(58 days)
No
The document describes standard cardiac monitoring algorithms (tachycardia, bradycardia, pause, AF detection) and noise/activity filtering, but does not mention AI or ML.
No.
The device is described as a "diagnostic monitoring device" intended to help physicians "monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias." It detects and stores EGM data but does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is for "monitoring and diagnostic evaluation," and the "Device Description" explicitly calls it an "implantable diagnostic monitoring device."
No
The device description explicitly states it is an "implantable diagnostic monitoring device, with subcutaneous electrodes" and mentions "hardware verification validation," indicating it includes physical hardware components.
Based on the provided information, the Confirm Rx™ ICM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Confirm Rx™ ICM Function: The Confirm Rx™ ICM is an implantable device that monitors electrical activity of the heart within the body (in vivo). It records and stores electrograms (EGMs) based on detected cardiac rhythms.
- Intended Use: The intended use describes monitoring and diagnostic evaluation of patients experiencing symptoms potentially related to cardiac arrhythmias. This is achieved by recording and analyzing the heart's electrical signals directly from within the body, not by testing samples taken from the body.
Therefore, the Confirm Rx™ ICM falls under the category of an implantable diagnostic monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Product codes (comma separated list FDA assigned to the subject device)
MXC, DSI
Device Description
The Confirm Rx™ ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include:
- Patient-initiated triggering of EGM storage using the myMerlin™™ Patient App for mobile devices. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review.
- Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals.
- Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration.
- The ability to identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable.
- Remote care monitoring.
The Confirm RxTM ICM (DM3500) is 4.95 x 0.95 x 0.33 cm in dimension and uses Bluetooth® wireless telemetry to communicate with external devices, including the Merlin PCS programmer and the myMerlin™ for Confirm Rx™ mobile application. An external magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions). The remote monitoring equipment for the Confirm RxTM ICM is the myMerlin™ for Confirm Rx ™ mobile application, installed on a patient's or Abbott-provided mobile device, using built-in cellular or Wi-Fi connectivity. The myMerlin™ for Confirm RxTM mobile application provides the means for the patient to activate EGM recording in the Confirm Rx™ ICM device. with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network (clinician portal).
The Confirm RxTM ICM is encased in parylene-coated titanium that incorporates two subcutaneous electrodes. The header material on the Confirm RxTM ICM is molded thermoplastic polyurethane (TPU). The battery chemistry of the Confirm Rx™ device is lithium carbon monofluoride.
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
The Confirm Rx™ Insertable Cardiac Monitor has not been specifically tested in pediatric patients below the age of 18 years.
The Confirm RxTM ICM has not been specifically tested 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing was conducted on the candidate Confirm Rx™ ICM DM3500 to support a determination of substantial equivalence to the predicate device, including:
- Software/Firmware Verification and System Verification
- Clip Testing
- Design Validation
Completion of all verification and validation activities demonstrated that the device with updated firmware meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K182981). The results of the testing show that the candidate Confirm RxTM ICM performs as intended and is safe for its intended use.
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
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is written in a bold, sans-serif font. The word "FDA" is in a blue box.
April 10, 2019
Abbott (St. Jude Medical) Laura Sparks Sr. Regulatory Affairs Specialist 15900 Valley View Ct. Sylmar, California 91342
Re: K190295
Trade/Device Name: Confirm Rx Insertable Cardiac Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MXC, DSI Dated: February 8, 2019 Received: February 11, 2019
Dear Laura Sparks:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Date Prepared: | February 8, 2019 | |
|---|---|---|
| Submitter: | Abbott (formerly St. Jude Medical), Cardiac Rhythm Management Division | |
| Address: | 15900 Valley View Ct. | |
| Sylmar, CA 91342 | ||
| USA | ||
| Phone: | (818) 362-6822 | |
| Establishment Registration: | 2017865 | |
| Contact Person: | Laura Sparks | |
| Regulatory Affairs Specialist | ||
| (818) 493-2734 | ||
| laura.sparks@abbott.com | Jennifer Dunham | |
| Manager, Regulatory Affairs | ||
| (818) 383-1630 | ||
| jennifer.dunham@abbott.com | ||
| Trade Name/Proprietary | ||
| Name: | Confirm Rx TM Insertable Cardiac Monitor System | |
| Common Name: | Insertable Cardiac Monitor | |
| Model Number: | DM3500 | |
| Classification Name: | Telephone electrocardiograph transmitter and receiver (21 CFR 870.2920) | |
| Product Code: | MXC, DSI | |
| Classification: | Class II | |
| Pediatric Use: | The Confirm Rx TM Insertable Cardiac Monitor has not been specifically | |
| tested in pediatric patients below the age of 18 years. |
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
510(k) K182981 Confirm Rx™ Insertable Cardiac Monitor System
INDICATIONS FOR USE
There are no changes to the Indications for Use as a result of this submission. The Indications for Use for the Confirm RxTM Insertable Cardiac Monitor (ICM) system are as follows:
The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
The Confirm RxTM ICM has not been specifically tested for pediatric use.
3
PRODUCT DESCRIPTION
The device description of the Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 is as follows:
- Confirm Rx™ ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include:
- Patient-initiated triggering of EGM storage using the myMerlin™™ Patient App for o mobile devices. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review.
- Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are o detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals.
- Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with o physician programmable values for AF duration.
- The ability to identify EGM anomalies as a consequence of noise or vigorous activity o and inhibit EGM storage as applicable.
- Remote care monitoring. o
TECHNOLOGICAL CHARACTERISTICS
The Confirm RxTM ICM (DM3500) is 4.95 x 0.95 x 0.33 cm in dimension and uses Bluetooth® wireless telemetry to communicate with external devices, including the Merlin PCS programmer and the myMerlin™ for Confirm Rx™ mobile application. An external magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions). The remote monitoring equipment for the Confirm RxTM ICM is the myMerlin™ for Confirm Rx ™ mobile application, installed on a patient's or Abbott-provided mobile device, using built-in cellular or Wi-Fi connectivity. The myMerlin™ for Confirm RxTM mobile application provides the means for the patient to activate EGM recording in the Confirm Rx™ ICM device. with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network (clinician portal). The Confirm Rx™ ICM (DM3500) will continue to use the same technology. See Figure 1 for a block diagram of the Confirm RxTM ICM system.
4
Image /page/4/Figure/3 description: This image shows a block diagram of an insertable cardiac monitor (ICM) system. The ICM is connected to the heart for sensing and communicates via telemetry to a patient application. The patient application consists of a patient activator and a patient transmitter, and it communicates with a clinician portal via the internet.
Figure 1: Block Diagram of Confirm RxTM ICM System
Only the Confirm Rx™ ICM DM3500 is the subject of this premarket notification. The Merlin PCS 3650 programmer and Merlin.net MN5000 are already FDA approved, with Confirm Rx™ supported on programmer software model 3330 v23.0.1 or higher (per P910023/S382 approved on October 20, 2017) and on Merlin.net v7.5 or higher (per P910023/S381 approved on October 20, 2017). The myMerlin™ for Confirm RxTM mobile applications are FDA cleared per 510(k) K163407 on September 29, 2017 (Android app, APP1000) and K173232 on November 2, 2017 (iOS app. APP1001). The magnet, Model 3111. is Class I exempt MDDS.
The Confirm RxTM ICM (both predicate (K182981) and candidate) is MR Conditional.
The Confirm Rx™ ICM is encased in parylene-coated titanium that incorporates two subcutaneous electrodes. The header material on the Confirm RxTM ICM is molded thermoplastic polyurethane (TPU). The battery chemistry of the Confirm Rx™ device is lithium carbon monofluoride.
The fundamental technological characteristics of the Confirm RxTM ICM are not changing. In comparison to the predicate device, the Confirm Rx™ ICM DM3500 (K182981), the candidate Confirm RxTM ICM DM3500 with modified FW has the same:
- Intended Use and Indications for Use
- Operating rules ●
- Device functionality
- Packaging materials and process
- Shelf life ●
- o Device Longevity
In comparison to the predicate Confirm RxTM ICM device (K182981), the candidate Confirm RxTM ICM DM3500 with modified firmware has the following differences:
5
- The candidate Confirm Rx™ ICM with updated firmware contains changes pertaining to ● its detection algorithms for the diagnosis of bradycardia, asystole (pause), and atrial fibrillation (AF):
- Second pass undersensing discriminators added to the Asystole and Bradycardia o detection algorithms to reject false Pause and Bradycardia detections.
- Second pass P-wave detection discriminator to reject false AF detections. o
- The candidate Confirm Rx™ ICM with updated firmware also contains the following ● changes:
- o Accounted for the current drain and time used to execute the undersensing and Pwave discriminators within the battery longevity calculation.
- Added a check for the presence of non-AF Electrogram Triggers within an AF o Entry Post-Trigger duration.
- Added a check if Atrial Summary Diagnostics were cleared during an ongoing AF o Episode.
- Modified the AF Episode Alert to be triggered 15 seconds after meeting the o defined episode duration threshold.
- Modified firmware to start its first periodic check of FRAM integrity on O launching the Therapy Application.
- Modified firmware to monitor duty cycle values to detect and log occurrences of o duty cycle values that have a higher value and duration than the defined thresholds.
- 0 Modified Bluetooth Low Energy (BLE) driver firmware to add the capability to reset the Real Time (RT) EGM buffer upon buffer overflows.
SUBSTANTIAL EQUIVALENCE
The Confirm Rx™ ICM with updated firmware is substantially equivalent to the predicate Confirm Rx™ ICM DM3500 (K182981). The indications for use are not impacted by the updated firmware. Both the candidate and the predicate device (K182981) have the same function and fundamental scientific technology. The minor differences do not raise new issues of safety and effectiveness. Thus, the candidate Confirm RxTM ICM (DM3500) with FW F9.3.0F is substantially equivalent to the predicate Confirm RxTM ICM (DM3500) (K182981).
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary testing was conducted on the candidate Confirm Rx™ ICM DM3500 to support a determination of substantial equivalence to the predicate device, including:
- o Software/Firmware Verification and System Verification
- Clip Testing ●
- Design Validation 0
Completion of all verification and validation activities demonstrated that the device with updated firmware meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K182981). The results of
6
the testing show that the candidate Confirm RxTM ICM performs as intended and is safe for its intended use.
CONCLUSION
The Confirm RxTM ICM is an implantable cardiovascular monitoring device, for which the candidate device shares its design and mechanism of action, as well as the indications for use, with the identified predicate Confirm RxTM ICM (K182981). The results of the verification and validation tests have demonstrated the candidate Confirm Rx™ ICM DM3500 with updated firmware functions in accordance with product specifications. The fundamental scientific technology of the Confirm Rx™ ICM DM3500 remains unchanged. The candidate Confirm RxTM ICM with updated firmware is substantially equivalent to the predicate Confirm Rx™ ICM (K182981) in terms of technological characteristics, intended use, and performance.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190295
Device Name
The Confirm RxTM Insertable Cardiac Monitor (ICM) System, Model DM3500
Indications for Use (Describe)
The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
The Confirm RxTM ICM has not been specifically tested 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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