Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial), Intraoperative: Abdominal, and Other: Urological.

Device Description

The MyLab15/20 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, PW Doppler and Color Flow Mapping and Tissue Enhancement Imaging (TEI). MyLab15/20 is able to produce real time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images

AI/ML Overview

The provided text is a 510(k) summary for the Esaote MyLab15/20 Ultrasound System (K061755). This document primarily focuses on demonstrating substantial equivalence to predicate devices for new indications and transducer types. It does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of diagnostic accuracy, clinical effectiveness, or AI algorithm performance.

The document states that the device is an ultrasound imaging system and its performance is implicitly demonstrated through substantial equivalence to other legally marketed ultrasound systems.

Therefore, most of the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types for test/training sets, training set sample size, and ground truth establishment for training set) is not present in the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices for specific clinical applications and imaging modes, not on presenting acceptance criteria and performance data against those criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy).

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

This information is not provided in the document. The submission is not related to a clinical study assessing diagnostic performance against a test set. It's a regulatory submission for device clearance based on equivalence.

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

This information is not provided in the document. No test set or ground truth establishment process is described.

4. Adjudication Method for the Test Set

This information is not provided in the document. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided in the document. The document pertains to an ultrasound imaging system, not an AI-assisted diagnostic tool, and therefore, an MRMC study for AI assistance would not be applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not provided in the document. The device is an ultrasound imaging system, not an AI algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

This information is not provided in the document. No specific ground truth is mentioned as the basis for performance evaluation in this 510(k) submission.

8. The Sample Size for the Training Set

This information is not provided in the document. As this is not an AI/algorithm submission, a "training set" in that context is not relevant.

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

This information is not provided in the document. Similar to point 8, this is not relevant to the type of device and submission described.

Summary

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510(k) Summary NIvLab15/20 Esaote Europe BV

K061755
510(k) Summary

AUG - 7 2006

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 1807.92(a).

807.92(a){ })

Submitter Information

Carri Graham, Official Correspondent	11460 N Meridian St., Ste 150
Carmel, Indiana 46032
Phone:	(317) 569-9500
Facsimile:	(317) 569-9520

Contact Person:	Carri Graham
Date:	June 21, 2006

807.92(a)(2)
Trade Name:	MyLab15/20 New Indications Ultrasound System
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulsed echo imaging system 892.1560Ultrasonic pulsed Doppler imaging system 832.1550
Classification Number:	90IYO90IYN

807.92(a)(3)	Predicate Device(s)
--------------	---------------------

K014168	Technos Esaote, S.p.A.
K043588	MyLab15/20 Ultrasound System Pie Medical
K053154	MyLab15/20 Just3D/4D Pie Medical

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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510(k) Summary MyLab15/20 Esaote Europe BV

K061755

807.92(a)(4)

Device Description

807.92(a)(5)

Intended Use(s)

Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Intraoperative: Abdominal, Other: Urological, Musculoskeletal (Conventional and Superficial).

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510(k) Summary MyLab15/20 Esaote Europe BV

K061755

Comparison Chart for Substantial Equivalence

GeneralCharacteristics	Esaote MyLab15/20K043588, K053154	Esaote TechnosK014168	Esaote MyLab15/20Current 510(k)
Applications
Intraoperative:Abdominal	No	Yes	Yes
Other: Urological	No	Yes	Yes

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510(k) Summary
MyLab15/20
Esaote Europe BV

	1------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
-----------------------------------Un 12 1 1 1 1 1 1 1 1 1	400000annono	Frenta Mul 2115/20

GeneralCharacteristics	Esaote MyLab15/20K043588, K053154	Esaote TechnosK014168	Esaote MyLab15/20Current 510(k)
Transducer Type
Linear	Yes	Yes	Yes
Convex	Yes	Yes	Yes
2D Freq MHz	2.7 - 15	2.8 - 12.5	2.7 - 15
Multifrequency	Yes	Yes	Yes
Special probes	• Endocavity probe• MechanicallyDriven 3D ConvexArray	• Endocavityprobe• MechanicallyDriven 3DConvex Array• CW DopplerProbe	• Endocavity probe• MechanicallyDriven 3D ConvexArray
Biopsy attachments
Convex	Yes	Yes	Yes
Linear	Yes	Yes	Yes
Imaging modes
Real Time 2D	Yes	Yes	Yes
M-mode	Yes	Yes	Yes
PW Doppler	Yes	Yes	Yes
CW Doppler	No	Yes	No
CFM Doppler	Yes	Yes	Yes
Amplitude Doppler	Yes	Yes	Yes
Triplex	Yes	Yes	Yes
3D/4D	Yes	Yes	Yes
Monitor size (inches)	• 15" CRTmonitor• 15" LCD	15" Color VGACRT Monitor	• 15" CRTmonitor• 15" LCD• 19" LCD
ECG	Optional	Optional	Optional
Digital archivalcapabilities	Yes	Yes	Yes
VCR & Videoprinters	Yes	Yes	Yes
M&A capabilities	Yes	Yes	Yes
Safety
Electrical safety	EN60601-1	EN60601-1	EN60601-1

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 7 2006

Esaote Europe BV % Ms. Carri Graham Consultant The Anson Group 11460 N Meridian St, Ste 150 CARMEL IN 46032

Re: K061755

Trade Name: MyLab 15/MyLab 20 Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: June 19, 2006 Received: June 21, 2006

Dear Ms. Graham:

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 MyLab 15/MyLab 20 Systems, as described in your premarket notification:

Image /page/4/Picture/10 description: The image shows a logo for the FDA Centennial 1906-2006. The logo is circular and contains the letters FDA in the center. The words "Centennial" are below the letters FDA. The text below the logo reads "Protecting and Promoting Public Health."

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Transducer Model Number

IOE323
CA123
C5-2 R13

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. may publish hat FDA's issuance of a substantial equivalence determination does not mean r loase be devices and i bre broundevice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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 CI It Fat 607); adoning (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 I notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. - 11.0 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

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Page 3 - Ms. Graham

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 (301) 594-1212.

Sincerely yours,

Daniel B. Leyron

for

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

Enclosure(s)

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Indications for Use

510(k) Number (if known):

K 061755

MyLab15/MyLab20 Systems Device Name:

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Severson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061755

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Image /page/8/Picture/0 description: The image shows the text "K061755" in a handwritten style on the top line. Below that, the text "MyLab15/20 Systems" is printed in a clear, sans-serif font. The handwritten text appears to be a code or identifier, while the printed text likely refers to a product or system name.

Clinical Application	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P [2]	P[3], P[4],P[5]
Abdominal	P	P	P	P	P	P [2]	P[3], P[4],P[5]
Intraoperative Abdominal	N	N	N	N	N	N[2]	N[3], N[4]
Intraoperative Neurological
Pediatric	P	P	P	P	P	P [2]	P[3], P[4],P[5]
Small Organ (specify) [1]	P	P	P	P	P	P [2]	P[3], P[4]
Neonatal Cephalic	P	P	P	P	P	P [2]	P[3], P[4]
Adult Cephalic
Cardiac	P	P	P	P	P	P [2]	P[3]
Transesophageal
Transrectal	P	P	P	P	P	P [2]	P[3], P[4]
Transvaginal	P	P	P	P	P	P [2]	P[3], P[4]
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P [2]	P[3], P[4]
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P	P [2]	P[3], P[4]
Musculo-skeletal Superficial	P	P	P	P	P	P [2]	P[3], P[4]
Other: Urological	N	N	N	N	N	N[2]	N[3], N[4]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+ CFM+Amplitude Doppler

[3] Tissue Enhancement Imaging (TEI)

[4] 3D Imaging

(5) 4D Imaging

Daniel H. Ingram

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

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K061755
IOE323

Clinical Application	Mode of Operation
	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N (2)	N (3)
Intraoperative (Abdominal)		N	N	N		N	N		N (2)	N (3)
Intraoperative Neurological
Pediatric
Small Organ (specify) [1]		N	N	N		N	N		N [2]	N [3]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N [2]	N [3]
Laparoscopic
Muscolo-skeletalConventional		N	N	N		N	N		N [2]	N [3]
Muscolo-skeletalSuperficial		N	N	N		N	N		N [2]	N [3]

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

[1] Small organs include Thyroid, Breast and Testicles.

(2) Applicable combined modes: B+M+PW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

iplease do not write below this line. Continute on another Page if needed)

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David be. Semon

(Division Sign-Off) Division of Reproductive, Abdoo and Radiological Devices 510(k) Numb

ートアルバイト (1) 2017 - 10:20

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K061755
CA123

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N		N	N		N (2)	N [3]
Abdominal		N	N	N		N	N		N (2)	N (3)
Intraoperative (Adominal)
Intraoperative Neurological
Pediatric
Small Organ (specify) [1]		N	N	N		N	N		N (2)	N [3]
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N		N (2)	N [3]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N (2)	N [3]
LaparoscopicMuscolo-skeletal
ConventionalMuscolo-skeletal
Superficial
Other: Urological		N	N	N		N	N		N (2)	N [3]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

(PLEASE DO NOT WRITE BELOW THIS LIKE. CONTINUE OF ANOTHER PAGE IF KELDED)

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Severson

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

ા ર

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Ko61755

C5-2 R13

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		N	N	N		N	N		N [2]	N [3]
Abdominal		N	N	N		N	N		N [2]	N [3]
Intraoperative (Adominal)
Intraoperative Neurological
Pediatric
Small Organ (specify) [1]		N	N	N		N	N		N [2]	N [3]
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N		N	N		N [2]	N [3]
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N		N	N		N [2]	N [3]
Laparoscopic
Muscolo-skeletalConventional
Muscolo-skeletalSuperficial
Other: Urological		N	N	N		N	N		N [2]	N [3]

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEBOED)

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Styrone

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

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.