(132 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description of the device and its function focuses on standard ECG recording and analysis.
No
The device is intended to record ECG data for diagnostic purposes (to assist in diagnosing arrhythmias), not to provide treatment or therapy.
Yes
The "Intended Use" states that recorded ECG data are "intended to be analyzed by Curvus Analyzer," and the "Device Description" clarifies that the system's purpose is "to assist them to diagnose arrhythmias (heart rhythm irregularities)." This indicates its role in a diagnostic process.
No
The device description explicitly states that the system consists of functional units including hardware components: "Curvus ECG Sensor to be applied to the patient's chest to measure ECG signal" and "Curvus ECG Recorder a hand-held device to store monitored data". While it includes software, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Curvus Regular Holter System directly measures the electrical activity of the heart (ECG) from the patient's chest. It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use is to record and analyze ECG data for the diagnosis of arrhythmias. This is a physiological measurement and analysis, not an in vitro examination of a specimen.
The device is a medical device used for physiological monitoring and diagnostic assistance, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MLO, DSI
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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
patient's chest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operators under the direct supervision of a trained Health Care Practitioner in a hospital or a clinic environment.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
| | Curvus Regular
Holter System
(subject device) | Vista Plus Holter
Recorder | Nuvant Mobile
Cardiac Telemetry
System |
|-------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Physiological
parameters | ECG, Heart Rate,
Activity | ECG, Heart rate | ECG, Heart Rate,
Activity, Posture,
Body Temperature,
Respiration Rate
Body Fluid Status |
| Displays findings in
Real Time | No | No | Yes |
| Number of channels | 1 | 1- 3 | 1 |
| Number of
electrodes (sensor) | 1 (wireless),
disposable sensor | 3 | 1 (wireless) |
| Recording duration | 72 hours | Up to 264 h | Not known |
| Communication
between sensor and
recorder | Radiofrequency
Technology | wires | Blue Tooth
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
disclosure | Yes (All data can be
retrieved via USB
after examination) | Yes | No (Data collected
when the device is
first applied,
irregular events and
patient triggered
events) |
| Real time built in
analysis | Yes, HR analysis
for real time viewed
in Examiner (when
connected via USB | Yes, real time HR
calculation | In sensor for
transmissions of
irregular events |
| Patient trigger
feature | Patient Event
Button on recorder | Patient event key +
voice recorder | Activated by using
a magnet over the
sensor |
| Pacer pulse
detection and
reporting | No | Yes | No |
| Replay and analysis
system | Yes, viewed in
Curvus Examiner
and Analyzer | Yes, Holter Soft
Ultima | Yes, telephonic
transmission to
Corventis server.
and analysis center. |
| | Curvus Regular
Holter System
(subject device) | Vista Plus Holter
Recorder | Nuvant Mobile
Cardiac Telemetry
System |
| PC based | Yes | Yes | Yes |
| OS compatibility | Windows XP | Windows 98,NT,XP | Not known |
| Input data | USB | CF card | GSM transmitted
data |
| Event list display | Yes | Yes | Yes |
| Arrhythmia
detection | Yes | Yes | Yes |
| ECG strip edition
and printing | Yes | Yes | Yes |
| QT-, HRV-, A-fib-
analysis | No | Yes | Not known |
| ST analysis | No | Yes, multichannel | No |
| Archiving | Yes | Yes | Yes |
.
2
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.
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
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 | |