(72 days)
No
The document describes standard ultrasound imaging techniques and digital signal processing (adaptive filters) for image enhancement, but does not mention AI or ML.
No
The device is an ultrasound diagnostic scanner intended for evaluation and imaging, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use... for the diagnostic ultrasound evaluation" of various clinical applications. The "Device Description" also refers to it as a "multi-functional ultrasound diagnostic scanner."
No
The device description explicitly states it is a "multi-functional ultrasound diagnostic scanner" and mentions the use of "linear, convex, radial and phased array scan type probes," which are hardware components.
Based on the provided information, 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.
- Device Function: The ARIETTA 65 is an ultrasound diagnostic scanner. It uses sound waves to create images of internal body structures. This is an in vivo (within the living body) diagnostic method, not in vitro.
- Intended Use: The intended use clearly states "diagnostic ultrasound evaluation" of various anatomical sites within the body. This aligns with in vivo imaging.
- Device Description: The description details the ultrasound technology, scanning methods, and display modes, all of which are characteristic of an ultrasound imaging system.
Therefore, the ARIETTA 65 is an ultrasound diagnostic device, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This ARIETTA 65 is intended for use in a Healthcare facility (hospital, private medical office, etc.) by Healthcare trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) -Gynecological, Other (spec.) - Wound, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
Product codes
IYN, IYO, ITX
Device Description
The ARIETTA 65 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.
The ARIETTA 65 can be used for individual or combined display in the image display model listed below.
- B mode is a display mode in which the tomographic imaqe is formed with plural . ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
- M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
- There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. ● PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
- Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.
The 4 methods of electronic scanning are as follows.
-
Linear Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. -
Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
-
. Sector Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. -
. Trapezoidal Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) -Gynecological, Other (spec.) - Wound, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare trained personnel (doctor, sonographer, etc.) / Healthcare facility (hospital, private medical office, etc.)
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
Not Found
Summary of Performance Studies
Validation Testing - Bench: Hitachi judged that ARIETTA 65 is substantially equivalent to the predicate.
Validation Testing - Clinical: None required
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
November 4, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Hitachi Healthcare Americas % Mr. Aaron Pierce Director, RA/QA 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K202422
Trade/Device Name: Arietta 65 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 14, 2020 Received: August 24, 2020
Dear Mr. Pierce:
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/cfpmp/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
1
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,
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
Indications for Use
510(k) Number (if known) K202422
Device Name ARIETTA 65
Indications for Use (Describe)
This ARETTA 65 is intended for use in a Healthcare facility (hospital, private medical office, etc.) by Healthcare trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) -Gynecological, Other (spec.) - Wound, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, clinical applications.
The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
| 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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3
510(k) Summary K202422
Submitter Information
| Submitter: | Hitachi Healthcare Americas
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371 |
|-------------------|----------------------------------------------------------------------------------------|
| Contact: | Aaron Pierce |
| Telephone number: | 330-425-1313 |
| Telephone number: | 330-963-0749 |
| E-mail: | piercea@hitachihealthcare.com |
| Date: | January 18, 2019 |
Subject Device Name
| Trade/Proprietary Name: | ARIETTA 65 |
|---|---|
| Regulation Number: | 21 CFR 892.1550 |
| Regulation Name: | Diagnostic Ultrasound System and Accessories |
| Product Code | 90-IYN, 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System |
| 90-IYO, 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System | |
| 90-ITX, 21 CFR 892.1570 Diagnostic Ultrasonic Transducer | |
| Class | II |
| Panel | Radiology |
Predicate Device Name
| Main Predicate Device: | ARIETTA 65 (K181376) |
|---|---|
| Regulation Number: | 21 CFR 892.1550 |
| Regulation Name: | Diagnostic Ultrasound System and Accessories |
| Product Code | 90-IYN, 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System |
| 90-IYO, 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System | |
| 90-ITX, 21 CFR 892.1570 Diagnostic Ultrasonic Transducer | |
| Class | II |
| Panel | Radiology |
| Reference Devices | NOBLUS™ Ultrasound Diagnostic System (K160559) ALOKA ARIETTA 850 (K183456) |
Indications for Use
This ARIETTA 65 is intended for use in a Healthcare facility (hospital, private medical office, etc.) by Healthcare trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Trans-rectal, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) -Gynecological, Other (spec.) - Wound, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, clinical applications.
The Modes of Operation are B mode, M mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
4
Device Description
Function
The ARIETTA 65 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.
The ARIETTA 65 can be used for individual or combined display in the image display model listed below.
- B mode is a display mode in which the tomographic imaqe is formed with plural . ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
- M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
- There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. ● PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
- Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.
The 4 methods of electronic scanning are as follows.
-
Linear Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. -
Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
-
. Sector Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.
- . Trapezoidal Scanning Method:
By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
5
Image /page/5/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is written in large, bold, black letters on the top line. Below it, the words "Inspire the Next" are written in a smaller, thinner, black font. There is a small red accent mark above the letter "t" in the word "Next".
Scientific Concepts
The principle of operation of ultrasound imaging involves generation of an ultrasound wave pulses with an electric signal applied to a transducer, direction of the resulting ultrasound wave into the tissue of the body, and reception and analysis of the echoes reflected back to the same or an adjacent transducer from the various tissues along the path of the ultrasound wave. The ultrasound waves comprising a beam travel in as straight line in homogeneous media. When an ultrasound wave reaches an interface between two media of different impedances, a portion of the beam energy may pass through the boundary (transmission), and a portion may be reflected. The direction of propagation of the transmitted beam is determined by the angle of incidence of the incident beam upon the boundary, and differences (if any) in the speed of sound in the two media. The direction of reflection is determined solely by the angle of incidence upon the boundary. The relative strength of the reflected wave depends upon the differences in the impedances between the two media. Reflection at a boundary between soft tissue and bone, as an example, involves a large impedance difference, and results in a relatively strong reflected echo. Reflection at a boundary between two soft tissue-types with a relatively small impedance difference, on the other hand, results in a relatively weak reflected echoed. The workstation is based on current PC technology using the Windows™ operating system.
Physical and Performance Characteristics
Analysis confirms the performance characteristics of the ARIETTA 65 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent.
Performance Comparison
As part of our design validation performance comparison analysis was conducted to demonstrate continued conformance with a special control or recognized standard.
No new hazards were identified with the ARIETTA 65. The subject device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform to applicable medical device safety standards.
| Testing Type | Rationale Analysis |
|---|---|
| Validation Testing - Bench | Hitachi judged that ARIETTA 65 is substantially equivalent to the predicate. |
| Validation Testing - Clinical | None required |
The analysis confirms the performance characteristics of the ARIETTA 65 are comparable to the predicate device and support our conclusion that the subject device is substantially equivalent.
6
Image /page/6/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font size, also in black. The logo is simple and modern, with a focus on the company name and its message of innovation.
Device Technological Characteristics
The technological characteristics differences between the ARIETTA 65 and the predicate device ALOKA ARIETTA 850 (K173739) are:
| ● | Physical characteristics of the
system | There are differences in appearance, weight, size, and hardware from the predicate
device. | | |
|---|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------|
| | | ARIETTA 65 | ARIETTA 65 (K181376) | |
| ● | Additional new probes | As compared to the predicate device, there are 27 additional probes available with the
ARIETTA 65 that were previously cleared: | | |
| | | New Probe | Predicate Probe | Previously Cleared Device |
| | | C35 | None | ARIETTA 60 (K140443) |
| | | C41 | None | ARIETTA 60 (K140443) |
| | | C42 | None | ARIETTA 60 (K140443) |
| | | C22P | None | ARIETTA 60 (K140443) |
| | | C25P | None | ARIETTA 60 (K140443) |
| | | C41V | None | Noblus (K160559) |
| | | C41RP | None | ARIETTA 60 (K140443) |
| | | C41B | None | ARIETTA 60 (K140443) |
| | | CC41R | None | ARIETTA 60 (K140443) |
| | | C22K | None | ARIETTA 60 (K140443) |
| | | C42K | None | ARIETTA 60 (K140443) |
| | | C42T | None | ARIETTA 60 (K140443) |
| | | R41R | None | ARIETTA 60 (K140443) |
| | | L34 | None | ARIETTA 60 (K140443) |
| | | L441 | None | ARIETTA 60 (K140443) |
| | | L64 | None | ARIETTA 60 (K140443) |
| | | L43K | None | ARIETTA Precision (K163505) |
| | | L44K | None | ARIETTA Precision (K163505) |
| | | L46K1 | None | ARIETTA Precision (K163505) |
| | | L51K | None | ARIETTA Precision (K163505) |
| | | L53K | None | ARIETTA Precision (K163505) |
| | | L44LA | None | ARIETTA Precision (K163505) |
| | | S31 | None | ARIETTA 60 (K140443) |
| | | S31KP | None | ARIETTA 60 (K140443) |
| | | VC35 | None | ALOKA ARIETTA 850 (K183456) |
| | | VC41V | None | ARIETTA 60 (K140443) |
| | | C41L47RP | None | ARIETTA 60 (K140443) |
| | Features | Shear Wave Measurement, Freehand 3D, Real-time 3D, and Marking Assist Display are
additional features that were previously cleared (ALOKA ARIETTA 850, K183456) and
have no effect on the safety and effectiveness of the device and in regards to indications | | |
| | | for use. | | |
7
Image /page/7/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters on the top line. Below it, the words "Inspire the Next" are written in a smaller, thinner, black font. The logo is simple and modern, with a focus on the company name and tagline.
Substantial Equivalence
A summary decision was based on a thorough analysis and comparison of the functions. scientific concepts, physical and performance characteristics, performance comparison and technological characteristics.
Overall Rationale Analysis
System Configuration
There are not differences between the predicate device in regards to system configuration.
Probes
The 27 additional probes for the system meet user requirements in indications for use and have no effect on the safety and effectiveness of the device. All probes have been previously cleared in Probe Comparison Chart below.
Transmit/Receive Parameters
There are no differences between the predicate device in recards to transmit/receive parameters.
Modes of Operation
The reference frequency has been revised but will have no effect on the safety and effectiveness of the device.
Features
The Shear Wave Measurement, Freehand 3D, Real-time 3D, and Marking Assist Display are additional features that were previously cleared in Aloka Arietta 850, K183456, and have no effect on the safety and effectiveness of the device and in regards to indications for use.
Based on analysis of the above-mentioned comparison, Hitachi has judged the ARIETTA 65 to have the equivalent safety and effectiveness of the predicate device, ARIETTA 65 (K181376).
Summary of Non-Clinical Testing
The ARIETTA 65 system is in conformance with the applicable parts of the following standards:
-
AAMI ANSI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) -
IEC 60601-2-37 Edition 2.1 2015
Medical electrical equipment - part 2-37: particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. (Radiology) -
IEC 60601-1-2 Edition 4.0: 2014-02
Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC)) -
AAMI I ANSI I ISO 10993- 1 :2009/(B) 2013 . Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including Technical Corrigendum 1 (2010)]
-
AAMI I ANSI I ISO 10993- 5:2009/(R) 2014 ● Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ANSI AAMI ISO10993-10: 2002 + am1 2006 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Summary of Clinical Testing
Clinical testing was not required.
8
Image /page/8/Picture/0 description: The image shows the Hitachi logo. The word "HITACHI" is in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font, also in black. The letter "t" in "Next" has a small red accent mark above it.
Conclusions
lt is the opinion of Hitachi, Ltd. that the ARIETTA 65 ultrasound diagnostic scanner and transducers are substantially equivalent to the predicate device. The subject device software features, intended use, materials, and diagnostic capabilities have been taken from the predicate device. In addition, we have concluded that the subject device and predicate device is substantially equivalent with respect to safety, effectiveness, and functionality.