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The Maxxim Medical angiographic catheters are designed to be used for delivering radiopaque contrast media into the coronary or peripheral vascular systems.

Device Description

The Pathfinder II Angiographic catheter has a polyurethane body, reinforced with stainless steel braid, containing barium sulfate and a blue colorant. The braiding provides torque-ability. The barium sulfate causes the device to be radio-detectable under a fluoroscope to assist in placing the device in the patient's vasculature. The proximal end of the body is bonded to a polycarbonate hub. The distal end has a polyurethane stem fused to the braided body. All catheters have the distal tip formed either into a pigtail for infusing fluids or into a special "selective" shape that is formed to facilitate rapid placement of the device in the desired location in the circulatory system by the doctor. All selective curves have a soft, atraumatic polyurethane tip fused to the stem. The pigtail catheters have their stems either straight or formed into an angle to allow for user preferences. Pigtail angiographic catheters have a pattern of "side holes" near the distal tip to allow increased infusion flow rate. The catheter is introduced using the Seldinger Technique, Artery Cut-down (Sones method), or the Introducer Technique.

AI/ML Overview

Here's an analysis of the provided text regarding the Pathfinder II Angiographic Catheter:

Please note: This FDA 510(k) summary is for a medical device (angiographic catheter), which is a physical product, not an AI/software device. Therefore, many of the typical acceptance criteria and study components requested (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of submission. The focus for a physical device is on engineering performance metrics, biocompatibility, and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Test	Acceptance Standard	Pathfinder II Angiographic Catheter Performance
Non-Clinical Performance Data (Tested to Consensus Standards):
ISO 10555-1:1995(E) General Requirements	Compliance with general requirements for sterile, single-use intravascular catheters (e.g., integrity, sterility, packaging, labeling, general physical properties relevant to safe use).	Device was "tested to" this standard, implying compliance. Specific numerical results are not provided in this summary but would be detailed in the full submission.
ISO 10555-2:1996(E) Angiographic Catheters	Compliance with specific requirements for angiographic catheters (e.g., specific dimensions, pressure resistance, torque, tip flexibility, radio-opacity).	Device was "tested to" this standard, implying compliance. Specific numerical results are not provided in this summary but would be detailed in the full submission.
ISO 10993-1 Biocompatibility	Biocompatibility as required by ISO 10993-1 (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility if applicable, implantation).	Device has been "tested for biocompatibility as required by ISO 10993-1," implying compliance with the biological safety requirements for a device that comes into contact with blood and tissue.
ISO 594/1-1986(E) Luer Taper (General)	Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General requirements (e.g., dimensions, leakage, unscrewing torque).	Device was "tested to" this standard, implying compliance for its Luer hub.
ISO 594-2-1986(E) Luer Taper (Lock Fittings)	Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 2: Lock Fittings (e.g., dimensions, leakage, unscrewing torque specific to locking Luer connections).	Device was "tested to" this standard, implying compliance for its Luer lock hub.
Tensile strength of all bonds	Sufficient strength to prevent separation of bonded components (e.g., hub-body, stem-body, stem-tip) during normal use, exceeding specified force thresholds.	"Among the performance data tested and compared were tensile strength of all bonds," implying that testing was conducted and met internal specifications informed by the ISO standards and predicate device. Specific thresholds and results are not provided in this summary.
Flow rates	Delivery of radiopaque contrast media at specified flow rates without excessive pressure drop or catheter damage. Must be comparable to or better than the predicate device.	"Among the performance data tested and compared were... flow rates," implying that testing was conducted and met internal specifications informed by the ISO standards and predicate device. The general characteristics table indicates a maximum pressure of 1200 psi, matching the predicate.
Burst strength	Ability to withstand specified internal pressure without rupture, exceeding required safety margins. Must be comparable to or better than the predicate device.	"Among the performance data tested and compared were... burst strength," implying that testing was conducted and met internal specifications informed by the ISO standards and predicate device. The general characteristics table indicates a maximum pressure of 1200 psi, matching the predicate.
Equivalence to Predicate Device:
Sterile packaging	On card/plastic tray inserted into a pouch made of Mylar® and Tyvek®.	On card or plastic tray inserted into a pouch made of Mylar® and Tyvek®. Meets.
Sterilization method	Ethylene Oxide Gas.	Ethylene Oxide Gas. Meets.
Shelf life	Three years.	Three years. Meets.
Intended use	To deliver radiopaque contrast media to selected sites in the vascular system.	For delivering radiopaque contrast media into the coronary or peripheral vascular systems. Meets. (Wording very similar, covering the same clinical scope.)
Hub with locking female Luer taper	Yes.	Yes. Meets.
Available sizes (French)	4 through 8.	5 through 8. Does not fully match (predicate has 4 Fr, new device does not), but is within typical ranges. The difference in minimum size would be considered minor for substantial equivalence.
Available lengths (cm)	80 through 125.	65 through 125. Does not fully match (predicate has 80cm min, new device has 65cm min), but is within typical ranges. The difference in minimum length would be considered minor for substantial equivalence.
Maximum guide wire O.D. (inches)	.038.	.038. Meets.
Hub material	Polycarbonate.	Polycarbonate. Meets.
Reinforcement braid material	300 Series stainless steel.	300 Series stainless steel. Meets.
Device radiopaque	Yes.	Yes. Meets. (Achieved via barium sulfate.)
Shaft (body) material	Polyurethane.	Polyurethane. Meets.
Stem material	Polyurethane.	Polyurethane. Meets.
Atraumatic tip material	Polyurethane.	Polyurethane. Meets.
Stem to atraumatic tip attachment method	Heat fuse.	Heat fuse. Meets.
Stem to body attachment method	Heat fuse.	Heat fuse. Meets.
Maximum pressure (psi)	1200.	1200. Meets.
Strain relief	No (Predicate).	Yes. Difference: New device has strain relief. The submission asserts "This difference does not affect the safety and effectiveness of the device." (This is usually a positive improvement, not a negative one for safety/effectiveness).
Catheter identification printed on hub	Yes.	Yes. Meets.
Colorants	Presumed different.	Different. Difference: Applicant states this "does not affect the safety and effectiveness of the device."
Tip material (details)	Presumed similar, or difference does not affect safety/effectiveness.	Polyurethane, white colorant, barium sulfate. Difference: Applicant states "If there is a difference, it does not affect the safety and effectiveness of the device."

Study That Proves the Device Meets the Acceptance Criteria:

The study proving the device meets acceptance criteria is a non-clinical performance study and a comparison to a legally marketed predicate device.

Non-Clinical Performance Study: The device was tested against recognized international consensus standards (ISO 10555-1, ISO 10555-2, ISO 10993-1, ISO 594/1, ISO 594-2). Specific tests mentioned include tensile strength of all bonds, flow rates, and burst strength. These tests demonstrate the physical and mechanical integrity and performance of the catheter.
Substantial Equivalence Comparison: A detailed comparison table ([1] "Legally marketed device to which equivalence is claimed") directly compares the technological characteristics of the Pathfinder II Angiographic Catheter to the Cordis Corporation Super Torque Plus™. This comparison aims to demonstrate that the new device is as safe and effective as the predicate device by showing similar design features, materials, and performance specifications. Where there are differences (e.g., presence of strain relief, specific range of sizes/lengths, colorants), the submission explicitly states that these differences do not affect the safety or effectiveness of the device.

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 for Test Set: This information is not provided in the 510(k) summary. For device testing to ISO standards, specific numbers of units would have been tested for each criterion, but these are typically found in the full test reports, not the summary.
Data Provenance: The testing was conducted by Maxxim Medical, Inc. (Argon Division) in Athens, Texas, USA. The studies are prospective in nature, as they involve testing newly manufactured devices against established standards and internal specifications.

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)

Not Applicable. This is a physical medical device submission, not an AI/software device that relies on expert interpretation of data or images to establish a "ground truth." The "ground truth" for this device's performance is objective measurements against engineering specifications and international standards, and comparison to the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are typically relevant for human interpretation tasks or clinical endpoints where there might be disagreement, often in the context of an AI/software device. For engineering tests of a physical device, the results are typically quantitative and objective, requiring no 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. An MRMC study is not applicable here. This type of study is used to assess the effectiveness of an AI system to assist human readers (e.g., radiologists interpreting images). This submission is for a physical angiographic catheter, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not applicable. There is no algorithm; this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is established by:
- Objective engineering specifications and measurements: The device must meet predefined physical, mechanical, and material properties (e.g., tensile strength, flow rate, burst pressure, dimensions, radio-opacity).
- International Consensus Standards (ISO): Compliance with these standards serves as a benchmark for safety and performance (e.g., sterility, biocompatibility, luer lock integrity).
- Predicate Device Characteristics: The characteristics and performance of the legally marketed predicate device (Cordis Super Torque Plus™) serve as a comparative standard for demonstrating substantial equivalence.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of a physical medical device submission. This term is relevant for machine learning or AI algorithm development.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, there is no ground truth established for one.

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