(127 days)
The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with a power injectable needle, the Dignity® Dual Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.
The Dignity® Dual power injectable implantable infusion port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. The Dignity® Dual Port device consists of two primary components: an injection port with a self-sealing septa and a radiopaque catheter. The Dignity® Dual Ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging.
The Dignity® Dual Port will be marketed in four kit configurations, which are listed below:
- 9.5F Standard Port Kit (Catalog number MRDP95ADN)
- 9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN)
- 9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS)
- 9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS)
The Dignity® Dual Port is comprised of a polysulfone cap (with silicone filled suture holes, or open suture holes), two silicone septa, and a polysulfone base assembly with a titanium tube that provides a channel from the stem to the distal reservoir. The reservoir is plastic (polysulfone). The Dignity® Dual catheter locking assembly (makrolon/pellethane) locks the chronoflex lumen to the plastic stem of the Dignity® Dual Port.
The provided text describes the "Dignity® Dual Port," a power injectable implantable infusion port. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to pre-existing devices. Therefore, the "study" referred to is a demonstration of equivalence through functional and material comparisons, rather than a traditional clinical study with human patients and outcomes data.
Here's the breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate/Reference Devices & Standards) | Reported Device Performance (Dignity® Dual Port - K153238) |
|---|---|
| Design: Double lumen, dual reservoir, power injection | Equivalent: Double lumen, dual reservoir, power injection |
| Dimensions: Base fits within 29mm x 39mm; Internal Volume 0.6 ml each reservoir; Depth Marking every 1cm (Predicate: K090512) | Equivalent: Base fits within 41mm x 12mm; Internal Volume: 0.7ml and 0.6 ml; Depth Marking every 1cm (Note: Dimensions are different, but deemed "Equivalent" in the context of the 510(k) summary, likely indicating functional equivalence despite size variation). |
| Indications for Use: Infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, withdrawal of blood samples; Power injection of contrast media up to 5 ml/s. (Predicate: K090512) | Equivalent: Infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, withdrawal of blood samples; Power injection of contrast media: 5 ml/s (19 or 20 gauge non-coring needle), 2 ml/s (22 gauge non-coring needle). (Additional detail for 22 gauge, but generally equivalent) |
| Catheter Size: 9.5F Double Lumen ChronoFlex Polyurethane Catheter (Predicate: K090512) | Equivalent: 9.5F Double Lumen ChoronFlex Polyurethane Catheter |
| Sterilization: ETO (Predicate: K090512) | Equivalent: ETO, ANSI/AAMI/ISO 11135-1:2007 SAL 10-6 |
| Power Injectable Rate: 5 ml/s (Predicate: K090512) | Equivalent: 5 ml/s |
| Materials: Plastic, Silicone, Polyurethane (Predicate: K090512) | Equivalent to Reference Devices (K070003, K120281): Thermoplastic Polymer, Silicone, Polyurethane, Titanium, Polycarbonate (Note: Uses different and additional materials compared to the predicate, but is deemed equivalent based on comparison to reference devices which use similar materials and have established biocompatibility.) |
| MRI Performance Testing: MRI Conditional; Power Injection (19Ga 4.9ml/s, 20Ga 4.9ml/s, 22Ga 1.9ml/s); Infusion Testing (1700ml/hr); Catheter Lock Disengagement (10 lbs); Needle Insertion (19Ga 2.88lb, 22Ga 2.05 lbs); Gravity Flow (1680 ml/hr). (Predicate: K090512) | Equivalent: MRI Conditional; Power Injection (19Ga 4.9ml/s, 20Ga 4.9ml/s, 22Ga 1.9ml/s); Infusion Testing: 1600ml/hr; Catheter Lock Disengagement: 6.9 lb; Needle Insertion: 19Ga 3.8lb, 22Ga 3.6 lbs; Gravity Flow: 1760 ml/hr. (Some values differ but are deemed equivalent by the submission.) |
| Biocompatibility: Meet ISO 10993-1 requirements for permanent implant with tissue and both indirect/direct blood contact (via reference devices K070003, K120281) | Met: Materials are equivalent to cleared reference devices (K070003, K120281) which performed biocompatibility per ISO 10993-1. Summary of prior testing confirms compliance. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with a distinct human "test set."
- Test Set: No independent human "test set" in the context of a clinical trial is described. The "testing" involves bench testing, material comparisons, and a comparison matrix against a predicate and reference devices.
- Data Provenance: The data provenance is primarily from bench/performance data and comparison to previously FDA-cleared devices (predicate K090512, reference K070003, K120281). This is not data from human subjects or from a specific country of origin in the way a clinical trial would generate it. All data would be generated in a lab setting by Medcomp® or its contracted testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Ground Truth Establishment: Not applicable in the context of this 510(k) summary. The "ground truth" for the current device's acceptability is established by demonstrating its equivalence to predicate devices that have already been determined safe and effective by the FDA. The performance standards are derived from established industry standards (e.g., ISO, ASTM) and the performance characteristics of the predicate device.
- Experts: No external experts are described as establishing "ground truth" for the test set. The submission itself is prepared by Medcomp®'s regulatory associate, Ms. Courtney Nix, and reviewed internally by Medcomp® and externally by the FDA (specifically the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" of patient data requiring adjudication. The assessment is a comparison of design, materials, and performance data against established standards and predicate device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret results with and without AI assistance. The Dignity® Dual Port is an implantable infusion port, a physical medical device, not an imaging or diagnostic AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The device is a physical implantable infusion port, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the submission is the established safety and effectiveness of the legally marketed predicate device (C.R. Bard PowerPort©, K090512) and reference devices (Medcomp® Pro-Fuse®, K070003; Medcomp® Dignity® Power Injectable Titanium Port, K120281), as interpreted through FDA regulations and consensus standards (ISO, ASTM). The equivalence is demonstrated through comparative analysis of specifications, materials, and bench test results against these established benchmarks.
8. The Sample Size for the Training Set
- Training Set: Not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
§ 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.