Esaote's Model 6400 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdomninal and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Description

Model 6400 is a mainframe system equipped with wheels allowing to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes.. 6400 control panel is equipped with a pull-out Qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 has been designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrades, defined herein, combine the cleared features of both 6400 and 7400 systems with new capabilities, listed below:

1. Managing of Intraoperative (Abdominal) application on both 6400 and 7400 upgrades.
1. Management of Pulsed Wave (PW) Doppler probe on both 6400 and 7400 upgrades.

The 6400 and 7400 Upgrades are manufactured under an I50 9001:2000 and ISO 13485 certified quality system.

AI/ML Overview

The provided text describes a 510(k) submission for upgrades to existing ultrasound systems (6400 and 7400). It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, it is explicitly stated that "No clinical tests were performed." This means there is no study detailed in this document that explicitly proves the device meets acceptance criteria through clinical performance metrics. The submission relies on the technological characteristics and equivalence to previously cleared devices.

Given this, I will answer the questions based on the information available, noting the absence of a specific performance study.

Acceptance Criteria and Device Performance

Since no clinical tests were performed to establish specific performance acceptance criteria for the upgrades (managing Intraoperative Abdominal application and Pulsed Wave Doppler probe), the document focuses on demonstrating that the upgraded devices maintain the safety and effectiveness of the predicate devices for their intended uses. The "acceptance criteria" are implied to be adherence to relevant safety and performance standards for ultrasound equipment and technological equivalence.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Safety Standards Conformance	The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety, and found to conform to:
- IEC 60601-1 (General medical electrical equipment safety)	- Confirmed adherence.
- IEC 60601-1-2 (Electromagnetic compatibility)	- Confirmed adherence.
- IEC 60601-2-37 (Specific requirements for ultrasonic medical diagnostic and monitoring equipment)	- Confirmed adherence.
- NEMA UD-3 (Real Time Display of Thermal and Mechanical Acoustic Output Indices)	- Confirmed adherence, providing Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values as predicate devices.
- NEMA UD-2 (Acoustic Output Measurement Standard)	- Confirmed adherence.
Functional Equivalence for Upgrades
- Intraoperative (Abdominal) application management	- Stated to be equivalent to Esaote 6200 model (K100931). The upgrades employ the same fundamental technological characteristics as predicate devices.
- Pulsed Wave (PW) Doppler probe management	- Stated to be equivalent to Esaote AU6 (Technos) model (K990360, K000681, K014168, K023255). The upgrades employ the same fundamental technological characteristics as predicate devices.
Clinical Use Equivalence	- Clinical uses for the 6400 and 7400 models (K111302) are not changed by the upgrades. - Clinical uses for the 6400 and 7400 Upgrades are equivalent to those of Esaote 6200 (K100931) and AU6 (Technos) (K990360, K000681, K014168, K023255). - The models continue to perform diagnostic general ultrasound studies across a wide range of applications (Cardiac, Vascular, Abdominal, Fetal, Musculoskeletal, etc.) and provide imaging for biopsy guidance and needle placement.

Study Details (or lack thereof)

Sample size used for the test set and the data provenance:
- No clinical test set was used. The submission explicitly states: "No clinical tests were performed."
- Data provenance is therefore not applicable to a clinical test set from this submission. Non-clinical testing relied on internal validation and verification processes against established standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set was used, and thus no ground truth established by experts for such a set in this submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set was used.
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:
- No MRMC study was done. This submission is for upgrades to an ultrasound imaging system, not an AI-assisted diagnostic device. The functionality being cleared involves managing new applications and probe types, not performance enhancement through AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is an ultrasound imaging system, and the "upgrades" are for hardware/software capabilities for managing specific applications and probe types, not for a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no clinical test set requiring ground truth was used. The "ground truth" for the non-clinical testing was conformance to engineering and medical device safety standards.
The sample size for the training set:
- Not applicable, as this submission does not describe an AI/machine learning device that would typically involve a "training set." The upgrades are technological enhancements to existing ultrasound systems.
How the ground truth for the training set was established:
- Not applicable, as there was no training set mentioned or implied.

Summary

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KB2466
Page 1 of 4

5 10(x) Suimisson 6400 and 7400 Upgrade Csante, S.p.A.

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 di Caciolle 15 Firenze, Italy 50127

Contact Person:

Allison Scott 317.569.9500 x106 allison.scott@navigant.com

Date:

August 6, 2013

807.92(a){2}

Devices

Common Name: Ultrasound Imaging System Trade Name: 6400 Ultrasound System 7400 Ultrasound System Classification Name(s): Ultrasound Pulse Doppler Imaging System 892.1550 Ultrasound Pulse Echo Imaging System 892.1560 Transducer, Ultrasonic, Diagnostic 892.1570 Classification Number: 901YN, 901YO, 901TX

807.92(a)(3)

Predicate Device(s)

Device	Owner	510(k)
64007400	Esaote	K111302
AU6 (Technos)	Esaote(BiosoundEsaote)	K990360, K000681,K014168, K023255
6200	Esaote	K100931

C 0 4 2013

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510(%) Submission 6400 and 7400 Upgrade Esante, 5.p.A.

807.92(a)(4)

Device Description

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrades, defined herein, combine the cleared features of both 6400 and 7400 systems with new capabilities, listed below:

1. Managing of Intraoperative (Abdominal) application on both 6400 and 7400 upgrades.
1. Management of Pulsed Wave (PW) Doppler probe on both 6400 and 7400 upgrades.

The 6400 and 7400 Upgrades are manufactured under an I50 9001:2000 and ISO 13485 certified quality system.

807.92(a){5}

Intended Use

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510(k) Submission 6400 and 7400 Ungrade Esante, S.p.A.

807.92(a)(6)

Technological Characteristics

The 6400 and 7400 Upgrades employ the same fundamental technological characteristics as their predicate devices. The 6400 Upgrade model is substantially equivalent to Esaote AU6 (Technos) model cleared via K990360, K014168, K023255, to Esaote 6200 model cleared by FDA via K100931 and to Esacte 6400 model cleared by FDA via K111302. The 7400 Upgrade model is substantially equivalent to Esaote AU6 (Technos) model cleared via K990360, K014168, K023255, to Esaote 6200 model cleared by FDA via K100931 and to Esaote 7400 model cleared by FDA via K111302.

· Clinical uses for which Esaote 6400 and 7400 models, cleared by FDA via K111302, are designed are not changed by 6400 and 7400 Upgrades, to be cleared via this submission.
· Clinical uses for which Esaote 6400 and 7400 Upgrades are designed are equivalent to those of Esaote 6200 model, cleared via K100931, and of Esaote AU6 (Technos) model, cleared via K990360, K000681, K014168, K023255.
6400 Upgrade and 7400 upgrade for managing Intraoperative (abdominal) application are . equivalent to those of Esaote 6200 model, cleared via K100931.
6400 and 7400 Upgrades for managing Pulsed Wave (PW) Doppler probe are equivalent to those . of Esaote AU6 (Technos) model, cleared via K990360, K000681, K014168, K023255.
· Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6200 and AU6 (Technos) are designed to meet the IEC60601-1.
Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400 and 6200 are designed to meet the IEC60601-. 1 and IEC60601-2-37 safety requirements.
· Esaote 6400 Upgrade, 7400 Upgrade, 6400, 7400, 6200 and AU6 (Technos) ultrasound models provide an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.

807.92(b)(1)

Summary of Non-Clinical Tests

The devices have 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 6060 1-2-37
NEMA UD-3 - Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. NEMA UD-2 - Acoustic Output Measurement Standard for Diagnostic Ultrasound

807.92(b){2}

Summary of Clinical Tests

No clinical tests were performed.

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K132466
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510(k) Submission 6400 and 7400 Ungrade Esaole, S.p.A.

807.92(b)(3)

Conclusion

The 6400 and 7400 Upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Commit Control - WY Xito Cook

Silver Spring, MI) 2014 3-0002

Public Health Sers ice

December 4, 2013

Esaote S.p.A. % Allison Scott. RAC Schior Consultant 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K132466

Trade/Device Name: Myl.abSeven 6400, MyLabAlpha 7400 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 1YN, 1YO. ITX Dated: November 11, 2013 Received: November 13. 2013

IDear Ms. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivulent (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 10 devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. und Cosmelic 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 practive, labeling, and prohibitions against misbranding and adultcration. Please note: CDRH docs not evaluate information related to contract liability waranties. We remind you, however, that device labeling must be truthful and not misleading.

This determination of substantial equivalence applies to the following transducers intended for use with the MyLabSeven 6400 and MyLabalpha 7400, as described in your premarket notification:

Transducer Model Number
SP24301.4523'Al.2442A1.2443AC2541	S2MC.WSSMCWSHIFC WS2MPWSI:3123	1.18.1.332.12612IOT34210.1.332

For 6400 systems only

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Page 2-Ms. Scott

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 (2 1 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note

the regulation enlitled, "Misbranding by reference to premarket notification" (21CFR 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/Satiety/ReportalProblem/deligult.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm.

Sincerely yours.

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

6400 and 7400 Systems

Indications for Use

510(k) Number (if known): KI32466

Device Name:

6400 and 7400 Ultrasound Systems

Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardlac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative abdominal and Other: Urologic. The 6400 system provides imaging for guldance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies Including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephallc, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intracperative abdominal and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and Imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

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

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 In Vitro Diagnostic Devices (OIVD)

Sm.h.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K132466 210(K)

Esapta, S.p.A.

6400 & 7400 Ultrasound Systems 510{k} Intracperative and PW Dopplar

1/1

Page 52 of 1901

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.