Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B, M, PWD and Color Doppler modes.

Device Description

The 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 imaging operation modes of B, M, PWD and Color Doppler.

AI/ML Overview

This document describes the Color Doppler Ultrasound System Models mEye1 and mEye2 (K182165) and its substantial equivalence determination to a predicate device. There is no study described within this document that performs a comparative effectiveness study with human readers or standalone algorithm performance, or establishes acceptance criteria based on diagnostic performance.

The acceptance criteria and study described are for non-clinical performance and safety standards, not for the diagnostic accuracy of the ultrasound system's output. The document explicitly states: "No clinical study is included in this submission." This means that no study was conducted to demonstrate the device's diagnostic performance for the specified indications for use, nor were acceptance criteria related to diagnostic performance established or met through a clinical study.

Therefore, many of the requested items cannot be answered given the provided text.

Here's a breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" here refer to conformance with established medical device safety and performance standards, rather than diagnostic accuracy metrics.

Acceptance Criteria (Standard/Requirement)	Reported Device Performance
IEC 60601-1-2005+A1:2012 (Electrical Safety)	Complied
IEC 60601-1-2:2014 (EMC)	Complied
IEC 60601-2-37:2007 (Performance - Ultrasonic Medical Diagnostic)	Complied
ISO 10993-5:2009 (Biocompatibility - Cytotoxicity)	Complied
ISO 10993-10:2010 (Biocompatibility - Irritation & Sensitization)	Complied
NEMA UD 2-2004 (R2009) (Acoustic Output)	Complied
Software Level	Moderate level of concern

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set or data provenance related to diagnostic performance is mentioned. The tests were non-clinical, likely performed in manufacturing facilities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set or establishment of ground truth by experts for diagnostic performance is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication for diagnostic performance is mentioned.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This device is a diagnostic ultrasound system, not an AI-powered CAD (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) system, so the concept of "human readers improve with AI vs without AI assistance" does not apply here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This is a medical imaging device, not an AI algorithm. Its performance is evaluated through compliance with technical and safety standards, and by demonstrating substantial equivalence to a predicate device.

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

Not applicable. For the non-clinical tests conducted, the "ground truth" was established by the technical specifications and requirements of the referenced standards (e.g., whether the device successfully met electromagnetic compatibility limits, or whether biocompatibility tests showed no cytotoxicity). There was no clinical ground truth established for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This document describes a medical imaging device, not an AI/ML algorithm that requires a training set.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.

December 20, 2018

Shenzhen Well.D Medical Electronics Co., LTD. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K182165

Trade/Device Name: Color Doppler Ultrasound System Model; mEye1 and mEye2 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 22, 2018 Received: December 3, 2018

Dear Diana 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hse 2. Nils

for Robert A. 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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Indications for Use

510(k) Number (if known) K182165

Device Name Color Doppler Ultrasound System Model: mEye1 and mEye2

Indications for Use (Describe)

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, transvaginal and trans-rectal applications in B, M, PWD and Color Doppler modes.

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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Diagnostic Ultrasound Indications for Use Format

System: Color Doppler Ultrasound System

Transducer: 5C2AN convex array probe

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1&3)	B	M	PWD	CWD	ColorDoppler	Combined(Specify)	Other*(Specify)
Ophthalmic	Ophthalmic
FetalImaging &Other	Fetal	N		N		N		THI
	Abdominal	N		N		N		THI
	Intra-operative(Specify)
	Intra-operative(Neuro)
	Laparoscopic
	Pediatric	N		N		N		THI
	Small Organ(Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal(Conventional)	N		N		N		THI
	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)

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

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Diagnostic Ultrasound Indications for Use Format

System: Color Doppler Ultrasound System

Transducer: 12L5AN linear array probe

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

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

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510(k) Summary

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

The assigned 510(k) Number: K182165

1. Date of Preparation: 12/20/2018
1. Sponsor Identification

SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD.

Well.d Park, Qinglan 3 Rd, National Biopharmaceutical Industrial Base, Pingshan New Area, Shenzhen, 518118, China.

Establishment Registration Number: 3008350665

Contact Person: Ning Bai Position: Management Representative Tel: +86-755-36900033 Fax: +86-755-36900033 Email: weld-200@163.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 001-3609253199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Color Doppler Ultrasound System Model: mEye1 and mEye2 Classification Name: Ultrasonic pulsed doppler imaging system Classification: II Product Code: IYN, IYO, and ITX Regulation Number: 21 CFR 892.1550, 21 CFR 892.1560 and 21 CFR 892.1570 Review Panel: Radiology

Indications for Use:

Diagnostic ultrasonic imaging for abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, trans-vaginal and trans-rectal applications in B, M. PWD and Color Doppler modes.

Device Description

1. Identification of Predicate Device
  Predicate Device 510(k) Number: K113613 Product Name: Apogee 1200 Digital Color Doppler Ultrasound Imaging System

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:

IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
A IEC 60601-1-2:2014, 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 - Part2 -37 Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
A ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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♪ ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
NEMA UD 2-2004 (R2009) Acoustic output measurement standard for diagnostic ultrasound equipment
Clinical Test Conclusion 7.

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed Device	Predicate DeviceK113613
Product Code	IYN, IYO and ITX	IYN, IYO and ITX
Class	II	II
Indications for Use	Diagnostic ultrasonic imaging forabdominal, pediatric, small organ,musculo-skeletal, cardiac, peripheralvascular, trans-vaginal and trans-rectalapplications in B, M, PWD and ColorDoppler modes.	Diagnostic ultrasonic imaging forabdominal, pediatric, small organ,musculo-skeletal, cardiac, peripheralvascular, trans-vaginal and trans-rectalapplications in B, M, PWD, CWD, ColorDoppler and 3D imaging modes.
Configuration	Host and Probe	Host and Probe
Sterile	No	No
Single Use	No	No
Probe Type	Convex array: 3.5MHzLinear array: 7.5MHz	Convex array: 2.0-6.1 MHzLinear array: 4.0-15.0 MHzPhase array: 2.0-4.4 MHz
Operation Mode	B, M, PWD and Color Doppler modes	B, M, PWD, CWD, Color Doppler and 3Dimaging modes
Applications	Abdominal, pediatric, small organ,musculo-skeletal, cardiac, peripheralvascular, trans-vaginal and trans-rectal	Abdominal, pediatric, small organ,musculo-skeletal, cardiac, peripheralvascular, trans-vaginal and trans-rectal
Screen Resolution	1024 x 768	1024 x 768
Power Supply	AC 100-240V, 50/60HzDC 14.4V	100-240V, 50/60Hz
Electrical Safety	Complied with IEC 60601-1	Complied with IEC 60601-1
EMC	Complied with IEC 60601-1-2	Complied with IEC 60601-1-2
Performance	Complied with IEC 60601-2-37	Complied with IEC 60601-2-37

Table 2 Substantially Equivalent Comparison

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Software Level	Moderate level of concern
Biocompatibility
Cytotoxicity	Complied with ISO 10993-5
Skin Irritation	Complied with ISO 10993-10
Sensitization	Complied with ISO 10993-10

The operation modes of the proposed device do not contain CWD and 3D imaging modes, which is different from that of predicate. There are only two types of probes in proposed device, which are less than that of predicate device. And it is not known whether the predicate device can be powered by battery or DC. However, the proposed device has been demonstrated that comply with requirements of electrical safety, EMC, performance and acoustic output. Therefore, the differences do not impact the safety and effectiveness.

Substantially Equivalent (SE) Conclusion 9.

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

Regulation Number and Section

N/A