The Guiding Catheter is indicated to provide a pathway through which therapeutic devices are introduced. The catheter is intended to be used in the peripheral vascular system.

Device Description

The Guiding Catheter is a single-use percutaneous catheter intended to be used in the peripheral vascular system to provide a pathway through which therapeutic devices are introduced. The Guiding Catheter is available in a variety of curves to accommodate various anatomies. The Guiding Catheter is comprised of a braid-reinforced catheter shaft terminating in an atraumatic, radiopaque tip. The device includes a proximal hub with luer fitting for fluid infusion and/or aspiration as well as strain relief. The catheter is a single use disposable device. The Guiding Catheter has an inner diameter of 6F, an outer diameter of 7F, and is compatible with an 0.035" guidewire.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called a "Guiding Catheter." It aims to demonstrate substantial equivalence to a predicate device, the Medtronic Launcher Guide Catheter (K022764).

Here's an analysis of the provided text in relation to acceptance criteria and the study that proves the device meets them:

I. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as quantitative targets in the typical "acceptance criteria" table format (e.g., sensitivity > X%, specificity > Y%). Instead, the document focuses on demonstrating that the Guiding Catheter is substantially equivalent to a legally marketed predicate device. This means the device must perform comparably to the predicate device and raise no new questions of safety or effectiveness.

The document presents a comparison of technological characteristics as the primary "performance" data, indicating how the proposed device aligns with the predicate.

Here's a table summarizing the characteristics presented and the conclusion of equivalence:

Feature	Guiding Catheter (proposed device)	Medtronic Launcher Guide Catheter (K022764)	Acceptance/Equivalence Conclusion
Intended Use	Percutaneous catheter for the delivery of therapeutic devices	Same	Substantially Equivalent
Indications for Use	To provide a pathway through which therapeutic devices are introduced. Intended for use in the peripheral vascular system.	To provide a pathway through which therapeutic devices are introduced. Intended for use in the coronary or peripheral vascular system.	Substantially Equivalent (Proposed device does not include coronary indication, but peripheral use is identical. This difference is considered minor and does not raise new questions of safety/effectiveness).
Device Class	Class II	Same	Substantially Equivalent
Product Code	DQY, 21 CFR 870.1250	Same	Substantially Equivalent
Prescription device	Yes	Same	Substantially Equivalent
Catheter Type	Percutaneous Catheter	Same	Substantially Equivalent
Guidewire compatibility	0.035"	Same	Substantially Equivalent
Catheter Outer Diameter	7.0F	Same	Substantially Equivalent
Catheter Inner Diameter	6.0F	Same	Substantially Equivalent
Catheter Length	55cm	Same	Substantially Equivalent
Low Friction Liner	Yes	Same	Substantially Equivalent
Radiopaque Catheter Distal Tip	Yes	Same	Substantially Equivalent
Braided Shaft Encapsulated in polymer	Yes	Same	Substantially Equivalent
Female luer hub with Strain Relieve	Yes	Same	Substantially Equivalent
Multiple Distal End Shapes Available	Yes	Same	Substantially Equivalent
Sterility	Provided Sterile	Same	Substantially Equivalent
Number of uses	Single patient use	Same	Substantially Equivalent
Principles of Operation	After percutaneous access is gained, the catheter is advanced over a guidewire to the desired location. A therapeutic is placed through the Guiding Catheter. The Guiding Catheter is removed using standard technique.	Same	Substantially Equivalent

II. Study Proving Device Meets Acceptance Criteria

The study described is the 510(k) premarket notification process, which involves demonstrating substantial equivalence through a combination of comparative analysis and various performance tests.

Sample Size Used for the Test Set and Data Provenance:
- The document mentions "Bench testing, including dimensional evaluation, tensile testing, torque testing, kink resistance testing, packaging testing, tip joint fatigue testing, burst proof testing, high pressure dynamic testing, particulate testing." It states, "All testing was performed on test units representative of finished devices."
- It also lists "Simulated Use testing" and "In Vivo Testing."
- Sample Size: The exact sample sizes for each type of testing (bench, simulated use, in vivo) are not specified in the provided text. It only indicates "test units representative of finished devices."
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given it's a premarket notification for a new device, the testing would typically be prospective, conducted by the manufacturer or a contract research organization.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This section is not applicable in the context of this 510(k) submission. The "ground truth" here isn't based on expert interpretations of medical images (as would be the case for an AI/CADe device). Instead, the "ground truth" is adherence to engineering specifications and performance comparable to a predicate device, verified through various physical and mechanical tests.
Adjudication Method for the Test Set:
- Not applicable. There's no human "adjudication" in the sense of consensus reading for medical images. The "adjudication" is achieved through standardized testing protocols (e.g., ASTM, ISO) and comparison of quantitative results to predefined engineering standards or the performance of the predicate device.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CADe devices where human readers' performance with and without AI assistance is evaluated. This submission is for a physical medical device (catheter) and relies on bench and in-vivo performance testing, not human reading performance.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/CADe algorithms. The device here is a physical Guiding Catheter.
The Type of Ground Truth Used:
- For the Guiding Catheter, the "ground truth" is established through:
  - Engineering Specifications/Standards: The device must meet specific physical and mechanical properties (dimensions, tensile strength, torque, kink resistance, burst pressure, etc.).
  - Predicate Device Performance: The device's performance characteristics are compared against those of the legally marketed predicate device to demonstrate substantial equivalence.
  - Biological Compatibility Standards: Adherence to ISO 10993-1 for biocompatibility using in vitro and in vivo models.
  - Simulated Use and In Vivo Testing: Direct measurement of the device's functional performance in environments mimicking its intended use.
The Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of this device's development and testing as described. Training sets are relevant for machine learning algorithms.
How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set mentioned, the establishment of ground truth for it is irrelevant to this submission.

In summary, the document demonstrates that the Guiding Catheter meets "acceptance criteria" by proving its substantial equivalence to a predicate device through a comprehensive set of bench tests, simulated use tests, and in vivo tests, all performed on representative finished devices, and ensuring compliance with relevant biocompatibility standards. The framework of this 510(k) submission is to show that the new device is as safe and effective as a previously cleared device, rather than to demonstrate a specific quantitative improvement over a baseline or human performance.

Summary

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November 24, 2021

Marybeth Gamber VP, Regulatory/Quality CenterPoint Systems LLC 3338 Parkway Blvd West Valley City, Utah 84119

Re: K210009

Trade/Device Name: Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: October 22, 2021 Received: October 25, 2021

Dear Marybeth Gamber:

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 Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210009

Device Name Guiding Catheter

Indications for Use (Describe)

The Guiding Catheter is indicated to provide a pathway through which therapeutic devices are introduced. The catheter is intended to be used in the peripheral vascular system.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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1 510(K) SUMMARY

1.1 Submitter

Name	CenterPoint Systems LLC
Address	3338 Parkway BlvdWest Valley City UT 84119
Phone	877-848-0828
Contact Person:	Marybeth Gamber, Vice President Regulatory Affairs & Quality Assurance
Date Prepared:	November 23, 2021

1.2 Device

Name of Device:	Guiding Catheter
Common or Usual Name	Guide Catheter
Classification Name:	Catheter, Percutaneous
Regulatory Class:	Class II per 21 CFR 870.1250
Product Code:	DQY

1.3 Predicate Device

Predicate Name and 510(k) Number: Medtronic Launcher Guide Catheter, K022764

This predicate has not been subject to a design-related recall.

No reference predicates were used in this submission.

1.4 Device Description

The Guiding Catheter is a single-use percutaneous catheter intended to be used in the peripheral vascular system to provide a pathway through which therapeutic devices are introduced.

The Guiding Catheter is available in a variety of curves to accommodate various anatomies. The Guiding Catheter is comprised of a braid-reinforced catheter shaft terminating in an atraumatic, radiopaque tip. The device includes a proximal hub with luer fitting for fluid infusion and/or aspiration as well as strain relief. The catheter is a single use disposable device. The Guiding Catheter has an inner diameter of 6F, an outer diameter of 7F, and is compatible with an 0.035" guidewire.

1.5 Indications for Use

The Guiding Catheter is indicated to provide a pathway through which therapeutic devices are infroduced. The catheter is intended to be used in the peripheral vascular system.

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1.6 Comparison of Technological Characteristics with the Predicate Device

The Proposed Device and Predicate Device are similar in indications for use, intended use, technological characteristics, and principles of operation.

The differences between the Proposed Device and the Predicate Device are minor and raise no different questions of safety and effectiveness, thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.

Feature	Guiding Catheter(proposed device)	Medtronic Launcher GuideCatheter (K022764)
Intended Use	Percutaneous catheter for thedelivery of therapeutic devices	Same
Indications for Use	The Guiding Catheter is indicatedto provide a pathway throughwhich therapeutic devices areintroduced. The catheter isintended to be used in theperipheral vascular system.	The Medtronic Guiding Catheter isdesigned to provide a pathwaythrough which therapeutic devicesare introduced. The Launchercatheter is intended to be used inthe coronary or peripheral vascularsystem.Substantially Equivalent: Theproposed device does not includethe coronary indication. Otherwisethe indications for use are identical.
Device Class	Class II	Same
Product Code	DQY, 21 CFR 870.1250	Same
Prescription device	Yes	Same
Catheter Type	Percutaneous Catheter	Same
Guidewire compatibility	0.035"	Same
Catheter Outer Diameter	7.0F	Same
Catheter Inner Diameter	6.0F	Same
Catheter Length	55cm	Same
Low Friction Liner	Yes	Same
Radiopaque CatheterDistal Tip	Yes	Same
Braided ShaftEncapsulated in polymer	Yes	Same
Female luer hub withStrain Relieve	Yes	Same
Multiple Distal EndShapes Available	Yes	Same
Sterility	Provided Sterile	Same
Number of uses	Single patient use	Same
Feature	Guiding Catheter(proposed device)	Medtronic Launcher GuideCatheter (K022764)
Principles of Operation	After percutaneous access is gained, the catheter is advanced over a guidewire to the desired location. A therapeutic is placed through the Guiding Catheter. The Guiding Catheter is removed using standard technique.	Same

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The Guiding Catheter is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Both the Guiding Catheter and the predicate use the same types of medical grade materials in the construction of the devices. This includes an imer liner, stainless steel braid, outer shaft jacket, a soft distal tip, and a female luer hub with strain relief. The substantial equivalence decision was also established based on the technical evaluation of the proposed and predicate devices. Therefore, the Guiding Catheter can be considered substantially equivalent to the predicate device.

1.7 Performance Data

All necessary performance testing has been conducted on the Guiding Catheter to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

Test	Consensus Standard/FDAGuidance/Description
Biocompatibility	FDA Final Guidance Document, "Use ofInternational Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1:Evaluation and testing within a risk managementprocess" (June 2016)
Bench testing, including dimensional evaluation,tensile testing, torque testing, kink resistancetesting, packaging testing, tip joint fatigue testing,burst proof testing, high pressure dynamic testing,particulate testing.	Confirm that the device meets intended productspecifications
Simulated Use testing	Confirm that the device will perform as intendedin a simulated environment
In Vivo Testing	Confirm the device will perform as intended inan in vivo model.

The device passed the following tests, which were conducted in accordance with noted standards:

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1.8 Conclusions

Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the Guiding Catheter is substantially equivalent to existing legally marketed devices.

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).