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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Curvus Regular Holter System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices through a comparative table of specifications and features, rather than explicitly stating acceptance criteria and then demonstrating performance against them. Therefore, the table below will reframe the "acceptance criteria" as the comparable features and specifications of the predicate devices against which the Curvus Regular Holter System is being evaluated for substantial equivalence. The "Reported Device Performance" will be what is stated for the Curvus Regular Holter System.

Acceptance Criteria (Predicate Device Specification/Feature)	Reported Device Performance (Curvus Regular Holter System)
Physiological parameters: ECG, Heart Rate, Activity (for Nuvant), Heart rate (for Vista Plus)	ECG, Heart Rate, Activity
Displays findings in Real Time: No (Vista Plus), Yes (Nuvant)	No
Number of channels: 1-3 (Vista Plus), 1 (Nuvant)	1
Number of electrodes (sensor): 3 (Vista Plus), 1 (Nuvant)	1 (wireless), disposable sensor
Recording duration: Up to 264 h (Vista Plus), Not known (Nuvant)	72 hours
Communication between sensor and recorder: Wires (Vista Plus), Bluetooth Technology (Nuvant)	Radiofrequency Technology
Sampling rate: 200 Hz (Vista Plus), Not known (Nuvant)	250 Hz
Resolution: 10 (Vista Plus), Not known (Nuvant)	12
Dynamic range: +/- 6 mV (Vista Plus), Not known (Nuvant)	+/- 6 mV
Bit resolution: 12 uV (Vista Plus), Not known (Nuvant)	12 uV
Memory type: CF card (Vista Plus), In sensor (Nuvant)	In recorder
Recording Full disclosure: Yes (Vista Plus), No (Nuvant)	Yes (All data can be retrieved via USB after examination)
Real time built in analysis: Yes, real time HR calculation (Vista Plus), In sensor for transmissions of irregular events (Nuvant)	Yes, HR analysis for real time viewed in Examiner (when connected via USB)
Patient trigger feature: Patient event key + voice recorder (Vista Plus), Activated by using a magnet over the sensor (Nuvant)	Patient Event Button on recorder
Pacer pulse detection and reporting: Yes (Vista Plus), No (Nuvant)	No
Replay and analysis system: Yes, Holter Soft Ultima (Vista Plus), Yes, telephonic transmission to Corventis server and analysis center (Nuvant)	Yes, viewed in Curvus Examiner and Analyzer
PC based: Yes (Vista Plus, Nuvant)	Yes
OS compatibility: Windows 98, NT, XP (Vista Plus), Not known (Nuvant)	Windows XP
Input data: CF card (Vista Plus), GSM transmitted data (Nuvant)	USB
Event list display: Yes (Vista Plus, Nuvant)	Yes
Arrhythmia detection: Yes (Vista Plus, Nuvant)	Yes
ECG strip edition and printing: Yes (Vista Plus, Nuvant)	Yes
QT-, HRV-, A-fib- analysis: Yes (Vista Plus), Not known (Nuvant)	No
ST analysis: Yes, multichannel (Vista Plus), No (Nuvant)	No
Archiving: Yes (Vista Plus, Nuvant)	Yes

2. Sample Size Used for the Test Set and Data Provenance

The provided summary states: "The Curvus Regular Holter System has been verified and validated according to the required specifications." However, it does not provide specific details about the sample size used for a test set or the provenance of the data (e.g., country of origin, retrospective or prospective). The validation mentioned appears to be related to meeting internal specifications rather than a clinical performance study using a defined test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. There is no mention of a ground truth established by experts for a specific test set.

4. Adjudication Method for the Test Set

No adjudication method is described as there is no detailed report of a performance study involving a test set with expert ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study is mentioned. The submission is for a Holter system that assists medical personnel in diagnosing arrhythmias, but it does not describe a study on the impact of its software on human reader performance. In 2010, the "AI" component would likely have referred to signal processing algorithms for arrhythmia detection, rather than advanced machine learning as understood today.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document mentions that the Curvus Analyzer "analyzes the retrieved data from the examination" and that the system has "Arrhythmia detection". It also states "Yes, HR analysis for real time viewed in Examiner (when connected via USB)". This indicates that the software performs its analysis independently of a human during the initial processing of the recorded data. However, this is not a formal "standalone performance study" with specific metrics (e.g., sensitivity, specificity) reported for its algorithmic performance against a ground truth. It is simply a functional description of the software's capabilities.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for any performance evaluation of the arrhythmia detection capabilities. Given that this is a 510(k) submission primarily for substantial equivalence based on technical specifications and functionality, a detailed clinical study with a rigorously established ground truth (e.g., expert consensus on ECGs) is not described in this summary.

8. The Sample Size for the Training Set

There is no mention of a training set sample size. This type of information is typically provided for devices utilizing machine learning or AI models, which were not explicitly the focus of 510(k) submissions in 2010 in the same way they are today. The device likely relies on established signal processing algorithms rather than trainable AI models.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as there is no mention of a training set or ground truth for such a set.

Summary

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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 RegularHolter System(subject device)	Vista Plus HolterRecorder	Nuvant MobileCardiac TelemetrySystem
Physiologicalparameters	ECG, Heart Rate,Activity	ECG, Heart rate	ECG, Heart Rate,Activity, Posture,Body Temperature,Respiration RateBody Fluid Status
Displays findings inReal Time	No	No	Yes
Number of channels	1	1- 3	1
Number ofelectrodes (sensor)	1 (wireless),disposable sensor	3	1 (wireless)
Recording duration	72 hours	Up to 264 h	Not known
Communicationbetween sensor andrecorder	RadiofrequencyTechnology	wires	Blue ToothTechnology
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 Fulldisclosure	Yes (All data can beretrieved via USBafter examination)	Yes	No (Data collectedwhen the device isfirst applied,irregular events andpatient triggeredevents)
Real time built inanalysis	Yes, HR analysisfor real time viewedin Examiner (whenconnected via USB	Yes, real time HRcalculation	In sensor fortransmissions ofirregular events
Patient triggerfeature	Patient EventButton on recorder	Patient event key +voice recorder	Activated by usinga magnet over thesensor
Pacer pulsedetection andreporting	No	Yes	No
Replay and analysissystem	Yes, viewed inCurvus Examinerand Analyzer	Yes, Holter SoftUltima	Yes, telephonictransmission toCorventis server.and analysis center.
	Curvus RegularHolter System(subject device)	Vista Plus HolterRecorder	Nuvant MobileCardiac TelemetrySystem
PC based	Yes	Yes	Yes
OS compatibility	Windows XP	Windows 98,NT,XP	Not known
Input data	USB	CF card	GSM transmitteddata
Event list display	Yes	Yes	Yes
Arrhythmiadetection	Yes	Yes	Yes
ECG strip editionand printing	Yes	Yes	Yes
QT-, HRV-, A-fib-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 (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

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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 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 | |

Regulation Number and Section

§ 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.