Fsaote'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).

Device Description

The MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician 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). The MyLab15/MyLab20 is equipped with either an LCD TFT color display or a CRT color monitor. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MyLab15/MyLab20 can drive convex (CA) and linear array (LA) probes. The MyLab15/MyLab20 permits storage of images on a USB memory stick. The MyLab15/MyLab20 also saves fetal biometry data, acquired during obstetric examinations, into a database in the internal memory of the system, in order to track the fetal growth through different examinations during the same gestation. Optional accessories available for the MyLab15/MyLab20 include an S-VHS video recorder and a monochrome or color printer.

AI/ML Overview

This document is a 510(k) summary for the MyLab 15 / MyLab 20 Ultrasound Imaging Systems. It lists the device's intended uses and compares it to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it refer to an AI/algorithm-based device. The document is for an ultrasound imaging system, which is a hardware device.

Therefore, I cannot extract the requested information from the provided text.

Specifically, the following information is not available in the provided document:

A table of acceptance criteria and the reported device performance: This document does not establish specific performance metrics or acceptance criteria for an algorithm or AI. It describes the general capabilities and intended uses of the ultrasound systems.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, data provenance, or sample sizes for testing an algorithm are mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Ground truth establishment for an AI algorithm is not discussed as no AI is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no algorithm or test set mentioned in this context.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This document predates widespread AI in medical imaging and does not refer to any AI assistance or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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JAN 25 2005

510(k) Summary My Lab 15 - My Lab 20 Pic Medical

K043588
Sizylft4

510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent

8000 Castleway Drive

Indianapolis, IN 46250

Phone:	(317) 849-1916
Facsimile:	(317) 5779070

Contact Person: Carri Graham

Date: December 15, 2004

807.92(a)(2)

Trade Name:	My Lab 15 / My Lab 20 Ultrasound Imaging Systems
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)

Pie Medical	Picus	K023512
Medison	128BW	K012887

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

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510(k) Summary My Lab 15 My Lab 20 Pic Medical

K043588
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807.92(a)(4)

Device Description

Intended Use(s) 807.92(a)(5)

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5 10(k) Summary My Lab 15 . My Lab 20 Pic Medical

K043588
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Comparison Chart for Substantial Equivalence

GeneralCharacteristics	EsaoteMyLab15/MyLab20	Esaote Picus(K023512)	Medison 128BW(K012887)
Applications
Fetal	Yes	Yes	Yes
Abdominal	Yes	Yes	Yes
Pediatric	Yes	No	Yes
Small Organ	Yes	Yes	Yes
Neonatal Cephalic	Yes	Yes	Yes
Adult Cephalic	No	No	Yes
Cardiac	Yes	Yes	Yes
Transrectal	Yes	Yes	Yes
Transvaginal	Yes	Yes	Yes
Peripheral Vascular	Yes	Yes	Yes
Musculo-skeletal(Conventional andsuperficial)	Yes	No	Yes
GeneralCharacteristics	EsaoteMyLab15/MyLab20	Esaote Picus(K023512)	Medison 128BW(K012887)
	Transducer Type
Linear	Yes	Yes	Yes
Convex	Yes	Yes	Yes
2D Freq MHz	2.7 - 12.5	2.5 - 10	2.0 - 10
PW Freq MHz	2.7 - 6.3	2.5 - 8	No
Multifrequencyprobes	Yes	Yes	Yes
Special probes	Endocavity probe	Endocavity probe	Endocavity probe
	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	No
CFM Doppler	Yes	Yes	No
Amplitude Doppler	Yes	Yes	No
Triplex	Yes	Yes	-
Monitor size (inches)	15" CRT monitor15" LCD	15" CRT monitor10" LCD	12" CRT monitor
ECG	Optional	Optional	No
Digital archivalcapabilities	Yes	Yes	Yes
VCR & Videoprinters	Yes	Yes	Yes
M&A capabilities	Cardiac, vascular,Obstetric,Gynaecologic,Urology, andgeneral purposemeasurements	Cardiac, vascular,Obstetric,Gynaecologic,Urology, andgeneral purposemeasurements	OB/Gyn andgeneral purposemeasurements
	Safety
Electrical safety	EN60601-1	EN60601-1	EN60601-1

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K04358
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510(k) Summary My Lab 1 5 - My Lab 20 Pic Medical

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2005

Pie Medical % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K043588

Trade Name: MyLab15 / MyLab20 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: December 21, 2004 Received: December 28, 2004

Dear Ms. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bowe 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 merodments, 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 the general controls pro 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 MyLab15 / MyLab20, as described in your premarket notification:

Transducer Model Number

LA523CA421P	EC123E8-5 R10
-----------------	-------------------

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Page 2 - Ms. Graham

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 additional controls. Existing major regulations affecting your device of the It may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Posteria concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I DA 3 issuated or a casevice complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cachar statutes and regulations and limited to: registration and listing (21 comply with an the 7ter s requirements, normands, and manufacturing practice requirements as set CITY at 607), adomig (21 OFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I ins device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, merading accusation of September 30, 1997 "Information for Manufacturers In Appendix U, (cherosou) of the Senies tic 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 nis lotter will and in you ding of substantial equivalence of your device to a legally marketed nonticate 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 If you 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 other gollers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

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Page 3 – Ms. Graham

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy C. Brogdon

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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4.3 Indications for Use

The following table provides the intended clinical use for the MyLab15/MyLab20:

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

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

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

[1] Small organs include Thylold, Dreast and Tostered
[2] Applicable combined modes: B+M+PW+ CFM+Amplitude Doppler
[2] Applicable combined modes: B+M+PW+ CFM+Amplitude Dopple

[2] Apphoable enhancement Imaging (TEI)

[3] Tissue enhancement imaging (TEI),

Prescription Use

Nancy C. Broadon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

510(k) Number K043588

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The following tables provide the intended clinical use for the MyLab15/MyLab20 probes in combination with the system:

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

Transducer: LA523

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

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

[ [ ] Small organs melude Tiryon, Droad, Live PW+CFM+Amplitude Doppler
[2] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler

[2] Tissue Enhancement Imaging (TEI)

Prescription Use

Nancy Brodon

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

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Transducer: CA421P

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

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

nal Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modern (1) www.

[2] Tissue Enhancement Imaging (TEI)

Organizing Ideas

Nancy C Brogdon

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, ari Radiological Devices 1 [((k) Number _

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Transducer: EC123

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)TEI (2)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N[1]	N
Transvaginal		N	N	N		N	N		N[1]	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)

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

Additional Comments:

Additional Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modes: (TED

[2] Tissue Enhancement Imaging (TEI)

្រីក្រោយក្រោះ

Narryl Brogdon
(Division Sign-Off)

(Division of Reproductive, Abdominal and Radiological Devices

510(k) Number K043588

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Transducer: E8-5 R10

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)TEI [2]
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal										N
Transrectal		N	N	N		N	N		N[1]	N
Transvaginal		N	N	N		N	N		N[1]	N
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
Conventional
Musculoskeletal Superficial
Other (specify)

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

Additional Comments:

Additional Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined model ... (TEU

[2] Tissue Enhancement Imaging (TEI)

Organization Chart

Nancy Brogdon

(Division Sign-Off) Abdominal; Division of Reproductive, and Radiological Devices 643588 510(k) Number _

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.