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510(k) Data Aggregation
(122 days)
The NovaCath™ Secure IV Catheter System 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 intravascularly. The needle-shielding feature aids in the prevention of needlestick injuries. Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure. The NovaCath™ may be utilized in any patient population with consideration given to vascular anatomy and appropriateness of procedure. The 18, 20 and 22 Gauge NovaCath™ devices are suitable for use with power injectors for up to a maximum of 300 psi.
The NovaCath™ Secure IV Catheter System is comprised of an over-the-needle, peripheral intravascular catheter made from a radiopaque slender, flexible plastic, integrated extension tubing with a secondary stabilization hub system, a female luer lock and clamp, and a passive needle shielding mechanism. The design of the NovaCath™ System is considered a closed system since it protects users from blood exposure during the catheter insertion procedure. The needle is withdrawn through a septum that will seal after the needle has been withdrawn and the luer lock is closed, blood is contained within the NovaCath™ System during insertion. The clamp on the extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or other end cap.
Acceptance Criteria and Study for NovaCath™ Secure IV Catheter System
The NovaCath™ Secure IV Catheter System is cleared based on demonstrating substantial equivalence to predicate devices and meeting relevant performance, biocompatibility, and sterilization standards. No specific quantitative "acceptance criteria" for a novel performance metric are presented in the document, as the clearance is based on equivalence and adherence to established standards.
The primary "study" proving the device meets the acceptance criteria is a simulated clinical use study for its sharps injury prevention feature, in addition to extensive non-clinical and biocompatibility testing. The data predominantly supports claims of equivalence to existing devices and compliance with recognized standards for medical devices of this type.
1. Table of Acceptance Criteria and Reported Device Performance
Given that the submission is for a 510(k) clearance based on substantial equivalence and adherence to recognized standards, the "acceptance criteria" are generally framed as meeting the requirements of these standards or demonstrating performance comparable to predicate devices. There are no specific quantitative metrics provided for "reported device performance" in the way one might see in a de novo pre-market authorization for a completely novel AI diagnostic, rather, it's about confirming compliance.
| Acceptance Criteria Category | Specific Acceptance Criteria (or Standard Met) | Reported Device Performance |
|---|---|---|
| General Device Design | Substantial equivalence to predicate devices (K032843, K971339, K051355) | The NovaCath™ System is "substantially equivalent in device description, intended use, function, principle of operation, and basic composition" to the predicate devices. Table 1 provides detailed comparisons, showing the NovaCath™ generally matches or improves upon predicate features (e.g., dual flash visualization, integrated passive sharps injury prevention, primary & secondary stabilization). |
| Performance Testing | ISO 10555-1: General requirements for sterile, single-use intravascular catheters | "Successfully tested to meet the applicable requirements outlined in ISO 10555-1." |
| ISO 10555-5: Over-needle peripheral catheters | "Successfully tested to meet the applicable requirements outlined in ISO 10555-5." | |
| Flow Rate | Comparable to predicate devices (e.g., BD Nexiva, BD Insyte) | For 20G: NovaCath™ reports 52.55 ml/min, which is comparable to predicate devices (BD Nexiva 20G: 45 ml/min, BD Insyte 20G: 65 ml/min). |
| Biocompatibility | FDA Blue Book Memorandum - #G95-1 Table 1 Initial Evaluation Test for Consideration and relevant ISO 10993 standards | "Successfully tested... to establish that the NovaCath™ Secure IV Catheter System meets the appropriate biocompatibility testing requirements." Classified as an external communicating, prolonged (24hrs to less than 30 days) circulating blood contact device. |
| Sterilization | ANSI/AAMI/ISO 11135-2 (Sterility Assurance Level of 10-6) | "Will be released to market with a Sterility Assurance Level of 10-6, per the requirements set forth in ANSI/AAMI/ISO 11135-2." Maximum levels of ethylene oxide and ethylene chlorohydrin residues will not exceed ISO 10993-7 limits. |
| Shelf-life | ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) | "Shelf-life and expiry dating meet the requirements of ASTM F1980-07," supported by real-time shelf-life data. |
| Sharps Injury Prevention | FDA Guidance for Medical Devices with Sharps Injury Prevention Features | A "simulated clinical use study was successfully conducted in accordance with: FDA Guidance for Medical Devices with Sharps Injury Prevention Features." The device is described as having an "integrated sharps injury prevention device (passive)" and that "Upon catheter insertion, blood is contained within the device to aid in the prevention of blood exposure" and the needle-shielding feature "aids in the prevention of needlestick injuries." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of an AI/ML algorithm evaluation, as this is a medical device clearance based on engineering, performance, biocompatibility, and simulated use testing.
- Simulated Clinical Use Study (Sharps Injury Prevention): The sample size for this study is not explicitly stated.
- Data Provenance: The document does not specify the country of origin for the simulated clinical use study or other testing data. It is a prospective study in the sense that it was conducted specifically to support this regulatory submission, but it is a "simulated" study, not involving actual patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring expert-established ground truth on a test set of data. The "ground truth" for the device's performance is established by adherence to recognized engineering, biocompatibility, and safety standards, and by successful completion of simulated use testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device involving multi-reader adjudication of a test set.
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 is not an AI/ML device and therefore no MRMC study with AI assistance was performed.
6. If a standalone (i.e. 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 (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's regulatory clearance is compliance with established international and national standards (e.g., ISO 10555-1, ISO 10555-5, ISO 10993, ANSI/AAMI/ISO 11135-2, ASTM F1980-07) and successful completion of simulated use testing to confirm safety features like sharps injury prevention and blood containment. For a physical device, this often involves objective measurements, material analysis, and functional tests rather than subjective expert consensus on image interpretation or pathology.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that utilizes a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that utilizes a training set.
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