(63 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its intended use does not mention any AI/ML capabilities. The performance studies focus on standard electrical and safety testing, not algorithmic performance metrics typically associated with AI/ML.
No.
The device is strictly for diagnostic evaluation of cardiac arrhythmias and does not provide any therapeutic intervention.
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 states it is a "device for use as either an Event Recorder (ER)... or Holter Monitor (HM)," implying a physical hardware component for recording ECG data. The description of transmitting data "over the telephone or directly to a host PC" further suggests a hardware device is involved in the initial data acquisition.
Based on the provided information, the IntriCon Sirona 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.
- Intended Use: The IntriCon Sirona is intended for the diagnostic evaluation of patients experiencing symptoms suggesting cardiac arrhythmia by recording and transmitting ECG data. This is a direct measurement of physiological signals from the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as an Event Recorder and Holter Monitor, which are types of medical devices used to record electrical activity of the heart.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are typical characteristics of IVD devices.
Therefore, the IntriCon Sirona falls under the category of a medical device used for physiological monitoring and diagnosis, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IntriCon Sirona is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. When event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.
The IntriCon Datrix Sirona is a combination Event Recorder and Holter Recorder that is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. In the Event Recorder mode, once event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. In the Holter Recorder mode, the device is intended for the recording of ECG data collected from ambulatory patients. The data is then reviewed by the physician after downloading and processing by a Holter playback system.
Product codes
MWJ
Device Description
The IntriCon Sirona is a device for use as either an Event Recorder (ER), with or without Arrhythmia Detection, or Holter Monitor (HM). The device can operate in one of three modes depending on clinician selected options.
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)
Non-Clinical And 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.
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 Sirona supports a claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Braemar Er900 (K071011/K072008), Datrix VX3 (K031074)
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
*//2
510(k) SUMMARY (as required by 807.92(c))
.
:
. ﺳ
...
| Regulatory Correspondent: | AJW Technology Consultants
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 |
| Date of Summary: | September 2, 2011 |
| Trade/Proprietary Name: | Sirona |
| Classification Name: | Electrocardiograph,ambulatory(without analysis) |
| Product Code: | MWJ |
| Intended Use: | The IntriCon Sirona is intended for diagnostic
evaluation of patients who experience transient
symptoms that may suggest cardiac arrhythmia.
When event data is recorded, patients transmit the
recorded ECG data over the telephone or directly to
a host PC for review by a licensed physician. |
| Device Description: | The IntriCon Sirona is a device for use as either an
Event Recorder (ER), with or without Arrhythmia
Detection, or Holter Monitor (HM). The device can
operate in one of three modes depending on
clinician selected options. |
| Predicate Device: | Braemar Er900 (K071011/K072008), Datrix VX3
(K031074). |
:
:
1
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.
Non-Clinical And Performance Testing:
Conclusion
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.
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 Sirona supports a claim of substantial equivalence.
Intricon Datrix Sirona Traditional 510(k)
2
Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest feathers or wings. The overall design is simple and monochromatic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 9 2011
IntriCon Datrix Corporation c/o Ms. Tanya O'Brien Clinical Affairs Specialist AJW Technology Consultants, Inc. 962 Allegro Lane Pollo Beach, FL 33572
Re: K112601
Trade/Device Name: IntriCon Datrix Sirona Event/Holter Recorder Regulatory Number: 21 CFR 870.2800 Regulation Name: Ambulatory Electrocardiograph Regulatory Class: II (two) Product Code: MWJ Dated: September 2, 2011 Received: September 7, 2011
Dear Ms. O'Brien:
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 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. 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 vour 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/CDRHOffices/ucm115809.html 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,
Bram D. Zuckerman, M.D.
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 Sirona Event/Holter Recorder
Model: Sirona
Indications for Use: The IntriCon Datrix Sirona is a combination Event Recorder and Holter Recorder that is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. In the Event Recorder mode, once event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. In the Holter Recorder mode, the device is intended for the recording of ECG data collected from ambulatory patients. The data is then reviewed by the physician after downloading and processing by a Holter playback system.
Contraindications:
-
- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
-
- Patients who the attending physician thinks should be hospitalized.
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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| Intricon Datrix Sirona Traditional 510(k) | |
| 510(k) Number | 14112601 |
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