MEDICAL MAGNETIC TAPE RECORDER

K102111 · Wpr Medical AS · DSI · Dec 7, 2010 · Cardiovascular

Device Facts

• Record ID: K102111
• Device Name: MEDICAL MAGNETIC TAPE RECORDER
• Applicant: Wpr Medical AS
• Product Code: DSI · Cardiovascular
• Decision Date: Dec 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

Curvus Sensor - Recorder: Curvus Regular Holter is intended to record single lead (channel) surface ECG data and accelerometer data from ambulatory patients (Holter) for a period of up to 72 hours (3 days). Recorded ECG data are intended to be analyzed by Curvus Analyzer. The Sensor and Recorder are intended for use outside of the hospital. Curvus software suite: Curvus Examiner is intended to program set up and closure of examination, while Curvus Analyzer analyzes the retrieved data from the examination. The system is intended to be used by trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.

Device Story

Curvus Regular Holter System collects single-lead ECG and accelerometer data from ambulatory patients via a wireless disposable chest sensor; data stored on a handheld recorder for up to 72 hours. Post-recording, data transferred via USB to PC-based Curvus Examiner and Analyzer software. System used by trained operators in clinical settings to assist cardiologists in arrhythmia diagnosis. Software provides full disclosure, event list display, and arrhythmia detection. Patient-triggered event button on recorder allows manual marking of symptomatic episodes. Benefits include ambulatory cardiac monitoring to facilitate rhythm irregularity identification.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including verification and validation of system specifications and testing against applicable standards for EMC and safety.

Technological Characteristics

Single-lead wireless disposable sensor; 250 Hz sampling rate; 12-bit resolution; +/- 6 mV dynamic range. PC-based software (Windows XP compatible). Data transfer via USB. System includes ECG sensor, handheld recorder, and analysis software. Sterilization method not specified.

Indications for Use

Indicated for ambulatory patients requiring 72-hour single-lead ECG and accelerometer monitoring to assist in the diagnosis of arrhythmias. Intended for use by trained operators under the supervision of a healthcare practitioner.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Vista Plus Holter Recorder (K042108)
• Nuvant Mobile Cardiac Telemetry System (K090696)

Submission Summary (Full Text)

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## 510(k) Summary

### Submitter: WPR Medical AS

P.O. Box Serviceboks 737 N-4808 Arendal, Norway 447 95 75 61 99

DEC - 7 2010

#### Contact Information:

Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridlev. MN 55432 763-574-1976

Submission Date: July 24, 2010

## Device Name and Classification: Curvus Regular Holter System. Class II. 870.2800. Product Code MLO

KIO2111

## Equivalent Device Identification: Vista Plus Holter Recorder, K042108 Nuvant Mobile Cardiac Telemetry System, K090696

Device Description: The Curvus Regular Holter System is a wireless mobile system for collecting a 1-lead electrocardiogram from a patient and to present the results to medical personnel such as cardiologists with the purpose to assist them to diagnose arrhythmias (heart rhythm irregularities). The Curvus Regular Holter System consists of a set of functional units including software:

- Curvus ECG Sensor to be applied to the patient's chest to measure ECG signal .
- Curvus ECG Recorder a hand-held device to store monitored data .
- Curvus ECG Examiner and Curvus ECG Analyzer software programs to be used by . medical staff for setup and closure of patient examination and for diagnostic evaluation.

#### Intended Use: ·

#### Curvus Sensor - Recorder:

Curvus Regular Holter is intended to record single lead (channel) surface ECG data and accelerometer data from ambulatory patients (Holter) for a period of up to 72 hours (3 days). Recorded ECG data are intended to be analyzed by Curvus Analyzer.

#### Curvus software suite:

Curvus Examiner is intended to program set up and closure of examination, while Curvus Analyzer analyze the retrieved data from the examination. The system is intended to be used by trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.

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| | Curvus Regular<br>Holter System<br>(subject device) | Vista Plus Holter<br>Recorder | Nuvant Mobile<br>Cardiac Telemetry<br>System |
|-------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Physiological<br>parameters | ECG, Heart Rate,<br>Activity | ECG, Heart rate | ECG, Heart Rate,<br>Activity, Posture,<br>Body Temperature,<br>Respiration Rate<br>Body Fluid Status |
| Displays findings in<br>Real Time | No | No | Yes |
| Number of channels | 1 | 1- 3 | 1 |
| Number of<br>electrodes (sensor) | 1 (wireless),<br>disposable sensor | 3 | 1 (wireless) |
| Recording duration | 72 hours | Up to 264 h | Not known |
| Communication<br>between sensor and<br>recorder | Radiofrequency<br>Technology | wires | Blue Tooth<br>Technology |
| Sampling rate | 250 Hz | 200 Hz | Not known |
| resolution | 12 | 10 | Not known |
| Dynamic range | +/- 6 mV | +/- 6 mV | Not known |
| Bit resolution | 12 uV | 12 uV | Not known |
| Memory type | In recorder | CF card | In sensor |
| Recording Full<br>disclosure | Yes (All data can be<br>retrieved via USB<br>after examination) | Yes | No (Data collected<br>when the device is<br>first applied,<br>irregular events and<br>patient triggered<br>events) |
| Real time built in<br>analysis | Yes, HR analysis<br>for real time viewed<br>in Examiner (when<br>connected via USB | Yes, real time HR<br>calculation | In sensor for<br>transmissions of<br>irregular events |
| Patient trigger<br>feature | Patient Event<br>Button on recorder | Patient event key +<br>voice recorder | Activated by using<br>a magnet over the<br>sensor |
| Pacer pulse<br>detection and<br>reporting | No | Yes | No |
| Replay and analysis<br>system | Yes, viewed in<br>Curvus Examiner<br>and Analyzer | Yes, Holter Soft<br>Ultima | Yes, telephonic<br>transmission to<br>Corventis server.<br>and analysis center. |
| | Curvus Regular<br>Holter System<br>(subject device) | Vista Plus Holter<br>Recorder | Nuvant Mobile<br>Cardiac Telemetry<br>System |
| PC based | Yes | Yes | Yes |
| OS compatibility | Windows XP | Windows 98,NT,XP | Not known |
| Input data | USB | CF card | GSM transmitted<br>data |
| Event list display | Yes | Yes | Yes |
| Arrhythmia<br>detection | Yes | Yes | Yes |
| ECG strip edition<br>and printing | Yes | Yes | Yes |
| QT-, HRV-, A-fib-<br>analysis | No | Yes | Not known |
| ST analysis | No | Yes, multichannel | No |
| Archiving | Yes | Yes | Yes |

.

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Summary of Testing: The Curvus Regular Holter System has been tested according to the applicable standards for EMC and Safety. The system has also been verified and validated according to the required specifications. 1

Conclusion: WPR believes the Curvus Regular Holter System to be substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

WPR Medical AS c/o Ms. Constance G. Bundy C.G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridley, MN 55432

DEC - 7 2010

K102111 Re:

> Trade/Device Name: Curvus Regular Holter System, including: Curvus Regular Holter, and Curvus Examiner and Curvus Analyzer Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II (two) Product Code: DSI Dated: November 18, 2010 Received: November 24, 2010

Dear Ms. Bundy:

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. Constance G. Bundy

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 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/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 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/ReportalProblem/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

phones R. Vilmer

B
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

DEC - 7 2010

510(k) Number (if known): K102111

Device Name: Curvus Regular Holter System

Indications For Use:

Curvus Sensor - Recorder:

Curvus Regular Holter is intended to record single lead (channel) surface ECG data and accelerometer data from ambulatory patients (Holter) for a period of up to 72 hours (3 days). Recorded ECG data are intended to be analyzed by Curvus Analyzer. The Sensor and Recorder are intended for use outside of the hospital.

Curvus software suite:

Curvus Examiner is intended to program set up and closure of examination, while Curvus Analyzer analyzes the retrieved data from the examination. The system is intended to be used by trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.

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)

Muna R. Jackson

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ K10 2 | |