(238 days)
No
The summary describes an automated ultrasound scanning system that acquires and reconstructs images, but there is no mention of AI or ML being used for image analysis, interpretation, or diagnosis. The system is described as an adjunct for image acquisition and review, not for automated detection or analysis of abnormalities.
No.
The device is indicated for imaging and diagnosis, specifically as an adjunct to mammography for B-mode ultrasonic imaging, not for treatment or therapy.
Yes
The device aids in making diagnoses by visually reconstructing ultrasonic images for review, providing adjunctive information to assist doctors in diagnosing abnormalities.
No
The device description explicitly states that the system is comprised of a patient scanning system and display system, which include hardware components like a scan module, associated assembly and electronics, and adjustable touch panels. While software is a key component for image processing and control, the device is not solely software.
Based on the provided text, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MedNovel Model AiVUS 1000 is an ultrasound imaging system adjunct. It uses ultrasonic imaging (a non-invasive technique using sound waves) to create images of the breast. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "B-mode ultrasonic imaging of patient's breast" and is an "adjunct to mammography". This is consistent with medical imaging, not in vitro testing.
- Device Description: The description details a "patient scanning system" and "display system" that acquire and display ultrasonic images. This aligns with imaging technology.
Therefore, the MedNovel Model AiVUS 1000 falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
IYO, LLZ, ITX
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
B-mode ultrasonic imaging
Anatomical Site
patient's breast
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
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.
Different sizes 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed Model AiVUS 1000 system did not require formal clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing. However, clinical sample images are used as an output to confirm that the indication for use for the device is met. In the performance of these tests the Model AiVUS 1000 system met the defined criteria for success. In addition, since 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, all the indication for use are evidenced. The proposed indication for use is satisfied.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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)
1
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
2
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
3
5. 510(k) Summary
| 510(k) Summary | K190314 | |
|---|---|---|
| Date Prepared: | May.20, 2019 | |
| Manufacturer: | MedNovel Technology Ltd | |
| Primary Contact | ||
| Person | Grace Dang | |
| Quality and Regulatory Affairs Executive | ||
| MedNovel Technology Ltd | ||
| Tel: +86 510 8815 9458 | ||
| E-mail: shujuan.dang@snyamedical.com | ||
| Secondary | ||
| Contact Person | Hui Luo | |
| Technical Director | ||
| MedNovel Technology Ltd | ||
| Tel: +86 18114862133 | ||
| E-mail: hui.luo@snyamedical.com | ||
| Device Name | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | |
| Classification | Classification name: | Ultrasonic Pulsed Echo Imaging |
| System | ||
| Classification Regulation: | 21 CFR 892.1560 Ultrasonic pulsed | |
| echo imaging system | ||
| 21 CFR 892.2050 Picture archiving | ||
| and communications system | ||
| 21 CFR 892.1570 Diagnostic | ||
| ultrasonic transducer | ||
| Classification Panel: | Radiology | |
| Device Class: | II | |
| Primary Product Code: | IYO, LLZ, ITX | |
| Primary Predicate | ||
| Device | Trade name: | |
| Manufacturer: | ||
| 510(k) Clearance: | ||
| Classification Regulation: | 21 CFR 892.1560 | |
| Classification name: | Ultrasonic Pulsed Echo Imaging | |
| System | ||
| 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 Imaging | |
| System | ||
| 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 Imaging | |
| System | ||
| Classification Panel: | Radiology | |
| Device class | II | |
| Product Code: | IYO | |
| Device Description | 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. | |
| Intended Use/
Indication for 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. | |
| Technology &
Fundamental
Scientific
Technology | The Model AiVUS 1000 system works together with legally approved
ultrasound imaging systems (LAUIS). The Model AiVUS 1000 system
acquires real-time B-mode ultrasonic images by video connection from the
LAUIS. While scanning, the Model AiVUS 1000 system moves the
transducer along the planned path inside the region of interest specified
by the operator. After the scanning, the acquired images are reconstructed
and 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.) are
contained in the workstation software which is a standalone product and
will be submitted for clearance later. | |
| Determination of
Substantial
Equivalence | MedNovel Tech claims that the Model AiVUS 1000 system is substantially
equivalent to the predicate devices (K081148 – Acuson S2000 ABVS
Ultrasound System, K141870 – Breast Volume Navigator and K963807 –
TomTec Echo-Scan). MedNovel Tech claims this equivalence because
the proposed device has an equivalent intended use, manufacturing
materials, operating principles, and physical and operational specifications
compared to the predicate devices. | |
| | This comparison of the specifications demonstrates the functional
equivalence of the products. The difference discussed in the above
chapters includes: (Details please see Section 12)
• working mechanism
• structure
• electric and environment requirements
• connectivity | |
| | • connection to ultrasound system
The safety concerns about structure, main power, connectivity and
connection to ultrasound system could be addressed by TUV report. As to
working mechanism, safety concerns come from image distortion, which
has 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 of
safety and effectiveness. Verification testing demonstrated that no
adverse 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 the
predicate 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 been
found to conform with applicable medical device safety standards. The
Model AIVUS 1000 systems complies with voluntary standards and FDA
Guidance documents: |
| | 1. | AAMI/ANSI ES60601-1, Medical Electrical Equipment -Medical
electrical equipment- Part1: General requirements for basic
safety and essential performance |
| | 2. | IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance -
Collateral Standard: Electromagnetic Disturbances -
Requirements And Tests |
| | 3. | IEC60601-1-6, Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability |
| | 4. | IEC62366-1, Medical Devices - Part 1: Application Of Usability
Engineering 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 - Part
10: Tests For Irritation And Skin Sensitization |
| | 8. | ANSI AAMI IEC62304, Medical Device Software - Software Life
Cycle Processes |
| | 9. | ISO14971, Medical device - Application of risk management to
medical devices |
| | 10. | ISO 15223-1, Medical devices — Symbols to be used with
medical device labels, labelling and information to be supplied —
Part 1:General requirements |
| | 11. | Guidance for Industry and FDA Staff - Content of Premarket
Submissions for Management of Cyber security in Medical
Devices (issued October 2, 2014) |
| | 12. | Guidance for Industry and FDA Staff – Use of International
Standard ISO 10993-1, "Biological evaluation of medical devices
– Part 1: Evaluation and testing within a risk management
process" (issued June 16, 2016) |
| | 13. Guidance for Industry and FDA Staff-Information to Support a
Claim of Electromagnetic Compatibility(EMC) of Electrically –
Powered Medical Devices (issued July 11,2016) | |
| | 14. Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers - Guidance for
Industry and FDA Staff | |
| | Performance Testing: | |
| | Verification testing was performed in Image Simulation Tests on breast
phantoms. All items in the test plan were verified and passed. | |
| | 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. | |
| | Additionally, verification/validation tests results metrics DOC0000101 Rev
A have been performed to address intended use, the technical claims,
requirement specifications and the risk management results. The results
demonstrate 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 AiVUS
1000 is substantially equivalent to the listed predicate devices (Acuson
S2000 ABVS Ultrasound System (K081148), Breast Volume
Navigator(K141870), TomTec ECHO-SCAN(K963807). | |
| Summary of
Clinical Tests | The proposed Model AiVUS 1000 system did not require formal clinical
study since substantial equivalence to the legally marketed predicate
device was proven with the verification/validation testing. | |
| | However, clinical sample images are used as an output to confirm that the
indication for use for the device is met. In the performance of these tests
the Model AiVUS 1000 system met the defined criteria for success. In
addition, since 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, all the indication for use are evidenced. The proposed indication for
use is satisfied. | |
| Conclusion | In summary, these data support the claim that the design, intended use,
technology and principal technological components of the proposed Model
AIVUS 1000 are substantially equivalent to the currently marketed primary
predicate device ABVS (K081148) and two referenced devices (K141870
and K963807). Based on the information provided above, the proposed | |
510(k) Summary
4
5
6
7
8
| Model AIVUS 1000 does not raise different questions of safety and
effectiveness compare to the currently marketed primary predicate device
ABVS(K081148). The proposed Model AiVUS 1000 is identical to the
primary predicate device ABVS(K081148), and therefore is considered
| substantially equivalent. |
|---|
| Additionally, substantial equivalence was demonstrated with non-clinical |
| performance (verification and validation) tests, which complied with the |
| requirements specified in the international and FDA-recognized consensus |
| standards. |
| The results of these tests demonstrate that the proposed Model AiVUS |
| 1000 meets the acceptance criteria and is adequate for its intended use. |