(144 days)
HELLIGE CardioServ SCP 910, NELLCOR Escort 300
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No
The document does not mention AI, ML, or related concepts, and the device description focuses on standard defibrillator and monitoring functions.
Yes
The device is intended for emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia, which describes a therapeutic purpose.
Yes
Explanation: The device description states it has an "ECG monitor" and is "capable of monitoring the heart rate" and "monitoring the saturation of O₂". These functions involve observing and measuring physiological parameters to understand a patient's condition, which falls under the definition of diagnosis or monitoring for diagnostic purposes.
No
The device description explicitly states it is a "portable defibrillator with ECG monitor, built-in recorder, and the capability of monitoring the saturation of O₂". These are hardware components, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- CardioServ's Function: The description of CardioServ clearly indicates it is a device used for external and internal defibrillation and monitoring of vital signs (heart rate and oxygen saturation). These are direct interventions and measurements on the patient's body, not tests performed on samples outside the body.
- Intended Use: The intended use is for "emergency resuscitation of cardiac arrest victims and clinical cardiac dysrhythmia," which involves direct medical intervention.
Therefore, CardioServ falls under the category of a therapeutic and monitoring medical device, 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 capable of monitoring the saturation of O₂ with adjustable alarm limits.
The intended use of CardioServ is identical to the intended use of the predicate devices.
Product codes
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Device Description
CardioServ S is a portable defibrillator with ECG monitor, built-in recorder, and the capability of monitoring the saturation of O₂ with adjustable alarm limits.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
trained operators
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CardioServ complies with the voluntary standards ANSI/AAMI DF2-1989, ANSI/AAMI ES1-1993. IEC 606-1. IEC 601-1-1, IEC 601-2-4, and prEN865.
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 NELLCOR Escort 300 Series
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
HELLIGE CardioServ SCP 910, NELLCOR Escort 300
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
962551
NOV 1 9 1996
Image /page/0/Picture/2 description: The image contains a single digit, specifically the number 5. The number is presented in a bold, sans-serif font. It is centered within a white square, with a thin gray border outlining the square's perimeter.
SECTION 2 - 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 S
Classification Name: DC-Defibrillator, low energy (including paddles)
Oximeter |
| Predicate Devices: | HELLIGE CardioServ SCP 910
NELLCOR Escort 300 |
| Device Description: | CardioServ S is a portable defibrillator with ECG monitor,
built-in recorder, and the capability of monitoring the saturation of O₂ with
adjustable alarm limits. |
| 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 capable of monitoring the saturation of O₂ with
adjustable alarm limits. |
| | The intended use of CardioServ is identical to the intended use of the
predicate devices. |
| Technology: | CardioServ employs the same technology as the predicate devices. |
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6
Performance:
CardioServ complies with the voluntary standards ANSI/AAMI DF2-1989, ANSI/AAMI ES1-1993. IEC 606-1. IEC 601-1-1, IEC 601-2-4, and prEN865.
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 NELLCOR Escort 300 Series