(85 days)
The Progreat™ is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities, visceral vessels, and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis in procedures including but not limited to Uterine Fibroid Embolization. The Progreat should not be used in cerebral vessels.
The Progreat catherer is available with or without the following accessories: guide wire, inserter, mandrel (stylet), syringe, wire stopper, and Y-connector. The catheter consists of metal coil reinforced multi-layer polymer tubing. The coil is embedded in the catheter wall the entire length of the catheter. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer which becomes lubricious when wet with saline solution or blood.
This document outlines an application for clearance of a medical device, the Progreat™ catheter, based on substantial equivalence to a previously cleared device (K033583). As such, it does not contain a study report for the device meeting specific quantitative acceptance criteria in the way a medical AI product might.
Therefore, many of the requested sections (2-9) regarding sample size, ground truth, expert adjudication, and comparative effectiveness studies are not applicable to this type of regulatory submission (a 510(k) for substantial equivalence of a physical device with minor changes/expanded indications where no new performance data was required).
However, I can extract information related to the device description, intended use, and the basis for its perceived performance and safety as presented.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Infusion of contrast media into specified peripheral, upper/lower extremity, visceral, and coronary vessels. Drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis (including UFE). | The Progreat™ is intended for these uses. (This reflects its design purpose, rather than a quantifiable performance metric in this context). |
| Safety (Biocompatibility) | Blood contacting materials must be biocompatible per FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993. | "Results of the testing demonstrate that the blood contacting materials are biocompatible." |
| Safety (Sterilization) | Sterilization conditions validated to a SAL of 10^-6 per AAMI/ANSI/ISO 11135 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. ETO residuals within maximum limits proposed for Part 821 of Title 21 in FR June 23, 1978. | "Sterilization conditions have been validated in accordance to AAMI/ANSI/ISO 11135... The device is sterilized to a SAL of 10^-6. ETO residuals for the Progreat will not exceed the maximum limits proposed..." |
| Performance (General) | Demonstrate performance substantially equivalent to the predicate device (K033583). No new issues of safety and effectiveness with expanded indications. | "This device is the identical device cleared under K033583... There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary. Therefore the performance of the Progreat Catheter is substantially equivalent to the performance of the Progreat, cleared under K033583." |
| Design/Materials | Identical design and materials to previously cleared device (K033583). | "This device is the identical device cleared under K033583. There are no material or design changes therefore there are no new issues of safety and effectiveness." |
| Risk Management | Risk/hazard analysis conducted according to EN1441 and ISO 14971. | "A risk/hazard analysis was conducted according to EN1441 Medical devices- Risk analysis and ISO 14971 Medical Devices -Application of risk management to medical devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is based on substantial equivalence to a prior device where no new performance testing data (i.e., a "test set") was required for the expanded indications. The performance is deemed identical to the predicate device due to identical design and materials.
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)
- Not Applicable. As no new performance studies were conducted, there was no test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set was used for performance evaluation in this submission.
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 is a physical medical device (catheter), not an AI diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth, in the context of performance studies for diagnostic or AI devices, is not relevant here as no such studies were performed for this substantial equivalence application. The "ground truth" for this device's safety and effectiveness relies on the previously cleared device's performance, safety, and the adherence to recognized standards for biocompatibility and sterilization.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of AI or machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" here is not an empirical performance trial but rather a demonstration of substantial equivalence to a previously cleared predicate device (K033583) and adherence to recognized standards.
The principal arguments for meeting acceptance criteria are:
- Identical Device: The Progreat™ catheter submitted in K033913 is explicitly stated as being the "identical device" cleared under K033583, with no material or design changes. This implies that its performance characteristics (e.g., flexibility, kink resistance, pressure resistance, smooth movement of guide wires) are the same as the predicate.
- Expanded Intended Use with No New Safety/Effectiveness Issues: The new application expands the intended use to include additional vessels and specific procedures like Uterine Fibroid Embolization. However, the submitter asserts that "There were no new issues of safety and effectiveness with regards to the new indication. No additional testing was deemed necessary." This implies that the existing safety and performance profile of the identical device is considered sufficient for these expanded indications.
- Adherence to Standards:
- Risk Management: A risk/hazard analysis was performed according to EN1441 and ISO 14971, indicating a structured approach to identifying and mitigating risks.
- Biocompatibility: Blood-contacting materials were tested in accordance with ISO-10993, and results demonstrated they are biocompatible.
- Sterilization: Sterilization conditions were validated to a Sterility Assurance Level (SAL) of 10^-6 according to AAMI/ANSI/ISO 11135, and ETO residuals meet regulatory limits.
- Accessories: The accessories supplied with the Progreat™ are also the "same as the ones used with the currently cleared device K033583."
In essence, the "proof" that the device meets acceptance criteria is the argument of substantial equivalence based on:
- Being the exact same device as a previously cleared one.
- Demonstrating that the expanded indications for use do not introduce new safety or effectiveness concerns.
- Compliance with established regulatory standards for biocompatibility, sterilization, and risk management.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).