(56 days)
Not Found
No
The summary describes a standard implantable cardiac monitor system with data storage and transmission capabilities. There is no mention of AI or ML being used for analysis or interpretation of the data.
No
The device is described as a "diagnostic monitoring device" used for "monitoring and diagnostic evaluation" of patients. It helps physicians "monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias." There is no indication that it provides any therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section states: "The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms..." and "The ICM is intended as a minimally invasive, implantable diagnostic monitoring device... which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias." The "Device Description" also refers to it as an "implantable diagnostic monitoring device."
No
The device description clearly lists multiple hardware components, including an implantable device, implant tools, and a magnet, in addition to the software 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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Confirm Rx™ ICM Function: The Confirm Rx™ ICM is an implantable device that monitors and records electrical activity of the heart within the patient's body (in vivo). It does not analyze specimens taken from the body.
- Device Description: The description clearly states it's an "implantable diagnostic monitoring device" with "subcutaneous electrodes."
- Intended Use: The intended use describes monitoring and evaluating patients based on symptoms and risk factors for cardiac arrhythmias, not analyzing biological samples.
Therefore, the Confirm Rx™ ICM falls under the category of an implantable medical device used for physiological monitoring and diagnosis, not an In Vitro Diagnostic.
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 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 RxTM ICM System consists of the following key features and components:
- Confirm RxTM 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. Specific features include:
- Patient-initiated triggering of EGM storage using the myMerlin™ mobile application. 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, 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 monitoring capabilities.
- Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool are used 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 to the skin during the insertion procedure. The blunt dissection tip of the insertion of the DM3510 insertion tool is inserted just past the skin creating a subcutaneous pocket parallel to the skin (Figure 1, a).
- With the insertion tool advanced as far as it can go, until the flared edge contacts the incision site. The plunger is withdrawn until the plunger stops and the preloaded device drops completely into the insertion channel. The plunger is advanced to insert the device into the subcutaneous pocket (Figure 1, b). The plunger has a feature to stop the introducer when the device is at the proper depth. This completes insertion (implantation) of the ICM, and the incision is closed per standard of care.
- Magnet: The magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
- 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 Bluetooth dongle, an MDDS component, communicates with the Confirm Rx™ device with Bluetooth telemetry (also referred to as Bluetooth Low Energy or Bluetooth LE). Programmer software Model 3330 v23.0.1 and later contains support for the Confirm Rx™ device and the Bluetooth dongle as well as tabs within the user interface for Implant View and Reason for Monitoring features.
- Implant View is designed to streamline programming at the time of implant. Upon 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 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™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)): The mobile application 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 may be provided with an Abbott-issued off the shelf Android mobile device, which is not a part of the medical device.
- Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net system allows physicians to remotely monitor and diagnose patients' cardiac events. The Merlin.net MN5000 v7.5 software and later contains support for the Confirm Rx™ device.
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.
Intended User / Care Setting
Physician, Clinician, Patient
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 device and system verification testing conducted on the candidate Confirm Rx™ ICM DM3500 supports a determination of substantial equivalence to the predicate device.
Completion of all verification activities demonstrated the device with updated MR Conditional labeling meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K193310). The results of the testing show that the candidate Confirm RxTM ICM performs as intended and is safe for its intended use.
The Confirm Rx™ ICM (both predicate (K193310) and candidate) is MR Conditional for scans in a 1.5T MRI environment. The testing performed supports additional 3T MR Conditional labeling.
The performed 3T testing meets the same clinical acceptance criteria that was previously evaluated for predicate 1.5T MR Conditional labeling demonstration of safety.
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 23, 2020
Abbott (St. Jude Medical) Laura Sparks Sr. Regulatory Affairs Specialist 15900 Valley View Ct. Sylmar, California 91342
Re: K202888
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: September 25, 2020 Received: September 28, 2020
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,
Jennifer Shih 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 System
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 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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K202888 510(k) SUMMARY
| Date Prepared: | September 25, 2020 | |
|---|---|---|
| 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 | |
| Sr. Manager, Regulatory Affairs | ||
| (818) 383-1630 | ||
| jennifer.dunham@abbott.com | ||
| Trade Name/Proprietary | Confirm Rx™ Insertable Cardiac Monitor | |
| Common Name: | Insertable Cardiac Monitor | |
| Model Number: | DM3500 | |
| Classification Name: | 21 CFR 870.2800, Medical magnetic tape recorder | |
| Product Code: | MXC, DSI | |
| Classification: | Class II | |
| Pediatric Use: | The Confirm Rx™ Insertable Cardiac Monitor has not been specifically | |
| tested in pediatric patients |
LEGALLY MARKETED DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
510(k) K193310 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 Rx™ ICM has not been specifically tested for pediatric use.
CONFIDENTIAL
4
PRODUCT DESCRIPTION
The Confirm RxTM ICM System consists of the following key features and components:
- Confirm RxTM 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. Specific features include:
- Patient-initiated triggering of EGM storage using the myMerlin™ mobile application. O 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, 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 monitoring capabilities O
- Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool are used ■ 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 to the skin during the insertion O procedure. The blunt dissection tip of the insertion of the DM3510 insertion tool is inserted just past the skin creating a subcutaneous pocket parallel to the skin (Figure 1, a).
- With the insertion tool advanced as far as it can go, until the flared edge contacts the o incision site. The plunger is withdrawn until the plunger stops and the preloaded device drops completely into the insertion channel. The plunger is advanced to insert the device into the subcutaneous pocket (Figure 1, b). The plunger has a feature to stop the introducer when the device is at the proper depth. This completes insertion (implantation) of the ICM, and the incision is closed per standard of care.
5
Image /page/5/Figure/3 description: The image shows two diagrams labeled (a) and (b). Diagram (a) shows a hand holding a device and inserting it into the skin. Diagram (b) shows a hand holding the same device and pulling it out of the skin, as indicated by an arrow.
Figure 1: Insertion Process
- Magnet: The magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
- 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 Bluetooth dongle, an MDDS component, communicates with the Confirm Rx™ device with Bluetooth telemetry (also referred to as Bluetooth Low Energy or Bluetooth LE). Programmer software Model 3330 v23.0.1 and later contains support for the Confirm Rx™ device and the Bluetooth dongle as well as tabs within the user interface for 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™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)): The ■ mobile application 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 may be provided with an Abbott-issued off the shelf Android mobile device, which is not a part of the medical device.
- Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net system allows physicians to remotely monitor and diagnose patients' cardiac events. The Merlin.net MN5000 v7.5 software and later contains support for the Confirm Rx™ device.
6
Image /page/6/Figure/3 description: The image shows a diagram of an insertable cardiac monitor system. The diagram includes components such as a clinician, programmer, external magnet, ICM (Insertable Cardiac Monitor), heart, patient application, clinician portal, and patient. 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
TECHNOLOGICAL CHARACTERISTICS
The Confirm Rx™ ICM (DM3500) is 49 x 9.4 x 3.1 mm in dimension and uses Bluetooth® wireless telemetry to communicate with external devices, including the Merlin PCS programmer and the myMerlin™ 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 Rx™ ICM is the myMerlin™ mobile application, installed on a patient's or Abbott-provided mobile device, using built-in cellular or Wi-Fi connectivity. The myMerlin™ mobile application provides the means for the patient to activate EGM recording in the Confirm RxTM 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 (DM3500) will continue to use the same technology. See Figure 2 for a block diagram of the Confirm RxTM ICM system.
The subject of this premarket notification is the Confirm Rx™ ICM DM3500 with updated MR Conditional labeling. There are no changes to the predicate (K193310) Confirm RxTM Insertable Cardiac Monitor DM3500, the incision tool DM3520 or insertion tool DM3510, or the myMerlin™ mobile applications within the scope of this premarket notification. The Merlin PCS 3650 programmer and Merlin.net MN5000 are already FDA approved, with Confirm RxTM 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 magnet is Class I exempt MDDS.
The Confirm Rx™ ICM (both predicate (K193310) and candidate) is MR Conditional for scans in a 1.5T MRI environment. The testing performed supports additional 3T MR Conditional labeling.
7
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 technology of the Confirm Rx™ ICM are not changing. In comparison to the predicate device, the Confirm Rx™ ICM DM3500 (510(k) K193310), the candidate Confirm Rx™ ICM DM3500 with added 3T MR Conditional labeling has the same:
- Intended Use and Indications for Use
- Operating rules 0
- o Device functionality
- Packaging materials and process ●
- Shelf life
- Software
- Device Longevity
In comparison to the predicate Confirm RxTM ICM device (K193310), the candidate Confirm Rx™ ICM DM3500 with 3T MR Conditional labeling has the following differences:
- The candidate Confirm Rx™ ICM with updated MR Conditional labeling allows for ● MRI scans in a 3T scanning environment.
SUBSTANTIAL EQUIVALENCE
The Confirm Rx™ ICM with updated MR Conditional labeling is substantially equivalent to the predicate Confirm Rx™ ICM DM3500 (K193310). The indications for use are not impacted by the updated MR Conditional labeling for use in a 3T MRI scanning environment. Both the candidate and the predicate device (K193310) have the same function and fundamental technology. The updated labeling does not raise new issues of safety and effectiveness. The performed 3T testing meets the same clinical acceptance criteria that was previously evaluated for predicate 1.5T MR Conditional labeling demonstration of safety. Thus, the candidate Confirm Rx™ ICM (DM3500) with the addition of 3T MR Conditional labeling is substantially equivalent to the predicate Confirm RxTM ICM (DM3500) (K193310).
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary device and system verification testing conducted on the candidate Confirm Rx™ ICM DM3500 supports a determination of substantial equivalence to the predicate device.
Completion of all verification activities demonstrated the device with updated MR Conditional labeling meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K193310). The results of
8
the testing show that the candidate Confirm RxTM ICM performs as intended and is safe for its intended use.
CONCLUSION
The Confirm Rx™ 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 Rx™ ICM (K193310). The results of the MRI verification testing have demonstrated the candidate Confirm Rx™ ICM DM3500 with updated MR Conditional labeling functions in accordance with product specifications. The fundamental technology of the Confirm Rx™ ICM DM3500 remains unchanged. The candidate Confirm RxTM ICM with the addition of 3T MR Conditional labeling is substantially equivalent to the predicate Confirm Rx™ ICM (K193310) in terms of technology, intended use, and performance.