K Number
K962547
Device Name
CARDIOSERV P
Date Cleared
1997-03-06

(251 days)

Product Code
Regulation Number
870.5550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia. CardioServ is intended to be used by trained operators CardioServ is designed for external and internal defibrillation (including cardioversion) CardioServ is capable of monitoring the heart rate with adjustable alarm limits. CardioServ is designed for external pacing with adjustable current and frequency. The intended use of CardioServ is identical to the intended use of the predicate devices.
Device Description
CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.
More Information

HELLIGE CardioServ SCP 910, Marquette Series 1500 Responder

HELLIGE CardioServ SCP 910, Marquette Series 1500 Responder

No
The summary describes a standard defibrillator with monitoring and pacing capabilities, and there is no mention of AI, ML, or related concepts.

Yes
The device is described as a defibrillator capable of external pacing, intended for emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia, which directly addresses medical conditions.

No
The device is primarily an emergency resuscitation and treatment device (defibrillator and external pacing) with monitoring capabilities, not a device whose primary intended use is to diagnose a condition.

No

The device description explicitly states it is a "portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing," which are all hardware components.

Based on the provided information, the CardioServ device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device used for the emergency resuscitation of cardiac arrest victims, clinical cardiac dysrhythmia, external and internal defibrillation, heart rate monitoring, and external pacing. These are all direct interventions and monitoring of the patient's physiological state, not tests performed on samples taken from the body.
  • Device Description: The description reinforces this by calling it a "portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing." These are all components of a device used for direct patient care and intervention.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.

Therefore, CardioServ is a medical device used for direct patient treatment and monitoring, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia.

  • CardioServ is intended to be used by trained operators
  • CardioServ is designed for external and internal defibrillation (including cardioversion)
  • CardioServ is capable of monitoring the heart rate with adjustable alarm limits.
  • CardioServ is designed for external pacing with adjustable current and frequency.

Product codes

Not Found

Device Description

CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained operators

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 results of these measurements demonstrated that CardioServ is as safe, as effective, and performs as well as the predicate devices CardioServ SCP 910 and Marquette Series 1500 Responder.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

HELLIGE CardioServ SCP 910, Marquette Series 1500 Responder

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).

(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”

0

KA62547

5

SECTION 2 - SUMMARY AND CERTIFICATION

MAR - 6 1997

2.1 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Submitter: | Marquette Electronics, Inc.
8200 W. Tower Avenue
Milwaukee, WI 53223
Telephone: (414) 355-5000
FAX: (414) 362-3553 | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------|----------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristin Pabst | | | | |
| Device: | Trade Name:CardioServ PClassification Name:DC-Defibrillator, low energy (including paddles)
Pacemaker, Cardiac, External Transcutaneous (Non-invasive) | Trade Name: | CardioServ P | Classification Name: | DC-Defibrillator, low energy (including paddles)
Pacemaker, Cardiac, External Transcutaneous (Non-invasive) |
| Trade Name: | CardioServ P | | | | |
| Classification Name: | DC-Defibrillator, low energy (including paddles)
Pacemaker, Cardiac, External Transcutaneous (Non-invasive) | | | | |
| Predicate Devices: | HELLIGE CardioServ SCP 910
Marquette Series 1500 Responder | | | | |
| Device Description: | CardioServ is a portable defibrillator with ECG monitor, built-in recorder, and the capability of external pacing with adjustable current and frequency. | | | | |
| Intended Use: | CardioServ is intended to be used for the emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia.
CardioServ is intended to be used by trained operatorsCardioServ is designed for external and internal defibrillation (including cardioversion)CardioServ is capable of monitoring the heart rate with adjustable alarm limits.CardioServ is designed for external pacing with adjustable current and frequency. The intended use of CardioServ is identical to the intended use of the predicate devices. | | | | |

510(k) Notification "CardioServ P" - June 26, 1996

1

6

Technology:

Performance:

CardioServ employs the same technology as the predicate devices.

CardioServ complies with the voluntary standards ANSI/AAMI DF2-1989, ANSI/AAMI ES1 1993, IEC 601-1, IEC 601-1-2, IEC 601-2-4, EN 60601-2-31.

The following quality assurance measures were applied to the development of CardioServ:

Requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group, field tests.

The results of these measurements demonstrated that CardioServ is as safe, as effective, and performs as well as the predicate devices CardioServ SCP 910 and Marquette Series 1500 Responder.