(6 days)
The CROSSER™ Recanalization System is indicated · to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy. The device is contraindicated for use in carotid arteries.
The CROSSER™ Catheter is only intended for use with the CROSSER™ Generator. Refer to the CROSSER™ Generator Manual of Operations for proper use.
The CROSSER™ Recanalization System is a high frequency mechanical vibration device designed for placement of guidewires through obstructed peripheral arteries by the removal or reduction of occlusive material. The system consists of an electronic CROSSER™ Generator, Foot Switch, high frequency Transducer, single-use CROSSER™ Catheter and sterile drape. The catheters are offered in a variety of configurations as shown in the table below. The system is required to be used with a power injector system for the delivery of saline. The CROSSER™ Catheter, which is intended for one procedure only, is connected to the CROSSER™ Generator through the high frequency The Foot Switch is used to activate the CROSSER™ System. The Transducer. CROSSER™ Generator and Transducer convert AC power into high frequency mechanical vibrations, which are propagated through a Nitinol core wire to the titanium or stainless steel tip of the CROSSER™ Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter. The vibrational energy ablates intravascular plaque by mechanical impact and cavitational effects.
The provided document, K112308, describes the CROSSER™ Recanalization System. However, it explicitly states that no new clinical studies or in-vivo tests were conducted for this 510(k) submission. Instead, it refers to prior bench testing and relies on the substantial equivalence to predicate devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria (especially clinical performance) is largely absent from this specific document.
Here's a breakdown based on the provided text, highlighting the absence of certain requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of specific acceptance criteria (e.g., success rates, safety endpoints) and corresponding device performance from a new study. It mentions an evaluation of "technological characteristics and performance criterion... through bench testing" and that the "Crosser System previously met all requirements."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined in this document for the specific 510(k) filing) | (Not explicitly reported from new studies in this document for the specific 510(k) filing) |
| Implied: Substantial Equivalence to predicate devices in terms of: | The device satisfied design requirements related to the modified indications for use statement, based on applicable standards, guidance, test protocols, and/or customer inputs. |
| - Similar intended use | Confirmed to have similar intended use as all predicates. |
| - Similar indications for use | Confirmed to have similar indications for use as all predicates, with a clarification of the atherectomy mechanism of action. |
| - Same target population | Confirmed to have the same target population as all predicates. |
| - Same fundamental scientific technology | Confirmed to have the same fundamental scientific technology as all predicates. |
| - Same/similar operating principle | Confirmed to have the same operating principle as Crosser predicates and similar to Diamondback and Jetstream predicates. |
| - Same mechanism of action | Confirmed to have the same mechanism of action as all predicates. |
| - Same materials (Crosser predicates) | Confirmed. |
| - Same packaging materials and configuration (Crosser predicates) | Confirmed. |
| - Same sterility assurance level and method of sterilization (Crosser predicates) | Confirmed. |
| - Facilitate intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions via atherectomy | This is the updated indication for use, which the device is claimed to meet based on substantial equivalence and prior testing. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/not provided for any new test set in this document. The submission relies on prior bench testing and established equivalence.
- Data Provenance: Not applicable/not provided for any new test set in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided because there was no new clinical test set with human-established ground truth. The submission refers to "internal Risk Assessment procedures" and "applicable standards, guidance, test protocols and/or customer inputs" from prior evaluations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/not provided, as there was no new clinical test set requiring adjudication 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 device is a mechanical medical device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an algorithm. Its performance is inherent to its mechanical and functional design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k) submission, the "ground truth" for substantial equivalence was based on bench testing for technological characteristics and performance criterion, and the previously established "requirements" from the original Crosser System clearances, as well as the indications for use and technological principles of the listed predicate devices (Diamondback 360 Orbital Atherectomy System and Jetstream System). No new pathology or outcomes data were presented.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this mechanical device submission.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this mechanical 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).