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510(k) Data Aggregation
(23 days)
The PVS 1700 Steerable Delivery System®-10 Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.
The PVS 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominal distal/proximal) tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.0165". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.
The provided document is a 510(k) summary for a medical device (PVS 1700 Steerable Delivery System®-10 Microcatheter), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.
Therefore, many of the requested details about specific acceptance criteria from a clinical study, sample size, expert ground truth establishment, and MRMC studies are not applicable or available in this type of regulatory submission. The device is primarily evaluated through bench testing and comparison to existing, cleared devices.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it provide detailed performance numbers in a table. Instead, it generally states that tests "yielded acceptable results" or "confirmed biocompatibility."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 standards for an external communicating, blood contact, short duration (<24 hours) device. | "Test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) devices." |
| Dimensional Inspection: Conform to specified dimensions. | "Verification testing for the subject device included dimensional inspection… Subject product testing is believed to have yielded acceptable results." (No specific dimensions or ranges reported, but implied conformance to design specifications). |
| Hub Integrity: Maintain structural integrity of the hub. | "Verification testing for the subject device included… hub integrity… Subject product testing is believed to have yielded acceptable results." (No specific integrity metrics reported). |
| Flow Rate Measurements: Achieve specified flow rates. | "Verification testing for the subject device included… flow rate measurements… Subject product testing is believed to have yielded acceptable results." (No specific flow rates reported). |
| Burst Strength: Withstand internal pressure without bursting. | "Verification testing for the subject device included… burst strength… Subject product testing is believed to have yielded acceptable results." (No specific burst pressure reported). |
| Tensile Strength: Withstand pulling forces without breaking. | "Verification testing for the subject device included… tensile strength… Subject product testing is believed to have yielded acceptable results." (No specific tensile strength reported). |
| Guidewire Compatibility: Function correctly with guidewires. | "Verification testing for the subject device included… guidewire compatibility testing and performance under simulated conditions. Subject product testing is believed to have yielded acceptable results." (No specific compatibility metrics reported). |
| Torsional Strength: Withstand twisting forces. | "In addition, torsional strength… tests also yielded acceptable results." (No specific torsional strength reported). |
| Torqueability: Ability to transmit torque for steering. | "In addition, …torqueability… tests also yielded acceptable results." (No specific torqueability metrics reported. The device is described as having "the ability to be steered like a guide wire as needed," which implies this aspect was evaluated and found acceptable). |
| Corrosion Resistance: Resist degradation from corrosion. | "In addition… corrosion resistance tests also yielded acceptable results." (No specific corrosion resistance metrics reported). |
| Substantial Equivalence: Similar in design, materials, sterilization, principles of operation, and indications for use to predicate devices, raising no new questions of safety and efficacy. | "Technological similarities between the PVS 1700 Steerable Delivery System®-10 and predicate devices include the basal tubular design and dimensions, polymeric materials and construction, and hydrophilic coating. In instances where the technological characteristics may differ slightly, it has been demonstrated that there are no new questions raised regarding safety and efficacy of the PVS 1700 Steerable Delivery System®-10." "Based on the indications for use, technological characteristics, and safety and performance testing, the subject PVS 1700 Steerable Delivery System®-10 meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data for clinical studies, as the evaluation primarily involved bench testing (performance testing) and biocompatibility testing. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).
For bench tests, typically multiple units of the device are tested, but the exact sample sizes for each specific test (e.g., how many catheters were burst tested) are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this device's evaluation (bench testing) is based on engineering specifications, material science standards (ISO), and direct physical measurements/observations, not on expert consensus from clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as this device was evaluated via bench testing rather than through a clinical study requiring human interpretation or adjudication of patient cases.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not relevant for the regulatory pathway (510(k) for a microcatheter) and the type of evidence presented (bench testing for substantial equivalence).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical microcatheter, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is primarily:
- Engineering specifications and design requirements: For dimensional inspection, flow rate, tensile strength, burst strength, torqueability, torsional strength, and guidewire compatibility.
- International Standards (ISO 10993-1 and ISO 10555-1): For biocompatibility and performance testing of intravascular catheters.
- Comparison to predicate devices: To establish substantial equivalence in terms of technological characteristics and indications for use.
8. The Sample Size for the Training Set
Not applicable. This isn't an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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