Color Doppler Ultrasound System; Model: mEye1 and mEye2

• K Number: K182165
• Device Name: Color Doppler Ultrasound System; Model: mEye1 and mEye2
• Manufacturer: Shenzhen Well.D Medical Electronics Co., LTD.
• Date Cleared: 2018-12-20 ( 132 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

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.

Predicate Devices

K113613

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound imaging modes and processing.

Therapeutic

No
The device is described as a "Diagnostic ultrasonic imaging" system. Its purpose is to acquire ultrasound signals and display images for diagnosis, not for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasonic imaging."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "integrated preprogrammed color ultrasound imaging system" and describes its function as acquiring ultrasound signals and displaying images, which indicates it includes hardware components for signal acquisition and display, not just software.

IVD (In Vitro Diagnostic)

No, 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.
• Device Description: The provided description clearly states that this is an ultrasound imaging system. Ultrasound uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
• Intended Use: The intended use describes diagnostic imaging for various anatomical sites. This is consistent with the function of an ultrasound machine, not an IVD.

Therefore, based on the provided information, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

IYN, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

abdominal, pediatric, small organ, musculo-skeletal, cardiac, peripheral vascular, transvaginal and trans-rectal areas of the human body.

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+A1:2012, IEC 60601-1-2:2014, IEC 60601-2-37: 2007, ISO 10993-5:2009, ISO 10993-10:2010, NEMA UD 2-2004 (R2009). 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.

K113613

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

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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 ([e-mail]) or phone [phone] 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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
Ophthalmic	Ophthalmic
Fetal
Imaging &
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)
Peripheral
Vessel	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	Color
Doppler	Combined
(Specify)	Other*
(Specify)
General
(Track 1 Only)
Ophthalmic	Ophthalmic
Fetal
Imaging &
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)
Peripheral
Vessel	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
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 3. 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: [phone], Fax: [phone] Email: [e-mail]

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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

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.

• 5. 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 Device
K113613 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | IYN, IYO and ITX | IYN, IYO and ITX |
| Class | II | II |
| 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. | Diagnostic ultrasonic imaging for
abdominal, pediatric, small organ,
musculo-skeletal, cardiac, peripheral
vascular, trans-vaginal and trans-rectal
applications in B, M, PWD, CWD, Color
Doppler and 3D imaging modes. |
| Configuration | Host and Probe | Host and Probe |
| Sterile | No | No |
| Single Use | No | No |
| Probe Type | Convex array: 3.5MHz
Linear array: 7.5MHz | Convex array: 2.0-6.1 MHz
Linear array: 4.0-15.0 MHz
Phase array: 2.0-4.4 MHz |
| Operation Mode | B, M, PWD and Color Doppler modes | B, M, PWD, CWD, Color Doppler and 3D
imaging modes |
| Applications | Abdominal, pediatric, small organ,
musculo-skeletal, cardiac, peripheral
vascular, trans-vaginal and trans-rectal | Abdominal, pediatric, small organ,
musculo-skeletal, cardiac, peripheral
vascular, trans-vaginal and trans-rectal |
| Screen Resolution | 1024 x 768 | 1024 x 768 |
| Power Supply | AC 100-240V, 50/60Hz
DC 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.