(218 days)
Not Found
Yes
The device description explicitly states that the main component is an "automated proprietary deep-learning algorithm," which is a type of machine learning.
No
The device is described as cloud-based software for the assessment of cardiac arrhythmias using ECG data. It provides supportive information for review by healthcare professionals and its interpretation results are not intended to be the sole means of diagnosis. It does not treat or alleviate a disease or condition.
No
Explanation: The "Intended Use" section clearly states, "Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information." This indicates that the device provides supportive information, but not a definitive diagnosis on its own.
Yes
The device is explicitly described as "cloud-based software" and its primary component is a "deep-learning algorithm." It functions by analyzing ECG data from external devices and systems via an API, and it lacks a user interface, requiring integration with external visualization software. While it interacts with hardware (ECG devices), the device itself is solely the software component.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The text explicitly states that DeepRhythmAl analyzes ECG data. ECG data is a recording of electrical activity of the heart, not a biological sample taken from the body (like blood, urine, or tissue).
- The intended use is for analyzing ECG recordings. The description focuses on processing data from devices like Holter monitors, event recorders, and other ECG systems. This is consistent with analyzing electrical signals, not biological samples.
Therefore, DeepRhythmAl falls under the category of a medical device that analyzes physiological signals, not an IVD.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients.
It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary.
The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
DeepRhythmAl is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.
Product codes
DOK, DPS, QYX
Device Description
The DeepRhythmAl is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.
DeepRhythmAl can be integrated into medical devices. The product supports downloading and analyzing data recorded in compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders used when assessment of the rhythm is necessary. The DRAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl doesn't have User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.
Input Imaging Modality
two lead ECG data
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result.
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
Moreover, to enable robust device validation, the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population. MDG validation database allowed for validation of additional compatible hardware configurations (MLII and MLIII leads)
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The DeepRhythmAl software for arrhythmia detection and automated analysis of ECG data has been subjected to performance testing according to the recognized consensus standards, ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 and AAMI/ANSI/EC57:2012, Moreover, to enable robust device validation, the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population. MDG validation database allowed for validation of additional compatible hardware configurations (MLII and MLIII leads).
Medicalgorithmics followed ANSI/AAMI/IEC 62304 and the FDA Guidance Document, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (January, 2002) with respect to software development and validation.
All necessary testing was conducted on the DeepRhythmAl to support a determination of substantial equivalence to the predicate and reference devices. Test results confirm that DeepRhythmAl meets its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
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December 4, 2024
Medicalgorithmics S.A. Joanna Dabala Product Compliance Leader Aleje Jerozolimskie 81 Warsaw, 02-001 Poland
Re: K241197
Trade/Device Name: DeepRhythmAI Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DPS, OYX Dated: November 7, 2024 Received: November 7, 2024
Dear Joanna Dabala:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Jennifer W. Shih -S
Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
DeepRhythmAl
Indications for Use (Describe)
DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients.
It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary.
The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
DeepRhythmAl is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.
| 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) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for MEDICALgorithmics. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, lighter font. The logo is simple and professional, and it conveys the company's focus on medical technology.
510(k) Summary
. Submitter's name and address:
Medicalgorithmics S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland
Contact Person: Joanna Dabała Phone: (+48) 733 888 448 Email: j.dabala@medicalgorithmics.com
Date Prepared:
2024-11-07
- ll. Device
Trade name:
DeepRhythmAl
870.1425 870.2340 870.1025
Class II
Common name: ECG Analysis System
Classification name: Programmable Diagnostic Computer/
Electrocardiograph/ Outpatient Cardiac Telemetry
Requlation number:
Regulatory Class:
DQK, DPS, QYX Classification Product code:
Substantial Equivalence lll.
The selected predicate device is:
-
- DeepRhythmAI, K210822 (Predicate Device),
IV. Device description
The DeepRhythmAl is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration with other medical products. The main component of DeepRhythmAl is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review.
5
Image /page/5/Picture/0 description: The image shows the logo for MEDICALgorithmics. The word "MEDICALgorithmics" is written in a bold, sans-serif font, with the first part of the word in a dark blue color and the second part in a slightly lighter blue. Below the main logo, there is a tagline that reads "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, sans-serif font.
DeepRhythmAl can be integrated into medical devices. The product supports downloading and analyzing data recorded in compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders used when assessment of the rhythm is necessary. The DRAI can also be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl doesn't have User Interface therefore it should be integrated with the external visualization software used by the ECG technicians for the ECG visualization and analysis reporting.
DeepRhythmAl is not for use in life supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
V. Indications for use
DeepRhythmAl is a cloud-based software for the assessment of cardiac arrhythmias using two lead ECG data in adult patients.
It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from dedicated ambulatory ECG devices such as Holter, event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary.
The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAl can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
DeepRhythmAl is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.
VI. Comparison to predicate device
The following tables provide a comparison of the detection features and device comparison of DeepRhythmAI and the predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for MEDICALgorithmics. The word "MEDICAL" is in large, bold, blue letters, with a blue square to the left of the word. The word "gorithmics" is in a smaller, but still bold, blue font. Below the company name is the phrase "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, lighter font.
Detection Features comparison:
| Device functionality | Subject device
(K241197) | Predicate device
(K182344) |
|----------------------------------------------------------------------------------------------|-----------------------------|-------------------------------|
| | DeepRhythmAl | DeepRhythmAl |
| QRS detection | YES | YES |
| Heart rate determination for
non-paced adult | YES | YES |
| R-R interval detection | YES | YES |
| Non-paced arrhythmias
interpretation | YES | YES |
| Non-paced ventricular
arrhythmias calls | YES | YES |
| Atrial fibrillation detection | YES | YES |
| Cardiac beats detection
(Ventricular ectopic beats,
Supraventricular ectopic
beats) | YES | YES |
| Patient populations | Adult | Adult |
Device comparison:
| Device
functionality | Subject device | Predicate device | Similarities/
Differences |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| | DeepRhythmAl
(DRAI) | DeepRhythmAl
(DRAI) | |
| Manufacturer | Medicalgorithmics S.A. | Medicalgorithmics S.A. | N/A |
| 510(k) Number | K241197 | K182344 | N/A |
| Classification | Class II | Class II | Equivalent |
| Regulation
Number(s) | 21 CFR §870.1425
21 CFR §870.2340
21 CFR §870.1025 | 21 CFR §870.1425
21 CFR §870.2340 | Equivalent |
| Classification
name | Programmable
Diagnostic Computer,
Electrocardiograph.
Outpatient Cardiac
Telemetry | Programmable
Diagnostic Computer,
Electrocardiograph | Equivalent |
| Product Code | DOK, DPS, QYX | DOK, DPS | Equivalent |
| Device
functionality | Subject device | Predicate device | Similarities/
Differences |
| | DeepRhythmAl
(DRAI) | DeepRhythmAl
(DRAI) | |
| Indications for
Use | DeepRhythmAl is a
cloud-based software for
the assessment of
cardiac arrhythmias
using two lead ECG data
in adult patients.
It is intended for use by
a healthcare solution
integrator to build web,
mobile or another types
of applications to let
qualified healthcare
professionals review and
confirm the analytic
result. The product
supports downloading
and analyzing data
recorded in the
compatible formats from
dedicated ambulatory
ECG devices such as
Holter, event recorder,
Outpatient Cardiac
Telemetry devices or
other similar recorders
when the assessment of
the rhythm is necessary.
The product can be
electronically interfaced
and perform analysis
with data transferred
from other computer-
based ECG systems,
such as an ECG
management system.
DeepRhythmAI can be
integrated into medical
devices. In this case, the
medical device
manufacturer will identify
the indication for use
depending on the
application of their
device. | DeepRhythmAl is a
cloud-based software for
the assessment of
cardiac arrhythmias
using two lead ECG data
in adult patients.
It is intended for use by
a healthcare solution
integrator to build web,
mobile or another types
of applications to let
qualified healthcare
professionals review and
confirm the analytic
result. The product
supports downloading
and analyzing data
recorded in the
compatible formats from
dedicated ambulatory
ECG devices such as
Holter, event recorder,
Mobile Cardiac
Telemetry or other
similar devices when the
assessment of the
rhythm is necessary.
The product can be
electronically interfaced
and perform analysis
with data transferred
from other computer-
based ECG systems,
such as an ECG
management system.
DeepRhythmAl can be
integrated into medical
devices. In this case, the
medical device
manufacturer will identify
the indication for use
depending on the
application of their
device. | Equivalent |
| Device
functionality | Subject device | Predicate device | Similarities/
Differences |
| | DeepRhythmAI
(DRAI) | DeepRhythmAI
(DRAI) | |
| | DeepRhythmAI is not for
use in life-supporting or
sustaining systems or
ECG Alarm devices.
Interpretation results are
not intended to be the
sole means of diagnosis.
It is offered to physicians
and clinicians on an
advisory basis only in
conjunction with the
physician's knowledge of
ECG patterns, patient
background, clinical
history, symptoms and
other diagnostic
information. | DeepRhythmAI is not for
use in life-supporting or
sustaining systems or
ECG Alarm devices.
Interpretation results are
not intended to be the
sole means of diagnosis.
It is offered to physicians
and clinicians on an
advisory basis only in
conjunction with the
physician's knowledge of
ECG patterns, patient
background, clinical
history, symptoms and
other diagnostic
information. | |
| Level of Concern | Moderate | Moderate | Equivalent |
| Components | Software only:
- A web API
- An automated
proprietary algorithm. | Software only: - A web API
- An automated
proprietary algorithm. | Equivalent |
| Interface | Web application
programming interface
(API) | Web application
programming interface
(API) | Equivalent |
| Part responsible
for ECG signal
analysis | The automated
proprietary deep-
learning algorithm, which
measures and analyzes
ECG data to provide
qualified healthcare
professional with
supportive information
for review. | The automated
proprietary deep-
learning algorithm, which
measures and analyzes
ECG data to provide
qualified healthcare
professional with
supportive information
for review. | Equivalent |
| Display or
Graphical User
Interface (GUI) | No primary display or
GUI | No primary display or
GUI | Equivalent |
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Image /page/7/Picture/0 description: The image shows the logo for MEDICALgorithmics. The logo is in blue and features the company name in a bold, sans-serif font. Below the company name is the tagline "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical technology.
8
Image /page/8/Picture/0 description: The image shows the logo for MEDICALgorithmics. The text "MEDICALgorithmics" is in a bold, blue font. Below the company name is the text "INNOVATIVE SOLUTIONS IN MEDICINE" in a smaller, thinner font, also in blue.
9
Image /page/9/Picture/0 description: The image shows the logo for MEDICALgorithmics. The word "MEDICAL" is in bold, blue letters, and the word "gorithmics" is in a smaller font size and is also blue. Below the logo, the words "INNOVATIVE SOLUTIONS IN MEDICINE" are written in a smaller font size.
Device comparison summary:
The algorithm responsible for arrhythmia detection has been changed. Performance data was evaluated on the same requirements according to the
international standards ANSI/AAMI EC57:2012 and ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 as the predicate device. Patient population and monitoring environments for devices are equivalent.
The subject device is considered substantially equivalent to the predicate devices.
VII. Summary of performance data
The DeepRhythmAl software for arrhythmia detection and automated analysis of ECG data has been subjected to performance testing according to the recognized consensus standards, ANSI/AAMI/IEC 60601-2-47:2012/(R)2016 and AAMI/ANSI/EC57:2012, Moreover, to enable robust device validation, the algorithm was tested against the proprietary database (MDG validation db) that includes a large number of recordings captured among the intended patient population. MDG validation database allowed for validation of additional compatible hardware configurations (MLII and MLIII leads)
Medicalgorithmics followed ANSI/AAMI/IEC 62304 and the FDA Guidance Document, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff" (January, 2002) with respect to software development and validation.
All necessary testing was conducted on the DeepRhythmAl to support a determination of substantial equivalence to the predicate and reference devices. Test results confirm that DeepRhythmAl meets its intended use.
VIII. Conclusion
In conclusion, DeepRythmAl has the same intended use as the predicate device, and any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, DRAI is substantially equivalent to the predicate device.