(28 days)
Not Found
No
The document describes "sensing and detection algorithms" and "Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected," but does not explicitly mention or provide details about the use of AI or ML. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
No
The device is described as a "diagnostic monitoring device" used to identify and document cardiac arrhythmias, rather than providing treatment. Its purpose is to monitor and diagnose, not to treat.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "monitoring and diagnostic evaluation of patients." The "Device Description" also refers to it as an "implantable diagnostic monitoring device."
No
The device description explicitly states it is an "Implantable Device" and includes "subcutaneous electrodes," indicating it is a hardware device with software components, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Confirm Rx™ ICM is an implantable device that monitors electrical activity of the heart (EGM - electrogram). It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring and diagnostic evaluation of patients experiencing symptoms related to cardiac arrhythmias and those at risk for or diagnosed with atrial fibrillation. This is done by recording and storing the heart's electrical signals in vivo.
Therefore, the Confirm Rx™ ICM is an implantable cardiac monitor, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Confirm RxTM 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 atial fibrillation or who are susceptible to developing atrial fibrillation.
The Confirm Rx ICM has not been specifically tested for pediatric use.
Product codes (comma separated list FDA assigned to the subject device)
DSI, MXC
Device Description
The Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability. It helps physicians monitor, diagnose, and document patients 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, including capability for the patient to identify symptoms which are stored with the EGM.
- Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected, with physician-programmable values.
- Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration.
- Ability to identify EGM anomalies due to noise or vigorous activity and inhibit EGM storage.
- Remote care monitoring.
The system also includes:
- Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously.
- Model 3111 Magnet facilitates faster startup of Bluetooth connection and provides user authentication.
- Clinician Programmer (Merlin PCS Programmer Model 3650) operates using Merlin PCS Model 3330 software, allowing physicians to program device parameters and retrieve diagnostic information.
- myMerlin™ Patient App (Model APP1000 Android) provides the means for the patient to activate EGM recording, with data pass-through to the Merlin.net Patient Care Network.
- Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator) allows physicians to remotely monitor and diagnose patients' cardiac events.
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 ICM has not been specifically tested for pediatric use. Explicitly: The Confirm Rx TM ICM has not been specifically tested in pediatric patients below the age of 18 years.
Intended User / Care Setting
Physicians / Remote care monitoring, clinic
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)
Non-clinical testing was performed. A Failure Mode and Effects Analysis (FMEA/FMECA) was used to assess the impact of minor design changes in the moisture getter's location and contact area with internal device components. It was determined that the overall risk is acceptable. Completion of all verification and validation activities demonstrated that the device with the peel and stick moisture getter material meets its predetermined design and performance specifications and that the product is substantially equivalent to the current device (Model DM3500, K190295).
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.
Not Found
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2019
Abbott Laura Sparks Senior Regulatory Affairs Specialist 15900 Valley View Ct. Sylmar, California 91342
Re: K192593
Trade/Device Name: Confirm Rx 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: DSI, MXC Dated: September 19, 2019 Received: September 20, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
for Nicole Goodsell 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Confirm RxTM Insertable Cardiac Monitor (ICM) (DM3500)
Indications for Use (Describe)
The Confirm RxIM 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 atial fibrillation or who are susceptible to developing atrial fibrillation.
The Confirm Rx 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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| Date Prepared: | September 18, 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 |
| Senior Regulatory Affairs Specialist | |
| (818) 493-2734 | |
| laura.sparks@abbott.com | |
| Jennifer Dunham | |
| Manager, Regulatory Affairs | |
| (818) 493-2363 | |
| jennifer.dunham@abbott.com | |
| Trade Name/Proprietary | |
| Name: | Confirm Rx TM ICM |
| 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 ICM 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) K190295: Confirm Rx™ Insertable Cardiac Monitor (ICM) System
INDICATIONS FOR USE
The are no changes to the Indications for Use as a result of this submission. The Indications for Use for the Confirm Rx™ 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 Rx ICM has not been specifically tested for pediatric use.
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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
- 트 Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously. The implantable device is pre-loaded into the insertion tool and packaged together with the incision tool.
- The DM3520 incision tool is used to make an angled cut, which is the sole incision O required to implant the ICM. The introducer end of the DM3510 insertion tool is inserted, creating the initial pocket (Figure 1).
- o With the insertion tool in place, the plunger is withdrawn to drop the pre-loaded device into the insertion channel. The plunger is pushed forward to insert the device into the pocket (Figure 1). This completes insertion (implantation) of the ICM, and the incision is closed per standard of care.
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Image /page/5/Figure/3 description: The image shows two diagrams labeled (a) and (b). Both diagrams depict a hand holding a surgical instrument, possibly a scalpel, and making an incision on a surface. Diagram (b) includes an arrow indicating the direction of movement of the instrument.
Figure 1: Insertion Process
- 트 Model 3111 Magnet (existing SJM donut magnet) facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
- 트 Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information. The Merlin PCS programmer, using the Model BLU1000 Bluetooth dongle, an off the shelf component, communicates with the Confirm RxTM device with Bluetooth telemetry (also referred to as Bluetooth Low Energy or BLE). Programmer software Model 3330 v23.0.1 and later will contain support for the Confirm Rx™ device, adding support for the Model BLU1000 Bluetooth dongle, and new tabs of Implant View and Reason for Monitoring features.
- Implant View is designed to streamline programming at the time of implant. Upon O initial interrogation at implant, the programmer automatically displays the Implant View in which the user can immediately input device and patient information to be stored onto the device, as well as set the Reason for Monitoring.
- Reason for Monitoring allows the user to select from a list of possible conditions for o which the patient is receiving the device (such as Syncope, Ventricular Tachycardia, Palpations, etc). The programmer then sets the AF duration parameter and EGM storage priority based on the reason selected. These parameters can be manually adjusted by the user later, if customization is preferred.
- myMerlin™ Patient App (Model APP1000 Android): The Patient App provides the ■ means for the patient to activate EGM recording in the Confirm Rx™ device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network. Patients who do not supply their own mobile device will be provided a Model MTX1000 mobile device. The MTX1000 is an off-the-shelf unit, a Samsung J3, and is not part of the medical device.
- 트 Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events. The Merlin.net MN5000 v7.5 contains updates that are specific to Confirm RxTM.
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TECHNOLOGICAL CHARACTERISTICS
The Confirm Rx™ 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™ mobile application. The remote monitoring equipment for the Confirm RxTM ICM is the myMerlin™ mobile application, installed on a patient's or Abbott-provided mobile device, using built-in cellular and Wi-Fi connectivity. The Confirm Rx™ ICM (DM3500) will continue to use the same technology.
Image /page/6/Figure/5 description: The image shows a block diagram of a cardiac monitoring system. The diagram includes components such as a clinician, programmer, external magnet, ICM insertable cardiac monitor, heart, patient application, clinician portal, patient activator, and patient transmitter. The diagram illustrates the flow of information and interactions between these components, including telemetry communications, sensing, and internet connectivity.
Figure 2: 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 Rx™ 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 RxIM ICM (both predicate (K190295) 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 Rx™ ICM are not changing. In comparison to the predicate device, the current Confirm Rx™ ICM DM3500 (cleared on April
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10, 2019 per 510(k) K190295), the candidate Confirm Rx™ ICM DM3500 with peel and stick moisture getter has the same:
- Intended Use and Indications for Use
- Operating rules
- Device functionality
- Packaging materials and process ●
- o Shelf life
- o Device Longevity
In comparison to the predicate device, the current Confirm Rx™ ICM DM3500 (cleared on April 10, 2019 per 510(k) K190295), the candidate Confirm RxTM ICM DM3500 with peel and stick moisture getter has the following differences:
- The candidate Confirm Rx™ ICM with peel and stick moisture getter contains minor ● design changes in the moisture getter's location and area of contact with internal device components:
- o Moisture getter is located on the hybrid
- Adhesive backing is in contact with the hybrid O
NON-CLINICAL TEST SUMMARY
The risk analysis method used to assess the impact of the peel and stick moisture getter documents the investigation of hazards and mitigation of associated risks and reports the result of the investigation. The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA/FMECA). It was determined that the overall risk is acceptable. Completion of all verification and validation activities demonstrated that the device with the peel and stick moisture getter material meets its predetermined design and performance specifications and that the product is substantially equivalent to the current device (Model DM3500, K190295).
CONCLUSION (SUBSTANTIAL EQUIVALENCE)
The results of the verification and validation tests and the risk analysis have demonstrated the Confirm Rx™ ICM DM3500 with peel and stick moisture getter functions in accordance with product specifications. The candidate Confirm Rx™ ICM DM3500 is substantially equivalent in terms of safety and technological characteristics to the identified predicate device. Product verification and validation testing demonstrate that the Confirm Rx™ ICM is as safe and as effective and performs as well as the predicate device. The indications for use are not impacted by the peel and stick moisture getter. The fundamental scientific technology of the Confirm RxTM ICM DM3500 remains unchanged. Thus, the candidate Confirm RxTM ICM DM3500 with peel and stick moisture getter is deemed to be substantially equivalent to the predicate Confirm Rx™ ICM DM3500 cleared on April 10, 2019 per 510(k) K190295.