The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.

Device Description

The subject Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.

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

AI/ML Overview

This FDA 510(k) clearance letter pertains to a medical device, not an AI/ML software. Therefore, the detailed acceptance criteria and study information requested, which are typical for AI/ML device evaluations, are not applicable in this context.

The document discusses the CPS Locator 3D Delivery Catheter, a physical medical device. The 510(k) process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing (bench testing, biocompatibility, sterilization, etc.) and, in this case, some real-world usage data. It does not involve AI/ML performance metrics like sensitivity, specificity, or ground truth established by expert consensus for diagnostic accuracy.

Here's a breakdown of why many of your requested points are not applicable, followed by the information that can be extracted:

Acceptance Criteria Table & Reported Performance: Not available in an AI/ML context. The document focuses on demonstrating the device's functional integrity and equivalence to a predicate.
Sample Size (Test Set) & Data Provenance: Not applicable for an AI/ML test set. The clinical data mentioned is retrospective/real-world observational data on the previously cleared device.
Number of Experts & Qualifications (Ground Truth): Not applicable as there's no diagnostic AI/ML algorithm requiring ground truth establishment by experts.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not applicable.
Standalone Performance: Not applicable as it's a physical catheter, not an AI/ML algorithm.
Type of Ground Truth: Not applicable. The "ground truth" for a physical device is its functional performance and safety during use.
Sample Size (Training Set): Not applicable as there's no AI/ML model to train.
How Ground Truth for Training Set was Established: Not applicable.

Information that can be extracted from the provided document regarding the CPS Locator 3D Delivery Catheter:

The document describes the acceptance criteria and study to demonstrate substantial equivalence for a physical medical device, not an AI/ML system. Therefore, many of the requested fields related to AI/ML software evaluation are not directly applicable.

Here's a summary of the relevant information provided:

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

Acceptance Criteria Category	Specific Tests/Performance Evaluated	Reported Device Performance (Summary)
Material & Biocompatibility	Biocompatibility testing (per ISO 10993-1)	Device passed all required biocompatibility tests.
Sterilization	Sterilization validation (per ISO 11137)	Device passed sterilization validation.
Packaging Integrity	Packaging validation (per ANSI/AAMI/ISO 11607-1)	Device passed packaging validation.
Manufacturing Quality	Visual Inspection	Not explicitly stated "passed," but implied by clearance.
Functional Performance (Simulated)	Simulated use testing (including use/compatibility with ancillary devices)	Device performed as intended in simulated use.
Leakage	Valve liquid leak test	Not explicitly stated "passed," but implied by clearance.
Mechanical Strength	Tensile tests	Not explicitly stated "passed," but implied by clearance.
Dimensional Accuracy	Sheath and Dilator Dimensional verification (OD/ID, working length)	Dimensions verified (similar to predicate, 9.0F OD, 7F ID).
Fluid Flow	Flush test	Not explicitly stated "passed," but implied by clearance.
Clinical Performance (Real-World Observational Data on K230363)	Post-market study (physician surveys)	100% successful delivery of ancillary device to target location. 31/44 cases specifically targeted LBB/LBBA. Minor blood loss reported by 5 of 42 physicians. No adverse events or unexpected complications.
	Retrospective observational study 1 (US centers, LBBAP implant procedures)	LBBAP successfully achieved in 95% of patients using the device. No reported complications or adverse events.
	Retrospective observational study 2 (US centers, LBBAP implant procedures)	Out of 66 patients undergoing successful lead implantation, 49 achieved LBBAP with device aid. No reported complications or adverse events.
	Publication in HeartRhythm (defibrillator lead at LBBAP)	Defibrillator lead successfully deployed in 7 of 8 patients targeting LBBA. One failure due to patient anatomy. No reported adverse events or complications.

2. Sample size used for the test set and the data provenance

Test Set (Bench/Performance Testing): Not explicitly stated as a separate "test set" for the new submission, but the document mentions "All testing was performed on test units representative of finished devices." The specific number of units for each bench test is not provided in this summary.
Clinical Data (Real-World Evidence):
- Post-market study: Data collected from 42 physicians at multiple US centers.
- Retrospective Observational Study 1: Not explicitly stated sample size, but mentioned "patients."
- Retrospective Observational Study 2: 66 patients.
- HeartRhythm Publication: 8 patients.
Data Provenance: Primarily United States (US) centers. The data is described as post-market, real-world observational, and retrospective from the previously cleared predicate device (K230363).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical medical device clearance, not an AI/ML diagnostic device requiring expert-established ground truth for performance metrics like sensitivity/specificity. The "ground truth" for the clinical data related to lead delivery success was based on actual surgical outcomes reported by physicians.

4. Adjudication method for the test set

Not Applicable. No expert adjudication for an AI/ML algorithm's output was performed.

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

Not Applicable. This is a physical medical device, not an AI/ML system.

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

Not Applicable. This is a physical medical device.

7. The type of ground truth used

For the clinical data, the "ground truth" was based on observed clinical outcomes (e.g., successful lead delivery, achievement of LBBAP, reported complications/adverse events) as documented and reported by treating physicians and study investigators. This is akin to patient outcomes data in real-world settings.

8. The sample size for the training set

Not Applicable. There is no AI/ML algorithm with a training set.

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

Not Applicable. There is no AI/ML algorithm with a training set.

Summary

FDA 510(k) Clearance Letter - CPS Locator 3D Delivery Catheter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 22, 2025

CenterPoint Systems
Conner Johnson
Senior Regulatory Specialist
3338 Parkway Blvd
West Valley City, Utah 84119

Re: K250147
Trade/Device Name: CPS Locator 3D Delivery Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY
Dated: July 21, 2025
Received: July 21, 2025

Dear Conner Johnson:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K250147 - Conner Johnson
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K250147 - Conner Johnson
Page 3

Sincerely,

ALEXANDRA K. MANARAS -S

For Jessica Batista
Acting Assistant Director
DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K250147

Device Name: CPS Locator 3D Delivery Catheter

Indications for Use (Describe)

The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Page 5

510(k) Summary

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1.1 Submitter

Name: CenterPoint Systems LLC
Address: 3338 Parkway Blvd
West Valley City UT
Phone: 801-602-1923
Contact Person: Conner Johnson, Senior Regulatory Specialist
Date Prepared: 27 March 2025

1.2 Device

Name of Device: CPS Locator 3D Delivery Catheter
Classification Name: Percutaneous Catheter
Regulatory Class: Class II per 21 CFR 870.1250
Product Code: DQY

1.3 Predicate Device

Predicate Name and 510(k) Number: CPS Locator 3D Delivery Catheter, K230363

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

1.4 Device Description

The subject Delivery Catheter (CPS Locator 3D Delivery Catheter) is a single-use percutaneous catheter intended for venous introduction of pacing or defibrillation leads.

1.5 Indications for Use

The subject Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.

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1.6 Comparison of Technological Characteristics with the Predicate Devices

The subject and predicate devices 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. 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	CPS Locator 3D Delivery Catheter (subject device)	Primary Predicate: CPS Locator 3D Delivery Catheter (K230363)	Same / Different between Proposed & Predicates
Intended Use	Percutaneous catheter for the delivery of leads	Percutaneous catheter for the delivery of catheters and leads	Substantially equivalent
Indications for Use	The Delivery Catheter is indicated for the introduction of pacing and defibrillation leads to the right heart, inclusive of the Left Bundle Branch Area.	The Delivery Catheter is indicated for the introduction of various types of catheters and pacing or defibrillator leads.	Substantially equivalent
Product Code	DQY	DQY	Same
Regulation number	21 CFR 870.1250	21 CFR 870.1250	Same
Prescription Device	Yes	Yes	Same
Catheter Type	Percutaneous Catheter	Percutaneous Catheter	Same
Guidewire Compatibility	0.035"	0.035"	Same
Outer Diameter	9.0F	9.0F	Same
Inner Diameter	7F	6.5F	Same
Working Length	42cm, 45cm	42cm, 45cm	Same
Components Provided	Catheter, Dilator	Catheter, Dilator	Same
Hydrophilic Liner	Yes	Yes	Same

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Feature	CPS Locator 3D Delivery Catheter (subject device)	Primary Predicate: CPS Locator 3D Delivery Catheter (K230363)	Same / Different between Proposed & Predicates
Radiopaque Distal Tip	Yes	Yes	Same
Valve	Yes	Yes	Same
Shaft Materials	PEBAX with Barium Sulfate and colorants	PEBAX with Barium Sulfate and colorants	Same
Braid Reinforcement	Yes	Yes	Same
Dilator	Yes	Yes	Same
Multiple Distal End Shapes Available	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
Principles of Operation	After venous access is gained, the catheter and dilator are advanced over a guidewire to the desired location. The dilator is removed and a lead is placed through the Delivery Catheter. The Delivery Catheter may be removed by slitting.	After venous access is gained, the catheter and dilator are advanced over a guidewire to the desired location. The dilator is removed and a lead is placed through the Delivery Catheter. The Delivery Catheter may be removed by slitting.	Same

The modified Delivery Catheter is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device.

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1.7 Performance Data

As the technological characteristics remain the same, no additional performance data was necessary to demonstrate substantial equivalence. All necessary performance testing has been previously conducted on the CPS Locator 3D Delivery 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.

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

Biocompatibility testing per FDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2023)
Sterilization validation per ISO 11137
Packaging validation per ANSI/AAMI/ISO 11607-1
Visual Inspection
Simulated use testing, including use/compatibility with ancillary devices
Valve liquid leak test
Tensile tests
Sheath and Dilator Dimensional verification, including OD/ID, working length
Flush test

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Page 5 of 6

1.8 Clinical Data

As part of the postmarket surveillance process at CenterPoint, and to obtain additional data for marketing purposes, CenterPoint has gathered post-market, and real world data collected from patient cases in which the device was used in accordance with the labelling and indications for use previously reviewed and cleared by the FDA (K230363). The clinical data summarized within this report includes:

Post market study conducted by CenterPoint in which physicians reported on various detailed aspects on the use of the marketed device. This study did not involve using patient-level data, but was a real-world observational study conducted with surveys from various physicians at multiple US centers. There were no predetermined endpoints in the study, as the study was used to collect physician evaluations on various characteristics of device performance in a real-world clinical setting in accordance with the cleared indications for use. There were no reported adverse events or unexpected complications reported during this study. Minor blood loss related to use of the device was reported by 5 of 42 physicians included in the study. 100% of the evaluations reported successful delivery of ancillary device (e.g. lead) to target location, including a majority (31/44) of the cases reporting specifically targeting LBB/LBBA for lead delivery.
Real-world evidence collected during use of the cleared device at four (US) centers during LBBAP implant procedures. The data was collected as part of two retrospective observational studies used to publish abstracts and presentations for the Heart Rhythm Society conference. In one study, the LBBAP was successfully achieved in 95% of patients, demonstrating successful lead delivery to the LBBA using the CPS Locator 3D Delivery Catheter. There were no reported complications or adverse events throughout the course of the study. The other study reported on 66 patients who underwent successful lead implantation procedures, including 49 patients in which LBBAP was successfully achieved with aid of the CPS Locator 3D Delivery Catheter. There were no reported complications or adverse events throughout the course of the study.
Publication in HeartRhythm aimed to analyze the feasibility, safety and short-term follow-up of a traditional defibrillator lead at the LBBAP location. This publication was included as part of the clinical literature summary included in the submission. The publication reported a defibrillator lead was successfully deployed in 7 of 8 patients who underwent lead implantation procedures targeting LBBA. In one (1) patient, the lead was not successfully delivered due to characteristics of the patient anatomy (i.e. fibrotic septum). There were no reported adverse events or complications during the study.

In accordance with 21 CFR 812.2, Paragraph (c), Section (2), all of the clinical data reported herein is exempted from the applicable requirements of clinical investigations, as the device (CPS Locator 3D Delivery Catheter) was introduced into commercial distribution after FDA determined substantial equivalence (K230363) to a device in commercial distribution, and was used in accordance with the indications in the labeling FDA previously reviewed (K230363). As

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Page 6 of 6

the real world data described above are exempted from applicable clinical investigation requirements, this report does not include a Financial Certification or Disclosure, registration on ClinicalTrials.gov (nor an associated Certification of Compliance), Institutional Review Board approvals, nor any other related Statement of Compliance or other documentation to demonstrate compliance with 21 CFR parts 50, 56 and 812.

The clinical data demonstrates that there are no new questions of safety and effectiveness when the CPS Locator 3D Delivery Catheter is used for lead delivery in the LBBA specifically, demonstrating the specific Indications for Use are substantially equivalent to the currently cleared general Indications for Use (K230363).

1.9 Conclusions

Based on the similarity of the subject and predicate devices in terms of the intended use, principle of operation and overall technological characteristics, the subject Delivery Catheter is substantially equivalent to the predicate device (K230363).

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).