(63 days)
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.
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.
The provided text is a 510(k) summary for the IntriCon Datrix Sirona Event/Holter Recorder. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria, particularly for performance metrics like sensitivity, specificity, or accuracy for arrhythmia detection.
The "Non-Clinical And Performance Testing" section broadly states: "Testing for the performance, functionality, and reliability characteristics of the device followed established test procedures in a quality system." It references compliance with several electrical safety and performance standards (IEC60601-1:1998, 2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998) but does not provide specific performance data or a statistical analysis of diagnostic accuracy.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because this information is not present in the provided document.
The document indicates that the device is an "Electrocardiograph, ambulatory (without analysis)" and states that "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... for review by a licensed physician." This strongly suggests that the device's primary function is data acquisition and transmission, with the diagnostic analysis being performed by a human physician, not the device itself. The phrase "without analysis" in the classification name further supports this.
Based on the provided text, the following information is either not applicable or not available:
- Table of acceptance criteria and reported device performance: Not available. The document primarily focuses on electrical safety and functional standards, not diagnostic performance metrics.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not available, as diagnostic analysis is stated to be performed by a "licensed physician" reviewing the transmitted data.
- Adjudication method for the test set: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is classified as "without analysis" and there's no mention of AI assistance. The physician performs the analysis.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's classification "without analysis" and intended use imply it does not perform standalone algorithmic analysis for diagnosis.
- The type of ground truth used: Not available.
- The sample size for the training set: Not applicable. There's no mention of an algorithm requiring training.
- How the ground truth for the training set was established: Not applicable.
Summary of what is available:
- Intended Use: Diagnostic evaluation of patients experiencing transient symptoms suggesting cardiac arrhythmia.
- Device Function: Records ECG data, which is then transmitted for review by a licensed physician. It can operate as an Event Recorder (with or without Arrhythmia Detection functionality, though the classification name says "without analysis") or Holter Monitor.
- Compliance: Tested to IEC60601-1:1998, 2nd edition, IEC 60601-1-2: 2001, AAMI EC 38-1998. These are generally electrical safety and basic functional standards for medical devices, not diagnostic performance standards for arrhythmia detection algorithms.
- Predicate Device Comparison: Claims "nearly identical technical data, same indications for use, same safety standards tested to" as Braemar Er900 (K071011/K072008) and Datrix VX3 (K031074). This is the basis for substantial equivalence, implying that if the predicates met certain performance, this device is expected to as well, but the specific performance data is not provided.
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510(k) SUMMARY (as required by 807.92(c))
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| Regulatory Correspondent: | AJW Technology Consultants962 Allegro LaneApollo Beach, FL 33572Tanya O'Brientmobrien@ajwtech.com813-645-2855813-677-4787 |
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| Submitter of 510(k): | IntriCon Datrix340 State PlaceEscondido, 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 diagnosticevaluation of patients who experience transientsymptoms that may suggest cardiac arrhythmia.When event data is recorded, patients transmit therecorded ECG data over the telephone or directly toa host PC for review by a licensed physician. |
| Device Description: | The IntriCon Sirona is a device for use as either anEvent Recorder (ER), with or without ArrhythmiaDetection, or Holter Monitor (HM). The device canoperate in one of three modes depending onclinician selected options. |
| Predicate Device: | Braemar Er900 (K071011/K072008), Datrix VX3(K031074). |
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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)
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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.
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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 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
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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:
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- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
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- 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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§ 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).