(171 days)
The intended use of the VanishPoint® I.V. Cathcter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). t The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.
The VanishPoint® I.V. Catheter is a safety device. The retracting introducer places the catheter portion in a vascular vessel in the same way as a conventional catheter, but upon removal of the placement needle, the caregiver activates a safety mechanism which retracts the needle completely into the handle/introducer assembly. In this way, if properly performed, it does not expose the caregiver to an accidental stick from a contaminated needle. The energy to retract the needle and chamber is provided by a spring interacting between the housing and the needle chamber assembly. Once the needle/chamber is retracted, the retracting introducer assembly is no longer required and taken away from the patient.
The provided text describes a 510(k) submission for a medical device (VanishPoint® I.V. Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new study to prove device performance against specific acceptance criteria. Therefore, several of the requested sections below cannot be fully populated as they pertain to such a study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (VanishPoint® I.V. Catheter, K051355) rather than presenting new performance data against specific acceptance criteria for a novel device. The text states:
- "The subject VanishPoint I.V. Catheter and the VanishPoint I.V. Catheter predicate device are very similar in design and technological characteristics."
- "The different materials are equivalent and the intended use is identical."
- "There is no substantive differences between the predicate device and subject device that would raise new issues of safety and effectiveness."
Therefore, the "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate device, which the new device is claimed to match. No specific performance metrics or their corresponding acceptance thresholds are listed.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or study with a defined sample size is described. The submission relies on the established safety and effectiveness of the existing predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No new clinical or performance study requiring expert adjudication for ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Not applicable. No MRMC study is mentioned. The device is a physical medical device (catheter), not one that typically involves human readers interpreting data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a 510(k) submission for a physical device demonstrating substantial equivalence, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).