VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
Device Facts
| Record ID | K223920 |
|---|---|
| Device Name | VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P |
| Applicant | Vinno Technology (Suzhou) Co.,Ltd |
| Product Code | IYN · Radiology |
| Decision Date | Jun 17, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Device Story
Professional digital color ultrasonic diagnostic apparatus; transmits ultrasound waves into body tissues; receives echoes to display images of tissues and blood flow. Used in hospital settings by trained healthcare professionals. Supports multiple modes: B, Harmonic, M, Color Flow, Power-Doppler, Pulsed Wave Doppler, Continuous Wave Doppler, 3D, 4D, Spatio Temporal Image Correlation, Tissue Doppler, Tissue Velocity Imaging, Elastography, and Contrast Agent Imaging. Provides real-time diagnostic imaging, measurement, and analysis. Benefits patients through non-invasive visualization of internal structures and fluid dynamics to aid clinical diagnosis.
Clinical Evidence
Bench testing only. No clinical data provided. Evidence includes biocompatibility testing per ISO 10993-1, electrical safety/EMC testing per IEC 60601-1/2-37/1-2, acoustic output testing per NEMA UD2/IEC 60601-2-37, and software verification/validation.
Technological Characteristics
General purpose ultrasound system; probe housing ABS, probe lens silicon rubber (ISO 10993 compliant). Supports B, M, Doppler (PW/CW/Color/Power/Tissue), 3D/4D, Elastography, and Contrast modes. Connectivity via USB, HDMI, S-Video, Bluetooth/Wireless. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Software level of concern: moderate.
Indications for Use
Indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology (including prostate); Transrectal; Cardiac (adult and pediatric); Peripheral Vascular; Small Organs/Parts (thyroid, breast, testicle, Musculoskeletal Conventional and Superficial); Pediatrics (including neonatal cephalic); and Adult Cephalic diagnostic ultrasound applications.
Regulatory Classification
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.
Predicate Devices
- HS40 Diagnostic Ultrasound System (K180409)
Submission Summary (Full Text)
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VINNO Technology (Suzhou) Co., Ltd. % Cordelia Liu Regulatory Registered Engineer 5F Building A, 4F Building C No. 27 Xinfa Rd. Suzhou Industrial Park Suzhou, Jiangsu 215123 CHINA
## Re: K223920
Trade/Device Name: VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E. VINNO E35P Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: April 12, 2023 Received: May 17, 2023
Dear Cordelia Liu:
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.
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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) 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.
# Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K223920
#### Device Name
VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNOX35、VINNO G55E、VINNO M55E、VINNO M55E、VINNO M55P、VINNO E35E、VINNOE35P
#### Indications for Use (Describe)
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculoskeletal Conventional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.
The operating modes supported by the device are B mode, Harmonic mode, M mode, Color Flow mode, Power-Doppler mode, Pulsed Wave Doppler mode, Continuous Wave Doppler, 3D mode, Spatio Temporal Image Correlation mode, Tissue Doppler mode, Tissue Velocity Imaging mode, Elastography mode and Contrast Agent Imaging mode.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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## 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: Allen Liu
Regulatory Affairs Phone: +86 512 62873806 Fax: +86 512 62873801 Email: allen.liu@vinno.com
Date of written: 16 Jun 2023
## II Device
Trade Name of Device: VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、 VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P
Regulation name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1550 Regulatory Class: II Product code: IYN, IYO, ITX
## III Predicate Devices
Trade name: HS40 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: k180409
## IV Device description
The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、 VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices are professional digital color ultrasonic diagnostic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and
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blood flow accordingly.
## V Indications for use
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); and Adult Cephalic diagnostic Ultrasound applications.
The operating modes supported by the device are B mode. Harmonic mode, M mode, Color Flow mode, Power-Doppler mode, Pulsed Wave Doppler mode, Continuous Wave Doppler, 3D mode, 4D mode, Spatio Temporal Image Correlation mode, Tissue Doppler mode, Tissue Velocity Imaging mode, Elastography mode and Contrast Agent Imaging mode.
## VI Comparison of technological characteristics with the predicate devices
The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、 VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices have the same technological characteristics and fundamental design as the predicate devices. The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、 VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices and the predicate device are all general purpose ultrasound devices designed to provide real-time images for diagnosis. The differences between The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X65、VINNO X35、VINNO G55E、 VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices and predicate devices do not alter suitability of the proposed device for its intended use.
See the following table for details on the comparison of technical features with the predicate device:
| Device feature | VINNO G50, VINNO G55, | SAMSUNG MEDISON HS40 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VINNO M50, VINNO E30, | k180409 (predicate device) |
| | VINNO X5, VINNO X6,<br>VINNO X7, VINNO M55,<br>VINNO E35, VINNO X65,<br>VINNO X55, VINNO X35,<br>VINNO G55E, VINNO<br>G55P, VINNO M55E,<br>VINNO M55P, VINNO<br>E35E, VINNO E35P<br>(subject device) | |
| Indications for use | The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.<br><br>This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); and Adult Cephalic diagnostic Ultrasound applications | The HS40 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal/Obstetric,Abdominal,Gynecology,Intra-operative,Pediatric,Small Organ,<br>Neonatal Cephalic,Adult Cephalic,Trans-rectal, Trans-vaginal,Muscular-Skeletal(Conventional,Superficial), Urology,Cardiac Adult,Cardiac Pediatric and Peripheral vessel |
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| The operating modes<br>supported by the device<br>are B mode, Harmonic<br>mode, M mode, Color<br>Flow mode,<br>Power-Doppler mode,<br>Pulsed Wave Doppler<br>mode, Continuous Wave<br>Doppler, 3D mode, 4D<br>mode, Spatio Temporal<br>Image Correlation mode,<br>Tissue Doppler mode,<br>Tissue Velocity Imaging<br>mode, Elastography<br>mode and Contrast<br>Agent Imaging mode. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User qualification | Qualified healthcare<br>professionals | Qualified physicians or<br>sonographers |
| Physical Specification | Width: 605mm;<br>Depth: 875mm;<br>Height: 1260mm;<br>Weight: Basic unit without<br>accessories approx:<br>60kg;<br>Control panel: Ergonomic<br>designed control panel<br>with interactive<br>back-lighting;<br>+60°to - 60°horizontal<br>swivel together with touch<br>panel and monitor;<br>Number of Probes:4 | Height: 1354~1620mm;<br>Width: 520mm;<br>Depth: 730mm;<br>Weight:51Kg(without<br>accessories);<br>Weight: Approx. 57Kg(with safe<br>working load) |
| Patient contact<br>materials | Probe housing: ABS,<br>Probe lens: Silicon rubber<br>Comply with ISO10993<br>series | Probe housing: ABS<br>Probe lens: Silicon rubber<br>Comply with ISO10993 series |
| Operating modes | B mode, Harmonic mode,<br>M mode, Color Flow<br>mode, Power-Doppler<br>mode, Pulsed Wave | Mode (2D), Color Doppler Mode<br>(C), Pulse Wave Doppler (PWD),<br>Continuous Wave<br>Doppler(CWD): Steered / Static |
| | Doppler<br>mode,<br>Continuous Wave<br>Doppler, 3D mode, 4D<br>mode, Spatio Temporal<br>Image Correlation mode,<br>Tissue Doppler mode,<br>Tissue Velocity Imaging<br>mode, Elastography<br>mode, Contrast Agent<br>Imaging mode. | Power Doppler Mode (PD),<br>S-Flow ™ Mode, M-Mode (M),<br>Anatomical M<br>Mode,Single/Dual/Quad Mode,<br>Volume Mode<br>TDI/TDW, ElastoScan Mode |
| Operating controls | Gain, Frequency, Focus<br>Position, TView, L/R, Full<br>screen, VT issue,<br>Dynamic Range, Line<br>density, VSharpen, Image<br>Angle, Persistence, Gray<br>Filter, Smooth, Focus<br>Width, Acoustic Power,<br>Biopsy, VNear,<br>EdgeEnhance,<br>NeedleEnhance, TI,<br>SGC, Depth,TGC slides<br>controls, B Steer, 2D<br>Automatic Optimization,<br>Harmonic<br>Imaging,VFusion,<br>Vspeckle, VSharpen,<br>U/D,<br>Trapezoid,PView,Map, M<br>mode, Sweep Speed,<br>Curve MAM, PRF, Wall<br>Filter, Packet Size, Color<br>Level, Invert, Color Map,<br>Sync Display, Radiant<br>Flow, Sync ROI,Base<br>Line Flash | Dynamic Range,Frame Average,<br>Frequency,Gain , Harmonic,<br>Pulse Inversion Harmonic (Probe<br>dependent),Line Density, Power,<br>Reject,<br>Scan Area, TGC, Write Zoom, -<br>MultiVision (Probe Dependent),<br>Beam Steering (Probe<br>Dependent), Trapezoid (Probe<br>Dependent), Free Angle Plane,<br>Filter, PRF (Scale), Sample<br>Volume Angle, Sample Volume<br>Position, Sample Rate, Sweep<br>Speed, Chroma Map, Gray Map,<br>Image Size, ClearVision, M Mode<br>Map, Alpha Blending, Blending<br>Level, Enhancement, Hide Color,<br>Balance, Baseline,Trace<br>Direction, Trace Method, Sound |
| | Reduction,Persistence,Transparency, Steer, Biplane probe | |
| Measurements | Abdominal, Obstetrics, Gynecology, Urology, Pediatrics, Cardiac, Vessel, Small organs(e.g. breast, testes, thyroid) , Trans-cranial Doppler, Fetal heart | Caliper, Abdomen, Cardiac, Gynecology, Vascular, Obstetrics, Fetal Heart, Urology, MSK, Small Parts, Pediatric |
| Comments | Comments and bodymarks | Comments and bodymarks |
| Probe types | Convex array<br>Linear array<br>Phased array<br>4D Probe<br>Endocavity<br>Micro Convex<br>Volume Convex | Convex array<br>Linear array<br>Phased array<br>Endo-Cavity<br>Micro-Convex Array<br>Pencil<br>Volume Probe |
| Display monitor | 21.5/23.8 inch LCD monitor | 21.5 inch LED monitor |
| Acoustic output | Comply with Track 3 limits:<br>Ispta.3≤720mW/cm²<br>MI≤1.9 | Comply with Track 3 limits:<br>Ispta.3≤720mW/cm²<br>MI≤1.9 |
| Conformity standards | IEC6061-1<br>IEC60601-1-2<br>IEC60601-2-37<br>IEC60601-1-6<br>IEC62366<br>NEMA UD 2 | IEC6061-1<br>IEC60601-1-2<br>IEC60601-2-37<br>IEC60601-1-6<br>IEC62366<br>NEMA UD 2 |
| Peripherals | Printers, USB DVDRW, ECG, S-Video output Cable, Buletooth/Wireless adapter, Foot switch, HDMI Monitor | S-Video Output, HDMI, Printers, DVD, USB, Foot switch, ECG, Monitor |
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## VII Performance data
The following performance data were provided in support of the substantial equivalence
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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 G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、 VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices are substantially equivalent to their predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the leqally marketed device.
#### Comparison:
-Both the subject and predicate device are used for the diagnostic ultrasonic imaging and fluid flow analysis. The indications for use of the subject devices - VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P are covered by the indications for use of the predicate device. Ophthalmic and Trans-esoph are not intended to be used.
-The subject and predicate device employ the same fundamental scientific technology and have similar physical designs.
-The operating modes of the subject devices are covered by the operating modes of the predicate device Diagnostic Ultrasound System.
-The operating controls are similar as the predicate device.
-The measurement part are also similar with the the predicate device.
-The probe types are the same as the predicate device HS40 Diagnostic Ultrasound
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System (K180409).
-The display monitor are almost similar with the predicate device.
-The contact materials are similar as those of the predicate device, and all passed the biocompatibility test respectively.
-The subject and predicate device are all track 3 devices meeting the maximum limits of the acoustic output parameters.
-The subject and predicate device conform to the same electrical safety standards.
-The subject and predicate device support similar interfaces with accessories.
