(293 days)
Patient Monitoring Cables are intended to be used to connect sensors, placed at appropriate sites on the patient to a monitoring device for general monitoring by health care professional.
Patient Monitoring Cables (SpO2 Extension Cable, CR002-5301) is comprised of Plug, Cable/Leadwires and Connector. It's intended to plug into monitoring device and connect with SpO2 sensor, for transmitting signals which generated by SpO2 sensor to monitoring device.
The provided text describes the 510(k) premarket notification for a medical device: "Patient Monitoring Cable (SpO2 Extension Cable)" (K192404).
Based on the content, this document does not describe a study involving an AI/ML algorithm or human readers for diagnostic purposes. Instead, it details the substantial equivalence review for a physical medical cable. Therefore, many of the requested points regarding AI/ML device acceptance criteria and study designs are not applicable.
However, I can extract the relevant information regarding the acceptance criteria and the "study" (referring to the testing performed for this physical device) that proves it meets those criteria:
Device: Patient Monitoring Cable (SpO2 Extension Cable)
Purpose: Connects SpO2 sensors to a monitoring device to transmit signals.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance (as applicable for a physical cable):
| Acceptance Criteria (Standards/Tests) | Reported Device Performance (Compliance Statement) |
|---|---|
| Safety and Essential Performance (Electrical) | |
| IEC 60601-1: 2005+A1:2012 (Medical Electrical Equipment - Part 1: General Requirements for basic safety and essential performance) | "subject device has assessed the differences to US national standard (ANSI AAMI 60601-1: 2005/(R)2012 And A1:2012), and the test report attaches the compliance." (Section 8) |
| ANSI AAMI EC53: 2013 (ECG Trunk Cables And Patient Leadwires) | Evaluated by lab bench testing according to this standard. (Section 8, Section 10 - Electrical safety and Performance row) |
| ISO 80601-2-61: 2017-12 (Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment) | Evaluated by lab bench testing according to this standard. (Section 8, Section 10 - Electrical safety and Performance row) |
| Performance Accuracy (Data Integrity) | |
| Integrity testing (to prevent measured data corruption) | "Patient Monitoring Cables has also been evaluated the performance accuracy through integrity testing, which proves that no measured data corrupt during communication between SpO2 sensors and host monitors." (Section 8) |
| Biocompatibility (Patient Contact) | |
| ISO 10993-1 (General principles governing biological evaluation of medical devices) for: Cytotoxicity, Sensitization, Irritation | "Meets ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation" (Section 10 - Biocompatibility row). Specifically, "conduct biocompatibility test on the SpO2 extension cable CR002-5301 including the following: Cytotoxicity, Sensitization, Irritation" (Section 9). The cable jacket (TPU) is categorized as "Surface-contacting device: Patient Skin" with a contact duration of " |
§ 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).