(122 days)
No
The summary describes a standard implantable cardiac monitor with looping memory for EGM storage and communication via a programmer. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is described as a "diagnostic monitoring device" used for "monitoring and diagnostic evaluation" and for sensing and storing electrograms, which are diagnostic functions, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states "indicated for monitoring and diagnostic evaluation," and the "Device Description" section refers to it as an "implantable diagnostic monitoring device."
No
The device description explicitly states it is an "implantable diagnostic monitoring device with subcutaneous electrodes" and includes hardware components like the implantable cardiac monitor and external patient activator.
Based on the provided text, the SJM Confirm® Implantable Cardiac Monitor 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 SJM Confirm® is an implantable device that monitors electrical activity of the heart in vivo (within the body) using subcutaneous electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring and diagnostic evaluation of patients based on symptoms and detecting cardiac arrhythmias within the patient's body.
Therefore, the SJM Confirm® Implantable Cardiac Monitor falls under the category of an implantable medical device for monitoring and diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.
Product codes (comma separated list FDA assigned to the subject device)
MXC, DXH and DSH
Device Description
The SJM Confirm® Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).
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)
In order to ensure that the SJM Confirm® ICM model DM2100, with alternate collector cell battery, meets the product and system specification tests were performed. Device testing (documented in 60041954, Attachment 3) and component level testing (documented in QTR40008803, Attachment 4), confirms that alternate collector cell battery has no effects on the device performance.
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).
0
PREMARKET NOTIFICATION [510(K)] SUMMARY
| Date Prepared: | July 10, 2012 |
|---|---|
| Submitter: | St. Jude Medical, CRMD |
| Address: | 15900 Valley View Court |
| Sylmar, CA 9134 | |
| Phone: | 818 493 3134 |
| Fax: | 818 493 3615 |
| Contact Person: | Plessy Paul |
| Trade Name/Proprietary | |
| Name: | SJM Confirm® Implantable Cardiac Monitor |
| Common Name: | Implantable Cardiac Monitor |
| Model Numbers: DM2100 | |
| Classification: | Class II, 21 CFR 870.2800 |
| Legally marketed device | |
| to which your firm is | |
| claiming equivalence: | SJM Confirm® Implantable Cardiac Monitor System |
Device Description:
The SJM Confirm® Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).
The indication for use is as follows:
The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.
Technological Characteristics of the Device Compared to the Predicate Device:
The SJM Confirm® ICM with the alternate collector cell battery has the same fundamental technological characteristics as the currently marketed SJM Confirm® ICM model DM2100, including same intended use, technology, design, material composition and energy source. The new implantable grade, collector design, Li-Thionyl Chloride Battery (LTC-3PN-S35) will be used as an alternate battery to our existing spike design LTC-3PN-S33. Both
NOV 1 5 2012
1
collector design and spike design are manufactured by EaglePicher. No modifications are being made to the external patient activator component or the associated programmer software.
Summary of Testing:
In order to ensure that the SJM Confirm® ICM model DM2100, with alternate collector cell battery, meets the product and system specification tests were performed. Device testing (documented in 60041954, Attachment 3) and component level testing (documented in QTR40008803, Attachment 4), confirms that alternate collector cell battery has no effects on the device performance.
Biocompatibility:
There is no change to the blood/tissue contact materials of the SJM Confirm® ICM device with alternate collector cell battery as compared to legally marketed St. Jude Medical Confirm® ICM Model DM2100 (K081365). Therefore, no biocompatibility testing was conducted.
Sterilization:
The SJM Confirm® ICM with alternate collector cell battery is sterilized using the same validated 100% Ethylene Oxide (EtO) sterilization process as legally marketed St. Jude Medical Confirm device, DM2100 (K081365).
Conclusion:
St. Jude Medical considers the SJM Confirm® ICM model DM2100, with alternate collector cell battery to be substantially equivalent to the legally marketed predicate and referenced device through the data and information presented.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV 15 2012
St. Jude Medical, CRMD c/o Ms. Plessy Paul Regulatory Affairs Specialist 15900 Valley View Court Sylmar, CA 91324
Re: K122090
Trade/Device Names: SJM Confirm® Implantable Cardiac Monitor, Model DM2100 Regulatory Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (Two) Product Code: MXC, DXH and DSH Dated: November 1, 2012 Received: November 5, 2012
Dear Ms. Paul:
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.
3
Page 2 - Ms. Plessy Paul
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Owe
201
-05'
Owen P. Faris -S 2012.11.15 15:51:53 -05.00.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K122090
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: SJM Confirm® ICM Model DM2100
Indications for Use:
The SJM Confirm® Implantable Cardiac Monitor is indicated for monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest cannot syncope, shortness of breath, and patients who are at risk for other cardiac arrhythmias.
Prescription Use X (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices
510(k) Numbe