(8 days)
The Attain™ Prevail® Left Heart Delivery System is indicated to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart.
The Medtronic Attain™ Prevail® Left Heart Delivery System features a steerable catheter and accessories to provide a pathway for delivery of transvenous devices to the coronary sinus and coronary vasculature of the heart. The components of the Attain Prevail Left Heart Delivery System include: Prevail steerable catheter, 45 cm straight guide catheter, 50 cm straight guide catheter, 0.016" stainless steel guide wire, 0.035" stainless steel guide wire, 3- way stopcock, Universal slitter, Introducer valve, Guide catheter dilator, Y-connector with adjustable hemostasis valve assembled with an extension tube, Guide wire torque tools, Guide wire clips. The Prevail steerable catheter features a single lumen for passage of devices up to 0.035' (0.89 mm) diameter or injection of contrast solutions. Transvenous devices with an inner diameter of 7 French (2.3 mm) or larger can be loaded on and delivered over the Prevail catheter. The catheter features a steerable distal section and is radiopaque for visibility under fluoroscopy. The Attain Prevail Left Heart Delivery System is provided STERILE and is intended for single use only.
Here's an analysis of the provided 510(k) summary, specifically addressing your questions about acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not detail specific, quantitative acceptance criteria for the device's performance. Instead, it makes a general statement:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| All specified design and performance requirements met. | "The Attain Prevail Left Heart Delivery System met all specified design and performance requirements." |
| Biocompatibility consistent with ISO-10993 requirements. | "All specified biocompatibility requirements were met." |
| Sterilization validation through an Ethylene Oxide (EtO) process. | "The Attain Prevail Left Heart Delivery System will be sterilized using a validated Ethylene Oxide (EtO) sterilization process." |
2. Sample Size Used for the Test Set and Data Provenance
The summary states, "Verification testing included system compatibility and packaging integrity testing." However, it does not specify the sample size used for these tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. The type of testing described (system compatibility, packaging integrity, biocompatibility) typically does not involve human expert adjudication in the same way, for example, an imaging diagnostic AI would.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the "verification testing" described, it's unlikely a formal human adjudication method (like 2+1 or 3+1) was employed. These tests would usually involve objective measurements and established protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in interpreting medical images or data. The Attain™ Prevail® Left Heart Delivery System is a physical medical device (a catheter and delivery system) used in procedures, not a diagnostic algorithm.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. As explained above, this device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device would be established by objective physical and chemical testing. For example:
- System Compatibility: Successful deployment of transvenous devices through the Prevail catheter, without entanglement, breakage, or failure to deliver within specified tolerances.
- Packaging Integrity: Maintenance of sterility and physical integrity of the product after simulated transport and storage.
- Biocompatibility: Laboratory tests (e.g., cytotoxicity, sensitization, irritation) according to ISO-10993 standards, demonstrating the materials do not elicit an adverse biological response.
- Sterilization Validation: Confirmation that the Ethylene Oxide (EtO) process achieves a specified sterility assurance level (SAL).
8. Sample Size for the Training Set
This is not applicable and not provided. The Attain™ Prevail® Left Heart Delivery System is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As explained in point 8, there is no "training set" for this device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).