Lumax® Guiding Catheters are conduits introduced, either singly or as a coaxial pair, into a vein or artery and tracked over a wire guide to the site of a vascular lesion where interventional devices can be delivered through the guiding catheter's internal lumen for treatment. The Lumax® Guiding Catheters may include either a single guiding catheter or a coaxial catheter pair (composed of an outer guiding catheter and an inner coaxial catheter). The single guiding catheters are available in a 7.0 French outer diameter in lengths of 80 or 90 cm. They are manufactured with a multilayered braided nylon shaft, bonded Luer hub, and radiopaque tip. The guiding catheters are designed with a multipurpose (MPA) distal curve configuration. The coaxial catheter pair comprises an outer guiding catheter matched to an inner coaxial catheter. The guiding catheter component is available in an outer diameter of 8.0 French and a length of 80 cm. The inner coaxial catheter is manufactured from radiopaque braided nylon tubing and has an outer diameter of 6.0 French and a length of 100 cm. For lubricity, the distal 40 cm of the inner catheter is treated with hydrophilic coating. The Lumax® Guiding Catheters are supplied as packaged, sterile devices, intended for single-patient use.

AI/ML Overview

The provided text describes the Lumax® Guiding Catheters and their acceptance criteria through various performance tests. However, it does not include a study that proves the device meets acceptance criteria for an AI/CADe device, as this device is a physical medical catheter, not a software or AI-based diagnostic tool.

Therefore, many of the requested categories for AI/CADe studies will not be applicable or present in this document.

Here's the information extracted from the document regarding the acceptance criteria and performance of the Lumax® Guiding Catheters:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Per ISO 10993-1 and FDA guidance for Cytotoxicity, Genotoxicity, Sensitization, Acute Systemic Toxicity, Intracutaneous Irritation, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time), and Thrombogenicity.	All test results met the acceptance criteria or demonstrated that the device is biocompatible.
Radiopacity	Not explicitly stated, but implies visibility and non-inferiority to user-defined standard.	The devices were visible, and visibility was qualitatively non-inferior to the user-defined standard.
Lubricity	Acceptance criteria for the comparison of means test and for the coated test articles.	The acceptance criteria for the comparison of means test and the coated test articles were met.
Tensile Strength	Predetermined acceptance criteria (in accordance with Annex B of BS EN ISO 10555-1).	The predetermined acceptance criteria for the studies were met.
Stress Cracking	Stress cracking requirements stated in ISO 80369-7.	The predetermined acceptance criteria for the study were met.
Dimensional Verification	Predetermined acceptance criteria.	The predetermined acceptance criteria for the study were met.
Visual, Dimensional, and Compatibility Verification	Internal requirements for compatibility, inner diameter, outer diameter, effective length, and visual inspection requirements of Section 4.12 of BS EN ISO 10555-1.	The predetermined acceptance criteria for the studies were met.
Air Leakage	Air leak requirements of BS EN ISO 10555-1.	The predetermined acceptance criterion for the study was met.
Liquid Leakage	Liquid leakage requirements of BS EN ISO 10555-1.	The predetermined acceptance criterion for the study was met.
Simulated Use	Predetermined acceptance criteria for ability to perform as intended in expected clinical use conditions.	The predetermined acceptance criteria for the study were met.
Particulate Testing and Coating Integrity	Not explicitly stated, but implies successful characterization.	This study successfully characterized the particulate counts and hydrophilic coating integrity of the Lumax® Guiding Catheters.
Rollback	Ability to be inserted through simulated tissue without signs of rollback of their tips and to meet requirements in Annex A of BS EN ISO 11070.	The predetermined acceptance criteria for the study were met.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes laboratory performance testing, not a clinical trial with a "test set" and "data provenance" in the context of an AI/CADe study.

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 information is not applicable and not provided. The testing described is performance testing of a physical device against engineering and safety standards, not an evaluation requiring expert interpretation of results to establish ground truth.

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

This is not applicable and not provided.

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 and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

This is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

The "ground truth" for this device's performance testing is based on established engineering standards (e.g., ISO, BS EN ISO) and pre-determined acceptance criteria for physical and mechanical properties, as well as biocompatibility.

8. The sample size for the training set

This is not applicable and not provided. This document describes the performance testing of a manufactured medical device, not the training of an AI model.

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

This is not applicable and not provided. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device's regulatory submission.

Summary

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December 12, 2019

Cook Incorporated David Lehr Regulatory Affairs Team Lead 750 Daniels Way Bloomington, Indiana 47404

Re: K191163

Trade/Device Name: Lumax Guiding Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 15, 2019 Received: November 18, 2019

Dear David Lehr:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191163

Device Name Lumax® Guiding Catheters

Indications for Use (Describe)

Intended for the intravascular introductional devices into the peripheral, including pulmonary, vasculature.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K191163

510(k) Summary

As required by 21 CFR §807.92 Date Prepared: November 27, 2019

Submitted Bv:

Applicant: Contact: Applicant Address: Cook Incorporated David Lehr, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x102309 (812) 332-0281

Device Information:

Contact Fax Number:

Contact Phone Number:

Trade Name: Common Name: Classification Panel: Regulation: Product Code:

Lumax® Guiding Catheters Percutaneous catheter Cardiovascular 21 CFR §870.1250 DQY

Predicate Devices:

ConcierGE® Guiding Catheter (K132409), manufactured by Merit Medical.

Device Description:

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inner catheter is treated with hydrophilic coating. The Lumax® Guiding Catheters are supplied as packaged, sterile devices, intended for single-patient use.

Intended Use:

Intended for the intravascular introduction of interventional devices into the peripheral, including pulmonary, vasculature.

Comparison of Technological Characteristics to Predicate:

The Lumax® Guiding Catheters and the predicate device, the ConcierGE® Guiding Catheter (K132409), manufactured by Merit Medical, are substantially equivalent in that they have similar indications for use, technological characteristics, methods of construction, and principles of operation. The differences between the subject device and the predicate device, including differences in indications for use wording, device dimensions, and device components, were appropriately assessed and do not present any new questions of safety and/or effectiveness. Based on the comparison of the design, indications for use, materials, fundamental technology, and principles of operation, the subject device is considered to be substantially equivalent to the currently marketed predicate device. The substantial equivalence comparison of the subject device to the predicate is provided in the following table.

	PREDICATE DEVICE	SUBJECT DEVICE
	ConcierGE® Guiding Catheter(K132409)	Lumax® Guiding Catheter
Manufacturer	Merit Medical	Cook Incorporated
Regulation Number	21 CFR §870.1250	Identical
Product Code	DQY
Classification Name	Percutaneous catheter
Class	II
Indications for Use	Intended for the intravascularintroduction ofinterventional/diagnostic devicesinto the coronary or peripheralvascular systems.	Intended for the intravascularintroduction of interventionaldevices into the peripheral,including pulmonary, vasculature.
Guiding Catheter Materials	Outer layer: PebaxWire braid: Stainless SteelInner lining: PTFERadiopaque tip: Unknown	Outer layer: NylonWire braid: Stainless SteelInner lining: PTFETip: Radiopaque Nylon/Tungsten
Guiding Catheter Sizes (Fr)	5, 6, 7, 8	7, 8
Guiding Catheter Lengths (cm)	100	80, 90
Guiding Catheter TipConfiguration	Various, including MP1(Multipurpose) Curve	MPA (Multipurpose) Curve

Substantial Equivalence Comparison Table

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	PREDICATE DEVICE	SUBJECT DEVICE
	ConcierGE® Guiding Catheter (K132409)	Lumax® Guiding Catheter
Inner Catheter Materials	N/A	Shaft: NylonHydrophilic Coating (40 cm)Tip: Radiopaque NylonAdapter: ABSConnector Cap: Acetal
Inner Catheter Size (Fr)		6 Fr
Inner Catheter Length (cm)		100 cm
Packaging	Unknown	Tyvek/Polyethylene-polyester Film
Sterilization (SAL 10-6)	EtO	Identical
Shelf Life	3 years	Identical

Substantial Equivalence Comparison Table (continued)

Technological Characteristics:

The subject device, Lumax® Guiding Catheters, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below.

Biocompatibility Testing – Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, Genotoxicity, Sensitization, Acute Systemic Toxicity, Intracutaneous Irritation, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis, Complement Activation, Partial Thromboplastin Time), and Thrombogenicity were performed on all components of the subject device. All test results met the acceptance criteria, where applicable, or demonstrated that the device is biocompatible.

Performance Testing

. Radiopacity - The radiopacity of the guiding catheter and inner coaxial catheter was tested. The devices were visible, and visibility was qualitatively non-inferior to the userdefined standard.
. Lubricity – The lubricity of the hydrophilic coating on the inner coaxial catheter was evaluated. The acceptance criteria for the comparison of means test and the coated test articles were met.
Tensile All bonds and joints were tested for tensile strength in accordance with Annex . B of BS EN ISO 10555-1. The predetermined acceptance criteria for the studies were met.
Stress Cracking The Luer locks of the subject device were evaluated according to the . stress cracking requirements stated in ISO 80369-7. The predetermined acceptance criteria for the study were met.
. Dimensional Verification - The outer diameters of the subject device were evaluated. The predetermined acceptance criteria for the study were met.

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Visual, Dimensional, and Compatibility Verification The subject device was tested . according to internal requirements for compatibility, inner diameter, outer diameter, and effective length verification. Additionally, the subject device was evaluated according to the visual inspection requirements of Section 4.12 of BS EN ISO 10555-1. The predetermined acceptance criteria for the studies were met.
. Air Leakage – The subject device was evaluated according to the air leak requirements of BS EN ISO 10555-1. The predetermined acceptance criterion for the study was met.
Liquid Leakage The subject device was evaluated according to the liguid leakage . requirements of BS EN ISO 10555-1. The predetermined acceptance criterion for the study was met.
Simulated Use The subject device was tested for its ability to perform as intended in . expected clinical use conditions. The predetermined acceptance criteria for the study were met.
. Particulate Testing and Coating Integrity – This study successfully characterized the particulate counts and hydrophilic coating integrity of the Lumax® Guiding Catheters.
Rollback – The guiding catheters were tested for their ability to be inserted through a simulated tissue without signs of rollback of their tips and to meet the requirements listed in Annex A of BS EN ISO 11070. The predetermined acceptance criteria for the study were met.

Conclusion:

The results of these tests support a conclusion that the Lumax® Guiding Catheters, subject of this submission, met the design input requirements based on the device's intended use and that they are substantially equivalent to the predicate device, the ConcierGE® Guiding Catheter (Merit Medical, K132409).

Regulation Number and Section

§ 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).