(258 days)
The ARROW catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). The second pressure lumen allows infusion of a solution with simultaneous measurement of pressure. The catheter is intended for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording only.
The ARROW Bipolar Pacina/Balloon Wedge Pressure Catheter is made of radiopaque polymenc tubing marked in 10 cm increments. The catheter body contains two separate pressure lumens, and a balloon inflation lumen, which lie parallel to each other and then form separate extensions at the proximal end of the catheter. The pressure lumens have female Luer fittings at extensions at the proximal end of the catheter. The "distal" pressure lumen terminates in an opening at the distal tip of the catheter. The "proximal" pressure lumen terminates in an opening 29,5 cm, proximal to the tip. The catheter electrically conducts through the use of two 2 mm platinum electrodes, located at 14 and 15.2 cm from the distal tip. This connection terminates proximal to the molded juncture with two extension leads marked "d" for distal and "p" for proximal.
This submission, K9600479, describes a medical device, the ARROW Bipolar Pacing/Balloon Wedge Pressure Catheter. The 510(k) summary provided primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and nonclinical bench testing. It does not contain the information necessary to fully answer all aspects of your request regarding clinical acceptance criteria and the study proving device performance against those criteria.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Study Details for K9600479
1. Table of Acceptance Criteria and Reported Device Performance
The provided text lists several nonclinical bench tests performed. It does not explicitly state "acceptance criteria" in a quantitative manner (e.g., "flow rate must be > X ml/min") nor does it provide the exact "reported device performance" values for these tests. Instead, it makes a general statement: "The nonclinical test results included in the submission comparable performance to the Elecath® device are as follows:". This suggests the acceptance criteria were likely comparative to the predicate device's performance for each test, but the specifics are not detailed.
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Catheter flow rate testing | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Column strength test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Balloon multiple inflation test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Tube electrode torque test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Catheter/electrode torque test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Catheter body torque test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Flexural modulus test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Juncture lead pull test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Electrical continuity test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Signal to noise ratio test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Impedance testing | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| High pot test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Catheter capacitance/inductance test | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
| Radiopacity testing | Comparable to Elecath® Ventricular Pacewedge® (K832850, K844003) | Comparable to Elecath® predicate device |
Missing Information: Specific quantitative acceptance criteria or numerical results for each test are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention any clinical test set, human subject data, or patient data. The "tests" listed are nonclinical bench tests. Therefore, sample size and data provenance in the context of clinical studies are not applicable based on this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as no clinical study or human data requiring expert ground-truthing is described in the provided 510(k) summary.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical study or human data requiring adjudication is described in the provided 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or mentioned. This type of study is relevant for evaluating diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The described device is a catheter, and the evaluation is based on its physical and electrical properties.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable in the context of this device. A "standalone" performance evaluation typically refers to the performance of an algorithm or AI system independent of human input, a concept primarily relevant to AI/ML software as a medical device. The tests performed are on a physical catheter device.
7. The Type of Ground Truth Used
The "ground truth" for the nonclinical bench tests would be established by engineering specifications, industry standards, or the performance characteristics of the predicate devices. For example, the "true" flow rate or electrical resistance as measured by calibrated equipment. There is no mention of expert consensus, pathology, or outcomes data, as these relate to clinical data which is not discussed.
8. The Sample Size for the Training Set
There is no mention of a training set. This device is a physical catheter, not an AI/ML algorithm that requires a training set. The tests described are engineering and materials performance tests.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as neither a training set nor an AI/ML algorithm is mentioned.
Summary of Missing Information and Scope Limitation:
The provided 510(k) summary for K9600479 focuses entirely on demonstrating substantial equivalence through nonclinical bench testing and comparison of technological characteristics to predicate devices. It does not include details about clinical studies, human subject data, or AI/ML algorithm performance. Therefore, many of your questions related to clinical acceptance criteria, human reader studies, and AI ground truth are beyond the scope of the provided text.
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.