(76 days)
The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut- Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.
The Cutter is an accessory manufactured for use with the RAPIDO Cut-Away Guiding Catheter, for the treatment of Congestive Heart Failure. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. This new removal process is necessitated by the larger IS-1 terminal pin that future leads will incorporate. The Cutter currently has only one manufacturing configuration.
The Cutter consists of three sections; A handle, a stainless steel blade and a lead management section. The lead management section stabilizes the lead, prior to, and during the cutting procedure. After the lead has been fixed in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the doctor pulls the catheter against the cutter blade. The hub is cut first and then the catheter section.
The provided text describes a medical device, the RAPIDO™ Cut-Away™ Cutter, and its clearance through the 510(k) pathway. This means it was found substantially equivalent to a predicate device, not necessarily that a full clinical study demonstrating its effectiveness against specific acceptance criteria was conducted or described in detail in this summary.
Based on the provided information, I can extract what is explicitly stated or can be reasonably inferred. Many of your requested details (e.g., sample size for the test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not typically part of a 510(k) summary for a device like this (a mechanical cutter) and are not included in the provided text. The performance data section is brief and refers to "acceptance criteria" but does not detail them.
Here's a breakdown of what can be provided from the text, with an acknowledgment of the missing information for other sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to cut the guiding catheter after lead implantation | "Testing demonstrated that the RAPIDO Cut-Away Cutters met the acceptance criteria and performed similarly to the predicate device." |
| No new safety issues | "No new safety or effectiveness issues were raised during the testing program." |
| No new effectiveness issues | "No new safety or effectiveness issues were raised during the testing program." |
| Substantial equivalence to predicate device (Medtronic Attain Cutter) in design and intended use | "The Guidant RAPIDO Cut-Away Cutters are substantially equivalent to the currently marketed Medtronic Attain Cutters (K024035, cleared 12/30/02) with regards to intended use and design." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified. It's highly likely to be internal engineering/bench testing rather than human clinical data, given the device type and 510(k) summary context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable/not specified. This type of device's performance evaluation typically relies on objective physical testing rather than expert-established ground truth in a diagnostic sense.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC study was almost certainly not done. This type of study is relevant for diagnostic imaging or interpretation tasks, not for a mechanical cutter.
6. If a Standalone (Algorithm Only) Performance Study was done
- Standalone Study: Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: For this mechanical device, "ground truth" would likely be defined by engineering specifications and objective measurements (e.g., successful cutting, intact lead after cutting, material integrity, force required). The summary states "Testing demonstrated that the RAPIDO Cut-Away Cutters met the acceptance criteria," implying these objective measures were successfully achieved.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This is a mechanical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth was Established: Not applicable.
§ 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).