(196 days)
No
The summary describes a cardiovascular monitoring device that records and plays back physiological signals. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies summary. The focus is on recording and playback, and demonstrating substantial equivalence to predicate devices through standard software and clinical testing.
No
The device is described as a cardiovascular monitoring device used to record and play back physiological signals, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the monitoring and diagnostic evaluation of patients."
No
The device description explicitly states it is a "cardiovascular monitoring device used to record and play back physiological signals," which implies hardware for signal acquisition and recording. The summary also mentions "Software Verification and System Validation" and "Clinical Study," which are typical for hardware-inclusive medical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The description of the SJM Confirm ICM clearly states it is a "cardiovascular monitoring device used to record and play back physiological signals." This indicates it is monitoring signals within the patient's body, not analyzing specimens outside the body.
- The intended use describes monitoring and evaluating patients based on symptoms and risk factors, and recording physiological signals. This aligns with an in vivo (within the body) monitoring device.
Therefore, the SJM Confirm ICM is a cardiovascular monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The SJM Confirm " 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 other cardiac arrhythmias.
The SJM Confirm ICM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Product codes
MXC
Device Description
The SJM Confirm ICM is a cardiovascular monitoring device used to record and play back. physiological signals.
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
Not Found
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 nonclinical and clinical testing was conducted on the SJM Confirm ICM to support a determination of substantial equivalence to the predicate devices, including:
- . Software Verification and System Validation
- . Clinical Study
There are no changes to the hardware, firmware, materials, manufacturing processes, sterilization, shelf life, or packaging of the SJM Confirm (DM2102) ICM as compared to the cleared SJM Confirm (DM2100) ICM included in this submission. Therefore, biocompatibility, sterilization, shelf life, packaging, electromagnetic compatibility (EMC), electrical safety, mechanical performance, firmware, component, and usability testing was not repeated since clearance of K122161, K122090, and K081365.
Software testing, system validation testing, and clinical performance testing were performed to demonstrate the SJM Confirm ICM meets the required performance criteria to support a determination of substantial equivalence to the predicate devices.
The results of testing show that the SJM Confirm ICM performs as intended and is safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K122161, K122090, K082475, K081365
Reference Device(s)
Not Found
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).
0
ST. JUDE MEDICAL, INC.
SJM Confirm (DM2102) ICM 5 10(k) Premarket Notification
SECTION 5 510(k) SUMMARY (CONT.)
510(k) Notification K
GENERAL INFORMATION
Applicant:
St. Jude Medical, Inc. 645 Almanor Avenue Sunnyvale, CA 94085 USA Phone: (408) 738-4883 Fax: (408) 735-8750
Contact Person:
Michael McSweeney Regulatory Affairs St. Jude Medical, Inc. 645 Almanor Avenue Sunnyvale, CA 94085 USA Phone: (408) 522-6112 Fax: (818) 256-8795 Email: mmcsweeney(@sjm.com
Date Prepared: November 13, 2013
DEVICE INFORMATION
Trade Name: SJM Confirm™ Implantable Cardiac Monitor (ICM), Model DM2102
Generic/Common Name:
Cardiovascular Monitoring Device
Classification:
21 CFR §870.2800, Medical magnetic tape recorder, Class II 21 CFR §870.2920. Telephone electrocardiograph transmitter and receiver. Class II
Product Code: MXC
1
K133481 page 2 of 3
ST. JUDE MEDICAL, INC.
SECTION 5 510(k) SUMMARY (CONT.)
PREDICATE DEVICE(S)
- St. Jude Medical, Inc. SJM Confirm (DM2100) ICM (K122161) .
- St. Jude Medical, Inc. SJM Confirm (DM2100) ICM (K122090) .
- Medtronic, Inc. Reveal XT Insertable Cardiac Monitor (K082475) .
- St. Jude Medical, Inc. SJM Confirm (DM2100) ICM (K081365) .
INDICATIONS FOR USE
The SJM Confirm " 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 other cardiac arrhythmias.
The SJM Confirm ICM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
PRODUCT DESCRIPTION
The SJM Confirm ICM is a cardiovascular monitoring device used to record and play back. physiological signals.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the SJM Confirm ICM are similar to the predicate devices. Performance data were provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The SJM Confirm ICM is substantially equivalent to the SJM Confirm (DM2100) ICM (K122161), the SJM Confirm (DM2100) ICM (K122090), the Medtronic, Inc. Reveal XT Insertable Cardiac Monitor (K082475), and the SJM Confirm (DM2100) ICM (K081365). The subject and the predicate devices are cardiovascular monitoring devices used to record and play back physiological signals. The indications for use for the SJM Confirm ICM are substantially equivalent to the indications for use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the SM Confirm ICM is substantially equivalent to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary nonclinical and clinical testing was conducted on the SJM Confirm ICM to support a determination of substantial equivalence to the predicate devices, including:
- . Software Verification and System Validation
- . Clinical Study
There are no changes to the hardware, firmware, materials, manufacturing processes, sterilization, shelf life, or packaging of the SJM Confirm (DM2102) ICM as compared to the cleared SJM Confirm (DM2100) ICM included in this submission. Therefore, biocompatibility, sterilization, shelf life, packaging, electromagnetic compatibility (EMC), electrical safety, mechanical performance, firmware, component, and usability testing was not repeated since clearance of K122161, K122090, and K081365.
2
SECTION 5 510(k) SUMMARY (CONT.)
Software testing, system validation testing, and clinical performance testing were performed to demonstrate the SJM Confirm ICM meets the required performance criteria to support a determination of substantial equivalence to the predicate devices.
The results of testing show that the SJM Confirm ICM performs as intended and is safe for its intended use.
CONCLUSION
The SJM Confirm ICM is an implantable cardiovascular monitoring device and shares its design and mechanism of action with the identified predicate devices. The results of nonclinical and clinical testing demonstrate that the SJM Confirm ICM functions to its specifications, performs as intended, and exhibits the appropriate characteristics of an implantable cardiovascular monitoring device. The SJM Confirm ICM is substantially equivalent to the predicate devices in terms of technological characteristics, intended use, and performance. No new issues of safety or effectiveness are raised by the SJM Confirm ICM.
SUMMARY
The SJM Confirm ICM is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66 G609 Silver Spring, MD 20993-0002
Image /page/3/Picture/3 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The logo is printed in black and white.
May 28, 2014
St. Jude Medical, Inc. Michael Mc Sweeney 645 Almanor Avenue Sunnyvale, CA 94085 US
Re: K133481
Trade/Device Name: SJM Confirm Implantable Cardiac Monitor (ICM, Model DM2102) Regulation Number: 21 CFR 870.2800 Regulation Name: Implantable Cardiac Monitor Regulatory Class: Class II Product Code: MXC Dated: May 5, 2014 Received: May 2, 2014
Dear Michael Mc Sweeney,
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, 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 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
4
Page 2 - Mr. Mc Sweeney
(QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfory/ou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
FDA
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K133481
ST. JUDE MEDICAL, INC.
SJM CONFIRM (DM2102) ICM 5 10(k) PREMARKET NOTIFICATION
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K133481
Device Name: SJM Confirm Implantable Cardiac Monitor (ICM). Model DM2102
Indications For Use:
The SJM Confirm " 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 other cardiac arrhythmias.
The SJM Confirm ICM, Model DM2102. is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Prescription Use _ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE: CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Date:
2014.05.28
17:42:42-04'00'