(50 days)
Not Found
No
The summary mentions "modified brady, asystole, and tachy detection algorithms" and "EMG detection/rejection," which are standard signal processing techniques, not necessarily AI/ML. There is no mention of AI, ML, DNN, or any related concepts, nor is there a description of training or test sets for an AI/ML model.
No.
The device is a monitoring system that records ECG data to identify cardiac arrhythmias, but it does not provide any treatment or therapy.
Yes
The device is described as a "monitoring system that records subcutaneous ECG" for "patients with clinical syndromes or situations at increased risk of cardiac arrhythmias" or "patients who experience transient symptoms that may suggest a cardiac arrhythmia", with the results supporting "adequate viability of the ECG signals for the diagnosis of various arrhythmias." Such a system, used for recording and analyzing physiological signals to identify medical conditions, fits the definition of a diagnostic device.
No
The device description explicitly states it includes an "implantable component" (Implantable Loop Recorder - ILR) and other hardware components (Personnel Diagnostic Manager - PDM, Base Station).
Based on the provided information, the Sleuth AT system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Sleuth AT system is an implantable device that records subcutaneous ECG directly from the patient's body. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended use is for monitoring cardiac arrhythmias in patients. This is a direct physiological measurement and monitoring function, not an in vitro diagnostic test.
The device is an implantable medical device used for physiological monitoring.
N/A
Intended Use / Indications for Use
The Transoma Medical Sleuth AT Implantable Cardiac Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- 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
Device Description
The Sleuth AT Implantable Cardiac System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station.
The Sleuth AT System incorporates modified brady, asystole, and tachy detection algorithms; additional trending capabilities; EMG detection/rejection; and program pending mode when compared to the original Sleuth System. There are no changes to the Indications for Use and only minor mechanical updates to the ILR and PDM.
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)
A clinical study (PULSE study) was conducted on the original version of the Sleuth system (Model 2010) at four major medical centers in Panama. Twenty-eight (28) patients were enrolled in the study. The patients had unexplained syncope/ pre-syncope or were at risk of arrhythmias. The results supported adequate viability of the ECG signals for the diagnosis of various arrhythmias. In the autotriggers from the population studied, it was found that the true and false positive rates were 0.23% and 99.77%, respectively.
Based on the similarity of the two devices, the new Sleuth AT's arrhythmia detector was verified using standard ECG databases, and ECGs collected in the above study of the predicate Sleuth system. The sensitivity and positive value of R-wave detection was 98.6% and 99.5% (MIT-BIH data base), which is similar or better than the predicate Sleuth system. Furthermore, when the collected clinical data was applied to the Sleuth AT detector, the percentage of auto-triggered events that were false positives was found to be 95.96%, while the fraction of true positive autotriggers was 4.04%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
true and false positive rates were 0.23% and 99.77%, respectively.
sensitivity and positive value of R-wave detection was 98.6% and 99.5%
percentage of auto-triggered events that were false positives was found to be 95.96%
fraction of true positive autotriggers was 4.04%.
Predicate Device(s)
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
SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS
1 General Information
Submitter's Name and Address:
Contact Person:
Date of Summary:
Proprietary Name of Device:
Common/Usual Name:
Classification Name:
Transoma Medical, Inc. 119 14th Street NW St. Paul. MN 55112 Phone: 651-414-5521 Fax: 651-481-7415
K083828 p. 1/3
FEB 1 1 2009
Lisa Stone Phone: 651-414-5521 Fax: 651-481-7415 Email: Istone@transomamedical.com
February 3, 2009
Sleuth AT Implantable Cardiac Monitoring System
Implantable ECG Monitoring System
Cardiac Implantable Event Recorder Product Code - MXC 21 CFR Part 870.2800 Device Class II
Legally Marketed Device to Which Substantial Equivalence is Claimed:
Sleuth Implantable ECG System K063035 and K073147
2 Device Description
The Sleuth AT Implantable Cardiac System is an electrocardiogram (ECG) monitoring system that includes an implantable component and that provides continuous ECG monitoring and episodic or segmented ECG recording. The Sleuth AT Implantable Cardiac System comprises three interrelated components: Implantable Loop Recorder (ILR), Personnel Diagnostic Manager (PDM) and Base Station.
The Sleuth AT System incorporates modified brady, asystole, and tachy detection algorithms; additional trending capabilities; EMG detection/rejection; and program pending mode when compared to the original Sleuth System. There are no changes to the Indications for Use and only minor mechanical updates to the ILR and PDM.
Section 012-1
1
SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS
Intended Use 3
The Transoma Medical Sleuth AT Implantable Cardiac Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- Patients with clinical syndromes or situations at increased risk of cardiac . arrhythmias
- Patients who experience transient symptoms that may suggest a cardiac arrhythmia .
Summary of Technological Characteristics 4
The Sleuth AT System incorporates substantially equivalent technology, comparable features, labeling, and intended use, and is similar to the predicate device currently available on the market.
Non-clinical Test Summary 5
The substantial equivalence of Sleuth AT System has been demonstrated via bench testing, including:
- Mechanical
- Electrical Safety, Immunity and Compatibility
- Heart Rate Detection
- Event Detection
- ECG Measurement Accuracy
- General Electrical Operation
- ECG Input Tolerance
- Communication Interface
- RF Communication Performance
- Battery Life
- ASIC Accelerated Life -
- ASIC Battery Voltage Measurement
- System Function and Environment
- Evaluation of New Algorithm
Clinical Study Summary 6
A clinical study (PULSE study) was conducted on the original version of the Sleuth system (Model 2010) at four major medical centers in Panama. The results of that study still support the new device Sleuth AT, due to the similarities between the two devices and verifications presented in the 510(k) Notification. The primary objectives of the PULSE study were to evaluate the diagnostic viability of the ECG signals and the performance of
Transoma Medical Special 510(k) - Sleuth AT System Confidential and Proprietary Information Section 012-2
2/3
2
SECTION 012 - SUMMARY OF SAFETY AND EFFECTIVENESS Ko83828
the system. Twenty-eight (28) patients were enrolled in the study. The patients had of 3/3
unavalained syncones prosone or were at risk of archythmias The results support unexplained syncope/ pre-syncope or were at risk of arrhythmias. The results supported adequate viability of the ECG signals for the diagnosis of various arrhythmias. In the autotriggers from the population studied, it was found that the true and false positive rates were 0.23% and 99.77%, respectively.
Based on the similarity of the two devices, the new Sleuth AT's arrhythmia detector was verified using standard ECG databases, and ECGs collected in the above study of the predicate Sleuth system. The sensitivity and positive value of R-wave detection was 98.6% and 99.5% (MIT-BIH data base), which is similar or better than the predicate Sleuth system. Furthermore, when the collected clinical data was applied to the Sleuth AT detector, the percentage of auto-triggered events that were false positives was found to be 95.96%, while the fraction of true positive autotriggers was 4.04%.
7 Conclusion
Based on the information provided above, the Sleuth AT System is substantially equivalent to the Sleuth System.
Transoma Medical Special 510(k) - Sleuth AT System Confidential and Proprietary Information
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2009
Transoma Medical, Inc. c/o Ms. Lisa J. Stone, RAC Regulatory Affairs Manager 119 14th Street NW St. Paul, MN 55112
Re: K083828
Trade/Device Name: Sleuth AT Implantable Cardiac Monitoring System Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MXC Dated: January 29, 2009 Received: January 30, 2009
Dear Ms. Stone:
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.
4
Page 2 - Ms. Lisa J. Stone, RAC
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); 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 yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K083828
Device Name: Sleuth AT Implantable Cardiac Monitoring System
Indications for Use:
The Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
- 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 X (Part 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)
Mitchell Sile for B Zuckerman
(Division Sign-Off) Division of Cardiovascular 510(k) Number