(225 days)
No
The summary describes a physical medical device (guiding catheter) and its performance testing, with no mention of software, algorithms, image processing, or AI/ML terms.
No
The device is a guiding catheter used for the introduction of other interventional devices for treatment, but it does not directly perform therapeutic action itself.
No
Explanation: The device is described as a catheter used for the intravascular introduction of other devices for treatment, not for diagnosis. Its purpose is to deliver interventional devices, not to collect diagnostic information.
No
The device description clearly details a physical medical device (catheter) with specific material properties, dimensions, and performance characteristics related to its physical form and function. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intravascular introductional devices into the peripheral, including pulmonary, vasculature." This describes a device used within the body for delivering other devices, not for testing samples outside the body.
- Device Description: The description details a catheter designed to be inserted into blood vessels to guide other interventional devices. This is a surgical/interventional tool, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
"Intended for the intravascular introductional devices into the peripheral, including pulmonary, vasculature."
Product codes
DQY
Device Description
"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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, including pulmonary, vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
"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.
- 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."
Key Metrics
Not Found
Predicate Device(s)
ConcierGE® Guiding Catheter (K132409)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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
2
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:
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
4
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 intravascular | |
| introduction of | ||
| interventional/diagnostic devices | ||
| into the coronary or peripheral | ||
| vascular systems. | Intended for the intravascular | |
| introduction of interventional | ||
| devices into the peripheral, | ||
| including pulmonary, vasculature. | ||
| Guiding Catheter Materials | Outer layer: Pebax | |
| Wire braid: Stainless Steel | ||
| Inner lining: PTFE | ||
| Radiopaque tip: Unknown | Outer layer: Nylon | |
| Wire braid: Stainless Steel | ||
| Inner lining: PTFE | ||
| Tip: Radiopaque Nylon/Tungsten | ||
| Guiding Catheter Sizes (Fr) | 5, 6, 7, 8 | 7, 8 |
| Guiding Catheter Lengths (cm) | 100 | 80, 90 |
| Guiding Catheter Tip | ||
| Configuration | Various, including MP1 | |
| (Multipurpose) Curve | MPA (Multipurpose) Curve |
Substantial Equivalence Comparison Table
5
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| ConcierGE® Guiding Catheter (K132409) | Lumax® Guiding Catheter | |
| Inner Catheter Materials | N/A | Shaft: Nylon |
| Hydrophilic Coating (40 cm) | ||
| Tip: Radiopaque Nylon | ||
| Adapter: ABS | ||
| Connector 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.
6
- 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).