(119 days)
The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media.
The P.A.S Port® T2 POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the P.A.S. Port® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec.
The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. When used with a power indicated Huber needle, the PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated for power injection of contrast media.
The PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems can be placed in the chest or arm, are supplied sterile, are non-pyrogenic and intended for single patient use only. The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems consists of a portal with one or two self-sealing septa, and catheter connector that are assembled during implantation. The systems are offered in either a kit or a tray configuration.
The provided text describes a 510(k) premarket notification for implantable venous access systems. It does not describe an AI device, therefore, many of the requested criteria (like ground truth, training/test sets, expert consensus, MRMC studies) are not applicable.
Here's the relevant information based on the provided text:
Device: PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems, and P.A.S. Port® T2 POWER P.A.C. Implantable Venous Access Systems.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties Suitability | Bench testing of the device confirmed the suitability of the device for its intended use. This implies that the device satisfied established criteria for its physical characteristics (e.g., strength, durability, patency, self-sealing septum integrity, catheter connector assembly). |
| Biocompatibility | Biocompatibility was established based on the similarity of the materials of construction to the predicate devices commercially marketed by Smiths Medical ASD, Inc. This indicates that the device's materials were deemed safe for implantation and did not elicit adverse biological responses, consistent with the predicate. |
| MR Safety | MR safety testing was performed on selected ports in accordance with established American Society for Testing and Materials (ASTM) standards. The devices were determined to be MR Conditional according to the terminology specified in ASTM Designation F2503-05. Testing was performed in the presence of a 3 Tesla MR imaging device. This means the devices meet specific conditions for safe use in an MRI environment (e.g., specific field strength, SAR limits, orientation) and do not pose an unacceptable risk when those conditions are met. |
| Substantial Equivalence to Predicate Port-A-Cath® Power P.A.C. (K070116) and Port-A-Cath® II Power P.A.C. (K072657) | The device is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on a comparison of the indications for use and the technological characteristics of the device. Bench tests confirmed the suitability of the device for its intended use. This means the device performs as safely and effectively as a legally marketed device that it is compared against, without raising different questions of safety and effectiveness. The FDA concurred with this determination. This is the overarching "acceptance criterion" for a 510(k) submission. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for bench testing or biocompatibility. "Selected ports" were used for MR safety testing, but the exact number is not provided.
- Data Provenance: The studies were non-clinical (bench testing, biocompatibility, MR safety). There is no mention of country of origin or whether clinical data was retrospective or prospective, as human clinical studies were deemed not necessary.
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 is not applicable as the studies were non-clinical bench tests and did not involve expert-reviewed data for ground truth establishment in the context of an AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this was not a study involving human interpretation or AI adjudication.
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
- No MRMC study was done. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests:
- Physical Properties: Engineering specifications and performance standards (e.g., pressure limits, flow rates, durability metrics).
- Biocompatibility: ASTM/ISO standards for material safety by comparison to predicate devices and likely material property data sheets.
- MR Safety: ASTM F2503-05 standard criteria for MR compatibility, which dictates specific parameters (e.g., temperature rise, artifact size, displacement force) under specific MR conditions (e.g., 3 Tesla field strength).
8. The sample size for the training set
- Not applicable as this is not an AI device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI device.
§ 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.