(238 days)
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.
The Model AiVUS 1000 is a transducer guiding adjunct which is intended to work in combination with specified legally marketed Ultrasound Diagnostic System (MyLab Gamma, K161359) and Transducer (SL1543, K132231) and previously released exam tables.
The Model AiVUS 1000 system is comprised of a patient scanning system and display system.
The Model AiVUS 1000 performs an automatic scan of the breast(s) using a probe guiding mechanism(s) imbedded within the scan module. The imbedded system software plots the path of the automated scan, records the ultrasonic images from paired ultrasound system, and has the capability to both display the real-time B-mode ultrasonic images acquired and after the fact review of the breast exam in DICOM supported file format as a means of providing adjunctive information after a patient obtains a mammogram. This adjunctive information may be useful to physicians wishing to have additional information to make diagnoses of any abnormalities detected.
The patient scanning system consists of a scan module and associated assembly and electronics. The scan module is centered above a patient's breast and then performs scanning by using the ultrasound linear transducer arrays. While scanning, the real-time images are acquired by video frame grabber. Acquired images are then reconstructed by the Model AIVUS 1000 system software to display the breast images on the Model AIVUS 1000 display system.
The Model AiVUS 1000 display system has two adjustable touch panels and associated assembly and electronics.
The MedNovel Model AiVUS 1000 is an Advanced Intelligent Volumetric Ultrasound System. The purpose of the study was to demonstrate substantial equivalence to predicate devices (K081148 – Acuson S2000 ABVS Ultrasound System, K141870 – Breast Volume Navigator and K963807 – TomTec Echo-Scan).
Here's an analysis of the acceptance criteria and study information provided:
-
Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly present a table of specific numerical acceptance criteria for image quality or diagnostic performance, nor does it present reported device performance in a quantified manner against such criteria. Instead, the summary states:
Acceptance Criteria (Implied) Reported Device Performance Imaging Quality "generate diagnostic quality images that are at least as good as those of the current standard of care, handheld ultrasound examination." Compliance with Standards "Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents." Intended Use Adequacy "Meet the accept criteria and is adequate for its intended use." -
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "clinical sample images in appendix H" and refers to "different size of breast types (A, B, C, D cup size) and different subject ethnicities (Han, Caucasoid, African) with a variety of lesions were captured during the collection of the clinical sample image data". However, a specific numerical sample size for the test set is not provided.
- Data Provenance: The document implies the data is retrospective as it refers to "clinical sample images in appendix H were provided to support the ability of proposed Model AiVUS 1000 to generate diagnostic quality images". The country of origin for the data is not specified.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document.
-
Adjudication Method for the Test Set:
This information is not provided in the document.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The device is intended to assist physicians by providing adjunctive information, not to replace mammography or human interpretation entirely. "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." Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable/provided.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The document states: "The AiVUS 1000 system is intended for acquiring ultrasound images only. Tools for evaluating abnormalities identified (size, location, etc.) are contained in the workstation software which is a standalone product and will be submitted for clearance later." This suggests that the current device only acquires images and does not perform automated diagnostic interpretation. Therefore, a standalone performance study of an algorithm is not applicable for the AiVUS 1000 itself, as its primary function is image acquisition and reconstruction, not autonomous diagnostic analysis. The statement "Verification testing was performed in Image Simulation Tests on breast phantoms" indicates some form of objective testing, but not for autonomous diagnostic performance.
-
Type of Ground Truth Used:
The document states that "clinical sample images in appendix H were provided to support the ability of proposed Model AiVUS 1000 to generate diagnostic quality images that are at least as good as those of the current standard of care, handheld ultrasound examination." While clinical images were used, the specific nature of the "ground truth" (e.g., expert consensus, pathology, outcome data) that confirmed the "diagnostic quality" is not explicitly detailed. It implies a comparison against the "current standard of care," which would involve expert interpretation, but the formal process for establishing this ground truth is not outlined.
-
Sample Size for the Training Set:
This information is not provided in the document. The document refers to "verification/validation tests results metrics DOC0000101 Rev A" and "Image Simulation Tests on breast phantoms," but does not detail a training set sample size for any machine learning component of the image acquisition. Given the device's stated function is image acquisition and reconstruction, not AI-driven diagnosis, a "training set" in the context of deep learning might not be applicable in the traditional sense for this specific device.
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How the Ground Truth for the Training Set Was Established:
As a training set is not explicitly mentioned and the device focuses on image acquisition and reconstruction rather than AI-driven diagnostic interpretation, the method for establishing ground truth for a training set is not applicable/provided.
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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 (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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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) | |
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| 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 | |
| PRAStaff@fda.hhs.gov | |
| "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 (301) 443-6740
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5. 510(k) Summary
| 510(k) Summary | K190314 | |
|---|---|---|
| Date Prepared: | May.20, 2019 | |
| Manufacturer: | MedNovel Technology Ltd | |
| Primary ContactPerson | Grace DangQuality and Regulatory Affairs ExecutiveMedNovel Technology LtdTel: +86 510 8815 9458E-mail: shujuan.dang@snyamedical.com | |
| SecondaryContact Person | Hui LuoTechnical DirectorMedNovel Technology LtdTel: +86 18114862133E-mail: hui.luo@snyamedical.com | |
| Device Name | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | |
| Classification | Classification name: | Ultrasonic Pulsed Echo ImagingSystem |
| Classification Regulation: | 21 CFR 892.1560 Ultrasonic pulsedecho imaging system21 CFR 892.2050 Picture archivingand communications system21 CFR 892.1570 Diagnosticultrasonic transducer | |
| Classification Panel: | Radiology | |
| Device Class: | II | |
| Primary Product Code: | IYO, LLZ, ITX | |
| Primary PredicateDevice | Trade name: | |
| Manufacturer: | ||
| 510(k) Clearance: | ||
| Classification Regulation: | 21 CFR 892.1560 | |
| Classification name: | Ultrasonic Pulsed Echo ImagingSystem | |
| Classification Panel: | Radiology | |
| Device class | II | |
| Product Code: | IYN, IYO, ITX | |
| Reference Device#1 | Trade name: | Breast Volume Navigator |
| Manufacturer: | MetriTrack, LLC | |
| 510(k) Clearance: | K141870 | |
| Classification Regulation: | 21 CFR 892.1560 | |
| Classification name: | Ultrasonic Pulsed Echo ImagingSystem | |
| Classification Panel: | Radiology | |
| Device class | II | |
| Product Code: | IYO | |
| Reference Device#2 | Trade name: | TomTec Echo-Scan |
| Manufacturer: | TomTec Imaging Systems, Inc. | |
| 510(k) Clearance: | K963807 | |
| Classification Regulation: | 21 CFR 892.1560 | |
| Classification name: | Ultrasonic Pulsed Echo ImagingSystem | |
| Classification Panel: | Radiology | |
| Device class | II | |
| Product Code: | IYO | |
| Device Description | The Model AiVUS 1000 is a transducer guiding adjunct which is intendedto work in combination with specified legally marketed UltrasoundDiagnostic System (MyLab Gamma, K161359) and Transducer (SL1543,K132231) and previously released exam tables.The Model AiVUS 1000 system is comprised of a patient scanning systemand display system.The Model AiVUS 1000 performs an automatic scan of the breast(s) usinga probe guiding mechanism(s) imbedded within the scan module. Theimbedded system software plots the path of the automated scan, recordsthe ultrasonic images from paired ultrasound system, and has thecapability to both display the real-time B-mode ultrasonic images acquiredand after the fact review of the breast exam in DICOM supported fileformat as a means of providing adjunctive information after a patientobtains a mammogram. This adjunctive information may be useful tophysicians wishing to have additional information to make diagnoses ofany abnormalities detected.The patient scanning system consists of a scan module and associatedassembly and electronics. The scan module is centered above a patient'sbreast and then performs scanning by using the ultrasound lineartransducer arrays. While scanning, the real-time images are acquired byvideo frame grabber. Acquired images are then reconstructed by theModel AIVUS 1000 system software to display the breast images on theModel AIVUS 1000 display system.The Model AiVUS 1000 display system has two adjustable touch panelsand associated assembly and electronics. | |
| Intended Use/Indication for use | The MedNovel Model AIVUS 1000 is indicated for use as an adjunct tomammography for B-mode ultrasonic imaging of patient's breast whenused with an automatic scanning linear array probe. The device is notintended to be used as a replacement for mammography.It is an adjunct (add on) accessory for existing ultrasound imagingsystems and is intended to control position and movement of ultrasound | |
| transducers for the systematic acquisition of 2 dimensional image slicesthroughout a volume of interest. | ||
| The MedNovel Model AiVUS 1000 system is capable of visuallyreconstructing the ultrasonic images for review with DICOM type fileswhich will assist the doctor in making diagnoses of any abnormalitiesdetected. | ||
| Technology &FundamentalScientificTechnology | The Model AiVUS 1000 system works together with legally approvedultrasound imaging systems (LAUIS). The Model AiVUS 1000 systemacquires real-time B-mode ultrasonic images by video connection from theLAUIS. While scanning, the Model AiVUS 1000 system moves thetransducer along the planned path inside the region of interest specifiedby the operator. After the scanning, the acquired images are reconstructedand stored as a multi-frame DICOM file.The AIVUS 1000 system is intended for acquiring ultrasound images only.Tools for evaluating abnormalities identified (size, location, etc.) arecontained in the workstation software which is a standalone product andwill be submitted for clearance later. | |
| Determination ofSubstantialEquivalence | MedNovel Tech claims that the Model AiVUS 1000 system is substantiallyequivalent to the predicate devices (K081148 – Acuson S2000 ABVSUltrasound System, K141870 – Breast Volume Navigator and K963807 –TomTec Echo-Scan). MedNovel Tech claims this equivalence becausethe proposed device has an equivalent intended use, manufacturingmaterials, operating principles, and physical and operational specificationscompared to the predicate devices. | |
| This comparison of the specifications demonstrates the functionalequivalence of the products. The difference discussed in the abovechapters includes: (Details please see Section 12)• working mechanism• structure• electric and environment requirements• connectivity | ||
| • connection to ultrasound systemThe safety concerns about structure, main power, connectivity andconnection to ultrasound system could be addressed by TUV report. As toworking mechanism, safety concerns come from image distortion, whichhas been addressed in the Risk Management File (39, 40, 42, 43, 44, 45)for the device. | ||
| In all, the differences discussed in this section do not raise new issues ofsafety and effectiveness. Verification testing demonstrated that noadverse effects have been introduced by these differences. | ||
| Therefore, MedNovel believes that the Model AiVUS 1000 is as safe and | ||
| effective and performs in a substantially equivalent manner to thepredicate device(s). | ||
| Summary of Non-Clinical Tests | The Model AiVUS 1000 systems has been evaluated for biocompatibility,as well as electrical, electromagnetic, and mechanical safety, and has beenfound to conform with applicable medical device safety standards. TheModel AIVUS 1000 systems complies with voluntary standards and FDAGuidance documents: | |
| 1. | AAMI/ANSI ES60601-1, Medical Electrical Equipment -Medicalelectrical equipment- Part1: General requirements for basicsafety and essential performance | |
| 2. | IEC60601-1-2, Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Disturbances -Requirements And Tests | |
| 3. | IEC60601-1-6, Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability | |
| 4. | IEC62366-1, Medical Devices - Part 1: Application Of UsabilityEngineering To Medical Devices | |
| 5. | ISO10993-1, Biological Evaluation Of Medical Devices - Part 1:Evaluation And Testing Within A Risk Management Process | |
| 6. | ISO10993-5, Biological Evaluation Of Medical Devices - Part 5:Tests For In Vitro Cytotoxicity | |
| 7. | ISO10993-10, Biological Evaluation Of Medical Devices - Part10: Tests For Irritation And Skin Sensitization | |
| 8. | ANSI AAMI IEC62304, Medical Device Software - Software LifeCycle Processes | |
| 9. | ISO14971, Medical device - Application of risk management tomedical devices | |
| 10. | ISO 15223-1, Medical devices — Symbols to be used withmedical device labels, labelling and information to be supplied —Part 1:General requirements | |
| 11. | Guidance for Industry and FDA Staff - Content of PremarketSubmissions for Management of Cyber security in MedicalDevices (issued October 2, 2014) | |
| 12. | Guidance for Industry and FDA Staff – Use of InternationalStandard ISO 10993-1, "Biological evaluation of medical devices– Part 1: Evaluation and testing within a risk managementprocess" (issued June 16, 2016) | |
| 13. Guidance for Industry and FDA Staff-Information to Support aClaim of Electromagnetic Compatibility(EMC) of Electrically –Powered Medical Devices (issued July 11,2016) | ||
| 14. Information for Manufacturers Seeking Marketing Clearance ofDiagnostic Ultrasound Systems and Transducers - Guidance forIndustry and FDA Staff | ||
| Performance Testing: | ||
| Verification testing was performed in Image Simulation Tests on breastphantoms. All items in the test plan were verified and passed. | ||
| Clinical sample images in appendix H were provided to support the abilityof proposed Model AiVUS 1000 to generate diagnostic quality images thatare at least as good as those of the current standard of care, handheldultrasound examination. | ||
| Additionally, verification/validation tests results metrics DOC0000101 RevA have been performed to address intended use, the technical claims,requirement specifications and the risk management results. The resultsdemonstrate that the Model AiVUS 1000: | ||
| • Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents.• Meet the accept criteria and is adequate for its intended use. | ||
| The results of these performance tests indicate that the Model AiVUS1000 is substantially equivalent to the listed predicate devices (AcusonS2000 ABVS Ultrasound System (K081148), Breast VolumeNavigator(K141870), TomTec ECHO-SCAN(K963807). | ||
| Summary ofClinical Tests | The proposed Model AiVUS 1000 system did not require formal clinicalstudy since substantial equivalence to the legally marketed predicatedevice was proven with the verification/validation testing. | |
| However, clinical sample images are used as an output to confirm that theindication for use for the device is met. In the performance of these teststhe Model AiVUS 1000 system met the defined criteria for success. Inaddition, since different size of breast types (A, B, C, D cup size) anddifferent subject ethnicities (Han, Caucasoid, African) with a variety oflesions were captured during the collection of the clinical sample imagedata, all the indication for use are evidenced. The proposed indication foruse is satisfied. | ||
| Conclusion | In summary, these data support the claim that the design, intended use,technology and principal technological components of the proposed ModelAIVUS 1000 are substantially equivalent to the currently marketed primarypredicate device ABVS (K081148) and two referenced devices (K141870and K963807). Based on the information provided above, the proposed |
510(k) Summary
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| Model AIVUS 1000 does not raise different questions of safety andeffectiveness compare to the currently marketed primary predicate deviceABVS(K081148). The proposed Model AiVUS 1000 is identical to theprimary predicate device ABVS(K081148), and therefore is consideredsubstantially equivalent. |
|---|
| Additionally, substantial equivalence was demonstrated with non-clinicalperformance (verification and validation) tests, which complied with therequirements specified in the international and FDA-recognized consensusstandards. |
| The results of these tests demonstrate that the proposed Model AiVUS1000 meets the acceptance criteria and is adequate for its intended use. |
§ 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.