The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation.

It is not allowed to use UBM on patients with eye trauma, inflammation or infection.

Device Description

MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable and two user-selectable APPs:

MD3XUBM.AP1-C V1.0 APP (included in MD3XUBM-C V1.0) runs on the windows operating system of the PC and allows the user to control probe scanning, image acquisition and display via the PC user interface.

MD3XUBM.AP1-S V1.0 APP (included in MD3XUBM-S V1.0) runs on the operating system of the legally marketed MD-2300S Ultrasonic A/B Scanner for Ophthalmology (K152318) and allows the user to control probe scanning, image acquisition and display via the MD-2300S user interface.

Under the excitation of electric pulse, the 50MHz ultrasound transducer emits ultrasonic pulse into eye and receives reflective echo from the surfaces of different tissue, thus forming real-time two-dimensional image of eye tissue.

AI/ML Overview

This FDA 510(k) summary for the MD-320W Ultrasound Biomicroscope details its substantial equivalence to a predicate device but does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria. The provided text focuses on comparing the new device's technological characteristics and intended use to a predicate device (VuPad Ophthalmic Ultrasound System), highlighting non-clinical testing for safety, EMC, and acoustic output.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and reported device performance.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
Whether a standalone performance study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance study.
The sample size for the training set.
How the ground truth for the training set was established.

The document only states that "The software and essential performance have passed verification and validation, and the results comply with the related requirements as per the FDA Guidance document 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' issued in June 27, 2019." This is a general statement about compliance with guidance and does not provide specific performance metrics or study details.

In summary, the provided text describes regulatory approval based on substantial equivalence to a predicate device, focusing on technical specifications and general safety/EMC testing, rather than detailed performance study data against specific acceptance criteria.

Summary

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MEDA Co., LTD % Linda Zhang RA, R & D Department F2C,F3D,F4C,F5, F6C, Building C2, Xinmao Science Skill Park, Huayuan Industry Development Area Tianjin, 300384 P.R. CHINA

Re: K213070

Trade/Device Name: MD-320W Ultrasound Biomicroscope Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX Dated: September 15, 2021 Received: September 23, 2021

November 18, 2021

Dear Linda Zhang:

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.

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

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801 and Part 809); 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213070

Device Name MD-320W Ultrasound Biomicroscope

Indications for Use (Describe)

MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.

The device is intended to be used in hospitalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation.

It is not allowed to use UBM on patients with eye trauma, inflammation or infection.

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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K213070

510(k) SUMMARY

1. Submitter Information

510(k) owner's name:	MEDA Co., Ltd.Add: F2C, F3D, F4C, F5, F6C, Building C2, Xinmao Science Ski Park, Huayuan Industry Development Area, Tianjin 300384, P. R. ChinaTel: +86-22-83713808Fax: +86-22-83713880
Contact person:	Linda ZhangAdd: C2-2-C, Xinmao Science Skill Park, Huayuan Industry Development Area, 300384 Tianjin, P. R. ChinaTel: +86-22-8371 3808 ext. 812Fax: +86-22-8371 3880E-mail: linda.zhang@meda.com.cn
Alternative Contact Person:	Kai ChenMedtech International, Inc. andUnited States Designated Agent of MEDA Co., Ltd.Add: 13505 Broadfield Drive, Potomac, MD 20854Tel: 240 888 4001Fax: 301 251 2881Email: Drkaichen@gmail.com
Date Prepared:	September 15, 2021

2. Device Information

Trade Name/Common Name: MD-320W Ultrasound Biomicroscope

	Classification Name: Ultrasonic Pulsed Echo Imaging System (IYO)Diagnostic Ultrasound Transducer (ITX)
Regulatory Class:	Class II
Regulation Number:	892.1560; 892.1570
Product Code:	IYO; ITX

Predicate Devices 3.

Device Name: VuPad Ophthalmic Ultrasound System

510(k) Number: K140199

Manufacturer: Sonomed Inc.

4. Device Description

MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It consists of AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, USB cable

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and two user-selectable APPs:

Indications for Use 5.

MD-320W Ultrasound Biomicroscope is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.

It is intended to be used in hospitals and ophthalmology clinics. The operators should be trained professionals and have basic capabilities for PC operation.

It is not allowed to use UBM on patients with eye trauma, inflammation or infection.

Comparison of Technological Characteristics 6.

The VuPad diagnostic ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurements of axial length for determination of IOL Power.

lt has 10MHz A-scan probe and 12.5 MHz, 20 MHz, 35 MHz and 50MHz B-scan probes. The function of the 35MHz and 50MHz probes is also called Ultrasound Biomicroscopy (UBM), which is used to collect live B-scan images of the anterior segment of the eye.

MD-320W Ultrasound Biomicroscope is fundamentally identical to the Ultrasound Biomicroscopy (UBM) capabilities of the VuPad System. The intended usage and method of application for these transducers are the same for both systems.

The subject and the predicate devices (UBM part) are based on the following same technological elements:

Item	ModelSubject Device	Predicate Device
510(K) number	MD-320W Ultrasound Biomicroscope	K140199
Intended Use	It is intended to be used in clinicalophthalmology for ultrasonicdiagnosis on the anterior segment ofeyes.	The VuPad ultrasound system isa multi-purpose computer-basedultrasonic diagnostic system forophthalmic application, intendedto both visualize the interior of
the eye by means of ultrasoundand to make measurementsinside the eye, including themeasurement of axial length fordetermination of IOL Power.*The UBM part is used to collectlive B-scan images of theanterior segment of the eye.Note: See §8 of 510(K)Summary of K140199.	Modes of Operation	B-Mode	B -Mode
	Selectable A-ScanVector while inB-Scan mode	Yes	Yes
	Technology	Visualization by Ultrasound	Visualization by Ultrasound
	General Method ofOperation	Echoes converted to images on ascreen. Measurement made by timedelays	Echoes converted to images ona screen. Measurement madeby time delays
	Digital System	Echoes converted into digital pulses,all operation carried out digitally	Echoes converted into digitalpulses, all operation carried outdigitally
	Probe /Transducertype	probe with sector scanning (OpenPivoting Single-Element)	Open Pivoting Single-Element
	TransducerFrequency Range(MHz)	50	35 and 50 for UBM
	Internal Storage	≥512GB (Stored in PC)	≥512GB (Stored in tablet PC)
	Control Interface	Operator uses PC with keyboard,mouse and footswitch, orMD-2300S with LCD touch screenand footswitch, to collect exam data.	Operator uses tablet PC withLCD touch screen and footpedal switch to collect examdata,
	DataStorageLocation	Storage within software databasewith ability to recall patient examrecords	Storage within softwaredatabase with ability to recallpatient exam records
	Printer	Any Windows-compatible printer(separate)	Any Windows-compatible printer(separate)
	Acoustic outputMI < 0.23ISPTA.3 < 17 mW/cm²ISPPA.3 < 28 W/cm²	Track 1	Track 1
	Compliancestandards	IEC 60601-1: 2005, AMD1: 2012;ANSI/AAMI ES 60601-1:2005(R)2012 and A1: 2012,C1:2009(R)2012 and	IEC 60601 -1,

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A2:2010/(R)2012;IEC 60601-2-37 (ed.2), am1;IEC 60601-1-2: 2014	IEC 60601-2-37,EN/IEC 60601-1-2 (2001)
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The differences of MD-320W Ultrasound Biomicroscope and its predicate device:

Model	MD-320W UltrasoundBiomicroscope	VuPad
510(K) number		K140199
Intended Use	It is intended to be used inclinical ophthalmology forultrasonic diagnosis on theanterior segment of eyes.	The VuPad ultrasound system isa multi-purpose computer-basedultrasonic diagnostic system forophthalmic application, intendedto both visualize the interior ofthe eye by means of ultrasoundand to make measurementsinside the eye, including themeasurement of axial length fordetermination of IOL Power.
Modes of Operation	B-Mode (anterior segment ofeyes)	Ophthalmic A and B Scans
B-Scan Lines per Scan	768	256
B-Scan Scan DisplayControls	TGC, Adjustable Gain: 1-99dB	Fully adjustable time-varied gain(TVG), baseline, log gain, andexponential gain
Probe /Transducer type	Mechanical Sector Scan Probe(open pivoting single-element)	Sealed Pivoting Single-Element,and Open PivotingSingle-Element for UBM
B-Scan TransducerFrequency.	50 MHz	10, 12.5, 20 MHz;35, 50 MHz for UBM.
B-Scan Axial Accuracy(Theoretical)	50 MHz: 0.0153mm	50 MHz: 0.0146mm
Hardware Configurationand Components	System consists of AC-DCpower adapter, main unit,50MHz sector scan probe, USBcable and two user-selectableAPPs.	System consists of unit withintegrated LCD touch screen, A-probe, sealed B-probe, opentransducer water path B-probe,calibration cylinder, probeholder, and foot pedal
B-Scan Video Clips	Capture and store 100- framevideo clips	Capture and store 50- framevideo clips
Display Screen	LCD Panel(10.1" diagonal wide-screen,1020 x 768 pixel resolution, or	Integrated LCD Panel(10.1" diagonal wide-screen,1920x1080 pixel resolution)
Model	MD-320W UltrasoundBiomicroscope	VuPad
	14" diagonal wide-screen,1366 x 768 pixel resolution)
Dimensions (inches)	1.6x 8.3x9.6	2 x 8x13.3

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The VuPad system is a multi-purpose ophthalmic ultrasonic diagnostic system with three relatively independent functions: biometric A-scan (10MHz), B-scan posterior segment imaging (12.5, 20MHz) and B-scan anterior segment imaging - UBM (35, 50MHz).

MD-320W Ultrasound Biomicroscope (UBM) is only used for imaging of the anterior segment of the eye, so it is compared with the UBM part of VuPad.

As can be seen from the above tables, MD-320W's intended use, working principle, structural composition, mode of operation, Probe/Transducer type and compliance standard are substantially equivalent as the UBM part of the predicate device.

The intended use and hardware configuration and components that differ from the predicate device are those outside the UBM function, such as the A-scan for biometrics, and the 12.5MHz, 20MHz Sealed Pivoting Single-Element probe for imaging of the posterior segment of the eye.

The differences in parameters such as Display Screen, Dimensions, B-Scan Video Clips and B-Scan Lines per Scan have no substantial impact on the intended use, safety and effectiveness of the device.

7. Brief Discussion of Non-clinical Tests

The safety and EMC testing were conducted on the MD-320W and the testing results comply with the requirements of IEC 60601-1 and IEC 60601-2-37 for safety and the IEC 60601-1-2 for EMC. The acoustic output parameters comply with the requirements of IEC 60601-2-37 and FDA Guidance on diagnostic ultrasound systems and transducers.

It is recommended to use FDA-cleared disposable sterile water sac which meets the relevant requirements of ISO10993 to contact patients, such as ClearScan Transducer Cover (K080119). The biocompatibility evaluation has been conducted by the manufacturer according to ISO 10993.

The software and essential performance have passed verification and validation, and the results comply with the related requirements as per the FDA Guidance document "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued in June 27, 2019.

8. Conclusions

The results of non-clinical tests as well as the software and essential performance verification and validation demonstrate that the MD-320W Ultrasound Biomicroscope is substantially equivalent in safety, effectiveness and performance to the legally marketed predicate device.

While there are some differences between the MD-320W Ultrasound Biomicroscope and its predicate device, they do not affect the safety or 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.