(130 days)
The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The Intermediate Catheter is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid, a stainless steel coil, a Nitinol coil, and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal distal outer diameter of 0.072" and a nominal proximal outer diameter of 0.078". It is available with a nominal inner diameter of 0.060". They are available in three working lengths, 105 cm, 115 cm. and 125 cm. The Intermediate Catheters have a PTFE-lined lumen, which is braid and coil reinforced, flexible, and has a hydrophilic coating. The Intermediate Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve and a split introducer sheath. The Intermediate Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
The document describes the non-clinical testing of an Intermediate Catheter for submission K152202 to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML device submission, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are interpreted in the context of typical FDA 510(k) submissions for non-AI devices.
Here's the breakdown of the information as requested, adapted for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Test Method Summary | Acceptance Criteria (Implicit from Results) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Per ISO 10993-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. (Found biocompatible and non-pyrogenic) |
| Sterilization Validation | Per ISO 11135 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Radiographic Detectability | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Visual Inspection | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Working Length | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Hub Compatibility | Per ISO 594-1 and ISO 594-2 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Outside Diameter | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Leak – Air | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Leak – Liquid | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Particulates | Per USP 788 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Catheter Burst | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Tensile | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Corrosion | Per ISO 10555-1 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Packaging - Dye Leak | Per ASTM F1929-12 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
| Packaging - Peel | Per ASTM F88-09 | All units tested must meet the acceptance criteria. | All samples met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "All units tested must meet the acceptance criteria. All samples met the acceptance criteria." This implies that a sufficient number of samples were tested for each specific test according to the requirements of the referenced ISO and ASTM standards. However, the exact sample sizes for each test are not explicitly stated in this summary.
The data provenance is from non-clinical bench testing and laboratory studies conducted by TNI Manufacturing, Inc. (the submitter). These are prospective tests designed to evaluate the physical, mechanical, and biological properties of the device. The country of origin of the data is implicit to be the USA, where TNI Manufacturing, Inc. is located. The biocompatibility testing explicitly states it was conducted "pursuant to 21CFR58, Good Laboratory Practices," which are U.S. regulations for nonclinical laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as this submission is for a physical medical device (catheter) and involves non-clinical bench testing, not an AI/ML device that generates diagnoses or interpretations requiring expert consensus as ground truth. The "ground truth" for these tests is established by the objective physical, chemical, and biological properties measured according to the specified international standards.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation or decision-making process for the "ground truth" in these non-clinical tests that would require adjudication. The tests involve objective measurements and adherence to predefined pass/fail criteria from the 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. The device is a physical catheter, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement with AI, or effect size related to AI assistance would be conducted or relevant for this type of submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (e.g., ISO, ASTM, USP). For example:
- Biocompatibility: Adherence to ISO 10993-1 guidelines, meaning the material does not elicit adverse biological responses.
- Sterilization Validation: Demonstrated sterility according to ISO 11135.
- Physical/Mechanical properties (e.g., Working Length, OD, Catheter Burst, Tensile): Conformance to specified dimensions, mechanical strengths, and absence of leaks or defects as defined by ISO 10555-1 and other relevant standards.
- Particulates: Conformance to USP 788 limits.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This is not applicable. There is no "training set" for a physical medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).