(248 days)
No
The document mentions "proprietary algorithms for analysis" but does not explicitly state or imply the use of AI or ML. The focus is on ECG data acquisition, storage, and forwarding for analysis by these algorithms and subsequent physician review.
No
The device is described as a "wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias," and its intended use is "for ECG reporting and arrhythmia detection." It monitors and analyzes data for diagnostic purposes, rather than providing treatment.
Yes
The "Intended Use / Indications for Use" section states: "MoMe® ARC is indicated for...Patients with symptoms that may be due to cardiac arrhythmias..." and the "Device Description" section states: "MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias..." These statements clearly indicate its purpose is to help in diagnosing cardiac arrhythmias.
No
The device description explicitly states that the MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories, which are hardware components. While it includes software (MoMe® Software Platform), it is not solely software.
Based on the provided text, the MoMe® ARC 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.
- MoMe® ARC Function: The MoMe® ARC device is described as a wireless, remote monitoring system that acquires, stores, and forwards ECG data. ECG data is a measurement of the electrical activity of the heart, obtained externally from the body using electrodes placed on the skin. It does not involve the analysis of samples taken from the body.
- Intended Use: The intended use is for ECG reporting and arrhythmia detection in patients with suspected cardiac arrhythmias, based on the electrical signals of the heart.
- Device Description: The description focuses on the hardware (Sensor, Gateway, Charging dock) and software for acquiring and transmitting ECG signals.
Therefore, the MoMe® ARC falls under the category of a medical device for physiological monitoring, specifically cardiac monitoring, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MoMe® ARC is indicated for:
- Patients who experience transient symptoms that may suggest cardiac arrhythmia.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
- Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
- Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
- ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.
MoMe® ARC is contraindicated for:
- MoMe® ARC is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
Note: MoMe® ARC does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.
Product codes (comma separated list FDA assigned to the subject device)
DSI
Device Description
MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link.
The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway. The user interface is composed of a mechanical button, display with touch screen, vibrator, and a speaker on the Gateway and a vibrator and LED on the Sensor.
The MoMe® ARC communicates with the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. The MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.
Once activated and operating normally the system requires no patient intervention to capture or analyze data. However, the MoMe® ARC has a patient triggered Event feature that allows for selection and recording of their symptoms if desired.
The device is intended for use under prescription only for monitoring patients with suspected cardiac arrhythmias.
MoMe® ARC:
- Is non-invasive and poses no significant safety issues
- . Uses existing electrode and ECG technology
- ls used in an adjunctive fashion, where physicians also use patient symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.
MoMe® ARC is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.
The intended use of the MoMe® ARC is for ECG reporting and arrhythmia detection in patients with non-life threatening arrhythmias.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician practices, clinics, research institutions
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing - Nonclinical
The MoMe® ARC submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Documents: Arrhythmia Detector and Alarm" released in October 2003. The test reports in the submission demonstrate that MoMe® ARC meets its intended use and design requirements.
The MoMe® ARC was tested and conforms to the following voluntary FDA recognized standards:
-
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MOD)
Note: Has been tested and complies with the requirements of Clause 8.5.5.2 - Energy reduction test.
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MOD)
-
- IEC 60601-1-2: Edition 4.1 2020-09 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- ANSI/AAMI/IEC 60601-2-47: 2012/(R)2016 Medical equipment Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
-
- IEC /TR 60601-4-2 Edition 1.0 2016-05 Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
-
FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0 5.
-
- IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
-
- ISO 10993-1: 2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity
-
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices Part 10: Tests for skin sensitization ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference material
-
- 10993-23 First edition 2021-01 Biological evaluation of medical devices Part 23: Tests for irritation
Performance Testing - Clinical
No clinical tests were required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2023
InfoBionic, Inc. % Rita King, CEO, MethodSense, Inc. 1 Copley Pkwy. Suite 410 Morrisville, North Carolina 27560
Re: K230265
Trade/Device Name: MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: DSI Dated: January 30, 2023 Received: January 31, 2023
Dear Rita King:
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" (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).
1
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 QS 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.
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).
Sincerely,
Shruti N. Mistry -S
for
Jennifer Shih 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
2
Indications for Use
510(k) Number (if known) K230265
Device Name
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
Indications for Use (Describe)
MoMe® ARC is indicated for:
-
Patients who experience transient symptoms that may suggest cardiac arrhythmia.
-
Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
-
Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
-
Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
-
ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.
MoMe® ARC is contraindicated for:
- MoMe® ARC is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
Note: MoMe® ARC does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.
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
Image /page/3/Picture/0 description: The image shows the logo for Infobionic. The logo consists of the word "INFOBIONIC" in a sans-serif font. The letters "INFO" are in blue, while the letters "BIONIC" are in green. The "O" in "BIONIC" is replaced with a heart symbol. To the left of the word "INFO" is a cluster of blue and green circles of varying sizes.
510(k) Summary
InfoBionic K230265
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | InfoBionic, Inc.
312 Billerica Rd. Office Link #5
Chelmsford, MA 02184
Phone: 1-978-674-8304
Fax: 1-978-359-2444 |
|------------------|------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Dave MacCucheon
Chief Operating Officer
Email: dmaccutcheon@infobionic.com
Phone: 1-617-755-6602 |
| Date Prepared: | September 1, 2023 |
Device Name and Classification
| Trade Name: | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection |
|---|---|
| System | |
| Common Name: | Continuous ECG Monitor and Arrhythmia Detection |
| Classification: | Class II |
| Regulation Number: | 21 CFR Part 870.1025 |
| Classification Panel: | Cardiovascular |
| Product Code: | DSI |
Predicate Device:
| Primary Predicate | |
|---|---|
| Trade Name | MoMe® Kardia Wireless Ambulatory ECG Monitoring and |
| Detection System | |
| Common Name | Continuous ECG monitor and Arrhythmia Detection |
| 510(k) Submitter / Holder | InfoBionic, Inc. |
| 510(k) Number | K160064 |
| Regulation Number | 21 CFR Part 870.1025 |
| Classification Panel | Cardiovascular |
| Product Code | DSI |
The predicate device has not been subject to a design-related recall.
4
Image /page/4/Picture/0 description: The image shows the logo for Infobionic. The logo consists of the word "INFOBIONIC" in blue and green letters, with a small blue heart in the middle of the word. To the left of the word is a cluster of blue and green dots arranged in a circular pattern.
Device Description and Intended Use
MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link.
The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway. The user interface is composed of a mechanical button, display with touch screen, vibrator, and a speaker on the Gateway and a vibrator and LED on the Sensor.
The MoMe® ARC communicates with the MoMe® Software System (K152491), a web-based remote server software with proprietary algorithms for analysis, using the MoMe® Device Communications Protocol. The MoMe® Software System analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review.
Once activated and operating normally the system requires no patient intervention to capture or analyze data. However, the MoMe® ARC has a patient triggered Event feature that allows for selection and recording of their symptoms if desired.
The device is intended for use under prescription only for monitoring patients with suspected cardiac arrhythmias.
MoMe® ARC:
- Is non-invasive and poses no significant safety issues
- . Uses existing electrode and ECG technology
- ls used in an adjunctive fashion, where physicians also use patient symptoms and other tests, in the diagnosis or monitoring of patients with cardiac arrhythmias.
MoMe® ARC is not an emergency service. If the patient is experiencing symptoms that he/she is concerned about, the patient needs to seek immediate medical attention.
The intended use of the MoMe® ARC is for ECG reporting and arrhythmia detection in patients with non-life threatening arrhythmias.
Indications for Use
MoMe® ARC is indicated for:
-
- Patients who experience transient symptoms that may suggest cardiac arrhythmia.
-
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
-
- Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
5
Image /page/5/Picture/0 description: The image shows the logo for Infobionic. The logo consists of the word "INFOBIONIC" in a sans-serif font. The "INFO" part of the word is in blue, while the "BIONIC" part is in green. There is a blue heart in the middle of the word. To the left of the word is a cluster of blue and green circles of varying sizes.
-
- Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
-
- ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.
MoMe® ARC is contraindicated for:
-
- MoMe® ARC is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
Note: MoMe® ARC does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.
- MoMe® ARC is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
6
Image /page/6/Picture/0 description: The image shows the logo for Infobionic. The logo is made up of the word "INFOBIONIC" in blue and green letters. To the left of the word is a cluster of blue and green dots. The "O" in "BIONIC" is replaced with a heart.
Substantial Equivalence
The table below provides a detailed comparison of MoMe® ARC to the predicate device.
| Characteristic | Subject Device
MoMe® ARC K3 | Predicate Device
MoMe® Kardia (K160064) | Comparison |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| FDA Classification | Class II | Class II | Identical |
| Intended Use | For ECG reporting and
arrhythmia detection in
patients with non-life
threatening arrhythmias | For ECG reporting and
arrhythmia detection in
patients with non-life
threatening arrhythmias | Identical |
| Indications for Use | Please refer to Indications for Use
in the "Substantial Equivalence"
section above. | Please refer to Indications for Use
in the "Substantial Equivalence"
section above. | Equivalent. Name change from
MoMe® Kardia to MoMe® ARC. |
| Product Code /
Classification
Code / Common
Name | DSI
21 CFR 870.1025
Arrhythmia detector and alarm | DSI
21 CFR 870.1025
Arrhythmia detector and alarm | Identical |
| Number of
electrodes | 3 | 3 | Identical |
| Number of ECG
Channels | 2 Channels | 2 Channels | Identical |
| Ambulatory ECG
Performance
Standards | IEC 60601-2-47 | IEC 60601-2-47 | Identical |
| ECG Acquisition | Body worn sensor, handheld
device with cellular module | Single unit body worn (sensor and
cellular model) | Equivalent. Refer to Note 1
below. |
| ECG
Transmission to
Cellular | Bluetooth | On board (single unit) | Different. Refer to Note 1 below. |
| ECG
Transmission to
Monitoring Center | Cellular | Cellular | Identical |
| Characteristic | Subject Device
MoMe® ARC K3 | Predicate Device
MoMe® Kardia (K160064) | Comparison |
| User Event
Trigger | Device User Interface | Device User Interface | Identical |
| Battery Type | Li lon rechargeable | Li lon rechargeable | Identical |
| Environments
where device may
be used | Physician practices, clinics,
research institutions | Physician practices, clinics,
research institutions | Identical |
| Environment
where device data
storage and
reports are
generated | Remote (cloud-based) server | Remote (cloud-based) server | Identical |
| Prescription Use | Yes, intended to be used by
physicians and health care
providers only, not for use by
patients. | Yes, intended to be used by
physicians and health care
providers only, not for use by
patients. | Identical |
| Physician access
to patient
physiological and
event information | Yes | Yes | Identical |
| Arrhythmia
Detection
Algorithm | Proprietary/Server Side | Proprietary/Server Side | Identical |
7
Image /page/7/Picture/0 description: The image shows the logo for Infobionic. The logo consists of a cluster of blue and green dots on the left side, followed by the word "INFOBIONIC" in blue and green letters. The "O" in "BIONIC" is replaced with a blue heart symbol.
Note 1. The predicate device, MoMe® Kardia (K160064) transmitted the ECG data between the Sensor and Gateway via a hardwired connection. The subject device, MoMe® ARC, transmits the Sensor and Gateway via a Bluetooth connection. This change in ECG transmission additionally allows for just the sensor component to be worn during and the gateway to be considered a hand-held device. This change of data transfer method has been validated through testing to demonstrate that this difference does not affect the safety and effectiveness of the device.
8
Image /page/8/Picture/0 description: The image shows the logo for Infobionic. The logo consists of the word "INFOBIONIC" in blue and green letters. To the left of the word is a cluster of blue and green circles of varying sizes. The "O" in "BIONIC" is replaced with a green heart.
Performance Testing - Nonclinical
The MoMe® ARC submission was written according to and in conformance with FDA Guidance "Class II Special Controls Guidance Documents: Arrhythmia Detector and Alarm" released in October 2003. The test reports in the submission demonstrate that MoMe® ARC meets its intended use and design requirements.
The MoMe® ARC was tested and conforms to the following voluntary FDA recognized standards:
-
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MOD)
Note: Has been tested and complies with the requirements of Clause 8.5.5.2 - Energy reduction test.
- ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005. MOD)
-
- IEC 60601-1-2: Edition 4.1 2020-09 Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
-
- ANSI/AAMI/IEC 60601-2-47: 2012/(R)2016 Medical equipment Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
-
- IEC /TR 60601-4-2 Edition 1.0 2016-05 Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
-
FIRST CVSS v3.0 Common Vulnerability Scoring System version 3.0 5.
-
- IEEE ANSI USEMCSC C63.27-2021 American National Standard for Evaluation of Wireless Coexistence
-
- ISO 10993-1: 2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicity
-
- ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices Part 10: Tests for skin sensitization ISO 10993-12 Fifth edition 2021-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference material
-
- 10993-23 First edition 2021-01 Biological evaluation of medical devices Part 23: Tests for irritation
Performance Testing - Clinical
No clinical tests were required to demonstrate substantial equivalence.
Conclusion
Based on the nonclinical performance testing, comparison, and analysis in this submission for the MoMe® ARC device, MoMe® ARC is as safe and effective (i.e. substantially equivalent) as the legally marketed predicate device. K160064.