(29 days)
P910023/S381
No
The document describes a mobile application for initiating recordings and transmitting data from an insertable cardiac monitor. There is no mention of AI or ML being used for analysis or interpretation of the data within the application or the device itself. The performance studies focus on risk analysis and verification/validation against a predicate device, not on the performance of an AI/ML algorithm.
No
The device is indicated for monitoring and diagnostic evaluation of symptoms and cardiac arrhythmias, and for remote monitoring. It does not provide any therapeutic intervention.
Yes
The device is indicated for the "monitoring and diagnostic evaluation of patients who experience unexplained symptoms" and for patients "who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation," which are diagnostic purposes. The device description also states it is used to "initiate recording of the heart's electrical activity," "read the information about the heart's activity," and "send this information to a clinician for remote monitoring," all of which contribute to a diagnostic evaluation.
Yes
The device description explicitly states that the myMerlin™ mobile application Model APP1001 is an "application" for patients and is installed on a patient's "mobile device". It functions to initiate recording, read information, and send data from the separate Confirm Rx™ ICM hardware device. The 510(k) summary focuses on the software application itself and its compatibility with a mobile operating system, not the hardware ICM. The predicate device is also a mobile application.
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. They are used outside of the body.
- Device Function: The Confirm Rx™ ICM and the myMerlin™ mobile application are used to monitor and record the electrical activity of the heart within the patient's body. The mobile application facilitates the initiation of recording and the transmission of this data.
- Lack of Sample Analysis: There is no mention of analyzing samples taken from the patient's body. The device directly interacts with the patient's internal physiological signals.
Therefore, the Confirm Rx™ ICM and its associated myMerlin™ mobile application fall under the category of implantable medical devices used for monitoring and diagnosis, not in vitro diagnostics.
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 arthythmias. 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.
Product codes
MXC, DSI
Device Description
The myMerlin™ mobile application Model APP1001 is an application for patients who are implanted with the Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 (K163407). The mobile application is used by patients to initiate recording of the heart's electrical activity by the Confirm Rx™ ICM device, read the information about the heart's activity from the Confirm Rx™ ICM device, and send this information to a clinician for remote monitoring. The myMerlin™ mobile application Model APP1001 is to be installed on a patient's mobile device with the iOS operating system which meets the specified minimum criteria for compatibility with the myMerlin™ mobile application.
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.
The Confirm Rx™ ICM has not been specifically tested in pediatric patients below the age of 18 years.
Intended User / Care Setting
Patients, clinician for remote monitoring
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)
The risk analysis method used to assess the impact of the modification of the myMerlin™ mobile application Model APP1001 documents the investigation of hazards and mitigation of risks associated with its use 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 candidate device meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate device (Model APP1000, K163407).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
P910023/S381
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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November 2, 2017
St. Jude Medical Jennifer Dunham Sr. Regulatory Affairs Specialist 15900 Valley View Ct. Sylmar, California 91342
Re: K173232
Trade/Device Name: myMerlin™ Mobile Application, Model APP1001 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MXC, DSI Dated: October 3, 2017 Received: October 4, 2017
Dear Jennifer Dunham:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Wilhelm
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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Indications for Use
510(k) Number (if known) K173232
Device Name
myMerlin™ Mobile Application, Model APP1001
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 arthythmias. 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.
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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510(k) SUMMARY
| Date Prepared: | October 3, 2017 |
|---|---|
| Submitter: | |
| Address: | St. Jude Medical, Cardiac Rhythm Management Division |
| 15900 Valley View Ct. | |
| Sylmar, CA 91342 | |
| USA | |
| Phone: | (818) 362-6822 |
| Contact Person: | Jennifer Dunham |
| Sr. Regulatory Affairs Specialist | |
| (818) 493-2363 | |
| jdunham02@sjm.com |
Colleen Canan
Sr. Regulatory Affairs Manager
(818) 493 2960
ccanan@sjm.com |
| Trade Name/Proprietary
Name: | myMerlin™ Mobile Application, Model APP1001 |
| Model Number: | APP1001 |
| Classification Name: | Medical magnetic tape recorder (21 CFR 870.2800) |
| Product Code: | MXC, DSI |
| Classification: | Class II |
| Pediatric Use: | The Confirm Rx™ 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) K163407: myMerlin™M Mobile Application Model APP1000
INDICATIONS FOR USE
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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510(k) SUMMARY
PRODUCT DESCRIPTION
The device description of the myMerlin™ mobile application Model APP1001 is as follows:
The myMerlin™ mobile application Model APP1001 is an application for patients who are implanted with the Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 (K163407). The mobile application is used by patients to initiate recording of the heart's electrical activity by the Confirm Rx™ ICM device, read the information about the heart's activity from the Confirm Rx™ ICM device, and send this information to a clinician for remote monitoring. The myMerlin™ mobile application Model APP1001 is to be installed on a patient's mobile device with the iOS operating system which meets the specified minimum criteria for compatibility with the myMerlin™ mobile application.
The myMerlin™ mobile application Model APP1001 is the subject of this premarket notification. The Confirm Rx™ ICM Model DM3500 and the myMerlin™ mobile application Model APP1000 (Android) were cleared on September 29, 2017 per 510(k) K163407.
Remote monitoring is performed via the Merlin.net Model MN5000 clinician portal software, for which an approvable letter pending 510(k) K163407 clearance was received on May 2, 2017 for PMA Supplement P910023/S381 (bundled). No additional changes to Merlin.net Model MN5000 are required due to the inclusion of the myMerlin mobile application Model APP1001.
TECHNOLOGICAL CHARACTERISTICS
The fundamental technological characteristics of the myMerlin™ mobile application Model APP1001 are the same as the predicate myMerlin™ mobile application Model APP1000 (K163407). Model APP1001 runs on the iOS operating system, while Model APP1000 (K163407) runs on the Android operating system. The myMerlin™ mobile application, both candidate Model APP1001 and predicate Model APP1000 (K163407), is software that is installed on a patient's mobile device, which uses built-in Bluetooth telemetry for communication with the Confirm Rx™ ICM DM3500 (K163407) and built-in cellular and Wi-Fi connectivity for transmission of data to the Merlin.net Model MN5000 clinician portal (reference PMA P910023/S381, bundled) for remote monitoring.
NON-CLINICAL TEST SUMMARY
The risk analysis method used to assess the impact of the modification of the myMerlin™ mobile application Model APP1001 documents the investigation of hazards and mitigation of risks associated with its use 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 candidate device meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate device (Model APP1000, K163407).
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510(k) SUMMARY
CONCLUSION (SUBSTANTIAL EQUIVALENCE )
The results of the verification and validation tests and the risk analysis have demonstrated the myMerlin™ mobile application Model APP1001 functions in accordance with product specifications. The myMerlin™ mobile application (candidate Model APP1001; predicate Model APP1000, K163407) is used in conjunction with the Confirm Rx™M Insertable Cardiac Monitor (ICM) System, Model DM3500 (K163407); therefore, the same indications that are listed in the Confirm RxTM ICM instructions for use apply. The indications for use are not impacted by the inclusion of the myMerlin™ mobile application Model APP1001. The fundamental scientific technology of the predicate myMerlin™M mobile application (APP1000, K163704) is the same as for the candidate myMerlin mobile application Model APP1001. Thus, the myMerlin™ mobile application Model APP1001 to be substantially equivalent to the predicate myMerlin™ mobile application (APP1000, K163407, cleared on September 29, 2017)