CMS600P2 B-Ultrasound Diagnostic System

• K Number: K170856
• Device Name: CMS600P2 B-Ultrasound Diagnostic System
• Manufacturer: Contec Medical Systems Co., LTD.
• Date Cleared: 2017-11-17 ( 240 days)
• Product Code: IYO , ITX
• Regulation Number: 892.1560
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K081873
• Predicate For: K232895

Intended Use

CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, peripheral vascular,and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.

This device is not intended for home use.

Device Description

The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution.

It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability.

The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design.

Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions.

With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. image processing functions. It is convenient for choice of optimal diagnostic image with image pigeonhole, browse, management functions. Measure, calculation, and report features are provided to facilitate image measurement.

The device supports linear probe and convex probe. The frequency of the device is 2.0 MHz-10.0 MHz. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology and urology etc. .

The device is consist of three parts: mainframe, transducer(probe), adapter.

AI/ML Overview

The provided text describes the 510(k) submission for the CMS600P2 B-Ultrasound Diagnostic System, asserting its substantial equivalence to a predicate device (EMP-2100 Full Digital Ultrasound Diagnostic Device).

Important Note: This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance against specific clinical acceptance criteria through a clinical trial with a human-in-the-loop AI system. Therefore, the information provided will pertain to demonstrating equivalence to an existing medical device's performance, rather than an AI's performance against specific clinical metrics. Many of the requested details, such as "effect size of human readers improving with AI vs. without AI assistance," "standalone (algorithm only) performance," or "adjudication method for the test set," are typically associated with AI/ML-driven devices and are not applicable to this traditional ultrasound system's 510(k) submission.

Here's an analysis based on the provided document:

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Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for the CMS600P2 B-Ultrasound Diagnostic System are primarily based on demonstrating substantial equivalence (SE) to a legally marketed predicate device (EMP-2100 Full Digital Ultrasound Diagnostic Device) in terms of:

• Intended Use and Indications for Use
• Technological Characteristics (e.g., imaging modes, frequency range, resolution, safety standards)
• Safety and Effectiveness (demonstrated through non-clinical testing and comparison to predicate)

The performance of the proposed device is assessed against the performance characteristics of the predicate device.

Table of Acceptance Criteria and Reported Device Performance (Comparison to Predicate Device)

Acceptance Criterion (Category / Characteristic)	Predicate Device Performance (EMP-2100)	Proposed Device Performance (CMS600P2)	Substantial Equivalence (SE) / Remark
General
Device Name	EMP-2100 Full Digital Ultrasound Diagnostic Device	CMS600P2 B-Ultrasound Diagnostic System	/ (Different names, but comparable)
Classification Name	System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic	System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic	SE
Product Code	IYO, ITX	IYO, ITX	SE
Regulation Number	892.1560, 892.1570	892.1560, 892.1570	SE
Intended Use	General-purpose, digital ultrasound diagnostic system for various applications (abdomen, gynecology, obstetric, urology, small-parts, cardiology, etc.)	General-purpose, digital ultrasound diagnostic system for various applications (abdomen, gynecology, obstetric, urology, small-parts, cardiology, etc.)	SE (Similar intended use)
Technical Specifications (Probe specific examples)
C3.5-80R60-A16A (Convex Probe)	Comparable Predicate Data Listed
Frequency	3.5MHz (for C128-50 Convex)	3.5MHz	Analyse 1 (Differences in performance specs, but tested for accuracy and effectiveness)
Detect Depth	≥200 mm (C128-50 Convex)	≥160 mm	Analyse 1
Resolution (Lateral)	≤3(depth≤80) ≤4(80 ≤130) (for C128-50 Convex)	≤3(Depth≤80) ≤4(80≤130)	Analyse 1
Resolution (Axial)	≤1 (depth≤50) ≤1 (depth≤40) (for C128-50 Convex)	≤2(Depth≤80) ≤3(80 ≤130)	Analyse 1
L7.5-80L40-A16A (Linear Probe)	Comparable Predicate Data Listed
Frequency	6.5MHz (L096-42C Linear)	7.5MHz	Analyse 1
Detect Depth	≥90 mm (L096-42C Linear)	≥50 mm	Analyse 1
Resolution (Lateral)	≤2(depth≤60) (L096-42C Linear)	≤2(Depth≤40)	Analyse 1
Resolution (Axial)	≤0.5(depth≤60) (L096-42C Linear)	≤1 (Depth≤50)	Analyse 1
E6.5-80R13-A16A (Endo-vaginal Probe)	Comparable Predicate Data Listed
Frequency	6.5MHz (C080-13G Micro Convex)	6.5MHz	Analyse 1
Detect Depth	≥90 mm (C080-13G Micro Convex)	≥40 mm	Analyse 1
Resolution (Lateral)	≤2(depth≤60) (C080-13G Micro Convex)	≤2(Depth≤30)	Analyse 1
Resolution (Axial)	≤0.5(depth≤40) (C080-13G Micro Convex)	≤1 (Depth≤40)	Analyse 1
System Features
Monitor Size	10 inch	10.1 inch	SE
Display Mode	B, B+B, B+M, M, 4B	B, 2B, BM, M, 4B	SE (Similar)
Image gray scale	256 level	256 level	SE
Image Storage	16	2048 frame	Analyse 1 (Internal memory difference, but tested functionality)
Cine Loop	256 frame	600 frame	Analyse 1 (Internal memory difference, but tested functionality)
Image Flip	Up/down, left/right	Up/down, left/right, black/white	Analyse 1 (Added capability but main function similar)
Image Process	Various	Various	Analyse 1 (Different specific functions, but overall image processing similar)
Measurement	Distance, circumference, area, volume, histogram, profile, time velocity heart rate	Distance, circumference, area, volume, heart, pregnant age, fetal weight, expected date	Analyse 1 (Different specific measurements, but overall measurement capability similar)
Notation	Date, Time, Name, Sex, Age, Doctor, Hospital name, probe frequency, etc.	Date, time, name, No., sex, age, doctor, hospital name, probe frequency, etc.	SE
Net weight	10kg	2.3 kg (include probe)	SE (Weight difference not considered to impact safety/efficacy if performance is SE)
Power supply	AC 100-240V, 47-60Hz	DC15V; Adapter:100 V~240 V, 50 Hz/60 Hz	Analyse 2 (Difference in power supply, but both passed IEC60601-1 safety test)
Dimensions (mm)	365 (H) X 292 (W) X 380 (D)	292 (L) × 232 (W) × 45 (H)	SE (Differences in size, but doesn't affect SE of core function)
Configuration	mainframe, transducer(probe)	mainframe, transducer(probe), adapter	SE (Both include core components)
Safety & Standards Compliance
Biocompatibility	ISO10993-5 & ISO10993-10	ISO10993-5 & ISO10993-10	SE
Electrical Safety	IEC60601-1	IEC60601-1	SE
EMC	IEC60601-1-2	IEC60601-1-2	SE
Performance Standards	UD2	IEC 60601-2-37; IEC61157	Analyse 1 (Different specific standards, but both demonstrate performance)
Acoustic Output	Meet the requirements of Track 1	Meet the requirements of Track 3	Analyse 1 (Different tracks, but both demonstrate compliance)
Skin Contacted Material	Probe Cover (ABS), Acoustic Lens (Silicone elastomer)	Probe Cover (ABS), Acoustic Lens (Silicone elastomer)	SE
Operation Environment	Temperature 5°C -40°C, RH up to 90%RH, Air pressure 70-106Kpa	Temperature: +10°C~ +40°C, RH: 30%~ 75%, Atmosphere pressure: 700 hPa ~ 1060 hPa	SE (Within acceptable ranges)
Storage environment	Temperature -5-40°C, RH up to 90%RH (no water drop), Air pressure 70-106Kpa	Temperature: -10°C~+55°C, RH: ≤93%, no condensation, Atmosphere pressure: 700 hPa ~ 1060 hPa	SE (Within acceptable ranges)
Sterile	No	No	SE
Single Use	No	No	SE

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Study Proving Acceptance Criteria Met: Non-Clinical Testing and Comparison

The study proving the device meets the acceptance criteria is primarily a non-clinical testing and comparison study against a predicate device, as explicitly stated in the document.

1. Sample Size Used for the Test Set and Data Provenance:

• Test Set: No separate "test set" in the sense of a distinct dataset for an algorithm's performance evaluation is mentioned, as this is a physical diagnostic device, not an AI/ML product. The "test set" would implicitly refer to the device itself undergoing various performance and safety tests.
• Data Provenance: Not applicable in the context of imaging data. The provenances are the device specifications and direct measurements from non-clinical tests conducted on the proposed device and compared to the predicate's known specifications and performance.
• Retrospective/Prospective: Not specified for the "data" as it pertains to device testing against engineering specifications and regulatory standards. The non-clinical tests were conducted on the proposed device.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. This submission is for a traditional ultrasound diagnostic system, not an AI/ML-driven device requiring expert consensus for image interpretation or "ground truth" establishment beyond the standard physical and electrical performance measurements. The "ground truth" here is the adherence to engineering specifications and safety standards, as well as the established performance of the predicate device.

3. Adjudication Method for the Test Set:

• Not applicable. No human interpretation or adjudication of diagnostic outputs from the device is described for the purpose of establishing clinical ground truth for a test set. Adjudication methods are typically relevant for studies evaluating human reader performance, especially with AI assistance.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not conducted. The submission explicitly states: "No clinical study is included in this submission." This type of study is common for AI-assisted diagnostic tools to show improvement in human reader performance, which is not the scope of this 510(k) for a basic ultrasound system.

5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation. It is an ultrasound diagnostic system where the user (physician) interprets the images.

6. The Type of Ground Truth Used:

• For the non-clinical tests (e.g., electrical safety, EMC, performance parameters like resolution and depth): The "ground truth" is established by engineering specifications, international consensus standards (IEC, ISO), and the documented performance characteristics of the legally marketed predicate device.
• For biocompatibility: The "ground truth" is established by ISO 10993 series standards for in vitro cytotoxicity, irritation, and delayed-type hypersensitivity.

7. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a "training set" of data.

8. How the Ground Truth for the Training Set Was Established:

• Not applicable. As no training set for an AI/ML algorithm is involved, this question is irrelevant.

Summary

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November 17, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Contec Medical System Co., Ltd. % Mr. Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206. Build 332. DaFangJu. No.25 BanBiDian Road LiYuan Town, TongZhou District, Beijing, 101121 CHINA

Re: K170856

Trade/Device Name: CMS600P2 B-Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: October 18, 2017 Received: October 23, 2017

Dear Mr. Wang:

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 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);

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Page 2 - Mr. Ray Wang

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Robert Ochs, Ph.D. 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

510(k) Number (if known) K170856

Device Name

CMS600P2 B-Ultrasound Diagnostic System

CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, peripheral vascular,and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.

This device is not intended for home use.

Please refer to the acoustic output declaration for each transducer as following pages.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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System: CMS600P2 B-Ultrasound Diagnostic System

Transducer:

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

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

Additional comment:Combined mode : B/M

Note 1:urology: prostate and vesica urinaria; Note 2: Thyroid Gland; Note 3: Hip Joint

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

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System: CMS600P2 B-Ultrasound Diagnostic System

Transducer:

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

Additional comment:Combined mode : B/M

Note 1:urology: prostate and vesica urinaria

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

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System: CMS600P2 B-Ultrasound Diagnostic System E6.5-80R13-A16A Transducer:

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

Additional comment:Combined mode : B/M

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

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System: CMS600P2 B-Ultrasound Diagnostic System Transducer:

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

Additional comment:Combined mode : B/M Note 2: Thyroid Gland

Note 3: Hip Joint

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

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Tab #4 510(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: K170856

• 1. Date of Preparation: 11/18/2017
• 2. Sponsor Identification

Contec Medical System Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China. Establishment Registration Number: 3006979678

Contact Person: Xueyong Li Position: Quality Manager Tel: [phone] Fax: [phone] Email:[e-mail]

• 3. Designated Submission Correspondent
     Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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4. Identification of Proposed Device

Trade Name: CMS600P2 B-Ultrasound Diagnostic System Common Name: Diagnostic Ultrasound System with Accessories Model(s): CMS600P2

Regulatory Information

Classification Name: System, Imaging, Pulsed Echo, Ultrasonic ; Transducer, Ultrasonic, Diagnostic

Classification:II Product Code:IYO & ITX Regulation Number:21 CFR 892.1560 & 21 CFR 892.1570 Review Panel:Radiology:

Intended Use Statement:

CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application.

The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, peripheral vascular,and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.

The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.

This device is not intended for home use.

Please refer to the acoustic output declaration for each transducer as following pages.

Device Description

● The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution.

● It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability.

● The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design.

● Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions.

● With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. image processing functions. It is convenient for choice of optimal diagnostic image with image pigeonhole, browse, management functions. Measure, calculation, and report features are provided to facilitate image measurement.

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• The device supports linear probe and convex probe. The frequency of the device is 2.0
  MHz-10.0 MHz. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology and urology etc. .

• The device is consist of three parts: mainframe, transducer(probe), adapter.

• The transducers provided are listed below in table 7-1, the specification of the system and transducers please refer to Tab 9 section 7 Technical Specifications. The picture and design drawing of the subject device and its transducer is presented in Tab 9 section 2 Device Illustration.

Transducer Model	Type	Frequency	Application
C3.5-80R60-A16A	convex probe	3.5 MHz	Abdomen, obstetrics, urology
L7.5-80L40-A16A	linear probe	7.5 MHz	small organs
E6.5-80R13-A16A	endo-vaginal probe	6.5 MHz	Gynecology and transvaginal

Image /page/9/Figure/6 description: The image shows the title of a table. The title is "Table 7-1 Transducer List". The title is written in a clear, sans-serif font and is centered on the page.

Image /page/9/Figure/7 description: The image shows the text "Fig 7-1 Working Frame of CMS600P2". The text appears to be a figure label or title, possibly from a technical document or manual. The text indicates that the figure is related to the working frame of a device or system named CMS600P2. The figure is labeled as "Fig 7-1", suggesting it is the first figure in chapter 7.

Image /page/9/Figure/8 description: The image shows a block diagram of a system. The system includes components such as a probe, beamforming, A/D converter, TGC control, multi-route pulse control, FPGA, image processing, arithmetic software package, ARM, LCD display, image and video memory, and keypad input. The components are connected by arrows, indicating the flow of data or control signals within the system.

• ર . Identification of Predicate Device(s)
  Predicate Device :

510(k) Number: K081873 Product Name: Full Digital Ultrasound Diagnostic Device Model Name: EMP-2100 Manufacturer: Shenzhen Emperor Electronic Technology Co., Ltd.

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• 6. 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:

• a. IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance

• b. IEC 60601-1-2:2007, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests

• IEC 60601-2-37:2007 Medical electrical equipment Part 2-37: Particular requirements for the C. basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

• IEC61157:1992 Requirements for the Declaration of the Acoustic Output of Medical Ultrasound d. Diagnostic Apparatus

• ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity. e.

• f. ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity

• Clinical Test Conclusion 7.

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device(s)	Predicate Device(s)	Remark
Device name	CMS600P2 B-Ultrasound Diagnostic System	EMP-2100 Full DigitalUltrasound Diagnostic Device	/
Classification Name	System, Imaging, Pulsed echo,UltrasonicTransducer, Ultrasonic, Diagnostic	System, Imaging, Pulsed echo,UltrasonicTransducer, Ultrasonic, Diagnostic	SE
Product Code	IYOITX	IYOITX	SE
Regulation Number	892.1560892.1570	892.1560892.1570	SE
ComparisonStatement	The proposed device has same classification information as the predicate device.
Intended Use	CMS600P2 B-Ultrasound Diagnostic System in ageneral-purpose, digital ultrasound diagnostic system forabdomen,gynecology, obstetric, urology,small-parts, andcardiology application.The system is intended to use for the following type of studies:fetal organ, abdominal, pediatric, small organs, neonatalcephalic, cardiac, transvaginal, peripheral vascular,andmusculo-skeletal (both conventional and superficial). Thedevice is intended to adult, pregnant woman, pediatric andneonate.The system is a prescription device intended to be used by or on	EMP-2100 Full Digital Ultrasound Diagnostic Device in ageneral-purpose, digital ultrasound diagnostic system forabdomen, gynecology,obstetric, urology,small-parts,andcardiology application.The system is intended to use for the following type ofstudies:fetal organ, abdominal, pediatric, small organs,Neonatal cephalic, cardiac, transvaginal, peripheralvascular,and musculo-skeletal (both conventional andsuperficial). The device is intended to adult, pregnantwoman, pediatric and neonate.The system is a prescription device intended to be used by or	SE

Table 7-1 Comparison of Technology Characteristics

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the order of a physician or similar qualified health care			on the order of a physician or similar qualified health care
professional.			professional.
This device is not intended for home use.			This device is not intended for home use.
Comparison	The proposed device has similar intended use as the predicate device.
	Main Unit Technical Specifications
Probe mode	C3.5-80R60-A16AConvex probe	L7.5-80L40-A16Alinear	E6.5-80R13-A16Aendo-vaginal	C128-50Convex	L096-42CLinear	C080-13GMicro Convex	C096-20AMicro Convex	/
	Scan angle/width	110°	6.3mm	114.6°	128°	40mm	120°	88°	Analyse1
	Maximum number ofActive elements for asingle pulse	5	5	5	32	32	32	32	Analyse 1
Frequency	3.5MHz	7.5MHz	6.5MHz	3.5MHz	6.5MHz	6.5MHz	3.5MHz	Analysel
Number of Element	80	80	80	128	96	80	96	Analyse1
Size of Element(mm)	0.48x7.5	0.5x6.3	0.33x7.3	0.41x13.4	0.34 x8.2	0.26 x8.2	0.24 x11.4	Analyse 1
Spacing ofelement(mm)	0.48	0.5	0.33	0.49	0.42	0.34	0.32	Analysel
Arraydimensions(mm)	38.4x7.5	40x6.3	26.4x7.3	62.8x13.4	40.3 x8.2	27.2 x8.2	30.7 x11.4	Analyse 1
Detect Depth(mm)	≥160	≥50	≥40	≥200	≥90	≥90	≥90	Analysel
Resolution(mm)	Lateral	≤3(Depth≤80)≤4(80≤130)	≤2(Depth≤40)	≤2(Depth≤30)	≤3(depth≤80)≤4(80 <depth≤130)	≤2(depth≤60)	≤2(depth≤60)	≤2(depth≤40)	Analyse 1
	Axial	≤2(Depth≤80)≤3(80 ≤1(Depth≤50) ≤1(Depth≤40) ≤1(80<depth≤130) ≤0.5(depth≤80) ≤0.5(depth ≤60) ≤0.5(depth≤40) Analyse 1
		≤130)	≤5	≤3	≤4	≤3	≤3	≤3	Analyse1
Blind Zone(mm)			≤5	≤3	≤4	≤3	≤3	≤3	Analyse1
Focus Position		4 focus, adjustable position		4 focus, position is not adjustable		4-steps dynamic focusing			Analyse1
Monitor Size		10.1 inch				10 inch			SE
Display Mode		B, 2B, BM, M, 4B				B, B+B, B+M, M, 4B			SE
Image gray scale		256 level				256			SE
Image Storage		2048 frame				16			Analyse1
Cine Loop		600 frame				256 frame			Analyse1
Image Flip		Up/down, left/right, black/white				Up/down, left/right			Analyse1
Image Process		Gamma (gray scale) correction, tissue harmonic imaging,histogram, local magnification				Dynamic range, edge enhancement, frame correlation, smooth,IP, gray map,r-correction, rejection			Analyse1
Measurement		Distance, circumference, area, volume, heart, pregnant age,fetal weight, expected date				Distance, circumference, area,volume, histogram, profile, timevelocity heart rate			Analyse1
Notation		Date, time, name, No., sex, age, doctor, hospital name, probefrequency, etc.				Date, Time, Name, Sex, Age, Doctor, Hospital name, probefrequency, etc.			SE
Net weight		2.3 kg (include probe)				10kg			SE
Power supply		DC15V; Adapter:100 V~240 V, 50 Hz/60 Hz				AC 100-240V, 47-60Hlz			Analyse2
Dimensions(mm)		292 mm(L) × 232 mm(W) × 45 mm(H)				365 (height) X292 (width) X380 (depth)			SE
Configuration		mainframe, transducer(probe)				mainframe, transducer(probe)			SE
Acoustic	Ispta. 3
OutputIsppa. 3		Meet the requirements of Track 3				Meet the requirements of Track 1			Analyse1
Parameter	MI
SkinContacted		Probe Cover (ABS)				Probe Cover (ABS)			SE
Material		Acoustic Lens (Silicone elastomer)				Acoustic Lens (Silicone elastomer)			SE

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510(k) Summary

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OperationEnvironment	Temperature: +10°C~ +40°CRelative humidity: 30%~ 75%Atmosphere pressure: 700 hPa ~ 1060 hPa	Temperature 5°C -40°C ,relative humidity up to 90%RHair pressure 70-106Kpa	SE
Storage environment	Temperature: -10°C~+55°C,Relative Humidity: ≤93%, no condensation.Atmosphere pressure: 700 hPa ~ 1060 hPa,	Temperature -5-40°C ,relative humidity up to 90%RH (no water I drop)air pressure 70-106Kpa	SE
Sterile	No	No	SE
Single Use	No	No	SE
ComparisonStatement:	The proposed device has the similar main unit specifications with the predicate device.
Applied Standards:
Biocompatibility	ISO10993-5&ISO10993-10	ISO10993-5&ISO10993-10	SE
Electrical Safety	IEC60601-1	IEC60601-1	SE
EMC	IEC60601-1-2	IEC60601-1-2	SE
Performance	IEC 60601-2-37;IEC61157	UD2	Analyse1
ComparisonStatement	The proposed probe has similar applied Standards with the predicate device.

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9. Substantially Equivalent (SE) Conclusion

SE Analysis :

The subject device has same classification information, same intended use, same indication for use, similar product design, similar specification, same safety elements, similar applied Standards as predicate device.

The differences are included as followings:

Analyse 1: The device and predicate device have difference in performance specification, such as scan/angle/width, maximum number of elements for a single pulse, frequency, number of element, size of element, spacing of element, array dimensions, detect depth and resolution. But the propose device have tested for measurement accuracy by accuracy testing and software validation, so these difference can prove the effectiveness of propose device.

The proposed device has tested according with the safety standard IEC 60601-1, IEC60601-1-2 for the safety. The proposed device has tested according with the accuracy report, IEC60601-2-37 report, IEC61157 Acoustic Output report for the effectiveness. The proposed device has tested according with the ISO 10993 series standard for the Biocompatibility .

Therefore, the differences above between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety. No new technology is applied in the subject device. Most of the main aspects on effectiveness and safety between the proposed device and predicate device are same. The differences are slight so that no substantial influence on the effectiveness and safety.

Analyse 2 : Although the Power supply specifications of CMS600P2 is different from the predicate device,but both the predicate device and the proposed device has passed the IEC60601-1 safety test, we believe these differences will not affect the effectiveness and safety compared with the predicate device.

Conclusion: The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.