(85 days)
No
The device description and performance studies focus on the mechanical and material properties of a steerable guide catheter, with no mention of AI or ML capabilities.
No.
The device is described as a steerable guide catheter used for introducing other catheters and providing a conduit, which are functions for accessing anatomical sites, not directly treating a medical condition.
No
The device is described as a "Steerable Guide Catheter" used for "introducing various catheters into the left side of the heart through the interatrial septum" or "into the right side of the heart." Its primary function is to "provide a conduit to access the left atrium" or "into the right side of the heart." This indicates a tool for access and delivery, not for diagnosing conditions.
No
The device description clearly outlines physical components such as catheter shafts, a handle with a steering knob, valves, and a dilator. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce various catheters into the heart. This is a procedural device used in vivo (within the body) for accessing anatomical locations.
- Device Description: The description details a physical catheter with mechanical components (shaft, handle, steering knob, valve, dilator). It facilitates access and positioning within the heart.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for direct use within a patient's circulatory system.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left side of the heart through the interatrial septum, right side of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Biocompatibility: 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
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 strengths
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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
3
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."
4
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.
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."
5
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 Medical
177 County Road B East
St. Paul, Minnesota 55117 USA |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone (408) 649-0345
Contact Person: Vidya Thyagarajan
Date Prepared: October 7, 2024 |
| II. DEVICE | Name of Device: MitraClip G5 Steerable Guide Catheter
TriClip G5 Steerable Guide Catheter
Common Name: Steerable Catheter
Classification Name: Catheter, Steerable
Regulatory Class: II
Product Code: DQY |
| III. PREDICATE DEVICES | TriClip Steerable Guide Catheter (K241538) |
IV. REFERENCE DEVICE MitraClip G4 Steerable Guide Catheter (K221397)
IV. 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.
V. INDICATIONS FOR USE
6
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 ●
7
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.