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.

Summary

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DEC 2 | 1999

510(k) Number: K990173

510(k) SUMMARY

Trade Name:	Pathfinder II Angiographic Catheter
Common Name:	Angiographic Catheter
Classification Name:	Diagnostic intravascular catheter (per CFR 21 Part 870.1200)
Product Code:	DQO
Submitted by:	Maxxim MedicalArgon Division1445 Flat Creek RoadAthens, Texas 75751Phone: 903-675-9321Fax: 903-677-9397
Contact person:	Eddie Monroe, VP QA/RA
Date prepared:	May 19, 1999

Legally marketed device to which equivalence is claimed:

Cordis Corporation, Super Torque Plus™

Description of Device

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.

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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.

Intended Use of Device:

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

Feature	Cordis Super Torque Plus™	Pathfinder II Angiographic Catheter
Sterile packaging	On card inserted into a pouch made of Mylar® and Tyvek®	On card or plastic tray inserted into a pouch made of Mylar® and Tyvek®
Sterilization method	Ethylene Oxide Gas	Ethylene Oxide Gas
Shelf life	Three years	Three years
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.
Hub with locking female Luer taper	Yes	Yes
Available sizes (French)	4 through 8	5 through 8
Available lengths (cm)	80 through 125	65 through 125
Maximum guide wire O.D. (inches)	.038	.038
Hub material	Polycarbonate	Polycarbonate
Reinforcement braid material	300 Series stainless steel	300 Series stainless steel
Device radiopaque	Yes	Yes
Shaft (body) material	Polyurethane	Polyurethane
Stem material	Polyurethane	Polyurethane
Atraumatic tip material	Polyurethane	Polyurethane
Stem to atraumatic tip attachment method	Heat fuse	Heat fuse
Stem to body attachment method	Heat fuse	Heat fuse
Maximum pressure (psi)	1200	1200
Strain relief	No	Yes
Catheter identification printed on hub	Yes	Yes

Comparison of Technological Characteristics to legally marketed device:

The colorants are assumed to be different. Maxxim Medical does not know the colorant used in the legally marketed device. This includes the braided body, the stem, the hub, the strain relief and the ink used for marking. This difference does not affect the safety and effectiveness of the device.

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Both devices have a soft polyurethane tip on selective catheters and side holes on pigtail catheters. The Pathfinder II Angiographic Catheter tips are made of polyurethane, white colorant and barium sulfate. The material of the legally marketed device is presumed to be similar. If there is a difference, it does not affect the safety and effectiveness of the device.

The Maxxim Medical device has been tested for biocompatibility as required by ISO 10993-1.

Summary Of Non-Clinical Performance Data

The Pathfinder II Angiographic Catheter has been tested to the following consensus standards:

1. ISO 10555-1:1995(E) Sterile, single use intravascular catheters Part 1: General Requirements
1. ISO 10555-2:1996(E) Sterile, single use intravascular catheters Part 2: Angiographic catheters.
1. ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing.
1. ISO 594/1-1986(E) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
1. ISO 594-2-1986(E) Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings

Among the performance data tested and compared were tensile strength of all bonds, flow rates and burst strength.

Clinical Data:

Clinical data are not needed for this device.

Conclusions:

We conclude that the Pathfinder II Angiographic Catheter is safe and effective and is equal to the predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1999

Mr. Eddie Monroe Maxxim Medical 1445 Flat Creek Road Athens, TX 75751

K990173 Re: Pathfinder II Angiographic Catheter Requlatory Class: II (two) Product Code: 74 DQO Dated: September 21, 1999 September 27, 1999 Received:

Dear Mr. Monroe:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Eddie Monroe

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Christopher for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1__of__of__1

510(k) Number (if known): K990173

Device Name: _ Pathfinder II Angiographic Catheter

Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	OR	Over-the Counter Use
(Per 21 CFR 801.109)
	(Division Sign-Off)and Neurological Devices	Division of Cardiovascular, Respiratory,

510(k) Number___

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).