(163 days)
The C3 Wave System is indicated for use as a supplemental aid in positioning for Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy). Note: Limiting, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P wave: atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and cronic obstructive pulmonary disease (COPD). Such patients are easily identified prior to PICC insertion. Use of additional confirmation method is necessary to confirm catheter tip location.
The C3 Wave system includes the iPad® monitor running the mobile application software, the C3 hub (a battery and power supply cord for the hub), a remote control, and an ECG clip cable (alligator clip). Procedural accessories include the ECG snap leads, ECG patient cable, ECG electrodes, remote cover, and prep pads which are provided as a convenience to the clinician.
The provided text describes the C3 Wave device and its regulatory submission, but it does not contain the detailed study information required to fully answer your request.
Specifically, the document states:
- "Design verification and validation activities were performed in accordance with Design Control requirements per 21 CFR 820.30 and demonstrate that the subject C3 Wave system meets predetermined performance specifications."
- "The performance evaluation plan included testing per the following recognized standards to assess conformance to IEC 60601-1 (3rd Edition). IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety - IEC 60601-1-2 Medical Electrical Equipment - Part 2: General Requirements for Basic Safety and Essential Performance - Collateral Standard Electro Magnetic Compatibility - Requirements and Test"
However, it does not provide:
- A table of acceptance criteria for its core function (PICC tip location) and the reported device performance against those criteria.
- Details on the sample size for any clinical test set or its provenance.
- The number or qualifications of experts used for ground truth.
- Adjudication methods.
- Whether MRMC, standalone, or training set studies were performed, or the details of these if conducted.
- The type of ground truth used for assessing PICC tip location accuracy.
The document focuses on regulatory compliance, electrical safety standards (IEC 60601 series), and biocompatibility testing for materials that may contact the patient. These are important for device safety and general performance but do not detail the clinical performance validation for its primary "PICC tip location" function.
Therefore, I cannot fully complete the table or answer all your questions with the provided text.
Here's what can be extracted and what is missing:
Acceptance Criteria and Study Details for C3 Wave System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for PICC Tip Location Accuracy) | Reported Device Performance |
|---|---|
| Not specified in text | Not specified in text |
Note: The document mentions performance testing relating to electrical safety (IEC 60601 series) and biocompatibility (ISO 10993-1), which the device passed. However, it does not provide acceptance criteria or performance data for the primary function of "real-time catheter tip location information by using the patient's cardiac electrical activity" in terms of accuracy or precision relative to a ground truth.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for clinical efficacy.
- Data Provenance: Not specified for clinical efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- Not specified. The device is for "real-time catheter tip location information" and acts as a "supplemental aid," but no details of human-in-the-loop performance studies are provided.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not specified for clinical performance. The functional descriptions imply standalone capability to detect P-wave changes, but explicit standalone clinical accuracy metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified for clinical efficacy. The Indications for Use state, "Confirmation of tip placement should be verified according to clinical judgement and established hospital protocol (e.g., Chest X-Ray, Fluoroscopy)," implying these might be used as ground truth in a clinical study, but no study details are provided.
8. The sample size for the training set:
- Not specified.
9. How the ground truth for the training set was established:
- Not specified.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”