The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes
-Cardiac [Adult and Pediatric]
-Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic, Transrectal. -Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)]
The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.
The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.

Device Description

Model 6430, commercial names MyLabX75 and MyLab XPro75, is a mainframe ultrasound system used to perform diagnostic general ultrasound studies. The primary modes of operation are: B-Mode, Tissue Enhancement Imaging (TEI), M-Mode, Multi View (MView), Doppler (both PW and CW), Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D, Qualitative Elastosonography (ElaXto) and Quantitative Elastosonography (QElaXto).
Model 6430 has a software option integrated, called PLA, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.
Model 6430 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6430 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.
Model 6430 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.
Model 6430 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, on server) via a LAN/USB port.
6430 project is mainly design change of 6450 devoted to reducing cost and to differentiate design and performances, 6430 will introduce in the Esaote's Mid-ultrasound tier functionalities that, at the moment are present only in our High -End Ultrasound tier, such as 2D Shear Wave Elastography (2D-SWE) and Virtual Navigator.
The marketing names for Model 6430 will be MyLabX75 and MyLab XPro75.
The difference between MyLab XPro75 is only in the licenses configuration: on MyLab XPro75 all the options are included while in the MyLabX75 some licenses can be ordered by customer.

AI/ML Overview

The provided text is a 510(k) summary for the Esaote MyLabX75 and MyLab XPro75 ultrasound systems. It explicitly states that no clinical tests were performed to demonstrate that the device meets acceptance criteria. The submission relies entirely on non-clinical data and equivalence to a predicate device.

Therefore, many of the requested details about acceptance criteria and study design are not applicable or cannot be extracted from this document.

Here's what can be extracted based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for performance; rather, it focuses on safety and technological equivalence.

Acceptance Criteria (High-Level)	Reported Device Performance
Safety (Acoustic output, biocompatibility, cleaning, thermal, electrical, electromagnetic, mechanical)	Conforms to recognized medical device safety standards (IEC 60601-1, -1-2, -1-6, -2-37, NEMA UD-2)
Intended Use/Functionality	Performs as intended in specified use conditions (based on verification and validation)
Technological Characteristics	Employs the same fundamental technological characteristics as the predicate device (Esaote Model 6450, K192157)
Accuracy and Precision of Measurements and Analysis Packages	Provides similar measurements and analysis packages with equal accuracy and precision to predicate.

2. Sample size used for the test set and the data provenance

Not Applicable. No clinical test set was used as "No clinical tests were performed." The submission relies on non-clinical data, typically engineering verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical test set was used, and thus no expert ground truth establishment for a clinical study.

4. Adjudication method for the test set

Not Applicable. No clinical test set was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. No clinical effectiveness study, and specifically no MRMC study, was performed. This device is an ultrasound system, not an AI-assisted diagnostic tool in the context of human reader improvement.

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

Not Applicable. This is an ultrasound imaging system, not a standalone diagnostic algorithm. The performance evaluation was based on non-clinical engineering tests and comparison to a predicate device's technological characteristics and safety standards.

7. The type of ground truth used

Not Applicable. As no clinical studies were performed, there was no ground truth for patient outcomes or expert consensus on diagnostic accuracy required in this submission. The "ground truth" for the non-clinical tests would be the compliance with engineering specifications and safety standards.

8. The sample size for the training set

Not Applicable. This document does not describe the development or training of any machine learning algorithms. It is a traditional 510(k) for an ultrasound imaging system.

9. How the ground truth for the training set was established

Not Applicable. As no machine learning training set is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Esaote S.p.A. % Alberto Carcagni Regulatory Officer Via Enrico Melen 77 Genoa, 16152 ITALY

September 16, 2021

Re: K212021

Trade/Device Name: 6430 MyLabX75, 6430 MyLab XPro75 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 15, 2021 Received: June 28, 2021

Dear Alberto Carcagni:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica Lamb

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212021

Device Name 6430 MyLabX75, 6430 MyLab XPro75

Indications for Use (Describe)

The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes

-Cardiac [Adult and Pediatric]

-Vascular [Neonatal, Adult Cephalic, Vascular generic] -General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological ] with invasive access Intraoperative (Abdominal), Laparoscopic, Transrectal. -Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)]

The equipment provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications. The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.

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)

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K212021 Traditional 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.

807.92(a)(1)

Submitter Information Esaote S.p.A. Via Enrico Melen 77 16152 Genova Italy Alberto Carcagnì, Regulatory Affairs Officer Contact Person: + 39 055 4229 365 Office +39 055 4229 424 Fax alberto.carcagni@esaote.com Date: 15th Jun, 2021 807.92(a)(2) Device Common Name: Ultrasound Imaging System Trade Name: 6430 MyLabX75, 6430 MyLab XPro75 Classification Name(s): Ultrasound Pulse Doppler Imaging System 892.1550 Ultrasound Pulse Echo Imaging System 892.1560 Transducer, Ultrasonic, Diagnostic 892.1570 90IYN, 90IYO, 90ITX Classification Number:

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Predicate Device(s)

Predicate	510(k)	Device	Owner
Primary	K192157	6450 - MyLabX8	Esaote S.p.A.

This predicate has not been subject to a design-related recall

807.92(a)(4)

Device Description

Model 6430 has a software option integrated, called PLA, designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a second imaging modality (CT, MR, US and PET). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

Model 6430 is equipped with a LCD color display where acquired images and advanced image features are shown. Model 6430 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. The touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry and has additional controls and mode-depending keys, integrated in the touchscreen.

Model 6430 can drive Phased Array (PA), Convex Array (LA), Linear Array (LA), Doppler and Volumetric probes.

Model 6430 is equipped with an internal Hard Disk Drive. Data can also be stored directly to external archiving media (Hard-Disk, PC, on server) via a LAN/USB port.

6430 project is mainly design change of 6450 devoted to reducing cost and to differentiate design and performances, 6430 will introduce in the Esaote's Mid-ultrasound tier functionalities that, at the moment are present only in our High -End Ultrasound tier, such as 2D Shear Wave Elastography (2D-SWE) and Virtual Navigator.

The marketing names for Model 6430 will be MyLabX75 and MyLab XPro75.

The difference between MyLab XPro75 is only in the licenses configuration: on MyLab XPro75 all the options are included while in the MyLabX75 some licenses can be ordered by customer.

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807.92(a)(5) Indications for Use/ Intended Use

The multifunctional ultrasound scanner MyLabX75 Family is used to collect, display, and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes

-Cardiac [Adult and Pediatric]

-Vascular [Neonatal, Adult Cephalic, Vascular generic]

-General Imaging [Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological | with invasive access Intraoperative (Abdominal), Laparoscopic,Transrectal.

-Women Health [OB/Fetal, Gynecology with invasive access (Transrectal, Transvaginal)]

The ultrasonic medical diagnostic equipment is intended to mechanical and electronic ultrasound probes (convex array, linear array and phased array) and Doppler probes.

The Fiber Guidance option assists ultrasound guidance in the phases of insertion and positioning of the introducer needle and optical fiber and procedure monitoring.

807.92(a)(6) Technological Characteristics

Model 6430 employs the same fundamental technological characteristics as the predicate device.

Model 6430 is substantially equivalent to Esaote Model 6450 including the guide for fibre installation for Percutaneous Laser Ablation. The PLA option has been cleared with Virtual Navigator Option (echo-laser) via K192157.

The following Features, firstly cleared with Esaote 6440 high-end model, have been introduced on 6430 middle-end model:

. 2D Shear Wave Elastography (2D-SWE)
PLA Echo guide for installation of fiber for laser ablation.
Transducer element Check*

The function Transducer Element Check, required by FDA (with Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, Guidance for Industry and Food and Drug Administration Staff, issued on June 27, 2019), is under development on 6430, with Esaote project PRJ000167, having Requirements defined in PRQ000229 and Software Requirements Specifications in SRS000160 documents.

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The Transducer Element Check will be released on Esaote systems following the plan reported in Project Development Plan PDP000050.

All the mentioned documents are enclosed in section 1.7.5.7 of this submission.

The subject and predicate device are based on the following same technological elements:

Clinical uses for which Esaote Model 6430 is designed are included in those of the Esaote Model 6450, already cleared via K192157.
Models 6430 and 6450 ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
Most part of the transducers for the use with the Esaote Model 6430 are also available with the Esaote Model 6450, already cleared via K192157.
Models 6430 and 6450 ultrasound models provide similar measurements and analysis packages, with equal accuracy and precision.
Models 6430 and 6450 ultrasound models have digital storage capabilities, including network connectivity.
Model 6430 imaging modes are available on other FDA cleared ultrasound systems, for instance Esaote 6440 ultrasound model
The Model 6430 QElaXto (Breast) and ElaXto (Thyroid) features are equivalent to the ones of Esaote's 6450, already cleared via K192157.

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807.92(b)(1)

Summary of Non-Clinical Tests

The 6450 model has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to conform to the following medical device safety standards.

. IEC 60601-1
. IEC 60601-1-2
IEC 60601-1-6
. IEC 60601-2-37
. NEMA UD-2

Summary of Clinical Tests

No clinical tests were performed.

807.92(b)(3)

Conclusions

The non-clinical data support the safety of the device and software verification and validation demonstrate that the Esaote Model 6430 ultrasound system should perform as intended in the specified use conditions.

MyLabX75 and MyLab XPro75 Models employ the same fundamental technological characteristics as the predicate devices.

All the features included in new 6430 MyLabX75 and MyLab XPro75 have been cleared in the predicated device 6450.

The 6430 project is mainly a design change of 6450 (previously cleared by FDA via K192157) devoted to reducing cost and to differentiate design and performances.

MyLabX75 will introduce in the Esaote's Mid-ultrasound tier functionalities that, at the moment are present only in our High -End Ultrasound tier, such as 2D Shear Wave Elastography (2D-SWE) and PLA fiber guide that helps in the insertion of the fiber guide but is not involved in the laser ablation.

The detailed features comparison between MyLabX8 is reported in section 1.5 Predicate Device Comparison, of this submission.

We can conclude that the MyLab XPro75 Models are substantially equivalent to primary predicate device, Esaote MyLabX8, cleared via K192157.

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.