(56 days)
No
The summary describes a standard ultrasonic imaging system and its components. There is no mention of AI, ML, or any advanced image processing techniques that would typically indicate the use of such technologies. The software described focuses on controlling the probe, image acquisition, and display.
No
The device is described as an "Ultrasound Biomicroscope" and its "Intended Use" states it is for "ultrasonic diagnosis on the anterior segment of eyes", indicating it is a diagnostic imaging device, not a therapeutic one.
Yes
Explanation: The "Intended Use" section explicitly states that the MD-320W Ultrasound Biomicroscope is for "ultrasonic diagnosis on the anterior segment of eyes."
No
The device description explicitly lists hardware components such as an AC-DC power adapter, main unit, 50MHz sector scan probe, footswitch, and USB cable, in addition to the software APPs.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "ultrasonic diagnosis on the anterior segment of eyes." This is an in vivo diagnostic procedure, meaning it's performed on a living organism (the patient's eye).
- Device Description: The description details how the device uses ultrasound pulses emitted into the eye and receives reflective echoes to form images of eye tissue. This is consistent with an in vivo imaging system.
- Lack of IVD Characteristics: IVD devices typically involve testing samples taken from the body (like blood, urine, tissue biopsies) in a laboratory setting to diagnose conditions. This device does not involve any such sample collection or laboratory analysis.
Therefore, the MD-320W Ultrasound Biomicroscope is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IYO, ITX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Anterior segment of eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals in hospital and ophthalmology clinics
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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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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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. China
Tel: +86-22-83713808
Fax: +86-22-83713880 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Linda Zhang
Add: C2-2-C, Xinmao Science Skill Park, Huayuan Industry Development Area, 300384 Tianjin, P. R. China
Tel: +86-22-8371 3808 ext. 812
Fax: +86-22-8371 3880
E-mail: linda.zhang@meda.com.cn |
| Alternative Contact Person: | Kai Chen
Medtech International, Inc. and
United States Designated Agent of MEDA Co., Ltd.
Add: 13505 Broadfield Drive, Potomac, MD 20854
Tel: 240 888 4001
Fax: 301 251 2881
Email: 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
4
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.
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 | Model
Subject Device | Predicate Device | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 510(K) number | MD-320W Ultrasound Biomicroscope | K140199 | |
| Intended Use | It is intended to be used in clinical
ophthalmology for ultrasonic
diagnosis on the anterior segment of
eyes. | The VuPad 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
measurement of axial length for
determination of IOL Power.
*The UBM part is used to collect
live B-scan images of the
anterior segment of the eye.
Note: See §8 of 510(K)
Summary of K140199. | Modes of Operation | B-Mode | B -Mode |
| | Selectable A-Scan
Vector while in
B-Scan mode | Yes | Yes |
| | Technology | Visualization by Ultrasound | Visualization by Ultrasound |
| | General Method of
Operation | Echoes converted to images on a
screen. Measurement made by time
delays | Echoes converted to images on
a screen. Measurement made
by time delays |
| | Digital System | Echoes converted into digital pulses,
all operation carried out digitally | Echoes converted into digital
pulses, all operation carried out
digitally |
| | Probe /Transducer
type | probe with sector scanning (Open
Pivoting Single-Element) | Open Pivoting Single-Element |
| | Transducer
Frequency 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, or
MD-2300S with LCD touch screen
and footswitch, to collect exam data. | Operator uses tablet PC with
LCD touch screen and foot
pedal switch to collect exam
data, |
| | Data
Storage
Location | Storage within software database
with ability to recall patient exam
records | Storage within software
database with ability to recall
patient exam records |
| | Printer | Any Windows-compatible printer
(separate) | Any Windows-compatible printer
(separate) |
| | Acoustic output
MI