The MitraClip G5 Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.
The TriClip G5 Steerable Guide Catheter is used for introducing various catheters into the right side of the heart.

Device Description

The MitraClip G5 Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The device provides a conduit to access the left atrium. The SGC's primary function is to dilate the atrial septum, maneuver to the target location above the mitral valve, and position the CDS. The MitraClip G5 Steerable Guide Catheter is provided sterile and for single use only.
The TriClip G5 Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The TriClip G5 Steerable Guide Catheter is provided sterile and for single use only.
The MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are equivalent in terms of design, material, principle of operation, and sterilization method. There are minor differences in design to facilitate access to different areas of the heart.

AI/ML Overview

This FDA 510(k) summary for the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through the kind of study typically associated with AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable or not provided in this document as it pertains to a physical medical device (catheter) and its inherent performance characteristics (e.g., tensile strength, steering performance), not an AI algorithm.

However, I can still extract the information regarding the device's acceptance criteria and the engineering and bench testing performed to demonstrate that the device meets its design specifications, as this is the "study" proving the device meets the acceptance criteria for a physical device.

Device: MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter

Type of Device: Percutaneous Catheter (Class II)

Purpose of the Submission: Demonstrate substantial equivalence to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to engineering, material, and functional specifications, and "reported device performance" refers to the results of bench and biocompatibility testing. The document states that testing was "conducted to demonstrate that the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter met all performance specifications." While specific numerical performance values are not detailed in this summary, the categories of tests act as implicit acceptance criteria.

Acceptance Criterion (Category of Test)	Reported Device Performance (Outcome)
Biocompatibility
Cytotoxicity	Acceptable (evaluated per ISO 10993-1)
Hemocompatibility	Acceptable (evaluated per ISO 10993-1)
Sensitization	Acceptable (evaluated per ISO 10993-1)
Irritation	Acceptable (evaluated per ISO 10993-1)
Acute Systemic Toxicity	Acceptable (evaluated per ISO 10993-1)
Materials-Mediated Pyrogenicity	Acceptable (evaluated per ISO 10993-1)
Design Verification (Bench Testing)
Visual inspection	Met performance specifications
Catheter dimensions	Met performance specifications
Curves and steering performance	Met performance specifications
Tensile strengths	Met performance specifications
Torsional strengths	Met performance specifications
Hemostasis	Met performance specifications
Particulate evaluation	Met performance specifications
Shelf-life verification	Met performance specifications
Sterilization
Sterility Assurance Level (SAL)	Achieved 10^-6 per ISO 11135
EO/ECH residuals	Acceptable per ISO 10993-7
Packaging
Packaging integrity and safety	Met acceptance criteria (per ISO 11607-1, 11607-2) following 2X sterilization, environmental conditioning, and transport simulation.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes are typically determined by statistical methods for each specific test (e.g., a certain number of catheters for tensile strength, a certain number of packaging samples).
Data Provenance: This is an internal company study (Abbott Medical). The data would be from controlled laboratory and manufacturing environments. This is retrospective in the sense that the testing is performed on manufactured devices to confirm their design and production quality before submission. There is no patient-specific data or country-of-origin context in this type of submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable in the context of this device. Ground truth for a physical catheter (e.g., whether it has adequate tensile strength) is established by engineering specifications, validated test methods, and measurement equipment, not by expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication typically applies to expert assessments of medical images or clinical outcomes. For device performance testing, results are typically objective measurements, passing/failing criteria, or standardized biological responses.

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 (catheter), not an AI/software. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility: Established by international standards (ISO 10993 series) and validated analytical/biological testing methods.
For design verification: Established by engineering design specifications and validated bench test methods.
For sterilization: Established by international standards (ISO 11135).
For packaging: Established by international standards (ISO 11607 series).

8. The Sample Size for the Training Set

Not Applicable. "Training set" refers to data used to train AI models. This is a physical device and does not involve an AI component.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As above, there is no "training set" for this physical device.

Summary for this specific document:

This FDA submission is for a conventional medical device (a steerable guide catheter) and focuses on demonstrating substantial equivalence to existing predicate devices. The "acceptance criteria" and "proof" primarily involve a battery of bench tests and biocompatibility assessments to ensure the device meets engineering specifications, is safe for its intended biological contact, and can be reliably sterilized and packaged. The methodologies described are standard for physical medical devices and do not involve the types of clinical performance studies, reader studies, or AI algorithm validation typically discussed for AI/SaMD submissions.

Summary

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December 31, 2024

Abbott Medical Vidya Thyagarajan Senior Specialist, Regulatory Affairs 177 County Road B East St. Paul, Minnesota 55117

Re: K243224

Trade/Device Name: MitraClip G5 Steerable Guide Catheter (SGC0801) TriClip G5 Steerable Guide Catheter (TSGC0801) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 7, 2024 Received: October 7, 2024

Dear Vidya Thyagarajan:

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.

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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" (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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory

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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).

Sincerely,

Rachel E. Neubrander -S

Rachel Neubrander, PhD Director DHT2B: Division of Circulatory Support, Structural, and Vascular 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) K243224

Device Name MitraClip G5 Steerable Guide Catheter

Indications for Use (Describe)

The MitraClip G5 Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K243224

Device Name TriClip G5 Steerable Guide Catheter

Indications for Use (Describe)

The TriClip G5 Steerable Guide Catheter is used for introducing various catheters into the right side of the heart.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K243224 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR 807.92 and the requirements of the Safe Medical Device Act (SMDA) of 1990.

I. SUBMITTER	Abbott Medical177 County Road B EastSt. Paul, Minnesota 55117 USA
	Phone (408) 649-0345Contact Person: Vidya ThyagarajanDate Prepared: October 7, 2024
II. DEVICE	Name of Device: MitraClip G5 Steerable Guide CatheterTriClip G5 Steerable Guide CatheterCommon Name: Steerable CatheterClassification Name: Catheter, SteerableRegulatory Class: IIProduct Code: DQY
III. PREDICATE DEVICES	TriClip Steerable Guide Catheter (K241538)

IV. REFERENCE DEVICE MitraClip G4 Steerable Guide Catheter (K221397)

IV. DEVICE DESCRIPTION

The TriClip G5 Steerable Guide Catheter (including a dilator) consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a dilator with a single central lumen. The device provides a conduit into the right side of the heart. The TriClip G5 Steerable Guide Catheter is provided sterile and for single use only.

The MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are equivalent in terms of design, material, principle of operation, and sterilization method. There are minor differences in design to facilitate access to different areas of the heart.

V. INDICATIONS FOR USE

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The MitraClip G5 Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The TriClip G5 Steerable Guide Catheter is used for introducing various cardiovascular catheters into the right side of the heart.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices are handheld catheter systems designed to facilitate access and placement of specified devices within the chambers of the heart. A comparison of the intended use and technological characteristics demonstrates that the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are substantially equivalent to the TriClip Steerable Guide Catheter (K241538) and MitraClip G4 Steerable Guide Catheter (K221397).

The MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter have the same intended use as the predicate and reference devices. The TriClip G5 Steerable Guide Catheter has the same indications for use as the TriClip Steerable Guide Catheter, and the MitraClip G5 Steerable Guide Catheter has the same indications for use as the MitraClip G4 Steerable Guide Catheter. Additionally, the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are equivalent to the predicate and reference devices in terms of design, material, principle of operation, and sterilization method. The different technological characteristics of the subject device include a new Guide Attach feature that secures the device to the updated G5 Stabilizer, as well as an alternate luer component with a different material and dimensions.

VIII. SUBSTANTIAL EQUIVALENCE

Performance testing was performed to demonstrate the device meets its design specification and is as safe and effective as the predicate devices. The following design verification and validation testing was provided in support of a substantial equivalence determination. Performance testing was leveraged from prior generations of the device, including the TriClip Steerable Guide Catheter and the MitraClip G4 Steerable Guide Catheter, where appropriate.

Biocompatibilitv

The biocompatibility evaluation of the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter was conducted in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The device is considered an external communicating device with limited (≤24 hour) contact with circulating blood, therefore, evaluation was conducted in the following categories:

Cytotoxicity .
Hemocompatibility ●
. Sensitization
Irritation
Acute Systemic Toxicity ●
Materials-Mediated Pyrogenicity ●

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Design Verification

The following bench testing was conducted to demonstrate that the MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter met all performance specifications:

. Visual inspection
Catheter dimensions
Curves and steering performance ●
. Tensile strenaths
Torsional strengths
Hemostasis ●
Particulate evaluation
Shelf-life verification .

Sterilization

The MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter is intended for single use only and is provided sterile via ethylene oxide (EO) gas to achieve a Sterility Assurance Level (SAL) of 10-6 per ISO 11135. An EO/ECH residuals assessment found the residuals to be acceptable per ISO 10993-7 following 2X sterilization.

Packaging

Packaging verification studies were performed in compliance with the applicable requirements of ISO 11607-1 and ISO 11607-2. All device packaging met acceptance criteria following 2X sterilization, environmental conditioning, and transport simulation.

IX. CONCLUSION

The subject MitraClip G5 Steerable Guide Catheter and TriClip G5 Steerable Guide Catheter are substantially equivalent to the predicate devices. This conclusion is based upon the devices' similarities in intended use and technological characteristics. There are no differences between the subject device and the predicates that raise new questions for safety and effectiveness.

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).