and reception of ultrasound
energy to enhance image
quality within the region of
interest. |
| Acoustic Array
Characteristics: | | | Different: Element count,
center frequency, element
size and elevation focus.
Acoustic characteristics have
met safety guidelines of
IEC60601-2-37. Safety and
effectiveness unchanged from
predicate. |
| Element count... | 80 | 128 | |
| Center frequency... | 6.5 | 5.0 | |
| Element size (pitch x
elevation)... | 0.321mm X 6.0mm | 0.25mm X 8.0mm | |
| Elevation focus... | 30mm | 40mm | |
| Acoustic Array | The transducer imaging
performance has been
evaluated in an acoustic
tank. | The transducer performance
has been evaluated in the
previous 510(k) filing
(K112953). | Same: The 9MC3 uses a same
acoustic array materials as
the predicate device and
therefore has same acoustic
characteristics. To ensure
proper safety guidelines are
met, acoustic testing was
performed per the IEC60601-
2-37 standard. |
| Patient Contact Material | Silicone ABS | Silicone ABS | Same: The contact material is
identical. |

21

The 9MC3 uses a same acoustic array materials as the predicate (8MC3) device and therefore has same acoustic characteristics. To ensure proper safety guidelines are met, acoustic testing was performed per the IEC60601-2-37 standard.

The 9MC3 consists of same patient contact material as the predicate device. To ensure proper safety guidelines are met, biocompatibility tests were run on the patient contact materials.

Transducer 8TE3

| Key Features | Subject Device Model
Terason(Oldelft) 8TE3
Transducer | Comparable Predicate
Device
Philips(Oldelft) S7-3t | Same or Different |
|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | ITX | ITX | Same |
| 510(k) Number | K1XXXXX | K132304 (EPIQ)
K070792 (iE33) | n/a |
| Indications for Use | The transducer is intended to
be used with a conventional
ultrasound system (Terason
uSmart3300) for trans-
esophageal (non-cardiac and
cardiac) imaging. | The transducer is intended to
be used with a conventional
ultrasound system (Philips
EPIQ) for trans-esophageal
(non-cardiac and cardiac)
imaging. | Same. The proposed
transducer and the
predicate transducer have
the identical claim of
imaging similar regions in
the human body. |
| Acoustic Array Technology | Piezoelectric elements | Piezoelectric elements | Same |
| Transducer Style | TE (Trans-esophageal) | TE (Trans-esophageal) | Same. |
| Acoustic Array
Characteristics:
Element count...
Center frequency...
Element size (pitch x
elevation)...
Elevation focus... | 64
5.0 MHz
0.16mm X 9.6mm
50mm | 64
5.0 MHz
0.16mm X 9.6mm
50mm | Same. |
| Acoustic Output and Device
Settings | The transducer performance
has been evaluated in an
acoustic tank | The transducer performance
has been evaluated in the
previous 510(k) filing
(K132304, K070792). | Same. |
| Patient Contact Material | Silicone | Silicone | Same. The 8TE3 and the
predicate S7-3t transducers
are both manufactured by
Oldelft and consist of
identical patient contact
materials. |

22

There are no differences between this device and the predicate device used in this comparison. The transducer has been added to the uSmart3300 Ultrasound system.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 8TE3 transducer is substantially equivalent to the predicate TE transducer with respect to safety and effectiveness.

PDOF Transducer

Key Features	Subject Device Model	Comparable Predicate Device	Same or Different
	Terason uSmart3300 PDOF
Transducer	Aloka(Terason) ProSound C3 UST-
T109 PDOF Transducer
Device
Classification	ITX	ITX	Same
510(k) Number	KXXXXX	K110482	n/a
Indications for
Use	The transducer is intended to
be used with a conventional
ultrasound system (Terason
uSmart3300) for Cardiac
continuous-wave Doppler
(CWD) (adult and pediatric).	The transducer is intended to be
used with a conventional
ultrasound system (Aloka/Terason
ProSound C3) for Cardiac
continuous-wave Doppler (CWD)
(adult and pediatric).	Same. The proposed transducer
and the predicate transducer have
the identical claim of imaging
similar regions in the human body.
Acoustic Array
Technology:	Piezoelectric elements	Piezoelectric elements	Same.
Regarding Safety: Both arrays allow
focused transmission and reception
of ultrasound energy to enhance
image quality within the region of
interest.
Acoustic Array
Style:	Pencil Transducer	Pencil Transducer
Acoustic Array
Characteristics:
Element count...	2	2	Same.
Center
frequency	2.0MHz	2.0MHz
Element size
(diameter)...	13.8mm	13.8mm
Elevation focus...	55mm	55mm

23

| Acoustic Array | The transducer CWD
performance has been
evaluated in an acoustic tank. | The transducer CWD performance
has been evaluated in the
previous 510(k) filing (). | Same. As the predicate device and
therefore has same acoustic
characteristics. To ensure proper
safety guidelines are met, acoustic
testing was performed per the
IEC60601-2-37 standard. |
|-----------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Contact
Material | Epoxy Noryl | Epoxy Noryl | Same. The PDOF transducer
consists of identical patient contact
materials as the predicate device. |

There are no differences between this device and the predicate device used in this comparison. The transducer has been added to the uSmart3300 Ultrasound system.

Based on the identical indications for use, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason PDOF transducer is substantially equivalent to the predicate PDOF transducer with respect to safety and effectiveness.

15L4 Transducer

| Key Features | Subject Device Model
Terason 15L4 Transducer | Comparable Predicate
Device
Sonosite Edge L25x/13-6
Transducer | Same or Different |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K1XXXXXX | K082098 | n/a |
| Classification | ITX | ITX | Same |
| Indications for Use | The transducer is intended
to be used with a
conventional ultrasound
system (Terason
uSmart3300) to image
ophthalmic, abdomen, small
parts, musculo-skel,
peripheral vascular regions.
Ophthalmic is the new IFU. | The transducer is intended
to be used with a
conventional ultrasound
system (Sonosite Edge) to
image ophthalmic,
abdomen, pediatric, small
parts, musculo-skel and
peripheral vascular regions. | Different: The proposed
transducer and the predicate
transducer have the claim of
imaging similar regions in the
human body. Ophthalmic is
the new Indication for Use. |
| Acoustic Array Technology: | Piezoelectric elements | Piezoelectric elements | Same: Identical material. |

24

Acoustic Array Style:	Linear Array	Linear Array	Effectiveness: Both arrays allow focused transmission and reception of ultrasound energy to enhance image quality within the region of interest.
Acoustic Array Characteristics: Element count... Center frequency... Element size (pitch x elevation)... Elevation focus...	128 elements 7.5 MHz 0.3mm X 4.0mm 20mm	128 elements 9.5 MHz (est) 0.195mm X 3.0mm (est) 18mm (est)	Same: element count. Acoustic characteristics have met safety guidelines of IEC60601-2-37.
Acoustic Output and Device Settings	The transducer performance has been evaluated in an acoustic tank.	The transducer performance has been evaluated in the 510(k) filing (K082098).	Different; acoustic output safety guidelines. Safety is not compromised. Effectiveness equal.
Patient Contact Material	Silicone ABS	Silicone ABS	Same. The 15L4 transducer consists of same patient contact materials as the predicate device. The safety of each device with respect to biocompatibility is equivalent.

The 15L4 uses a same acoustic array than the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines for ophthalmic use are met, acoustic testing was performed per the IEC60601-2-37 standard.

The 15L4 transducer consists of same patient contact materials as the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 15L4 transducer is substantially equivalent to the Sonosite L25x transducer (K082098) with respect to safety and effectiveness. Based on test results, the 15L4 transducer can be safely used for ophthalmological use.

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12L5A Transducer

| Key Features | Subject Device Model
Terason 12L5A Transducer | Comparable Predicate Device
Sonosite Edge L25x/13-6
Transducer | Same or Different |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification | ITX | ITX | Same |
| 510(k) Number | KXXXXX | K082098 | n/a |
| Indications for
Use | The transducer is intended to be
used with a conventional
ultrasound system (Terason
uSmart3200T) to image
ophthalmic, fetal, abdominal,
pediatric, small organ, cephalic,
musculo-skel, cardiac and
peripheral vessel.
Ophthalmic is the new IFU. | The transducer is intended to
be used with a conventional
ultrasound system (Sonosite
Edge) to image ophthalmic,
abdomen, pediatric, small parts,
musculo-skel and peripheral
vascular regions. | Same. The proposed transducer
and the predicate transducer
have the identical claim of
imaging similar regions in the
human body. |
| Acoustic Array
Technology: | Piezoelectric elements | Piezoelectric elements | Same.
Regarding Safety: Both arrays
allow focused transmission and
reception of ultrasound energy
to enhance image quality within
the region of interest. |
| Acoustic Array
Style: | Linear Array | Linear Array | Same in elevation Safety and
effectiveness unchanged from
predicate |
| Acoustic Array
Characteristics:
Element count... | 128 | 128 | |
| Center
frequency... | 7.5MHz | 9.5MHz (est) | |
| Element size
(pitch x
elevation)... | 0.3mm X 4.0mm | 0.195mm X 3.0mm (est) | |
| Elevation focus... | 19mm | 18mm (est) | |
| Acoustic Array | The transducer imaging
performance has been evaluated in
an acoustic tank. | The transducer performance
has been evaluated in the
previous 510(k) filing
(K082098). | Same. As the predicate device
and therefore has same acoustic
characteristics. To ensure proper
safety guidelines are met,
acoustic testing was performed
per the IEC60601-2-37 standard. |
| Patient Contact
Material | Silicone ABS | Silicone ABS | Same. The 12L5A transducer
consists of same patient contact
materials as the predicate
device. |

26

The 12L5A uses a same acoustic array than the predicate device and therefore has same acoustic characteristics. To ensure proper safety guidelines for ophthalmic use are met, acoustic testing was performed per the IEC60601-2-37 standard.

The 12L5A transducer consists of same patient contact materials as the predicate device.

Based on the test results, technological characteristics and performance testing, Teratech Corporation, Inc. believes the Terason 12L5A transducer is substantially equivalent to the Sonosite L25x transducer (K082098) with respect to safety and effectiveness. Based on test results, the 12L5A transducer can be safely used for ophthalmological use.

Previously filed transducers:

The following transducers are identical to those previously cleared under FDA 510(k) K140773, May 30, 2014 for the Terason uSmart3300:

. 4V2
5C2A
. 8EC4A
. 8L2
. 8V3A
12L5A (not including Ophthalmic use)
. 15L4 (not include Ophthalmic use)
. 16HL7.

27

3. Accessories / Kits:

There are no new accessories associated with the new transducers or ophthalmic indications for use.

| uSmart3300
Transducer | Starter Contents | FDA 510k Clearance # | Replacement Kit | FDA 510k Clearance
Numbers |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 5C2A | Protek kit #7138 | K973958 | Protek 16 Ga biopsy kit
#4216

Protek 18 Ga biopsy kits
#4218

Protek 22 Ga biopsy kits
#4222

Biopsy kits include
needle guide, probe
cover, and gel | K140773

K973958 |
| 15L4 | Civco 612-085 (inplane)
needle guide Starter Kit

Civco 683-002
(transverse) needle
guide starter kit | K882383/A | Civco 610-579 | K140773

K882383/A |

Accessories previously cleared under FDA 510(k) K140773 include:

4) Conclusion

The intended uses and features are consistent with the traditional clinical practices and FDA guidance of Diagnostic ultrasound systems and transducers. The uSmart3300 and predicate devices both conform to applicable electric safety medical device standards with compliance verified through independent evaluation. The uSmart3300 and predicate devices both meet FDA requirements for track 3 devices, indications for use, biocompatibility, and are manufactured using FDA GMPs and ISO-13485 quality systems. Teratech Corporation believes that the uSmart3300 ultrasound system is substantially equivalent with regards to safety and effectiveness to the predicate devices as noted above.

B1. Non Clinical Tests

The Terason™ uSmart3300 system has been tested for compliance to the following standards (with the corresponding report referenced for each standard).

IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Basic Safety.
- Intertek Test Record Number 101288219BOX-004.

28

IEC60950-1 Information Technology Equipment Safety Part 1: . General Requirements
- o IEC60950-1 IEI Integration Corp. Test Report Number, 1308046001.
IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: . Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment.
- IEC60601-2-37 Transducer Model 8TE3 |Intertek Report O 101501543BOX-006]
- IEC60601-2-37 Transducer Model 12L5A Ophthalmic [Intertek O Report 100404853BOX-006]
- IEC60601-2-37 Transducer Model 15L4 Ophthalmic [Intertek O Report 100404853BOX-007]
- IEC60601-2-37 Transducer Model 9MC3 [Intertek Report O #100404854BOX-001b]
- o IEC60601-2-37 Transducer Model PDOF IIntertek Report #100404858BOX-002].

IEC 60601-2-37 reports associated with previously cleared transducers can be found in FDA 510(k) K140773.

IEC60601-1-2:2007 / EN60601-1-2:2007 Electromagnetic . Compatibility, Harmonic Current Emissions
- o IEC60601-1-2:2007 8TE3 Transducer [Oldelft Technical Report 2011-002]
- IEC60601-1-2:2007 EMC Emissions Evaluation of Terason uSmart3300 Cart with 3 port MUX [Intertek Report #101753715BOX-001]

IEC 60601-1-2:2007 reports associated with previously the cleared Terason uSmart3300 ultrasound system can be found in FDA 510(k) K140773.

. NEMA UD 3 Acoustic Output Display Terason uSmart3300 Ultrasound System User Guide, Volume 2 (16-3312).

29

Biocompatibility Tests, ISO 10993 Part 5 and Part 10 .
- Biocompatibility reports for all transducers.