Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard ultrasound imaging modes and features.

Therapeutic

No
Explanation: The device is described as an "integrated preprogrammed color ultrasound imaging system" intended for "visualization of ultrasound of internal organs, for medical diagnostic purposes only." This indicates its function is diagnostic, not therapeutic.

Diagnostic

Yes

The "Intended Use" section explicitly states that the system is intended "for medical diagnostic purposes only." Additionally, the "Device Description" mentions its purpose for "clinical diagnostic imaging applications," and the "Predicate Device(s)" are listed as "Diagnostic Ultrasound System."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system," which implies the presence of hardware components for acquiring and displaying ultrasound signals, not just software. The performance studies also mention compliance with hardware-related standards like IEC 60601-1 and IEC 60601-2-37.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
Device Function: The iNSIGHT Color Doppler Ultrasound System is described as an imaging system that visualizes internal organs using ultrasound. This is a non-invasive imaging technique performed on the body, not on samples taken from the body.
Intended Use: The intended use clearly states "visualization of ultrasound of internal organs, for medical diagnostic purposes only." This aligns with in-vivo imaging, not in-vitro testing.
Device Description: The description details various ultrasound imaging modes and capabilities, all of which are related to generating images of internal structures within the body.

Therefore, the iNSIGHT Color Doppler Ultrasound System is a diagnostic imaging device, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The iNSIGHT Color DopplerUltrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The iNSIGHT Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the following imaging operations: B, M, PW, CW, CDI, PDI, DPDI, TDI, MC and THI imaging mode, Spatial Compounding Imaging, Panoramic B and Color mode, Freehand 3D, 4D Imaging, Strain imaging, ARFI Elasticity Imaging.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Internal organs, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, Cardiology. Specific anatomical sites are also listed for various transducers, including Ophthalmic, Fetal, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Peripheral vessel.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2005 + CORR. 1: 2006 + CORR. 2:2007 + AM 1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007 General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-37: 2007 Medical electrical equipment - Part2 -37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
NEMA UD 2-2004 (R2009) Acoustic output measurement standard for diagnostic ultrasound equipment
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity:
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;

Discussion about the testing of strain and elasticity quantitative measurements:
The bench testing for the features providing strain and elasticity quantitative has been conducted to show that the accuracy of the strain and elasticity imaging of the proposed device; the result has been analyzed that they are accepted for clinical use.

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K090059, K130881

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

June 23, 2015

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

Saset (Chengdu) Inc. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai 200120 CHINA

Re: K150002

Trade/Device Name: iNSIGHT Color Doppler Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: June 15, 2015 Received: June 17, 2015

Dear Ms. Hong:

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.

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); 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.

1

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.

Michael D'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K150002

Device Name

Trade Name: iNSIGHT Color Doppler Ultrasound System

Models of iNSIGHT Color Doppler Ultrasound System: iNSIGHT 25C, iNSIGHT 35R, iNSIGHT 23R, iNSIGHT 11R, iNSIGHT 10B and iMago c21; Models of Probes: SH3C50, SH3P30, SH4DC54, SH6E47 and SH7L38

Indications for Use (Describe)

The iNSIGHT Color DopplerUltrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

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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3

System: iNSIGHT Color Doppler Ultrasound System

Transducer: SH3C50 Convex Array Transducer

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

Clinical Application	Mode of Operation
		B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
General
(Track 1 Only)	Specific
(Track 1&3)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal	N	N	N		N	BMDC	1,2,3
	Abdominal	N	N	N		N	BMDC	1,2,3
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	BMDC	1,2,3
	Small Organ(Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

1. Tissue Harmonic Imaging (THI)
1. Freehand 3D imaging
1. STIC
1. ARFI strain image
9.4D Imaging
1. Spatial Compounding Imaging
1. Panoramic B and Color mode
1. Strain image
1. Tissue Doppler Imaging (TDI)

4

System: iNSIGHT Color Doppler Ultrasound System

Transducer: SH3P30 Phased Array Transducer

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

Clinical Application	Mode of Operation
General
(Track 1 Only)	Specific
(Track 1&3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Specify)
	Neonatal Cephalic
	Adult Cephalic	N	N	N		N	BMDC	1
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult	N	N	N	N	N	BMDC	1,5,8
	Cardiac Pediatric	N	N	N	N	N	BMDC	1,5,8
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

1. Tissue Harmonic Imaging (THI)
1. Freehand 3D imaging
1. STIC
1. ARFI strain image
9.4D Imaging
1. Spatial Compounding Imaging
1. Panoramic B and Color mode
1. Strain image
1. Tissue Doppler Imaging (TDI)

5

System: iNSIGHT Color Doppler Ultrasound System

Transducer: SH4DC54 Volume Transducer

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1&3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal	N	N	N		N	BMDC	1,2,3,9
	Abdominal	N	N	N		N	BMDC	1,2,3,9
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
Peripheral
Vessel	Peripheral vessel
	Other (Specify)

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

1. Tissue Harmonic Imaging (THI)
1. Freehand 3D imaging
1. STIC
1. ARFI strain image
9.4D Imaging
1. Spatial Compounding Imaging
1. Panoramic B and Color mode
1. Strain image
1. Tissue Doppler Imaging (TDI)

6

System: iNSIGHT Color Doppler Ultrasound System

Transducer: SH6E47 Cavity Transducer

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

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1&3)	B	M	PWD	CWD	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal
	Abdominal
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	N	N	N		N	BMDC	1,2
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric	N	N	N		N	BMDC	1,2
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel
	Other (Specify)
Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1&3)	B	M	PWD	CWD	Color
Doppler	Combine
d
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
Other	Fetal
	Abdominal	N	N	N		N	BMDC	1,2,3,4,6,7
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	BMDC	1,2,3,4,6,7
	Small Organ(Specify)	N	N	N		N	BMDC	1,2,3,4,6,7
	Neonatal Cephalic
	Adult Cephalic	N	N	N		N	BMDC	1,2,3,4,6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N		N	BMDC	1,2,3,4,6,7
	Musculo-skeletal
(Superficial)	N	N	N		N	BMDC	1,2,3,4,6,7
	Intravascular
	Other (Specify)
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral
Vessel	Peripheral vessel	N	N	N		N	BMDC	1,2,3,4,6,7
	Other (Specify)

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

1. Tissue Harmonic Imaging (THI)
1. Freehand 3D imaging
1. STIC
1. ARFI strain image
9.4D Imaging
1. Spatial Compounding Imaging
1. Panoramic B and Color mode
1. Strain image
1. Tissue Doppler Imaging (TDI)

7

System: iNSIGHT Color Doppler Ultrasound System

Transducer: SH7L38 Linear Array Transducer

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

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

Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging.

1. Tissue Harmonic Imaging (THI)
1. Freehand 3D imaging
1. STIC
1. ARFI strain image
9.4D Imaging
1. Panoramic B and Color mode 6. Strain image
1. Tissue Doppler Imaging (TDI)

Spatial Compounding Imaging

8

Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K150002

1. Date of Preparation: 12/19/2014
1. Sponsor Identification

Saset (Chengdu) Inc.

A-601, Huoju Building, #16 Chuangye RD B Hi-Tech Avenue, Hi-Tech Zone Chengdu, Sichuan, 610041, China

Establishment Registration Number: 3007751490

Contact Person: Mr. Dong Chyuan Liu Position: General Manager Tel: 0086-28-85130926-808 Fax: 0086-28-85130926-100 Email: dongcliu@163.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

9

4. Identification of Proposed Device

Trade Name: iNSIGHT Color Doppler Ultrasound System Common Name: Diagnostic Ultrasound System and Transducers

Models of iNSIGHT Color Doppler Ultrasound System: iNSIGHT 37C, iNSIGHT 25C, iNSIGHT 35R, iNSIGHT 23R, iNSIGHT 11R, iNSIGHT 10B and iMago c21

Models of Probes: SH3C50, SH3P30, SH4DC54, SH6E47 and SH7L38

Regulatory Information Classification Name: Ultrasound Pulsed Doppler Imaging System; Classification: II; Product Code: IYN: Regulation Number: 21 CFR 892.1550; Review Panel: Radiology:

Classification Name: Ultrasonic Pulsed Echo Imaging System; Classification: II; Product Code: IYO; Regulation Number: 21 CFR 892.1560; Review Panel: Radiology;

Classification Name: Diagnostic Ultrasound Transducer; Classification: II; Product Code: ITX; Regulation Number: 21 CFR 892.1570; Review Panel: Radiology:

Intended Use Statement:

The iNSIGHT Color Doppler Ultrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.

Device Description

The iNSIGHT Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the following imaging operations: B, M, PW, CW, CDI, PDI, DPDI, TDI, MC and THI imaging mode, Spatial Compounding Imaging, Panoramic B and Color mode, Freehand 3D, 4D Imaging, Strain imaging, ARFI Elasticity Imaging.

10

ર . Identification of Predicate Device
510(k) Number: K090059 Product Name: iMago c21 Diagnostic Ultrasound System Model Name: iMago c21

510(k) Number: K130881 Product Name: Acuson S2000 and S3000 Diagnostic Ultrasound Systems Model Name: Acuson S2000

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
IEC 60601-1:2005 + CORR. 1: 2006 + CORR. 2:2007 + AM 1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007 General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests.
A IEC 60601-2-37: 2007 Medical electrical equipment - Part2 -37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
A NEMA UD 2-2004 (R2009) Acoustic output measurement standard for diagnostic ultrasound equipment
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity:
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;

Discussion about the testing of strain and elasticity quantitative measurements:

The bench testing for the features providing strain and elasticity quantitative has been conducted to show that the accuracy of the strain and elasticity imaging of the proposed device; the result has been analyzed that they are accepted for clinical use.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

11

8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device	Predicate Device
		K090059	K130881
Product Code	IYN, IYO and ITX	IYN, IYO and ITX	IYN/ IYO/ ITX/OBJ
Intended Use	The iNSIGHT Color Diagnostic Ultrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.	The iMago c21 medical ultrasound system is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.	The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral vascular applications.
The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other clinical diagnosis purposes.
The arterial health package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk; A

Table 1 Comparison of Technology Characteristics

12

| | | | | consensus Statement from the Amerian
Association of Echocardiography; Carotid
Intima-Media Thickness Task Force,
Endorsed by the Society for Vascular
Imaging" |
|------------------------|---------------|------------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Configuration | | Color Doppler Ultrasound
System | Color Doppler Ultrasound
System | Color Doppler Ultrasound System |
| | | Probes | Probes | Probes |
| | | / | / | Ultrasound Catheter |
| Acoustic Track | | Track 1 | Track 1 | Track 3 |
| Biocom | cytotoxicity | ISO 10993-5 | ISO 10993-5 | ISO 10993-5 |
| patibilit | sensitization | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 |
| y | irritation | ISO 10993-10 | ISO 10993-10 | ISO 10993-10 |
| Electrical Safety | | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| EMC | | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| Particular Performance | | IEC 60601-2-37 | IEC 60601-2-37 | IEC 60601-2-37 |

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.