MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150

• K Number: K052805
• Device Name: MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
• Manufacturer: ESAOTE S.P.A.
• Date Cleared: 2005-10-17 ( 13 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K040596 , K050326 , K051308 , K051837
• Predicate For: K070903 , K071996 , K081794 , K091009 , K103152 , K111302

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal. For Model 6150 (MyLab70), Urological is also included.

Device Description

The 7300 (MyLab30), 7350 (MyLab50) and 6150 (MyLab70) system designs remain the same as those previously cleared by FDA via K040596, K050326, and K051308, respectively. They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

AI/ML Overview

The provided 510(k) summary for the MyLab30, 50, 70 Systems from Esaote, S.p.A. is a premarket notification for a diagnostic ultrasound imaging system. It establishes substantial equivalence to previously cleared predicate devices.

This document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance data.

The document is a regulatory submission for a medical device that outlines its intended use, describes the device, references predicate devices, and lists requested new indications for various transducers and systems. It primarily focuses on showing that the new device (or updates to existing devices) is substantially equivalent to legally marketed predicate devices, as required by the FDA 510(k) process.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance: Not available in the provided text.
2. Sample Sizes and Data Provenance (Test Set): Not available in the provided text.
3. Number and Qualifications of Experts (Ground Truth for Test Set): Not available in the provided text.
4. Adjudication Method (Test Set): Not available in the provided text.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not available in the provided text.
6. Standalone (Algorithm Only) Performance Study: Not applicable or not available in the provided text, as this is an ultrasound system, not an AI algorithm.
7. Type of Ground Truth Used: Not available in the provided text.
8. Sample Size for Training Set: Not applicable or not available in the provided text, as this is an ultrasound system, not an AI algorithm requiring a training set in the conventional sense.
9. How Ground Truth for Training Set was Established: Not applicable or not available in the provided text.

The document primarily focuses on:

• Device Description: The MyLab30, MyLab50, and MyLab70 are compact/mainframe ultrasound systems for diagnostic general ultrasound studies, including various clinical applications (Cardiac, Peripheral Vascular, Abdominal, Fetal, etc.). They operate in B-Mode, M-Mode, Doppler, Color Flow Mapping, and Tissue Enhancement Imaging (TEI).
• Predicate Devices: K040596 (MyLab30), K050326 (MyLab50), K051308 (MyLab70), and K051837 (MyLab90).
• New Indications/Features: The submission adds specific probes (2.0 CW, 5.0 CW Doppler Probes, IOE323 probe), Biopsy Attachment (ABS15), VPAN, Compound Imaging, and for some models, Intelligent Real Time Processing, and an "Intraoperative Abdominal" indication for use across various modes with specified transducers. The forms indicate "N" (new indication) for certain clinical applications and modes for the new IOE323, 2 CW, and 5 CW transducers, confirming these as the newly sought clearances.
• Regulatory Compliance: The systems are manufactured under ISO 9001:2000 and ISO 13485 certified quality system. The FDA letter grants substantial equivalence subject to a post-clearance special report containing acoustic output measurements based on production line devices.

Summary

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510(k) Summary MyLab30. 50. 70 Systems Esaole. S.p.A.

K 052805

0C7 1 7 2005

510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 1807.92(a).

807.92(a)(1)

Submitter Information

Carri Graham, Official Correspondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250 Phone: [phone] x103 Facsimile: [phone]

Contact Person:	Carri Graham
Date:	September 29, 2005
807.92(a)(2)
Trade Name:	MyLab30, 50, 70 Systems
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulse doppler imaging system 892.1550Ultrasonic pulsed echo imaging system 892.1560
Classification Number:	90IYN; 90IYO

807.92(a)(3)

Predicate Device(s)

K040596	7300 (MyLab30)	Esaote, S.p.A.
K050326	7350 (MyLab50)	Esaote, S.p.A.
K051308	6150 (MyLab70)	Esaote, S.p.A.
K051837	6100 (MyLab90)	Esaote, S.p.A.

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510(k) Summary Mr Lab30, 50, 70 Systems Esaote. S.p.A.

807.92 (a)(4)

Device Description

The 7300 (MyLab30), 7350 (MyLab50) and 6150 (MyLab70) system designs remain the same as those previously cleared by FDA via K040596, K050326, and K051308, respectively. They are compact ultrasound systems used to perform diagnostic general ultrasound studies. Their primary modes of operation are: B-Mode, M-Mode, Doppler and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes.

The 7300 (MyLab30), 7350 (MyLab50) and 6150 (MyLab70) models are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

807.92(a)(5)

Intended Use(s)

Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal.

Esaote's Model 7350 (MyLab50) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Intraoperative Abdominal.

Esaote's Model 6150 (MyLab70) is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatic Other: Urological, and Intraoperative Abdominal.

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To be added via this 510(k)	MyLab90 (6100)K051837(Predicate)	MyLab30CV (7300)K040596	MyLab50 (7350)K050326	MyLab70 (6150)K051308
Doppler Probes- 2.0 CW- 5.0 CW	✔	YES	✔	✔
IOE Probe- IOE323	✔	YES	✔	✔
Biopsy Attachment- ABS15	✔	YES	YES	YES
VPAN	✔	YES	YES	YES
Compound Imaging	✔	YES	YES	YES
Intelligent Real TimeProcessing	NO	NO	NO	YES
Intraoperative AbdominalIndication for Use	✔	YES	YES	YES

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Notice

It has come to our attention that certain individuals and entities are falsely claiming to be affiliated with or endorsed by Zeno Power Systems, Inc. These individuals and entities are misrepresenting themselves and their products or services as being associated with Zeno Power Systems, Inc., when in fact they are not.

Zeno Power Systems, Inc. is not responsible for any actions, representations, or omissions made by these individuals or entities. We urge you to exercise caution and due diligence when dealing with anyone claiming to be affiliated with Zeno Power Systems, Inc.

If you have any questions or concerns about the legitimacy of any individual or entity claiming to be affiliated with Zeno Power Systems, Inc., please contact us directly at [e-mail].

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is composed of three stylized lines that resemble a human figure.

Public Health Service

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Esaote, S.p.A. % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K052805

Trade Name: Model 7300 (MyLab30), Model 7350 (MyLab50), and Model 6150 (MyLab70) Ultrasound Imaging Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 29, 2005 Received: October 4, 2005

Dear Ms. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 I cactar Food, Drag, and sions of the Act. The general controls provisions of the Act include ane general only provents for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for r ms determination 7300 (MyLab30), Model 7350 (MyLab50), and Model 6150 (MyLab70) Ultrasound Imaging Systems, as described in your premarket notification:

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Transducer Model Number

$$\frac{\text{IOE323}}{\underline{\text{CW}}}$$

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat FDA has made a determination that your device complies with other requirements of the Act that I Drinas Intact and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic for an as a tion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Sceking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at [phone]. 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

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Page 3 – Ms. Graham

Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Nancy C. Burgdon

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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Diagnostic Ultrasound Indications for Use Form

Model 7300

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

Intended Use: Diagnostic
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P [2]	P [3]
Abdominal		P	P	P		P	P		P [2]	P [3]
Intraoperative(Abdominal)		N	N	N		N	N		N [2]	N [3]
IntraoperativeNeurological
Pediatric		P	P	P		P	P		P [2]	P [3]
Small Organ (specify) [1]		P	P	P		P	P		P [2]	P [3]
Neonatal Cephalic		P	P	P		P	P		P [2]
Adult Cephalic		P	P	P		P	P		P [2]
Cardiac		P	P	P		P	P		P [2]	P [3]
Transesophageal		P	P	P		P	P		P [2]
Transrectal		P	P	P		P	P		P [2]
Transvaginal		P	P	P		P	P		P [2]
Transurethral
Intravascular
Peripheral Vascular		P	P	P		P	P		P [2]
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		P [2]
Musculo-skeletalSuperficial		P	P	P		P	P		P [2]
Other (specify)

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

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

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

(3) Tissue Enhancement Imaging (TEI)

Compound Imaging VPAN Tissue Velocity Mapping (TVM) CMM CnTl

(PLEASE DO ROT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF

concurrence of CDRH, Office of Device Evaluation (t

Prescription Use (Per 21 CFR 801.109)

Nancy C. Roardon

Divisi n of Reproductive and logical Devic 510(k) Number

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Diagnostic Ultrasound Indications for Use Form

Model 7350

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

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

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

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

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

• [3] Tissue Harmonic Imaging (TEI)
  CMM

Tissue Velocity Mapping (TVM)

VPAN

Compound Imaging

• CnTI
  (PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Burden
(Division Sign-Off)

Division of Reproductive, Abdi and Radiological Devices 510(k) Number

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Diagnostic Ultrasound Indications for Use Form

Model 6150

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

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

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

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

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

• |3| Tissue Harmonic Imaging (TEI)
  CMM VPAN Compound Imaging CriTI Tissue Velocity Mapping (TVM)

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

concurrence of CDRH, Off

Prescription Use (Per 21 CFR 801.109)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052805

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7300, 7350, and 6150 Systems

IOE323

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

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

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

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

• [3] TEI (Tissue Enhanced Imaging)
  VPAN

Compound Imaging CnTI

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

concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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7300 System

2 CW

	Mode of Operation
Clinical Application	A	B	M	PWD(PW)	CWD(CW)	ColorDoppler(CFM)	AmplitudeDoppler(PD)	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac					N
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
LaparoscopicMuscolo-skeletal
ConventionalMuscolo-skeletalSuperficial
Other

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

(PLEASE DO NOT WRITE BELOW THIS LINE. COETIEUE OR ANOTHER PAGE IF NEEDED)

511(x) Number ________________________________________________________________________________________________________________________________________________________________

concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brigdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
K052205

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7300 System

5 CW

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

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

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

concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broughton

(Division Sign-Off) Entision of Reproductive, Abdominal, and Rediological Devices 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.