(98 days)
No
The description mentions an "arrhythmia detection algorithm" but does not provide any details suggesting it uses AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is intended for "diagnostic evaluation of patients" and records ECG data for review, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia."
No
The device description explicitly mentions a "recorder" which is a hardware component used for acquiring and transmitting ECG data. It also mentions cables and electrodes, further indicating hardware is involved.
Based on the provided information, this device 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. They are used to examine these samples outside of the body.
- Device Function: The IntriCon Datrix Centauri MT APETS is described as a device that records patient ECG data. This is a measurement of electrical activity within the body, not an analysis of a sample taken from the body.
- Intended Use: The intended use is for "diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia." This involves monitoring and recording physiological signals directly from the patient.
Therefore, the device falls under the category of a medical device used for physiological monitoring and recording, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
DSI
Device Description
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.
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
licensed physician
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)
Testing to applicable standards: IEC60601-1:1998, 2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998.
Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Braemar, Inc. Fusion Wireless Recorder (K081444), Datrix E-Tac EX-1000 Electrocardiographic Event Recorder (K042022)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K111160
p1/2
510(k) SUMMARY (as required by 807.92(c))
.
AUG - 1 2011
ﯿﺴﻪ
ェ
.
| Regulatory Correspondent: | AJW Technology Consultants Inc
962 Allegro Lane
Apollo Beach, FL 33572
Tanya O'Brien
tmobrien@ajwtech.com
813-645-2855
813-677-4787 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | IntriCon Datrix
340 State Place
Escondido, CA 92029
Terrie Heidemann
theidemann@ecgrecorder.com |
| Date of Summary: | 20 April 2011 |
| Trade/Proprietary Name: | IntriCon Datrix Centauri MT Ambulatory Patient
ECG Telemetry System (APETS) |
| Classification Name: | Arrhythmia Detector and Alarm |
| Product Code: | DSI |
| Intended 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
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. |
| Device Description: | 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
..............................................................................................................................................................................
| | 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. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device: | Braemar, Inc. Fusion Wireless Recorder (K081444),
Datrix E-Tac EX-1000 Electrocardiographic Event
Recorder (K042022) |
| Substantial Equivalence: | 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. |
| 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, and
reliability characteristics of the device followed
established test procedures in a quality system. |
| Conclusion | 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. Therefore, the
IntriCon Datrix Centauri MT APETS supports a
claim of substantial equivalence. |
and the contraction of the comments of the consistence the consistence and any and
·
. . . . . . . . . .
and the contraction of the states of the subscribed on
.
2
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.
3
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
4
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:
-
- 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)