(85 days)
CP Medical's Disposable Temporary Pacing Cable with safety connectors is indicated for use as an electrical extension cable used to transmit signal from, or power or excitation signal to, patient-connected electrodes. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device, i.e., analyzer. The alligator clips are color-coded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-).
The cable is designed to carry a maximum electrical load of 300 volts, and will be compatible with most external pacemakers, pace analyzers, and patient pacing leads currently on the market.
The cable is a sterile or nonsterile, disposable device.
The CP Medical device consists of 22-gauge metallic wire and safety connectors for cardiovascular monitoring application. The cable is bipolar, providing alligator clips at the end of the cable that will be attached to the patient's lead, and a safety plug at the other end that allows electrical connection to the external pacemaker or testing device (i.e., analyzer). The alligator clips are colorcoded and imprinted with the polarity: The red clips are positive (+) and the black clips are negative (-). The cable is a sterile (or OEM non-sterile), disposable device.
The provided document (K022075) describes a 510(k) premarket notification for a medical device: the CP Medical Disposable Temporary Pacing Cable. This device is a simple electrical cable used to transmit signals or power, not an advanced diagnostic or therapeutic device that would typically involve a detailed clinical study with performance metrics like sensitivity, specificity, or reader studies.
Therefore, the requested information regarding acceptance criteria and performance studies, as it applies to software or diagnostic AI devices, is not applicable to this submission. This 510(k) relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to recognized standards for electrical safety and manufacturing.
Here's why the questions are not applicable and what information is available in the document:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. Acceptance criteria for this type of device focus on manufacturing quality, material compatibility, electrical safety, and adherence to established standards, rather than diagnostic performance metrics.
- Information available: The submission states that the "Manufacture of this device, and QC testing, will be in substantial compliance with current ANSI/AAMI EC53:1995, EC53:1998 amendment, IEC 60601 subclause 56.3 and 21CFR 820 (QSR)." These are standards for medical electrical equipment and quality systems, which serve as the "acceptance criteria" for its design and manufacturing. The device is designed to carry a maximum electrical load of 300 volts and be compatible with external pacemakers, pace analyzers, and patient pacing leads.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set of patient data or clinical images is involved. Testing would involve engineering verification and validation against the specified electrical and mechanical properties, not clinical outcomes from a "data set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here. The "truth" for this device would be its ability to safely and effectively conduct electrical signals as designed, which is assessed through engineering testing and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication of clinical cases or data is relevant for this type of device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a passive medical component, not an AI-powered diagnostic or assistive tool. MRMC studies are completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this device's safety and effectiveness lies in its adherence to recognized electrical and material standards, and its demonstrated ability to function as an electrical conductor as intended. This is typically verified through bench testing and compliance documentation.
8. The sample size for the training set:
- Not Applicable. This device is not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used.
Summary in relation to the prompt:
The K022075 submission for the CP Medical Disposable Temporary Pacing Cable is a traditional 510(k) based on substantial equivalence to a predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to engineering and quality control testing performed during manufacturing, ensuring the device meets its design specifications (e.g., maximum voltage capacity, material composition, electrical safety) and complies with relevant industry standards (ANSI/AAMI EC53, IEC 60601, 21 CFR 820). It explicitly states that "Manufacture of this device, and QC testing, will be in substantial compliance with current ANSI/AAMI EC53:1995, EC53:1998 amendment, IEC 60601 subclause 56.3 and 21CFR 820 (QSR)." These standards inherently contain the "acceptance criteria" for such a device.
§ 870.2900 Patient transducer and electrode cable (including connector).
(a)
Identification. A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.(b)
Classification. Class II (performance standards).