(150 days)
The Medcomp® Gen III Power Injectable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system 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 power injectable infusion 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 Medcomp® Gen III Power Injectable Port includes the Dignity® Mini. Low Profile and Pro-Fuse® Low Profile and Standard are subcutaneously implantable single fluid reservoir port offered with a choice of a silicone or polyurethane cather either pre-attached by the manufacturer or attachable for application by the inserting physician. The Pro-Fuse® product line offers a round base while the Dignity® product line offers a shovel nose concaved sides and smooth contours. The Dignity® product line is offered in Midsize. which has a smaller base than the predicate, K070003. The Dignity® product line is offered in Low Profile, which is a smaller base than the Midsize therefore is smaller than predicate, K070003. The Dignity® product line is offered in Mini, it is the smallest offered profile.
Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catherer lock provides securement of the catheter to the port stem. The port is accessed by inserting needle through the skin into the self-sealing septum.
The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port.
Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.
The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.
The provided text describes the Medcomp® Gen III Power Injectable Port and its 510(k) submission (K132177). This document focuses on demonstrating substantial equivalence to a predicate device (K070003) rather than a standalone study proving device performance against specific novel acceptance criteria.
The acceptance criteria are implicitly defined by the safety and performance requirements for implantable infusion ports and are primarily demonstrated through comparison to the predicate and established international standards (ISO 10555-1, ISO 10993).
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding performance results for each criterion. Instead, it lists various "Bench / Performance Data" tests performed and states that the "results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."
Essentially, the acceptance criterion for each test is that the new device's performance is equivalent to, or meets the established safety and performance characteristics of, the predicate device and relevant ISO standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical/Physical Performance equivalent to predicate and ISO 10555-1, including: |
- Power Injection Simulation
- Elongation & Tensile
- Priming Volume
- Gravity Flow
- Stem Break Force
- Cap/Base Bond Integrity
- Catheter Lock Integrity
- Clearance Volume
- Needle Insertion/Extraction Force
- Reservoir Pressure
- Static Burst Pressure | "In vitro testing was performed on the Power Injectable. Implantable Infusion Port to assure reliable design and performance in accordance with the FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990."
"Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols."
"The following testing was performed on all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini. in accordance with requirements of ISO 10555-1 for all configurations listed in pursuant of this application to market."
"The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."
No specific numerical performance values are provided, only an assertion of equivalence. |
| Biocompatibility in accordance with ISO 10993 | "Testing for all materials used for the Power Iniectable Infusion Port has been submitted in previously cleared Medcomp device predicate K070003. All biocompaibility testing demonstrals used meet the requirements of ISO 10993." |
| Substantial Equivalence to Predicate K070003 | "The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes (number of units or batches tested) for the "Bench / Performance Data" tests. It mentions "all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini" were tested, indicating multiple product variants were included.
The data provenance is implied to be from in vitro testing performed by the manufacturer (Medcomp®) in the US, as it's a submission to the FDA. It is prospective for the Gen III device, as these tests were conducted on the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this type of submission. This is a premarket notification for a medical device (implantable port) based on substantial equivalence and bench testing, not an algorithmic diagnostic device requiring expert interpretation of clinical images for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or performance, often for diagnostic accuracy, which is not the nature of this submission. The "ground truth" for the performance tests would be the measured physical properties of the device against engineering requirements or established standards.
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
This is not applicable. An MRMC comparative effectiveness study is specific to diagnostic imaging devices or AI algorithms where human reader performance is a key metric. This submission is for an implantable infusion port.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical medical device, not an algorithm or AI system. The "standalone" performance here relates to the device's physical and mechanical properties, which were tested in a "standalone" manner (i.e., the device itself was subjected to bench tests).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the bench tests are:
- Engineering specifications and measurements: For parameters like priming volume, burst pressure, tensile strength, etc.
- Compliance with international standards: ISO 10555-1 for performance and ISO 10993 for biocompatibility.
- Performance of the predicate device (K070003): The new device's performance is shown to be equivalent to the previously cleared predicate.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.