Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

K190314 · Mednovel Technology, Ltd. · IYO · Oct 9, 2019 · Radiology

Device Facts

• Record ID: K190314
• Device Name: Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
• Applicant: Mednovel Technology, Ltd.
• Product Code: IYO · Radiology
• Decision Date: Oct 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The MedNovel Model AiVUS 1000 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of patient's breast when used with an automatic scanning linear array probe. The device is not intended to be used as a replacement for mammography. It is an adjunct (add on) accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. The MedNovel Model AiVUS 1000 system is capable of visually reconstructing the ultrasonic images for review with DICOM type files which will assist the doctor in making diagnoses of any abnormalities detected.

Device Story

AiVUS 1000 is a transducer-guiding accessory for existing ultrasound systems (e.g., MyLab Gamma). It consists of a patient scanning module and a display system with dual touch panels. The scan module, positioned over the breast, uses an automated mechanism to move a linear array transducer along a planned path. It captures real-time B-mode ultrasound images via a video frame grabber. The system software reconstructs these 2D slices into a volume, storing them as multi-frame DICOM files for physician review. Used in clinical settings by healthcare professionals, the device provides adjunctive imaging to assist in diagnosing breast abnormalities detected via mammography. It does not perform automated analysis or measurement of lesions; such tools are reserved for future workstation software. The device benefits patients by providing systematic, reproducible volumetric ultrasound data to support clinical decision-making.

Clinical Evidence

No formal clinical study performed. Substantial equivalence supported by bench testing, including image simulation tests on breast phantoms and verification/validation of technical requirements. Clinical sample images were provided to demonstrate the system's ability to generate diagnostic-quality images across various breast types and ethnicities.

Technological Characteristics

Automated scanning module for linear array ultrasound transducers; video frame grabber input; dual touch-panel display. Connectivity via DICOM. Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-1-6, IEC62366-1, ISO10993-1/5/10, ISO14971, and ISO15223-1. Software developed per ANSI AAMI IEC62304.

Indications for Use

Indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the breast in adult patients. Used with an automatic scanning linear array probe to acquire 2D image slices for volume reconstruction. Not a replacement for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Acuson S2000 ABVS Ultrasound System (K081148)

Reference Devices

• Breast Volume Navigator (K141870)
• TomTec Echo-Scan (K963807)

Submission Summary (Full Text)

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October 9, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The text reads "U.S. FOOD & DRUG ADMINISTRATION".

MedNovel Technology Ltd. % Jia Yu Quality and Regulatory Affairs Manager 1154 Cadillac Court MILPITAS CA 95035

Re: K190314

Trade/Device Name: Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, LLZ, ITX Dated: September 9, 2019 Received: September 12, 2019

Dear Jia Yu:

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

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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 ([e-mail]) or phone [phone] 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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## 4. Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| | Form Approved: OMB No. 0910-0120 |
| | Expiration Date: 06/30/2020 |
| Indications for Use | |
| | See PRA Statement below. |
| 510(k) Number (if known) | K190314 |
| Device Name | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 |
| Indications for Use (Describe) | The MedNovel Model AiVUS 1000 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of patient's breast when used with an automatic scanning linear array probe. The device is not intended to be used as a replacement for mammography. |
| | It is an adjunct (add on) accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2 dimensional image slices throughout a volume of interest. |
| | The MedNovel Model AiVUS 1000 system is capable of visually reconstructing the ultrasonic images for review with DICOM type files which will assist the doctor in making diagnoses of any abnormalities detected. |
| Type of Use (Select one or both, as applicable) | |
| | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services | |
| Food and Drug Administration | |
| Office of Chief Information Officer | |
| Paperwork Reduction Act (PRA) Staff | |
| [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services [phone]

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## 5. 510(k) Summary

| | 510(k) Summary | K190314 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May.20, 2019 | |
| Manufacturer: | MedNovel Technology Ltd | |
| Primary Contact<br>Person | Grace Dang<br>Quality and Regulatory Affairs Executive<br>MedNovel Technology Ltd<br>Tel: [phone]<br>E-mail: [e-mail] | |
| Secondary<br>Contact Person | Hui Luo<br>Technical Director<br>MedNovel Technology Ltd<br>Tel: [phone]<br>E-mail: [e-mail] | |
| Device Name | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | |
| Classification | Classification name: | Ultrasonic Pulsed Echo Imaging<br>System |
| | Classification Regulation: | 21 CFR 892.1560 Ultrasonic pulsed<br>echo imaging system<br>21 CFR 892.2050 Picture archiving<br>and communications system<br>21 CFR 892.1570 Diagnostic<br>ultrasonic transducer |
| | Classification Panel: | Radiology |
| | Device Class: | II |
| | Primary Product Code: | IYO, LLZ, ITX |
| | Primary Predicate<br>Device | Trade name: |
| | | Manufacturer: |
| | | 510(k) Clearance: |
| Classification Regulation: | | 21 CFR 892.1560 |
| Classification name: | | Ultrasonic Pulsed Echo Imaging<br>System |
| | Classification Panel: | Radiology |
| | Device class | II |
| | Product Code: | IYN, IYO, ITX |
| Reference Device<br>#1 | Trade name: | Breast Volume Navigator |
| | Manufacturer: | MetriTrack, LLC |
| | 510(k) Clearance: | K141870 |
| | Classification Regulation: | 21 CFR 892.1560 |
| | Classification name: | Ultrasonic Pulsed Echo Imaging<br>System |
| | Classification Panel: | Radiology |
| | Device class | II |
| | Product Code: | IYO |
| Reference Device<br>#2 | Trade name:…