INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER

K112601 · Intricon Datrix Corporation · MWJ · Nov 9, 2011 · Cardiovascular

Device Facts

• Record ID: K112601
• Device Name: INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER
• Applicant: Intricon Datrix Corporation
• Product Code: MWJ · Cardiovascular
• Decision Date: Nov 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended 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.

Device Story

Ambulatory ECG recorder operating as Event Recorder (ER) or Holter Monitor (HM); clinician-selectable modes. Inputs: ECG signals from ambulatory patients. Transformation: records ECG data for later review. Output: stored ECG data transmitted via telephone or direct PC connection for physician analysis. Used in ambulatory settings; operated by patients. Physician reviews data on host PC or Holter playback system to diagnose cardiac arrhythmias. Benefits: enables remote or post-ambulatory diagnostic evaluation of transient cardiac symptoms.

Clinical Evidence

Bench testing only. Performance, functionality, and reliability characteristics verified through established test procedures in a quality system. Compliance with IEC60601-1:1998, IEC 60601-1-2:2001, and AAMI EC 38-1998 standards.

Technological Characteristics

Ambulatory ECG recorder; supports Event Recorder and Holter Monitor modes. Connectivity via telephone or direct PC interface. Standards: IEC60601-1:1998 (2nd ed), IEC 60601-1-2:2001, AAMI EC 38-1998.

Indications for Use

Indicated for diagnostic evaluation of patients experiencing transient symptoms suggesting cardiac arrhythmia. Contraindicated for patients with potentially life-threatening arrhythmias requiring inpatient monitoring or patients requiring hospitalization.

Regulatory Classification

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.

Predicate Devices

• Braemar Er900 (K071011/K072008)
• Datrix VX3 (K031074)

Submission Summary (Full Text)

{0}------------------------------------------------

K112601

*//2

## 510(k) SUMMARY (as required by 807.92(c))

.

:

. ﺳ

...

- -

| Regulatory Correspondent: | AJW Technology Consultants<br>962 Allegro Lane<br>Apollo Beach, FL 33572<br>Tanya O'Brien<br>[e-mail]<br>813-645-2855<br>813-677-4787 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter of 510(k): | IntriCon Datrix<br>340 State Place<br>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<br>evaluation of patients who experience transient<br>symptoms that may suggest cardiac arrhythmia.<br>When event data is recorded, patients transmit the<br>recorded ECG data over the telephone or directly to<br>a host PC for review by a licensed physician. |
| Device Description: | The IntriCon Sirona is a device for use as either an<br>Event Recorder (ER), with or without Arrhythmia<br>Detection, or Holter Monitor (HM). The device can<br>operate in one of three modes depending on<br>clinician selected options. |
| Predicate Device: | Braemar Er900 (K071011/K072008), Datrix VX3<br>(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 [phone] or [phone] 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:

- 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- 2. 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 |

14 of 589