(85 days)
Not Found
No
The description mentions an "algorithm" for evaluating S-ECG data, but there is no mention of AI, ML, or any related concepts like training sets or performance metrics typically associated with AI/ML models. The performance studies focus on software verification and system validation, not AI/ML model performance.
No
The device is intended to monitor and record S-ECG for the clinical evaluation and diagnosis of cardiac arrhythmias, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for the "clinical evaluation and diagnosis of cardiac arrhythmias," and the device description mentions it "evaluates S-ECG waveform data for indications of cardiac arrhythmias and 'marks' the S-ECG signal for clinical presentation."
No
The device description clearly outlines a physical, subcutaneously-implanted sensor device (Model M301) with electrodes and an integrated battery, in addition to the software components.
Based on the provided information, the LUX-Dx Insertable Cardiac Monitor (ICM) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- LUX-Dx Function: The LUX-Dx monitors and records subcutaneous electrocardiogram (S-ECG). This is a measurement of electrical activity within the body, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is for the clinical evaluation and diagnosis of cardiac arrhythmias based on the recorded S-ECG. This is a direct measurement of physiological activity.
Therefore, the LUX-Dx falls under the category of an in vivo diagnostic device, as it is implanted within the body to collect data directly from the patient.
N/A
Intended Use / Indications for Use
The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECC). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.
The LUX-Dx has not been tested specifically for pediatric use.
Product codes
MXD
Device Description
The LUX-Dx ICM sensor device (Model M301) evaluates S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation when the algorithm criteria are met. The device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The sensor device is powered by an integrated battery. The electrodes used for detecting the S-ECG signal are located on each end of the sensor device, in the header and at the base of the battery. The LUX-Dx system includes the following main components:
- LUX-Dx™ sensor device a subcutaneously-implanted sensor device for cardiac arrhythmia event ● data collection and transmission. In addition, symptom events are collected and transmitted from the sensor device.
- . Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the LUX-Dx sensor device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
- . LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
- . System Accessories- for insertion of the sensor device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate sensor/MM app communication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous layer of the fourth intercostal space of the left chest wall
Indicated Patient Age Range
The LUX-Dx has not been tested specifically for pediatric use.
Intended User / Care Setting
Not Found
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
Boston Scientific performed safety risk management activities and design verification and validation testing to demonstrate that the LUX-Dx sensor device software is substantially equivalent to the predicate device software. The system conforms to user needs and intended use and software requirements and design specifications.
Performance Testing - Bench:
- . Software Verification
- . System Verification
- Confirmatory Validation ●
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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May 25, 2021
Boston Scientific Corporation Melissa Klamerus Principal Regulatory Affairs Specialist 4100 Hamline Ave North St. Paul, Minnesota 55112
Re: K210608
Trade/Device Name: LUX-Dx Insertable Cardiac Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MXD Dated: February 24, 2021 Received: March 1, 2021
Dear Melissa Klamerus:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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,
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
Enclosure
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Indications for Use
510(k) Number (if known) K210608
Device Name LUX-Dx™ Insertable Cardiac Monitor
Indications for Use (Describe)
The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECC). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.
The LUX-Dx has not been tested specifically for pediatric use.
| 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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4100 Hamline Avenue North St Paul, MN 55112-5798 651.582.4000 Tel 651.582.5134 Fax www.bostonscientific.com
510(k) Summary
1. Submitter
Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, Minnesota 55112-5798
- Contact: Melissa Klamerus Principal Regulatory Specialist Phone: (612) 247-6878 Email: melissa.klamerus@bsci.com
Date Prepared: 23 February 2021
2. Device
Trade Name: LUX-Dx™ Insertable Cardiac Monitor Common Name: Arrythmia detector and alarm Product Code/Panel: MXD, Cardiovascular Device Class and Panel: Class II Classification Regulation: 21 CFR 870.1025
3. Predicate Device
Trade Name: LUX-Dx™ Insertable Cardiac Monitor Manufacturer: Boston Scientific Corp Clearance Number: K193473, 26 June 2020 Common Name: Arrythmia detector and alarm Product Code/Panel: MXD, Cardiovascular Device Class and Panel: Class II Classification Regulation: 21 CFR 870.1025
4. Indication for Use
The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of
4
developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.
The LUX-Dx has not been tested specifically for pediatric use.
5. Device Description
The LUX-Dx ICM sensor device (Model M301) evaluates S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation when the algorithm criteria are met. The device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The sensor device is powered by an integrated battery. The electrodes used for detecting the S-ECG signal are located on each end of the sensor device, in the header and at the base of the battery. The LUX-Dx system includes the following main components:
- LUX-Dx™ sensor device a subcutaneously-implanted sensor device for cardiac arrhythmia event ● data collection and transmission. In addition, symptom events are collected and transmitted from the sensor device.
- . Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the LUX-Dx sensor device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
- . LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
- . System Accessories- for insertion of the sensor device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate sensor/MM app communication.
| Characteristic | Model M301 LUX-Dx ICM | Model M301 LUX-Dx ICM
Patient Patch v1.00 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Indications for use | The LUX-Dx Insertable Cardiac Monitor (ICM) is
intended to monitor and record subcutaneous
electrocardiogram (S-ECG). The recorded S-ECG
is used for the clinical evaluation and diagnosis
of cardiac arrhythmias. The LUX-Dx is indicated
for use in patients that have a known heart
condition and are at risk of developing an
abnormal heart rhythm, or have symptoms that
may suggest a cardiac arrhythmia such as
dizziness, palpitations, syncope, chest pain,
and/or shortness of breath.
The LUX-Dx has not been tested specifically for
pediatric use. | Identical |
| Usage | Single use | Identical |
6. Substantial Equivalence
5
| Characteristic | Model M301 LUX-Dx ICM | Model M301 LUX-Dx ICM
Patient Patch v1.00 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Sterility | Supplied sterile | Identical |
| Volume Dimension | 1.2 cc | Identical |
| MR Conditional | 1.5 T and 3T | Identical |
| Energy Source | Battery powered - LiMnO2 | Identical |
| Longevity | 3 years | Identical |
| Device Software
Version | FW v 1.00.00 | FW v 1.00.00 Patient Patch v1.00 |
| Remote Monitoring | Yes | Identical |
| Packaging | Sterile kit including ICM device and custom
implant tools.
Accessories: External, non-sterile devices are
packaged separately. | Identical |
7. Summary of Performance Testing
Boston Scientific performed safety risk management activities and design verification and validation testing to demonstrate that the LUX-Dx sensor device software is substantially equivalent to the predicate device software. The system conforms to user needs and intended use and software requirements and design specifications.
Performance Testing - Bench:
- . Software Verification
- . System Verification
- Confirmatory Validation ●
8. Conclusion
Based on the intended use, fundamental technological characteristics, and performance testing, the proposed LUX-Dx sensor device software has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device software.