(144 days)
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.
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.
The provided text describes a medical device, the "CardioServ S," which is a portable defibrillator with ECG monitor and O₂ saturation monitoring capabilities. However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details related to an AI/machine learning component.
The "Performance" section explicitly states that "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." It also mentions "Requirements specification reviews, code inspections, software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group, field tests" as quality assurance measures. The conclusion is that "CardioServ is as safe, as effective, and performs as well as the predicate devices CardioServ SCP 910 and NELLCOR Escort 300 Series."
Therefore, based on the provided text, I cannot fulfill your request for the following information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on regulatory compliance through adherence to voluntary standards and comparison to predicate devices, rather than a performance study with specific metrics and acceptance criteria as described in your request, which are typically associated with AI/ML-driven medical devices.
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962551
NOV 1 9 1996
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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 AvenueMilwaukee, WI 53223Telephone: (414) 355-5000FAX: (414) 362-3553 |
|---|---|
| Contact Person: | Kristin Pabst |
| Device: | Trade Name: CardioServ SClassification Name: DC-Defibrillator, low energy (including paddles)Oximeter |
| Predicate Devices: | HELLIGE CardioServ SCP 910NELLCOR 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 withadjustable alarm limits. |
| Intended Use: | CardioServ is intended to be used for the emergencyresuscitation of cardiac arrest victims and clinical cardiacdysrhythmia. |
| ♦ 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 withadjustable alarm limits. | |
| ♦ CardioServ is capable of monitoring the saturation of O₂ withadjustable alarm limits. | |
| The intended use of CardioServ is identical to the intended use of thepredicate 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
§ 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.