(98 days)
The IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.
The IntriCon Datrix Centauri MT APETS is a device used for recording patient ECG data for as long as 30 days. Selected data are sent for review from the recorder, through a phone service to a receiving station where they are available for review by a physician or other qualified medical professional. The Centauri MT APETS is capable of 1, 2, and 3-channel recording, depending on the type of cable being used. The recorder can run for up to 30 days. Battery life depends on the mode and battery option chosen by the user. The patient's ECG signal is acquired via commercially available silver-chloride electrodes appropriate for long-term recording.
The provided 510(k) summary for the IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) does not include explicit acceptance criteria nor a detailed study proving the device meets said criteria.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Braemar, Inc. Fusion Wireless Recorder (K081444) and Datrix E-Tac EX-1000 Electrocardiographic Event Recorder (K042022)). The conclusion states: "Comparison to the predicate devices listed shows nearly identical technical data, same indications for use, same safety standards tested to, and raises no new questions of safety or efficacy."
The submission focuses on compliance with general safety and performance standards rather than specific diagnostic accuracy metrics.
Here's an breakdown of the information that can be extracted, and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| None explicitly stated as quantifiable performance metrics. The approval is based on "substantial equivalence" to predicate devices and adherence to general safety standards. | None explicitly stated as quantifiable performance metrics. The device "continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity..." but no performance metrics (e.g., sensitivity, specificity for arrhythmia detection, or accuracy of transmission) are provided. |
Missing Information:
- Specific numerical targets for performance (e.g., sensitivity, specificity, positive predictive value, negative predictive value for arrhythmia detection).
- Data demonstrating the device's ability to accurately detect and transmit various types of arrhythmias.
2. Sample Size Used for the Test Set and Data Provenance:
Missing Information:
- Sample Size for Test Set: The document does not describe any specific clinical or performance test set used to evaluate the device's diagnostic accuracy. It mentions "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system," but details of these tests, including sample size for diagnostic performance, are absent.
- Data Provenance: Without a description of a test set, there is no information on country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Missing Information:
- As no specific test set for diagnostic performance is described, there is no mention of experts or how ground truth was established for such a set.
4. Adjudication Method for the Test Set:
Missing Information:
- No test set for diagnostic performance is described, therefore no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Missing Information:
- No MRMC comparative effectiveness study is mentioned. The submission is focused on the device's standalone functionality and equivalence to predicates, not its impact on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance: The device's intended use explicitly states it "automatically generates an event triggered by an arrhythmia detection algorithm." This implies a standalone algorithm component. However, no performance metrics (e.g., sensitivity, specificity for various arrhythmias) for this algorithm are provided in the document. The submission relies on "substantial equivalence" to predicate devices, which presumably have a similar algorithmic function.
7. Type of Ground Truth Used:
Missing Information:
- Given the lack of a detailed diagnostic performance study, the type of ground truth (e.g., expert consensus, pathology, outcomes data) used for any such evaluation is not stated.
8. Sample Size for the Training Set:
Missing Information:
- No information about a training set or its sample size is provided. This is typical for submissions focused on established technologies demonstrating substantial equivalence, where detailed de novo algorithm development data might not be required.
9. How the Ground Truth for the Training Set Was Established:
Missing Information:
- As no training set is mentioned, there is no information on how its ground truth would have been established.
Summary of Acceptance Criteria and Study Limitations:
The provided 510(k) summary is for a device seeking clearance based on "substantial equivalence" to existing predicate devices. This type of submission generally does not require a detailed clinical performance study with explicit acceptance criteria for diagnostic accuracy, nor does it typically detail the development and validation of AI algorithms with associated training and test sets in the same manner as a de novo submission or a device with novel technology.
The "Performance Testing" section primarily lists compliance with general electrical safety and EMC standards (IEC60601-1:1998, IEC 60601-1-2: 2001, AAMI EC 38-1998) and states that "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system." This indicates engineering and functional testing, not necessarily a clinical study for diagnostic performance.
Therefore, this document does not contain the detailed information requested regarding specific acceptance criteria, diagnostic performance study design, sample sizes, ground truth establishment, or expert involvement for evaluating the arrhythmia detection algorithm's accuracy. The approval is based on the claim that the device is "substantially equivalent" to already-cleared devices, implying its performance characteristics are comparable to those predicates.
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510(k) SUMMARY (as required by 807.92(c))
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AUG - 1 2011
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| Regulatory Correspondent: | AJW Technology Consultants Inc962 Allegro LaneApollo Beach, FL 33572Tanya O'Brientmobrien@ajwtech.com813-645-2855813-677-4787 |
|---|---|
| Submitter of 510(k): | IntriCon Datrix340 State PlaceEscondido, CA 92029Terrie Heidemanntheidemann@ecgrecorder.com |
| Date of Summary: | 20 April 2011 |
| Trade/Proprietary Name: | IntriCon Datrix Centauri MT Ambulatory PatientECG Telemetry System (APETS) |
| Classification Name: | Arrhythmia Detector and Alarm |
| Product Code: | DSI |
| Intended Use: | The IntriCon Datrix Centauri MT AmbulatoryPatient ECG Telemetry System (APETS) isintended for diagnostic evaluation of patients whoexperience transient symptoms that may suggestcardiac arrhythmia. The device continuouslymonitors, automatically generates an event triggeredby an arrhythmia detection algorithm or manuallyby the patient, and automatically transmits therecorded cardiac activity associated with thesesymptoms for review by a licensed physician. |
| Device Description: | The IntriCon Datrix Centauri MT APETS is adevice used for recording patient ECG data for aslong as 30 days. Selected data are sent for reviewfrom the recorder, through a phone service to areceiving station where they are available forreview by a physician or other qualified medicalprofessional. The Centauri MT APETS is capable of |
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| 1, 2, and 3-channel recording, depending on thetype of cable being used. The recorder can run forup to 30 days. Battery life depends on the mode andbattery option chosen by the user. The patient'sECG signal is acquired via commercially availablesilver-chloride electrodes appropriate for long-termrecording. | |
|---|---|
| Predicate Device: | Braemar, Inc. Fusion Wireless Recorder (K081444),Datrix E-Tac EX-1000 Electrocardiographic EventRecorder (K042022) |
| Substantial Equivalence: | Comparison to the predicate devices listed showsnearly identical technical data, same indications foruse, same safety standards tested to, and raises nonew questions of safety or efficacy. |
| Performance Testing: | Testing to applicable standards: IEC60601-1:1998,2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998.Testing for the performance, functionality, andreliability characteristics of the device followedestablished test procedures in a quality system. |
| Conclusion | Comparison to the predicate devices listed showsnearly identical technical data, same indications foruse, same safety standards tested to, and raises nonew questions of safety or efficacy. Therefore, theIntriCon Datrix Centauri MT APETS supports aclaim of substantial equivalence. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
IntriCon Datrix Corporation c/o Ms. Tanya O'Brien Clinical Affairs Specialist AJW Technology Consultants, Inc. 962 Allegro Lane Pollo Beach, FL 33572
1 2011 ઠ્ઠાંડિ
K11160 Re:
KTTT100
Trade/Device Name: IntriCon Datrix Centrauri Ambulatory Patient ECG Telemetry System (APETS) Regulatory Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: II (two) Product Code: DSI Dated: July 11, 2011 Received: July 14, 2011
Dear Ms. O'Brien:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 10 commored print to thirs 20, 377 7, 101 11:51
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that to not require subject to the general controls provisions of the Act. The rou may, merelove, manel 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 your device is elassified (600 a007 0) . 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.
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Page 2 - Ms. Tanya O'Brien
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 that I DA has made a decemmations administered by other Federal agencies. You must of any I odolar statuates and regarations, 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 n you desire specific da vies to: your your centers Offices/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 note the regulation antined, "incertains of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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 Statement
510(k) Number (if known):
Device Name: IntriCon Datrix Centauri Ambulatory Patient ECG Telemetry System (APETS)
IntriCon Datrix Centauri MT Model:
Indications for Use: The IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously montons, automatically generates an event triggered by an arrhythmia detection algorithm or manuoly by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.
Contraindications:
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- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- Patients who the attending physician thinks should be hospitalized. 2.
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)
Intricon Centauri MT 510(k)
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.