Esaote's Model 7410 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transrectal, Pediatric and Other: Urologic. The 7410 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 7410 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 operations are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM), 3D and 4D. 7410 is equipped with a LCD color display where acquired images and advanced image features are shown. 7410 system can drive Phased, Convex, Linear array, Doppler probes and Volumetric probes (Bi-Scan probes). On 7410 system the touchscreen has an emulation of the Qwerty alphanumeric keyboard that allows data entry. 7410 system is equipped with wireless capability. Model 7410 has been designed to be powered by battery.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Esaote 7410 Ultrasound System, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for an ultrasound system, which primarily demonstrates substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria or conducting a dedicated performance study against new criteria. Therefore, the "acceptance criteria" here are implicitly the performance specifications and safety standards met by the predicate devices. The "reported device performance" is the assertion that the new device (7410 System) meets these same technological characteristics and standards.

Acceptance Criteria (Implicit from Predicate Devices & Standards)	Reported Device Performance (Esaote 7410 Ultrasound System)
Technological Characteristics- Equivalent fundamental technological characteristics to predicate devices (Esaote 7400, Esaote Europe 6420)- Equivalent clinical uses to predicate devices- Compliance with IEC60601-1- Compliance with IEC60601-1 and IEC60601-2-37 safety requirements- Acoustic Output Display feature per AIUM / NEMA standards (equivalent Ispta and MI maximal values)- Similar measurements and analysis package to predicate devices- Digital storage capabilities, including network connectivity- Wireless capability- Battery powering capability	- The 7410 system employs the same fundamental technological characteristics as its predicate devices (Esaote 7400 via K111032, K132331, K132466; and Esaote Europe 6420 via K141486).- Clinical uses for the 7410 system are equivalent to those of the Esaote 7400 model and Esaote Europe 6420.- Designed to meet IEC60601-1.- Designed to meet IEC60601-1 and IEC60601-2-37 safety requirements.- Provides an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.- Provides similar measurements and analysis package.- Has digital storage capabilities, including network connectivity.- Equipped with wireless capability, substantially equivalent to 7400 cleared for wireless capability.- Designed to be powered by battery, substantially equivalent to 7400 cleared for battery powering.
Safety Standards / Non-Clinical Tests- Acoustic output evaluation- Biocompatibility evaluation- Cleaning and disinfection effectiveness evaluation- Thermal, electromagnetic, and mechanical safety evaluation- Conformity to IEC 60601-1- Conformity to IEC 60601-1-2- Conformity to IEC 60601-2-37- Conformity to NEMA UD-3- Conformity to NEMA UD-2	- The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electromagnetic, and mechanical safety.- Found to conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-3, and NEMA UD-2.- The system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

Acceptance Criteria (Implicit from Predicate Devices & Standards)

Reported Device Performance (Esaote 7410 Ultrasound System)

Technological Characteristics- Equivalent fundamental technological characteristics to predicate devices (Esaote 7400, Esaote Europe 6420)- Equivalent clinical uses to predicate devices- Compliance with IEC60601-1- Compliance with IEC60601-1 and IEC60601-2-37 safety requirements- Acoustic Output Display feature per AIUM / NEMA standards (equivalent Ispta and MI maximal values)- Similar measurements and analysis package to predicate devices- Digital storage capabilities, including network connectivity- Wireless capability- Battery powering capability

- The 7410 system employs the same fundamental technological characteristics as its predicate devices (Esaote 7400 via K111032, K132331, K132466; and Esaote Europe 6420 via K141486).- Clinical uses for the 7410 system are equivalent to those of the Esaote 7400 model and Esaote Europe 6420.- Designed to meet IEC60601-1.- Designed to meet IEC60601-1 and IEC60601-2-37 safety requirements.- Provides an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.- Provides similar measurements and analysis package.- Has digital storage capabilities, including network connectivity.- Equipped with wireless capability, substantially equivalent to 7400 cleared for wireless capability.- Designed to be powered by battery, substantially equivalent to 7400 cleared for battery powering.

Safety Standards / Non-Clinical Tests- Acoustic output evaluation- Biocompatibility evaluation- Cleaning and disinfection effectiveness evaluation- Thermal, electromagnetic, and mechanical safety evaluation- Conformity to IEC 60601-1- Conformity to IEC 60601-1-2- Conformity to IEC 60601-2-37- Conformity to NEMA UD-3- Conformity to NEMA UD-2

- The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electromagnetic, and mechanical safety.- Found to conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD-3, and NEMA UD-2.- The system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

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

The document explicitly states: "No clinical tests were performed." This is a 510(k) submission based on substantial equivalence to predicate devices and non-clinical engineering/safety testing, not a performance study involving a test set of patient data.

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

Not applicable, as no clinical tests were performed and thus no ground truth was established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical tests were performed.

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. This is not an AI/CADe/CADx device and no MRMC study was conducted.

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 algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical performance study was conducted requiring ground truth. The basis for clearance is substantial equivalence to legally marketed predicate devices and conformity to recognized safety standards.

8. The sample size for the training set

Not applicable, as no algorithm requiring a training set was developed or evaluated.

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

Not applicable, as no algorithm requiring a training set was developed or evaluated.

Summary of the Document's Nature:

This document is a 510(k) Pre-market Notification for the Esaote 7410 Ultrasound System. Its primary purpose is to demonstrate substantial equivalence to already legally marketed predicate ultrasound devices (Esaote 7400 and Esaote Europe 6420). This means the new device shares the same intended use and fundamental technological characteristics, and any differences do not raise new questions of safety or effectiveness. The "studies" performed are non-clinical engineering and safety tests to ensure the device meets recognized industry standards for medical electrical equipment and diagnostic ultrasound. No new clinical performance studies were conducted to establish specific accuracy, sensitivity, or specificity metrics for diagnostic image interpretation by the device itself.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2014

Esaote S.p.A. % Ms. Allison Scott Senior Consultant Navigant Consulting, Inc. 9001 Wesleyan Road Suite 200 INDIANAPOLIS IN 46268

Re: Trade/Device Name: 7410 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 31, 2014 Received: July 31, 2014

Dear 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 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. 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.

This determination of substantial equivalence applies to the following transducers intended for use with the 7410 Ultrasound Systems, as described in your premarket notification:

	Transducer Model Number
SP2730	AL2442	SL1543
SL2325	SL3235	SL3323
SL3332	AC2541	SC3123
SC3421	S2MCW	S5MCW
SHFCW	SE3123	ST2612
SB2C41

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

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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); 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 Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sm.7)

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K142077

Device Name MyLabGamma (7410)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Page 1 of 18

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Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 2 of 18

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	N	N	N	N	N	N	N	N	N	N: 5, 6
Fetal	N	N	N	N	N	N	N	N	N	N: 5, 6
Abdominal	N	N	N	N	N	N	N	N	N	N: 5
Intraoperative (Abdominal)	N	N	N	N	N	N	N	N	N	N: 5
Intraoperative Neurological	N	N	N	N	N	N	N	N	N	N: 5
Pediatric	N	N	N	N	N	N	N	N	N	N: 5
Small Organs [1]	N	N	N	N	N	N	N	N	N	N: 5
Neonatal Cephalic	N	N	N	N	N	N	N	N	N	N: 5
Adult Cephalic	N	N	N	N	N	N	N	N	N	N: 5
Cardiac [2]	N	N	N	N	N	N	N	N	N	N: 5
Transesophageal (Cardiac) [2]	N	N	N	N	N	N	N	N	N	N: 5
Transesophageal (Non Cardiac)	N	N	N	N	N	N	N	N	N	N: 5
Transrectal	N	N	N	N	N	N	N	N	N	N: 5
Transvaginal	N	N	N	N	N	N	N	N	N	N: 5
Transurethral	N	N	N	N	N	N	N	N	N	N: 5
Intravascular	N	N	N	N	N	N	N	N	N	N: 5
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N: 5
Laparoscopic	N	N	N	N	N	N	N	N	N	N: 5
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N: 5
Musculo-skeletal Superficial [3]	N	N	N	N	N	N	N	N	N	N: 5
Other (Urological)	N	N	N	N	N	N	N	N	N	N: 5
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
						Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P	P	P	P	P		P	P: 5
Abdominal	P	P	P	P	P	P	P			P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P		P	P: 5
Small Organs [1]
Neonatal Cephalic	P	P	P	P	P	P	P		P	P: 5
Adult Cephalic	P	P	P	P	P	P	P		P	P: 5
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P		P	P: 5
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P		P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular			P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]			P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]			P		P	P	P		P	P: 5
Other (Urological)
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P		P	P	P		P	P: 5
Small Organs [1]	P	P	P		P	P	P		P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P		P	P	P		P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E
						Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	E	E	E		E	E	E		E	E: 5
Small Organs [1] Neonatal Cephalic	E	E	E		E	E	E		E	E: 5
Adult Cephalic Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	E	E	E		E	E	E		E	E: 5
Laparoscopic
Musculo-skeletal Conventional	E	E	E		E	E	E		E	E: 5
Musculo-skeletal Superficial [3]	E	E	E		E	E	E		E	E: 5
Other (Urological)
SL3235 Intended use: Diagnostic ult						asound imaging or fluid flow analysis of human body as follows: Mode of Operations Mode of Operation:
inical Applicatio	ਸ	N	PWD	CWD	Color Doppler	mplitude Doppler (PD)	Combinedす	Color Velocity apping (TVM	Harmonic maging (TE	Other (speci
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Small Organs	d	d	d		d	d	d		d	സ. d
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gnostic ultrasound imaging or fluid flow analysis of human body Dia Intended i 7410

under Append by FDA; E:Ad P: Previously : N

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CFM+PD

Small organs includes Breast, Thyroid and etc.
Cardiac is Adult and Pediatric

Cardiac is Aquin and I volume
Musculo skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CW+CFL

[5] Compound Imaging (Mview)

[6] 3D/4D

To be cleared with this submission

{4}------------------------------------------------

ound imaging or fluid flow analysis of human body as follo . Di SP2730
Intended use

N: New indication; P: Previously cleared by FDA; E:Added under Appendix

[1]. Small Organs includes Breast, Thyroid and etc.

Other Organs includes Disease, Injury, etc.
Cardiac is Adult and Pediatric

Cardiac is Not and Involuntary
Muscle is Skeletal - Nerve Block

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CW+CFM+PD

[5] Compound Imaging (Mview

reviously cleared via k14148

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDR

Page 3 of 18

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scription Use Only Per 21 CFR 801 Part D Concurrence of CDR

Only be part of creation
ER 801210

AL2442
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview

reviously cleared via k14148

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Page 48 of 1535

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRR

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mview)

Previously cleared via k14148

SL 1543
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Page 5 of 18

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Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

tion; P: Previously cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[2] Cardiac is Adult and Pediatric.

32 Musculo Skeletal - Nerve Block

(4) Combined modes are: B+M; B+M+PW; CF

[5] Compound Imaging (Mview)

Under 510K submission
K142008

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 6 of 18

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Page 7 of 18

: Description of contents of 21 CFR Part 801 Prescription Device Labeling

scription Use Only Per 21 CFR 801 Part D Concurrence of CDR

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview

reviously cleared via k14148

{9}------------------------------------------------

Prescription: Use only for clinical research. 21 CFR part 801.421. CAUTION: New Drug - Limited by Federal (or United States) law to investigational use.

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Transesophageal (Non Cardia

Cardiac [2]

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Small Organs [1]
Neonatal Cephalic
Adult Cephalic

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Harmonic
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Color Velocity
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Combined
[4]

Amplitude
Doppler
(PD)

Color
Doppler

CWD

PWD

Clinical Application

0phthalmic

intraoperative (Abdominal)
Intraoperative Neurologica

Pediatric

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SL3323
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

P: 5

또 : [

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P: 5

P: 5 P: 5 P: 5

d P d

ﮩﻢ d d

Transrectal
Transvaginal
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Peripheral Vascular

Laparoscopic
Musculo-skeletal Conventional

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Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix

[1] Small Organs includes Breast, Thyroid and Testic
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

USD Small Organs Includes Breast, Thyroid

Cardiac ICU and Pediatric
Lung Specialists 1 New Block

[3] M
[4]

Combined moden ore: RMBW+CEM

Compound Imaging (Mvi

eviously cleared via k1414

cription Use Only Per 21 CFR 801 Part D Concurrence of CD

Page 8 of 18

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scription Use Only Per 21 CFR 801 Part D Concurrence of CDF

	d	d
	d	d
	C	d

C	d	d
œ	d	d	ed by FDA; E:Added under Appendix E	1 -----------------------------------
d	d	d

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview

reviously cleared via k14148

SL3332Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P	P	P	P	P	P	P	P	P	P: 5
Fetal	P	P	P	P	P	P	P	P	P	P: 5
Abdominal	P	P	P	P	P	P	P	P	P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric	P	P	P	P	P	P	P	P	P	P: 5
Small Organs [1]	P	P	P	P	P	P	P	P	P	P: 5
Neonatal Cephalic
Adult Cephalic
Cardiac [2]	P	P	P	P	P	P	P	P	P	P: 5
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P: 5
Laparoscopic
Musculo-skeletal Conventional [3]	P	P	P	P	P	P	P	P	P	P: 5
Musculo-skeletal Superficial [3]	P	P	P	P	P	P	P	P	P	P: 5

{11}------------------------------------------------

AC2541

ended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:
Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P		P	P: 5
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P		P	P	P		P	P: 5
Laparoscopic
Musculo-skeletal Conventional	P	P	P		P	P	P		P	P: 5
Musculo-skeletal Superficial [3]	P	P	P		P	P	P		P	P: 5
Other (Urological)	P	P	P		P	P	P		P	P: 5

AC2541
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[ I ] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

Cardiac in Adult and Pediatric

Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

[5] Compound Imaging (Mview)

Previously cleared via K141486

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 10 of 18

{12}------------------------------------------------

Prescription only. Do not use prior to consultation with your DRH care team.
21 CFR Part 801.109 - Caution: Federal law restricts this device to sale by or on the order of a physician.

PWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]
P	P	P	P
	P	P	P
	P	P	P
P	P	P	P
P	P	P
P	P	P

Transesophageal (Cardiac)
Transesophageal (Non Cardiac

Cardiac [2]

Other (specify

Harmonic
Imaging (TEI)

Color Velocity
Mapping (TVM)

Clinical Application

Ophthalmic

bdominal

Fetal

SC3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows:

P: 5

ntraoperative Neurological ntraoperative (Abdominal)

Pediatric

Small Organs [1]
Neonatal Cephalic dult Cephalic

P: 5

Peripheral Vascular

aparoscopic

ransurethral

ransrectal

ntravascular ransvaginal

Musculo-skeletal Conventional Musculo-skeletal Superficial

Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix 2

[1] Small Organs includes Breast, Thyroid and Testic
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

TO Small Organs Includes Breast, Thyroid, Adrenals, Pituitary, Ovaries, Testicles, Thymus, and Pancreas

TO Adults, Adults and Pediatrics, Pediatrics

Cardiac is Atrial and Ventricular
Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+

Compound Imaging (Mvie

eviously cleared via k1414

scription Use Only Per 21 CFR 801 Part D Concurrence of CDF

Page 11 of 18

{13}------------------------------------------------

Page 12 of 18

Description of current Part 801 Prescription Drug Compounding Requirements under 21 CFR Only for Use in Conference Discussion

scription Use Only Per 21 CFR 801 Part D Concurrence of CDR

Mode of Operations
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P		P
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal	P	P	P		P	P	P		P	P: 5
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular			P	P		P	P		P	P: 5
Laparoscopic					P			P
Musculo-skeletal Conventional			P	P		P	P		P	P: 5
Musculo-skeletal Superficial [3]			P	P		P	P		P	P: 5
Other (Urological)	PP	P	P		P	P	P		P	P: 5

SC3421
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

2] Cardiac is Adult and Pediatric

[3] Musculo Skeletal - Nerve Block

[4] Combined modes are: B+M+PW+CFM+F

[5] Compound Imaging (Mview

reviously cleared via K141486

{14}------------------------------------------------

S2MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)				P
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional[3]
Musculo-skeletal Superficial [3]
Other (Urological)
N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:

C. Audion, A. Hall, and B. Delivoria-Papadopoulos, "Brain pH in Newborn Lambs During Slow Constant Infusion of Sodium Bicarbonate," Pediatric Research, 16:11, November 1982.

Musculo Skeletal - Nerve Block
(Suitable to Neck and Extremities)

[4] Combined modes are;

[5] Compound Imaging (Mview

Previously cleared via K141486

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 13 of 18

{15}------------------------------------------------

S 5MCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human b Mode of One

Mode of Operations
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
P: New indication; P: Previously cleared by FDA; F:Added under Appendix F

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:

Cardiac Right and Pericardiac
Surface to Human and Robotic
Musculo Skeletal - Nerve Block

[4] Combined modes are:

[5] Compound Imaging (Mview

Previously cleared via K141486

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 14 of 18

{16}------------------------------------------------

SHFCW
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human b Mode of One

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)

N: New indication; P: Previously cleared by FDA; E:Added under Appendix E

[1] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are:

(1) SIMILAR STRAINS INDUCED BREAST TUMOR GROWTH
(2) Induction, Adhesion and Delivery

Cardiac is heart and I would
Musculo Skeletal - Nerve Block

Combined modes are:

[5] Compound Imaging (Mview

Previously cleared via K141486

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 15 of 18

{17}------------------------------------------------

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal	P	P	P		P	P	P		P	P: 5
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal	P	P	P		P	P	P		P	P: 5
Transvaginal	P	P	P		P	P	P		P	P: 5
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial [3]
Other (Urological)	P	P	P		P	P	P		P	P: 5
Clinical Application	B	M	PWD	CWD	Color Doppler	Amplitude Doppler (PD)	Combined [4]	Color Velocity Mapping (TVM)	Harmonic Imaging (TEI)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)		P	P	P	P	P	P	P	P	P: 5
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional [3]
Musculo-skeletal Superficial [3]
Other (Urological)
Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler(PD)	Combined[4]	Color VelocityMapping (TVM)	HarmonicImaging (TEI)	Other (specify)
Ophthalmic	P	P	P		P	P	P
Fetal	P	P	P		P	P	P		P	P: 5, 6
Abdominal									P	P: 5, 6
Intraoperative (Abdominal)
Intraoperative Neurological
Pediatric
Small Organs [1]
Neonatal Cephalic
Adult Cephalic
Cardiac [2]
Transesophageal (Cardiac)
Transesophageal (Non Cardiac)
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional[3]
Musculo-skeletal Superficial [3]
Other (Urological)

SE3123
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow of

o ž

[ ] ] Small Organs includes Breast, Thyroid and Testicles
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

C) Small Organs (Thymus, Breast, Liver, etc.)

Cardiac is Adult and Pediatric

Musculo Skeletal - Nerve Block

Combined modes are: B+M+PW+CFI

5] Compound Imaging (Mview

reviously cleared via K141486

Page 16 of 18

{18}------------------------------------------------

escription Use Only Per 21 CFR 801 Part D Concurrence of CDRF

ST2612
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow of 2

bb ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ ry J: 1 o ž

[1] Small Organs includes Breast, Thyroid and Testicle
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CW+CW+CFM+PD

(1) Small Organs Includes Breast, Thyroid, Adrenal, and Pituitary, etc.
(2) Cardiac Adult and Pediatric

Murmurs, S1, S2, L, Normal, Blood Pressure
Cardiac Is Adult and Pediatric

MUSLIN SKELETON TOTE BAG
CAMILLA WWW.CAMILLADALLOZ.COM

Compound Imaging (Mvier

[TCI Compound Imaging (MCW)]

reviously cleared via K141486

Page 17 of 18

{19}------------------------------------------------

SB2C41
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follow

N: New indication; P: Previously cleared by FDA; E:Added under Appendix

Small Organs includes Breast, Thyroid and ...

Carson is certified April 11, 2018, and
Musculo Skeletal - Nerve Block

[1] Small Organs includes Breast, Thyroid and Testicle:
[2] Cardiac is Adult and Pediatric
[3] Musculo Skeletal - Nerve Block
[4] Combined modes are: B+M+PW+CFM+PD

[5] Compound Imaging (Mviev

[6] 3D/4D

Previously cleared via K141486

Prescription Use Only Per 21 CFR 801 Part D Concurrence of CDRH

Page 18 of 18

{20}------------------------------------------------

510(k) Submission 7410 System Esaote, 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

Allison Scott Contact Person: 317.228.8719 allison.scott@navigant.com

Date: July 31, 2014

807.92(a)(2)

Devices

Common Name:	Ultrasound Imaging System
Trade Name:	7410 Ultrasound System
Classification Name(s):	Ultrasound Pulse Doppler Imaging System 892.1550Ultrasound Pulse Echo Imaging System 892.1560Transducer, Ultrasonic, Diagnostic 892.1570
Classification Number:	90IYN, 90IYO, 90ITX

807.92(a)(3)

Predicate Device(s)

Device	Owner	510(k)
7400	Esaote	K111302, K132231,K132466
6420	EsaoteEurope	K141486

{21}------------------------------------------------

510(k) Submission 7410 System Esaote, S.p.A.

807.92(a)(4)

Device Description

7410 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use

Esaote's Model 7410 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 and Other: Urologic. The 7410 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.

807.92(a)(6)

Technological Characteristics

7410 system employs the same fundamental technological characteristics as its predicate devices.

7410 model is substantially equivalent to Esaote 7400 model cleared by FDA via K111032, K132331, K132466 and to Esaote Europe 6420 cleared by FDA via K141486.

Clinical uses for which Esaote 7410 system is designed is equivalent to those of Esaote 7400 model, cleared via K111302, K132231 and K132466 and to those of Esaote Europe 6420 cleared by FDA via K141486.
· Esaote 7410 system is designed to meet the IEC60601-1.
· Esaote 7410 system is designed to meet the IEC60601-1 and IEC60601-2-37 safety requirements.
Esaote 7410 system provides an Acoustic Output Display feature per AIUM / NEMA standards, with equivalent Ispta and MI maximal values.
Esaote 7410 and 7400 and Esaote Europe 6420 systems provide similar measurements and analysis package.

{22}------------------------------------------------

· Esaote 7410 and 7400 and Esaote Europe 6420 systems have digital storage capabilities, including network connectivity.
Esaote 7410, equipped with wireless capability, is substantially equivalent to 7400 cleared for wireless capability via K111302, K132231 and K132466.
Esaote 7410, designed to be powered by battery, is substantially equivalent to 7400 cleared for battery powering via K111302, K132231 and K132466.

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, 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.

807.92(b)(3)

Conclusion

7410 system is substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

[3] M [4]

cription Use Only Per 21 CFR 801 Part D Concurrence of CD

Traditional 510(k) Summary

Submitter Information

Devices

Predicate Device(s)

Device Description

Intended Use

Technological Characteristics

Summary of Non-Clinical Tests

Summary of Clinical Tests

Conclusion

§ 892.1550 Ultrasonic pulsed doppler imaging system.

[3] M
[4]