(241 days)
The Invisiport™ is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.
The Invisiport™ consists of an injection port made from material evaluated for hiocompatibility. The Invisiport has a self-sealing silicone septum. An open ended radiopaque catheter is pre-attached to the port. The silicone septum covers a reservoir that can be accessed with a non-coring Huber type needle. Power injection of contrast for imaging examinations can be performed when the port is accessed with a power-injectable Huber needle or infusion set.
This submission describes the Invisiport™, an implantable infusion port. The acceptance criteria and the study proving it meets these criteria are outlined primarily through a comparison to predicate devices and a statement of compliance with relevant FDA guidance.
1. Table of Acceptance Criteria and Reported Device Performance
The device does not have explicit "acceptance criteria" presented as quantitative thresholds in the provided text for performance outcomes. Instead, substantial equivalence is established by demonstrating that its technical characteristics and performance are comparable to legally marketed predicate devices and that it meets a general standard of efficacy and safety as outlined by FDA guidelines. The table below summarizes the comparison:
| Feature | Acceptance Criteria (Inferred from Predicate Devices & Guidance) | Reported Invisiport™ Performance |
|---|---|---|
| Indications for Use | Must be equivalent to predicate devices, including for power injection of contrast media. | Equivalent to predicate devices, including power injection compatibility (5 ml/s limit, same as Bard Power Port). |
| Port Access | Hospital/clinic, licensed healthcare provider. | Same as predicates. |
| Location of Implant | Peripheral or thoracic (consistent with various predicates). | Peripheral or thoracic. Noted to be the same as PeriPort, GrantAdler Rhapsody, and Port-A-Cath for recommended peripheral implantation site (upper arm). |
| Design | Septum/port with attachable catheter (based on predicates). | Septum/port with integrated catheter. Comment notes this is "As a convenience to the user," implying it's a design difference, but doesn't state it fails any criteria. |
| Catheter Length | Within the range of predicate devices (76 cm for PeriPort/PORT-A-CATH, up to 52 cm for GrantAdler, up to 45 cm for Bard Power Port). | 53.3 cm. Reported as "Within the range of the predicates." |
| Catheter ID | Within the range of predicate devices (1.0 mm for PeriPort/PORT-A-CATH, 2 mm for GrantAdler). | 1.3 mm. Reported as "Within the range of the predicates." |
| Catheter OD | Within the range of predicate devices (1.7 mm for PeriPort, 2.33 mm (7 Fr) for GrantAdler, 2.7 mm (8 Fr) for Bard Power Port, 1.9 mm for PORT-A-CATH). | 2.0 mm. Reported as "Within the range of the predicates." |
| Biocompatibility | Material evaluated for biocompatibility. | Made from material evaluated for biocompatibility. (Implied by description and general regulatory requirements). |
| Self-sealing septum | Must have a self-sealing septum. | Has a self-sealing silicone septum. |
| Radiopacity | Catheter should be radiopaque. | Open ended radiopaque catheter. |
| General Performance (Safety & Effectiveness) | Device must pass performance tests according to FDA guidance (Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990; Submission and Review of Sterility Information in Premarket Notification 510(k) Submissions for Devices Labeled as Sterile, December 12, 2008). | The device passed all testing conducted according to relevant FDA guidance. Conclusion states Invisiport™ met "all established acceptance criteria for performance testing" and no new questions of safety or effectiveness are raised. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for performance testing (e.g., number of devices tested for catheter length, ID, OD, or other performance characteristics). The tests are described as being conducted "according to methods presented in FDA Guidance," suggesting laboratory-based performance testing rather than human clinical trials. Thus, the concept of "data provenance" (country of origin, retrospective/prospective) as it applies to clinical data is not relevant here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study appears to be a technical, laboratory-based performance evaluation against established engineering and material standards, rather than one requiring clinical expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable to the type of performance testing described. Adjudication methods are typically employed in studies where expert review is needed to establish ground truth for subjective interpretations (e.g., image analysis, clinical diagnoses).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission is a 510(k) premarket notification for a medical device (implantable infusion port), which typically relies on demonstrating substantial equivalence to predicate devices through technical and laboratory performance testing, rather than comparative clinical efficacy studies with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The Invisiport™ is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone" or "algorithm only" performance does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be derived from:
- Predicate Device Specifications: The technical characteristics (e.g., catheter length, ID, OD) are compared directly to ranges or values of legally marketed predicate devices.
- FDA Guidance Documents: Performance tests were conducted "according to methods presented in FDA Guidance," implying a benchmark against established regulatory standards and test methodologies for implanted infusion ports. These guidances establish the "truth" for safety and performance metrics (e.g., biocompatibility testing, sterility, mechanical integrity).
8. The Sample Size for the Training Set
This question is not applicable. The Invisiport™ is a physical medical device, not an AI system. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As stated above, there is no training set.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.