K Number

Device Name

GYNESONICS EC6 TRANSDUCER

Manufacturer

GYNESONICS, INC.

Date Cleared

2006-10-27

(184 days)

Product Code

ITX

Regulation Number

892.1570

Intended Use

The GYNESONICS EC6 Ultrasound Transducer 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 GYNESONICS Model EC6 Ultrasound Transducer is intended for use with the TERATECH t3000, 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

K03191, K043278

Reference Devices

TERASON 8EC4 Smart Probe (K03191), TERASON 10LAP4 Smart Probe (K043278)

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, performance metrics, or other indicators typically associated with AI/ML in medical devices.

Therapeutic

No
The device is described as being for "diagnostic ultrasound 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 diagnostic ultrasound imaging".

SaMD (Software as a Medical Device)

The device description explicitly states it is an "Ultrasound Transducer," which is a hardware component used in ultrasound imaging systems.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for "diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device used to visualize internal structures and processes within the body, which is the domain of medical imaging, not in vitro diagnostics.
Device Description: The device is an "Ultrasound Transducer" intended for use with an "ultrasound imaging system." This further confirms its role in medical imaging.
Anatomical Site: The listed anatomical sites are all parts of the human body where ultrasound imaging is performed.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an in vitro diagnostic device.

In summary, the GYNESONICS EC6 Ultrasound Transducer is a medical imaging device used for diagnostic purposes within the human body, not an in vitro diagnostic device used to analyze samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

ITX

Device Description

The GYNESONICS Model EC6 Ultrasound Transducer is intended for use with the TERATECH t3000, a portable ultrasound imaging system. Technical specifications for GYNESONICS Model EC6 the with the Model t3000 are as follows:

| Probe
Description
(Frequency /
Elements) | Array
Type | Pitch
(mm) | Elevation
Width
(mm) | Geometric
Focus
(mm) | Azimuth
Radius
(mm) | Azimuth
Length
(mm) |
|---------------------------------------------------|---------------|---------------|----------------------------|----------------------------|---------------------------|---------------------------|
| 6 MHz /64 | Phased | 0.110 | 2.5 | na | Flat | 7.0 |

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Human body - specific indications listed in the "DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM" include: 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

Includes uses in military field settings in addition to hospital/clinic settings.

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)

TERASON 8EC4 Smart Probe (K03191), TERASON 10LAP4 Smart Probe (K043278)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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

K06 // 53

510(k) Summary for GYNESONICS Model EC6 Probe

SPONSOR 1.
Gynesonics, Inc. 604 Fifth Ave. Suite D Redwood City, CA 94063

0C1 2 7 2006

Contact Person:

Jessica Grossman, MD President Phone: (415) 317-3242 Fax: (650) 299-1566 E-mail: jgrossman@gynesonics.com

January9, 2006 Date Prepared:

DEVICE NAME 2.

Proprietary Name:	GYNESONICS Model EC6 Probe
Common/Usual Name:	Diagnostic Ultrasound Transducer
Classification Name:	Diagnostic Ultrasound Transducer
(21 CFR 892.1570, 90-ITX)

3. PREDICATE DEVICES

TERASON 8EC4 Smart Probe (K03191) TERASON 10LAP4 Smart Probe (K043278)

Intended Use 4.
The GYNESONICS EC6 Ultrasound Transducer 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.
.

Kob 1153

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The GYNESONICS Model EC6 Ultrasound Transducer is substantially equivalent to the TERASON 8EC4 and 10LAP4 Smart Probes, which are currently in commercial distribution in the United States. The GYNESONICS Model EC6 Ultrasound Transducer is similar in design and materials to the predicate probes; when operated with the TERATECH Model t3000 portable imaging system, 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 a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 2 7 2006

Re: K061153

Trade Name: TERASON™ t3000 and Echo Ultrasound Systems Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: October 9, 2006 Received: October 10, 2006

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 TERASON™ t3000 and Echo Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

GYNESONICS EC6

Image /page/2/Picture/13 description: The image is a black and white circular logo. The logo has the letters "FDA" in large bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. The text "FDA Centennial" is surrounded by a circular border of text.

Protecting and Promoting Public Health

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.

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Ralph Shuping at (240) 276-3666.

Sincerely yours,

Daniel br. Syzman

for

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

Enclosure(s)

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

TERASON ™ t3000 and Echo Ultrasound Systems								K061753
Transducer:	(see comments)
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
General	Specific	B	M	PWD	CWD	Color
Doppa	Comb.
Modesb	Othera
(Track I Only)	(Tracks I & III)
Ophthalmic	Ophthalmic
	Fetaln	P1,4	P2,4	P2,4	P2,4	P2,4	P2,4	P2,4
	Abdominald:	P1,4	P2,4	P2,4	P1	P2,4	P2,4	P2,4
	Intra-operative (Spec.)d,e		P4	P4		P4	P4	P4
	Intra-operative (Neuro)		P5	P5		P5	P5	P5
	Laparoscopic		P6	P6		P6	P6	P6
Fetal
Imaging
& Other	Pediatricc:	P1,4	P2,4	P2,4	P1	P2,4	P2,4	P2,4
	Small Organ (Thyroid,
Breast, Testes, etc.)d:	P2,4	P2,4	P2,4	P1	P2,4	P2,4	P2,4
	Neonatal Cephalicc:	P1,4	P2,4	P2,4	P1	P2,4	P2,4	P2,4
	Adult Cephalicc:	P1,4	P2,4	P2,4	P1	P2,4	P2,4	P2,4
	Trans-rectalf:	P2,4	P3,4	P3,4		P3,4	P3,4	P3,4
	Trans-vaginalg:	P3,4	P3,4	P3,4		P3,4	P3,4	P3,4
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)d:	P2,4	P2,4	P2,4		P2,4	P2,4	P2,4
	Musculo-skel. (Superfic)d:	P2,4	P2,4	P2,4		P2,4	P2,4	P2,4
	Intra-luminal
	Other (Specify)
	Cardiac Adult	P1	P2	P2	P1	P2	P2	P2
Cardiac	Cardiac Pediatric	P1	P2	P2	P1	P2	P2	P2
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vesseld:	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 Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler.

B+M; B+PWD; 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

9 includes ultrasound guidance of transvaginal biopsy, infertility monitoring of follicle development.
" Includes guidance of amniocentesis, infertility monitoring of follicle development. 1
System uses previously cleared under K992505 with 3 MHz Model L3 (Linear).
2 System uses previously cleared under K012191.
3 System uses previously cleared under K012103.

1 System uses previously cleared under K030191.

3 System uses previously cleared under K040840.

System uses previously cleared under K043278.
' System uses previously cleared under K051334.

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)

Yerich A. Serman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061153

Gynesonics, Inc. 510(k) GYNESONICS Model EC6 Probe 1/9/06

Page 4.3-2

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM

System:	TERASON Model t3000 Portable Ultrasound System
Transducer: GYNESONICS EC6
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.)e,a	N	N	N		N	N	N
	Intra-operative (Neuro)
	Laparoscopic	N	N	N		N	N	N
	Pediatricc:
	Small Organ (Thyroid,
Breast, Testes, etc.)d:
	Neonatal Cephalicc:
	Adult Cephalicc:
	Trans-rectall:
	Trans-vaginalo:	N	N	N		N	N	N
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)o:
	Musculo-skel. (Superfic)o:
	Intra-luminal
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esoph. (Cardiac)
	Other (Specify)
Peripheral
Vessel	Peripheral vessell:
	Other (Specify)

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. °B+M; B+PWD; 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.

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

° Includes intrauterine scanning. Additional Comments: P': uses previously cleared under K992505 with 3 MHz Model L3 (Linear); 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 br. Syson

(Division Sign-Off) Division of Reproductive. Abdominal and Radiological Devices 510(k) Number _

Gynesonics, Inc. 510(k) GYNESONICS Model EC6 Probe 119/06