(92 days)
P910023/S65, P910023/S69, P880086/S61
No
The document does not mention AI, ML, or related terms, and the description focuses on standard cardiac monitoring technology.
No.
The device is described as a "diagnostic monitoring device" that records ECG and stores electrograms, which are used for diagnosis rather than treatment.
Yes
The "Device Description" explicitly states, "The SJM Confirm Implantable Cardiac Monitor is a minimally invasive, 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 information, the SJM Confirm™ ICM is not an IVD (In Vitro Diagnostic) device.
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 to examine these samples outside of the body.
- SJM Confirm™ ICM Function: The SJM Confirm™ ICM is an implantable device that records subcutaneous ECG. This means it is placed inside the patient's body and measures electrical activity of the heart directly from under the skin. It does not analyze samples taken from the body.
The device is a diagnostic tool, but it operates in vivo (within the living body) rather than in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The SJM Confirm ICM is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
- patients with clinical syndromes or situations at increased risk of cardiac arrhythmias.
- patients who experience transient symptoms that may suggest a cardiac arrhythmia.
Product codes
MXC, DSH, DXH
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 Version 6.8.1 (or higher)).
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)
Verification and validation activities necessary to ensure that the SJM Confirm ICM product and system requirements were fulfilled, and to ensure that the product design conforms to the user needs and intended uses were identified and successfully performed. Product verification was successfully performed and is documented in the following reports:
- QTR2288: Confirm ICM Mechanical Test Report
- QTR2280: Confirm ICM Electrical Test Report
- QTR2286: Confirm ICM EMC Test Report
- QTR2267: Patient Activator Test Report
- Firmware SVRs
- QRS Detection Accuracy and AF Detection Algorithm Report
- System Validation Report
- GLP Study Report
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic Reveal Plus ILR K994331
Reference Device(s)
Epic + ICD P910023/S65, Atlas + ICD P910023/S69, Affinity SR P880086/S61
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
K081365
Page 1 of 4
PREMARKET NOTIFICATION [510(K)] SUMMARY
AUG 1 5 2008
| Date Prepared: | August 11, 2008 |
|---|---|
| Submitter: | St. Jude Medical, CRMD |
| Address: | 701 E. Evelyn Avenue |
| Sunnyvale, CA 94086 | |
| Phone: | 408 522 6494 |
| Fax: | 408 522 6440 |
| Contact Person: | Elisabeth E. Neely |
| Trade Name/Proprietary Name: | SJM Confirm Implantable Cardiac Monitor System |
| Common Name: | Implantable Cardiac Monitor |
| Model Numbers: DM2100, DM2100A | |
| Classification: | Class II, 21 CFR 870.2800, 21 CFR 870.2920 |
| Legally marketed device | |
| to which your firm is | |
| claiming equivalence: | Medtronic Reveal Plus ILR K994331 |
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 Version 6.8.1 (or higher)).
The indication for use is as follows:
The SJM Confirm™ ICM is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
- . patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
- . patients who experience transient symptoms that may suggest a cardiac arrhythmia
Technological Characteristics of the Device Compared to the Predicate Device:
The SJM Confirm ICM uses similar technology; has similar intended use, functions, materials and method of operation of the following predicate device described in Table 1 below.
Image /page/0/Picture/12 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of black squares on the left, with one square rotated. To the right of the grid is the text "ST. JUDE MEDICAL" in a serif font. Below the text is the tagline "MORE CONTROL LESS RISK" in a smaller, sans-serif font.
1
K081365
Page 2 of 4
| Feature | SJM Confirm | Medtronic Reveal Plus |
|---|---|---|
| Subcutaneous ECG | Yes | Yes |
| Recording | ||
| Pre and Post Event | Yes | Yes |
| Storage | ||
| EGM Storage | 33 minutes | 21 minutes (without compression) |
| Sampling Rate | 128 Hz | 100 Hz |
| Dimensions (mm) | 18 x 56 x 8 | 19 x 61 x 8 |
| Width | ||
| Volume | 6.5 cc | 8 cc |
| Weight | 12 g | 17 g |
| Electrode Spacing | 39 mm | 38.5 mm |
| Shelf life | 12 months | 14 months |
| Auto Activation | Yes | Yes |
| Triggers | ||
| Manual (Patient) | Yes | Yes |
| Activation Trigger | ||
| High Rate Trigger | Yes | Yes |
| Programmable High | Yes | Yes |
| Rate Count | ||
| Low Rate Trigger | Yes | Yes |
| Asystole Trigger | Yes | Yes |
Table 1: SJM Confirm ICM Compared to Predicate Device
Image /page/1/Picture/3 description: The image contains the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left, with one square rotated. To the right of the grid is the text "ST. Jude Medical" in a serif font. Below the text is the tagline "More control. Less risk."
2
K081365
Page 3 of 4
Summary of Studies:
Verification and validation activities necessary to ensure that the SJM Confirm ICM product and system requirements were fulfilled, and to ensure that the product design conforms to the user needs and intended uses were identified and successfully performed. Product verification was successfully performed and is documented in the following reports:
| Appendix 7.1 | QTR2288: Confirm ICM Mechanical Test Report |
|---|---|
| Appendix 7.2 | QTR2280: Confirm ICM Electrical Test Report |
| Appendix 7.3 | QTR2286: Confirm ICM EMC Test Report |
| Appendix 7.4 | QTR2267: Patient Activator Test Report |
| Appendix 7.5 | Firmware SVRs |
| Appendix 7.6 | QRS Detection Accuracy and AF Detection |
| Algorithm Report | |
| Appendix 7.7 | System Validation Report |
| Appendix 7.8 | GLP Study Report |
Biocompatibility:
There is no change to the blood/tissue contact materials of the SJM Confirm ICM device as compared to legally marketed St. Jude Medical pacemakers and ICDs (e.g., Epic + ICD P910023/S65 and Affinity pacemaker P880086/S61). Therefore, no additional biocompatibility testing was considered necessary per ISO 10993-1. See Table 2 below.
Image /page/2/Picture/6 description: The image shows the logo for St. Jude Medical. The logo consists of a square grid of smaller squares on the left, followed by the text "ST. JUDE MEDICAL" in a bold, sans-serif font. Below the text, there is a smaller tagline that reads "MORE CONTROL. LESS RISK."
3
KC81365
Page 4 of 14
| Component | Material | Trade Name of Material | Predicate SJM
Device | PMA Number
(Approval Date) |
|---------------------|--------------------|------------------------------------------|----------------------------|---------------------------------------------------------|
| Can | Titanium (grade 1) | n/a | Epic + ICD, Atlas
- ICD | P910023/S65
(4/23/03) ,
P910023/S69
(10/17/03) |
| Header
Electrode | Titanium (grade 1) | n/a | Epic + ICD, Atlas - ICD | P910023/S65
(4/23/03) ,
P910023/S69
(10/17/03) |
| Header | Epoxy | Hysol High Purity Epoxy | Epic + ICD, Atlas - ICD | P910023/S65
(4/23/03) ,
P910023/S69
(10/17/03) |
| Parylene
Coat | Parylene | Parylene-C Conforming
Coating polymer | Affinity SR | P880086/S61
(6/17/99) |
| Table 2: SJM Confirm ICM Patient Contact Materials | |||
|---|---|---|---|
| -- | -- | -- | ---------------------------------------------------- |
Sterilization Validation:
The SJM Confirm ICM is sterilized using the same validated 100% Ethylene Oxide (EtO) sterilization process as legally marketed St. Jude Medical pacemakers. The sterility assurance level (SAL) is 10 % A sterilization assessment report is provided in Appendix 6. The patient activator, Model DM2100A, is not sterile.
Conclusion:
St. Jude Medical considers the SJM Confirm ICM system to be substantially equivalent to the legally marketed predicate and referenced device.
The results of the tests and compliance with applicable standards (reference Section 6) provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.
Image /page/3/Picture/8 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of black squares on the left, followed by the text "St. Jude Medical" in a serif font. Below the company name is the tagline "More Control. Less Risk."
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 5 2008
St. Jude Medical c/o Ms. Elizabeth Neely Regulatory Affairs Cardiac Rhythm Management Division 701 East Evelyn Avenue Sunnyvale, CA 94086
Rc: K081365
Trade/Device Name: Confirm Model DM2100 Implantable Cardiac Monitor Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MXC, DSH, DXH Dated: July 9, 2008 Received: July 10, 2008
Dear Ms. Neely:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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);
5
Page 2 - Ms. Elizabeth Ncely
labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
ell.mall
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 3 - Ms. Elizabeth Neely
Indications for Use
510(k) Number (if known):
Device Name:____Confirm Model DM2100 Implantable Cardiac Monitor
Indications For Use:
The SJM Confirm ICM is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
- patients with clinical syndromes or situations at increased risk of cardiac arrhythmias .
- patients who experience transient symptoms that may suggest a cardiac arrhythmia .
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K081365 |
| Page 1 of | 1 |