(364 days)
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, pediatric, musculo-skeletal (conventional, superficial), transrectal, trans-vaginal, cardiac adult, cardiatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices are laptop digital color ultrasonic diagnostic devices which transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow accordingly. The devices are capable of digital acquisition, processing and display and operate from an integrated battery or separate power supply/charger.
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The VGuide NGS function detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. Spatial positioning of the needle, with respect to the ultrasound image, is then updated in real time. This guides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
The provided text describes a 510(k) premarket notification for the VINNO 8, VINNO 6, and VINNO 5 ultrasound devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device's performance against specific clinical acceptance criteria through a clinical study.
Therefore, the response will focus on the information relevant to the substantial equivalence determination and the general performance testing mentioned, noting where specific information requested in the prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, effect size) is not applicable or not provided within this type of regulatory submission.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission intending to demonstrate substantial equivalence, the "acceptance criteria" are generally that the new device performs "as safely and as effectively" as the legally marketed predicate device. This is primarily shown through a comparison of technological characteristics and compliance with recognized standards, rather than specific clinical performance metrics for a novel AI algorithm.
| Acceptance Criteria (Demonstrated through Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Technological Characteristics Equivalence | The VINNO 8, VINNO 6, VINNO 5 ultrasound devices have the same technological characteristics and fundamental design as the predicate devices (GE Healthcare LOGIQ e and Philips CX50 Diagnostic Ultrasound System). Differences do not alter suitability for intended use. Features like indications for use, user qualification, physical design, patient contact materials, operating modes, operating controls, measurements, probe types, display monitor, acoustic output, conformity standards, and peripherals are compared and found to be similar or equivalent. |
| Biocompatibility | Evaluated in accordance with ISO 10993-1:2009. All evaluation acceptance criteria were met. |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1 (safety), IEC 60601-2-37 (safety for ultrasonic equipment), and IEC 60601-1-2 (EMC). |
| Software Verification and Validation | Conducted and documented as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). The software was considered a "moderate" level of concern. |
| Acoustic Output | Performed according to NEMA UD2 and IEC60601-2-37. Complies with Track 3 limits: Ispta.3 ≤ 720mW/cm² and MI ≤ 1.9. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a submission for a general diagnostic ultrasound system, not an AI/ML device that requires a test set of patient data to evaluate algorithmic performance. The "performance data" provided relates to engineering and regulatory compliance testing.
Therefore, information on "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) for a performance study of an AI algorithm is not applicable and not provided in this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there is no "test set" of patient data for evaluating an AI algorithm's performance described, information on experts for establishing ground truth is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similarly, as no patient-data-based test set evaluation is described, adjudication methods are not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document describes a general diagnostic ultrasound system. It does not appear to incorporate an AI component for interpretation or assistance to human readers that would necessitate an MRMC study. Therefore, an MRMC comparative effectiveness study is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is for a diagnostic ultrasound machine, not a standalone AI algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As this submission is for an ultrasound system itself, not an AI diagnostic algorithm, the concept of "ground truth" concerning patient diagnoses is not applicable to the performance data presented (which covers electrical safety, biocompatibility, software verification, and acoustic output).
8. The sample size for the training set
This document does not describe the development or testing of an AI/ML algorithm that would involve a training set. Therefore, "sample size for the training set" is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no AI/ML training set mentioned, this information is not applicable and not provided.
In summary: The provided 510(k) submission demonstrates the substantial equivalence of the VINNO ultrasound systems to predicate devices through technical specifications, compliance with relevant industry standards (e.g., IEC, ISO, NEMA), and standard safety and performance testing for general medical imaging equipment. It does not involve the clinical study methodologies (e.g., test sets, training sets, expert review, MRMC studies) typically associated with the evaluation of AI/ML-driven diagnostic devices.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
VINNO Technology (Suzhou) Co., Ltd. % Ms. Sherry Zhang Regulatory Affairs 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park Suzhou, Jiangsu 215123 CHINA
January 23, 2020
Re: K190120
Trade/Device Name: VINNO 8, VINNO 6, VINNO 5 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: December 6, 2019 Received: December 9, 2019
Dear Ms. 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); 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 medical devices and radiation-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,
Michael D'Hara
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
510(k) Number (if known) K190120
Device Name VINNO 8, VINNO 6, VINNO5
Indications for Use (Describe)
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, pediatric, musculo-skeletal (conventional, superficial), transrectal, trans-vaginal, cardiac adult, cardiatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
| 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
l Submitter
Device submitter: VINNO Technology (Suzhou) Co., Ltd. 5F Building A, 4F Building C No. 27 XinFa Rd. Suzhou Industrial Park, SuZhou 215123 Jiangsu China
Contact person: Sherry Zhang Regulatory Affairs Phone: +86 15850113783 Fax: +86 512 62873801 Email: Sherry.Zhang@vinno.com
Date of preparation: Dec 5th, 2019
II Device
Trade Name of Device: VINNO 8, VINNO 6, VINNO 5 Regulation name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Requlatory Class: II Product code: IYN, IYO, ITX
III Predicate Devices
Trade name: LOGIQ e Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K151028
Trade name: CX50 Diagnostic Ultrasound System Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K162329
Trade name: eZono™ 4000 Ultrasound System Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550
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Requlatory Class: II Product code: IYN, IYO, ITX Premarket Notification: K140254
IV Device description
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices are laptop digital color ultrasonic diagnostic devices which transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow accordingly. The devices are capable of digital acquisition, processing and display and operate from an integrated battery or separate power supply/charger.
Mode of operations for each probe supported by the VINNO 8, VINNO 6, VINNO 5 ultrasound devices is listed in below table.
| Probe | B | M | PWD | CWD | TissueDoppler | ColorDoppler | Color MDoppler | PowerDoppler | TissueVelocity | ImagingHarmonic | Imaging3D/4D | CBI | EI | Combinemodes[1] | VINNO 5 | VINNO 6 | VINNO 8 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G2-5C | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | ||
| U5-15LE | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | ||
| S1-6P | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | ||
| F2-5C | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| F4-9E | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| G4-9M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| F4-12L | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| D3-6C | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| G1-4P | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | X |
| X4-12L | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | |
| X6-16L | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X | |
| X6-16LG | N | N | N | N | N | N | N | N | N | N | N | N | N | N | X | X |
Note:
N = new indication; P = previously cleared by FDA
[1] Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD;
The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The VGuide NGS function detects the position and orientation of magnetized needles in
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the presence of the probe and displays this information relative to the ultrasound image. Spatial positioning of the needle, with respect to the ultrasound image, is then updated in real time. This guides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
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V Indications for use
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, adult cephalic, pediatric, musculo-skeletal (conventional, superficial), trans-rectal, trans-vaginal, cardiac adult, cardiac pediatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinics and clinical point-of-care for diagnosis of patients.
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The detail indications for use of each probe are listed below.
| Anatomy/Region of Interest | Exam Type, Means of Access | Interventional Guidance | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Transducer | Fetal | Abdominal | Pediatric | Small Organ [2] | Neonatal Cephalic | Adult Cephalic | Cardiac Adult | Cardiac Pediatric | Peripheral vessel | Musculo-skeletal (Conventional) | Musculo-skeletal (Superficial) | Thoracic/Pleural | Trans-rectal | Trans-vaginal | Trans-urethral | Transesophageal | Intraoperative | Vascular Access | Nonvascular [1] | |
| G2-5C | N | N | N | N | ||||||||||||||||
| U5-15LE | N | N | N | N | N | N | N | |||||||||||||
| S1-6P | N | N | N | N | N | N | N | |||||||||||||
| X6-16L | N | N | N | N | N | N | N | |||||||||||||
| X6-16LG | N | N | N | N | N | N | N | |||||||||||||
| F2-5C | N | N | N | N | ||||||||||||||||
| F4-9E | N | N | N | N | N | |||||||||||||||
| G4-9M | N | N | N | N | N | N | ||||||||||||||
| F4-12L | N | N | N | N | N | N | N | |||||||||||||
| X4-12L | N | N | N | N | N | N | N | |||||||||||||
| D3-6C | N | N | ||||||||||||||||||
| G1-4P | N | N | N | N | N | N | N |
Notes:
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N = new indication; P = previously cleared by FDA
[1] Nonvascular means Biopsy Guidance
[2] Small organs include breast, testes, thyroid
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VI Comparison of technological characteristics with the predicate devices
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices have the same technological characteristics and fundamental design as the predicate devices. The VINNO 8, VINNO 6, VINNO 5 ultrasound devices and the predicate device are all lap-top general purpose ultrasound devices designed to provide real-time images for diagnosis. The differences between the VINNO 8, VINNO 6, VINNO 5 ultrasound devices and predicate devices do not alter suitability of the proposed device for its intended use.
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| Devicefeature | VINNO 8, VINNO 6, VINNO 5(subject device) | GE Healthcare LOGIQ eK151028 (predicate device) | Philips CX50 DiagnosticUltrasound System K162329(predicate device) |
|---|---|---|---|
| Indications foruse | The device is intended forultrasound imaging,measurement and analysis ofhuman body and fluid for multipleclinical applications including:abdominal (GYN and Urology),Thoracic/Pleural, Fetal/Ob, smallorgan (including breast, thyroid,testes), peripheral vessel,neonatal cephalic, adult cephalic,pediatric, musculo-skeletal(conventional, superficial),trans-rectal, trans-vaginal,cardiac adult, cardiac pediatric,magnetic Needle guidance andimaging guidance ofinterventional procedures (e.g.biopsy). | The LOGIQ e is intended forultrasound imaging,measurement and analysis of thehuman body for multiple clinicalapplications including:ophthalmic: fetal/ob; abdominal(gyn & urology); pediatric; smallorgan (breast, testes, thyroid);neonatal and adult cephalic;cardiac (adult & pediatric);peripheral vascular;musculoskeletal conventional &superficial; transrectal;transvaginal; transesophageal;intraoperative (abdominal,thoracic and peripheral);thoracic/pleural for motion andfluid detection and imagingguidance of interventionalprocedures (e.g. Nerve block;vascular access). | Ophthalmic, Intraoperative,Laparascopic, Fetal, Abdominal,Pediatric, Small Organ, AdultCephalic, Neonatal Cephalic,Trans-vaginal, Musculoskeletal,Gynecological, Cardiac Adult,Cardiac Pediatric, Trans-esoph,Intracardiac echo, PeripheralVessel, Other (Carotid) |
| User | Qualified healthcare | Qualified physicians or | Qualified physicians or |
| qualification | professionals | sonographers | sonographers |
| PhysicalDesign | Laptop design with lithiumbattery, also available to be usedwith a mobile cart1 probe port | Laptop design with lithiumbattery, also available to be usedwith a mobile cart1 probe port | Laptop design with lithiumbattery, also available to be usedwith a mobile cart1 probe port |
| Patient contactmaterials | Probe housing: ABS,Probe lens: Silicon rubberComply with ISO10993 series | Probe housing: ABSProbe lens: Silicon rubberComply with ISO10993 series | Probe housing: ABSProbe lens: Silicon rubberComply with ISO10993 series |
| Operatingmodes | B, M, Color Flow, PDI, PWD,CWD, Harmonic, 3D/4D, ColorM, Elastography, TVI/TVD,Contrast agent imaging | B, M, M-Color Flow, AnatomicalM, Color Anatomical M, CFM,PDI, High-Res PDI, CWD, PWD,TVI/TVD, Needle Recognition,3D | B, M, Anatomical M, Color M,Color, CWD, Harmonic, PDI,PWD, TDI, Power/Dirpower,3D/4D, Elastography, StressEcho, Contrast agent imaging |
| Operatingcontrols | Gain, Depth, Focus, TGC, BSteer, 2D AutomaticOptimization, Harmonic Imaging,L/R, U/D, Frequency, PRF, WallFilter, Packet Size, Color Level,Invert, Color Map, Line Density,Sync Display, Persistence, FlashReduction, Base Line,Transparency, Steer, FocusPosition, Focus Number,VFusion, VSpeckle, DynamicRange | Depth, Gain, Focus, AutoOptimize, MD cursor, Frequency,CrossXBeam, TGC, Tilt,Reserve, Dynamic Range, LineDensity, Grey Maps, FrameAverage, Colorize, EdgeEnhance, Steer, Rotation, VirtualConvex, SRI HD, Virtual Apex,Centerline, Rejection,Suppression, Scan Area, LOGIQView, Fusion Background Area, | Depth, Gain, Dynamic Range,TGC, Angle, Color Gain, WallFilter, Baseline, Sweep Speed,Doppler DR, Colorize, iBeam,iClear, TSI, Sync Display, Steer,Focus Position, Focus Number,iTouch |
| Measurements | Depth, Distance, Perimeter, Area, | Depth, Distance, Circumference, | Depth, Distance, Circumference, |
| Volume, Angle, Stenosis, A/B ratio, Time, Speed, Heart Rate, Stenosis, A/B ratio, Acceleration, PS, ED, TAMAX, TAMEAN, RI, PI, PS.ED ratio, ED/PS ratio, Flow volume, MaxPG, MeanPG, Stroke Volume, Heart rate | Area, Angle, Stenosis, A/B ratio, Slope, Heart Rate, Velocity, Time, Acceleration, Frequency, TAMAX, TAMEAN, RI, PI, Ratios, Heart rate, Auto Doppler Trace function with automatic calculations | Area, Time, Heart Rate, Angle, Stenosis, A/B ratio, Volume, Auto volume measurements, Auto NT measurements, Auto OB measurement, Color Speed, Orthopaedic surgery | |
| Comments | Comments and bodymarks | Comments and bodymarks | Comments and bodymarks |
| Probe types | Convex arrayLinear arrayPhased array | Convex arrayLinear arraySector array | Curved arrayLinear arrayPhased array |
| Displaymonitor | 15.6 inch LCD monitor | 15 inch LCD monitor | 15.6 inch LCD monitor |
| Acousticoutput | Comply with Track 3 limits:$Ispta.3≤720mW/cm²$$MI≤1.9$ | Comply with Track 3 limits:$Ispta.3≤720mW/cm²$$MI≤1.9$ | Comply with Track 3 limits:$Ispta.3≤720mW/cm²$$MI≤1.9$ |
| Conformitystandards | IEC6061-1IEC60601-1-2IEC60601-2-37NEMA UD 2 | IEC6061-1IEC60601-1-2IEC60601-2-37NEMA UD 2 | IEC6061-1IEC60601-1-2IEC60601-2-37NEMA UD 2 |
| Peripherals | LAN, USB storage device, HDMI,Footswitch, Printers, ECG lead,Mobile Cart, USB Bluetooth | LAN, USB storage device, HDMI,Footswitch, Printers, USB ECG,Barcode Scanner, External DVDR/W, Mobile Cart | LAN, USB storage device, HDMI,Footswitch, Printers, USB ECG,Barcode Scanner, External DVDR/W, Mobile Cart |
Table 1 Substantial equivalence discussion
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VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the probes was evaluated in accordance with ISO 10993-1:2009. All evaluation acceptance criteria were met
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Ultrasound System. The system complies with the IEC 60601-1 and IEC 60601-2-37 for safety and the IEC 60601-1-2 for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Acoustic output testing
Acoustic output testing was performed according to NEMA UD2 and IEC60601-2-37.
VIII Conclusion
The VINNO 8, VINNO 6, VINNO 5 ultrasound devices are substantially equivalent to their predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.