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510(k) Data Aggregation
(127 days)
The disposable ECG cable is intended to be used with ECG. The device is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
The device is an external device used to transmit ECG signals from electrodes that are affixed to the patient's body for both diagnostic and monitoring purposes. One end of each leadwire is attached to ECG patient electrodes; the other end is affixed / molded into one end of the trunk cable which are plug into an ECG monitor. The proposed device is disposable.
The provided text describes a 510(k) premarket notification for a "Disposable ECG Cable" (K200026) and a comparison with a predicate device. This submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets acceptance criteria in the way this request envisions (e.g., performance metrics like sensitivity/specificity for an AI algorithm).
Medical devices like ECG cables are typically evaluated against established technical standards and for safety and effectiveness, rather than having acceptance criteria and performance reported in terms of diagnostic accuracy metrics.
Therefore, many of the requested points are not applicable to this type of device submission. However, I can extract the relevant information.
Acceptance Criteria and Device Performance for Disposable ECG Cable (K200026)
Based on the provided document, the "acceptance criteria" are derived from compliance with recognized international and national standards for medical electrical equipment and biocompatibility. The "reported device performance" is demonstrated through successful adherence to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Standard Complied With) | Reported Device Performance (Compliance Statement) |
|---|---|---|
| Electrical Safety | IEC 60601-1: 2005+CORR.1: 2006+CORR.2: 2007+A1: 2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance) | Complied with IEC 60601-1 |
| ANSI/AAMI EC53: 2013 (ECG Trunk Cables and Patient Leadwires) | Complied with EC53 | |
| Biocompatibility | ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | Complied with ISO 10993-5 (Cytotoxicity evaluation conducted) |
| ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) | Complied with ISO 10993-10 (Sensitization and Irritation evaluation conducted) | |
| FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | Biocompatibility evaluation conducted in accordance with FDA Guidance for ISO 10993-1 | |
| Intended Use | Substantial equivalence in intended use to predicate device, connecting electrodes to ECG for monitoring/diagnostic evaluation. | "The intended use and technological features of the proposed subject device do not substantially differ from the legally marketed predicate device." |
| Materials | No new questions of safety and effectiveness raised by differing materials (TPU, Gold plated brass vs. TPU, PET, Nickel plated brass) | Tested according to ISO 10993-5 and ISO 10993-10 to ensure safety. "Therefore, this difference does not raise new questions of safety and effectiveness for subject device." |
| Usage (Disposable) | No new questions of safety and effectiveness raised by disposable vs. reusable usage. | Tested according to IEC 60601-1 and EC53. "Therefore, this difference does not raise new questions of safety and effectiveness for subject device." |
| Patient End Termination | No new questions of safety and effectiveness raised by differing termination type (Clip vs. Banana, Snap). | Tested according to IEC 60601-1 and EC53. "Therefore, this difference does not raise new questions of safety and effectiveness for subject device." |
Study Details:
For a device like an ECG cable, the "study" is typically a series of non-clinical bench tests and biocompatibility assessments demonstrating compliance with the aforementioned standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified in terms of distinct units. The testing is performed on samples of the device as required by the standards (e.g., number of units necessary to perform electrical safety tests, or for biocompatibility tests).
- Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. It indicates the manufacturer is in Shenzhen, China. The studies are prospective (tests performed specifically for this submission).
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)
- This question is Not Applicable (N/A) for this type of device. There's no "ground truth" to be established by clinical experts in this context. The performance is determined by meeting engineering and biological safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A: No adjudication method is used as there is no subjective assessment of clinical data or diagnoses involved. Compliance is determined by objective measurements against standard requirements.
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
- N/A: This is not an AI-enabled diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A: This is not an algorithm-based device. No standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A: For this device, "ground truth" is established by the specifications and measurable parameters defined in the referenced industry standards (e.g., electrical resistance limits, insulation integrity, biological response to materials).
8. The sample size for the training set
- N/A: This device does not involve machine learning or AI algorithms requiring a training set.
9. How the ground truth for the training set was established
- N/A: This device does not involve machine learning or AI algorithms.
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