The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads. The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035" guidewire.

AI/ML Overview

The provided text, a 510(k) summary for the CPS Locator 3D Delivery Catheter, does not contain the information requested about acceptance criteria or a study proving that an AI/device meets specific performance criteria.

This document describes a medical device (a delivery catheter) and its substantial equivalence to a predicate device, focusing on physical and functional characteristics, indications for use, and manufacturing/sterilization compliance, not on an AI-driven diagnostic or performance study.

Therefore, I cannot provide the requested information, which typically pertains to the validation of AI-based medical devices or diagnostic tools. The document's purpose is to demonstrate that the catheter itself is substantially equivalent to an already cleared device, not to present data on a new, AI-driven performance metric.

Summary

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March 9, 2023

CenterPoint Systems LLC Marybeth Gamber VP. Regulatory & Ouality 3338 Parkway Blvd West Valley City, Utah 84119

Re: K230363

Trade/Device Name: CPS Locator 3D Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DOY Dated: February 8, 2023 Received: February 10, 2023

Dear Marybeth Gamber:

We have reviewed vour 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.

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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 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.

Hetal-B. Patel -S

Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K230363

Device Name Delivery Catheter

Indications for Use (Describe)

The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.

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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6 510(K) SUMMARY

6.1 Submitter

Name	CenterPoint Systems LLC
Address	3338 Parkway BlvdWest Valley City UT
Phone	877-848-0828
Contact Person:	Marybeth Gamber, Vice President Regulatory Affairs & Quality Assurance
Date Prepared:	08 February, 2023

6.2 Device

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

6.3 Predicate Device

Predicate Name and 510(k) Number: CenterPoint Systems SSPC Delivery Catheter, K190475

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

No reference predicates were used in this submission.

Device Description 6.4

The Delivery Catheter is a single-use percutaneous catheter intended to introduce various types of catheters and pacing or defibrillator leads.

The Delivery Catheter is packaged with a dilator for introduction into the vasculature. Proximally, the Delivery Catheter is equipped with a hemostatic valve, and the distal soft, rounded, radiopaque tip facilitates imaging under fluoroscopy. The Delivery Catheter is designed to be slittable, thereby allowing its removal after device placement. The proposed modified Delivery Catheter include introduction of new models which incorporate different curves and lengths, which are available to accommodate various anatomies. The proposed

510(k) Summary

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Delivery Catheter has an inner diameter of 7F, an outer diameter of 9F, and the dilator is compatible with a 0.035" guidewire.

6.5 Indications for Use

The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.

The indications for use statement is identical to the predicate device.

6.6 Comparison of Technological Characteristics with the Predicate Device

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

The differences between the Proposed Device and the Predicate Device are minor thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with

Feature	Proposed Delivery Catheter	Predicate Delivery Catheter(K190475)	Comparison betweenProposed & PredicateDevices
Intended Use	Percutaneous catheter for thedelivery of catheters and leads	Percutaneous catheter for thedelivery of catheters and leads	Same
Indications forUse	The Delivery Catheter isindicated for the introduction ofvarious types of catheters andpacing or defibrillator leads.	The Delivery Catheter isindicated for the introduction ofvarious types of catheters andpacing or defibrillator leads.	Same
Product Code	DQY	DQY	Same
Regulationnumber	21 CFR 870.1250	21 CFR 870.1250	Same
PrescriptionDevice	Yes	Yes	Same
Catheter Type	Percutaneous Catheter	Percutaneous Catheter	Same
GuidewireCompatibility	0.035"	0.035"	Same
Outer Diameter	9.0F	8.0F	SubstantiallyEquivalent
Inner Diameter	7F	6.5F	SubstantiallyEquivalent
WorkingLength	42cm, 45cm	40cm	SubstantiallyEquivalent
ComponentsProvided	Catheter, Dilator	Catheter, Dilator	Same
HydrophilicLiner	Yes	Yes	Same
RadiopaqueDistal Tip	Yes	Yes	Same
Valve	Yes	Yes	Same

21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.

510(k) Summary

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Feature	Proposed Delivery Catheter	Predicate Delivery Catheter(K190475)	Comparison betweenProposed & PredicateDevices
Braidreinforcement	Yes	Yes	Same
Dilator	Yes	Yes	Same
Multiple DistalEnd ShapesAvailable	Yes	Yes	Same
Sterility	E-Beam sterilization, SAL 10-6	E-Beam sterilization, SAL 10-6	Same.
Number of uses	Single patient use	Single Patient Use	Same
Principals ofOperation	After venous access is gained, the catheter and dilator areadvanced over a guidewire tothe desired location. Thedilator is removed and acatheter or lead is placedthrough the Delivery Catheter.The Delivery Catheter may beremoved by slitting.	After venous access is gained, the catheter and dilator areadvanced over a guidewire tothe desired location. Thedilator is removed and acatheter or lead is placedthrough the Delivery Catheter.The Delivery Catheter may beremoved by slitting.	Same

The Proposed Device is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the Proposed Device can be considered substantially equivalent to the predicate device.

Performance Data 6.7

All necessary performance testing has been conducted on the Proposed Device to assure substantial equivalence to the predicate device and to demonstrate the device performs as intended. All performance testing was conducted in accordance with well-established methods, with data that can be reviewed in a summary. All testing was performed on test units representative of finished devices.

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

Test	Consensus Standard/FDA Guidance/Description
Biocompatibility	FDA Final Guidance Document, "Use of InternationalStandard ISO 10993-1, "Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a riskmanagement process" (2020)
Bench testing, including sterilebarrier testing, dimensionalevaluation, anddestructive/tensile testing	Confirm that the proposed changes to the device meetintended product specifications

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Test	Consensus Standard/FDA Guidance/Description
Simulated Use testing	Confirm that the proposed changes to the device willperform as intended in a simulated environment

6.8 Conclusions

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

510(k) Summary

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).