(320 days)
Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
Integral-Process Medical Patient Cable and Leadwire Systems are electrical cables interfacing and connecting transducers/sensors/electrodes placed on patients, to monitoring/recording/diagnostic devices/equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use. This cabling facilitates the conduction of signals between the patient and the monitoring/recording/diagnostic device. Integral-Process manufactures all type of interfacing transducer and patient cables, as replacement cables and/or as sub-contractor of main brands. These Medical Patient Cable and Leadwire systems are divided into 3 categories: 1) Electrocardiograph (EKG/ECG) cables, 2) SpO2 cables, and 3) IBPT cables.
The provided text describes a 510(k) premarket notification for "Integral-Process Medical Patient and Leadwire Systems." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study to prove acceptance criteria for a novel device performance.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth used, how ground truth for training was established) are not applicable in this context, as they pertain to performance studies typically conducted for new or significantly modified devices, especially those involving AI/ML.
This submission is about establishing that a cable and leadwire system performs comparably to already approved cables.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device (Integral-Process Medical Patient Cable and Leadwire Systems) is a Class II medical device (Product Code: DSA, Regulation Number: 21 CFR 870.2900 - Cable, Transducer and Electrode, Patient, (Including Connector)).
For such devices seeking 510(k) clearance, acceptance criteria are generally met by demonstrating conformance to recognized consensus standards and by showing substantial equivalence to legally marketed predicate devices. The "performance" in this context refers to the device's ability to facilitate signal conduction and meet safety/electrical requirements, rather than a diagnostic or clinical performance metric.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance (Summary) |
|---|---|
| Electrical Performance & Safety: | Demonstrated conformance to relevant electrical safety and performance standards. |
| ANSI / AAMI EC53:1995 (R)2001 | |
| IEC 60601-1:1998; Am1; A2:1995 | |
| 21CFR898 (Electrode Lead Wires) | |
| AAMI/ANSI EC53:2013 (ECG Cables) | |
| IEC 60601-2-25:2011 (Electrocardiographs) | |
| IEC 60601-2-27:2011/AC1:2012 (ECG Monitoring) | |
| IEC 60601-2-34:2011 (IBP Monitoring) | |
| IEC 60601-2-49 2011 (Multi-function Monitoring) | |
| Biocompatibility: | Demonstrated conformance to relevant biocompatibility standards for skin-contact components. |
| ISO 10993-1 (Evaluation & Testing) | |
| ISO 10993-5 (In Vitro Cytotoxicity) | |
| ISO 10993-10 (Irritation & Sensitization) | |
| Risk Management: | Application of risk management processes per ISO 14971. |
| ISO 14971 2007 | |
| Quality System: | Manufacturing practices comply with quality system standards. |
| cGMP (21 CFR 820) | |
| ISO 13485:2012 / 2003 | |
| Mechanical Performance: | Demonstrated conformance to connector retention force standards. |
| ANSI / AAMI EC53A:1998 (R)2001 |
Explanation of "Study that Proves the Device Meets the Acceptance Criteria":
The document explicitly states: "Other effectiveness and safety compliance (electrical safety and biocompatibility of skin-contact components) to required standards and requirements are demonstrated in the market authorization file." This indicates that the "study" for these acceptance criteria involved testing against the listed consensus standards. While the specific test results are not detailed in this summary, the claim is that they exist in the full submission. The main "proof" of meeting acceptance criteria for a 510(k) is demonstrating that the device is "as safe, as effective for their intended use and perform as well as or better than the legally marketed devices." This is achieved through a comparison to predicate devices and showing conformance to recognized standards.
2. Sample Size Used for the Test Set and the Data Provenance:
- Test Set Sample Size: The document mentions that while there are around 1260 part numbers for cables, "a limited quantity of samples to have a good representation of the total range" was selected for comparison. This "sampling" approach is used to represent the different categories of connectors (monitor side, intermediate, yoke side leadwires, patient side leadwires). The specific number of each type of cable tested is not explicitly stated, but several examples are given in the comparison table (e.g., 72512-US, 70626NGJ3-US, 90797IP).
- Data Provenance: Not applicable for device performance testing here. The studies mentioned are primarily standard compliance tests on manufactured devices, not clinical data from patients. The manufacturer (INTEGRAL PROCESS SAS) is based in France.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This submission involves physical device testing against engineering and safety standards and a comparison against the technical characteristics of predicate devices. It does not involve human interpretation of medical images or data requiring expert "ground truth."
4. Adjudication Method for the Test Set:
- Not applicable. As there is no expert interpretation or human element involved in establishing "ground truth" for this type of device, an adjudication method is irrelevant.
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 device is a passive cable and leadwire system, not an AI or imaging device that would involve human readers or diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a cable system and does not contain an algorithm.
7. The Type of Ground Truth Used:
- For the purpose of establishing substantial equivalence and meeting safety/performance criteria, the "ground truth" is derived from:
- Consensus Standards: The requirements and methodologies defined in national and international standards (e.g., AAMI, IEC, ISO).
- Predicate Device Characteristics: The established design features, materials, and performance specifications of legally marketed predicate devices.
- Engineering Test Results: Measurements and observations from physical and electrical tests conducted on the Integral-Process cables themselves, demonstrating their conformity to established specifications.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set for an algorithm is involved.
§ 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).