Who is the manufacturer of NuCath Wedge Pressure Catheter?

Pfm Medical, Inc. filed the 510(k) submission for NuCath Wedge Pressure Catheter (K213666).

What is the FDA product code for NuCath Wedge Pressure Catheter?

DQO. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for NuCath Wedge Pressure Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NuCath Wedge Pressure Catheter?

NuMed Balloon Wedge Pressure Catheter (K864943).

Who can help prepare an FDA 510(k) submission like NuCath Wedge Pressure Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NuCath Wedge Pressure Catheter

K213666 · Pfm Medical, Inc. · DQO · Oct 6, 2022 · Cardiovascular

Device Facts

Record ID	K213666
Device Name	NuCath Wedge Pressure Catheter
Applicant	Pfm Medical, Inc.
Product Code	DQO · Cardiovascular
Decision Date	Oct 6, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1200
Device Class	Class 2

Intended Use

The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).

Device Story

NuCath Wedge Pressure Catheter is an intravascular diagnostic catheter with a distal balloon; used to measure right heart pressures (CVP, RVP, PAP, PAWP). Device is inserted into the vasculature; balloon is inflated to facilitate pressure measurement. Operated by clinicians in a clinical setting. Output is a pressure reading obtained via the catheter lumen, which informs clinical decision-making regarding hemodynamic status. Benefits include accurate, minimally invasive monitoring of right heart hemodynamics.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included visual inspection, tip pulling/torquing, burst strength, balloon fatigue, inflation/deflation, radiopacity, and bond strength. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Intravascular diagnostic catheter; 4F, 5F, 6F sizes. Materials: Pebax, Bismuth Subcarbonate, TiO2, Nylon. Sensing: balloon-tipped pressure measurement. Sterilization: 100% Ethylene Oxide (SAL 10^-6). Standards: ISO 10555-1, ISO 10555-4, ASTM F640-12, ISO 80369-1/7/20.

Indications for Use

Indicated for measuring right heart pressures, including central venous, right ventricle, pulmonary artery, and pulmonary artery wedge pressures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

NuMed Balloon Wedge Pressure Catheter (K864943)

Reference Devices

Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter (K960479)

Related Devices

K963335 — HARMAC BALLOON WEDGE PRESSURE CATHETER · Harmac Medical Products, Inc. · Oct 16, 1997
K962829 — HARMAC BALLOON ANGIOGRAPHIC CATHETER · Harmac Medical Products, Inc. · Oct 16, 1997
K963248 — FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) · J-Lloyd Medical, Inc. · Feb 3, 1997
K193466 — Swan-Ganz Catheters · Edwards Lifesciences, LLC · Feb 16, 2020
K963336 — HARMAC THERMODILUTION CATHETER · Harmac Medical Products, Inc. · Aug 14, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. October 6, 2022 PFM Medical, Inc. Jessica Jho Regulatory Affairs Consultant 1916 Palomar Oaks Way Suite 150 Carlsbad, California 92008 Re: K213666 Trade/Device Name: NuCath Wedge Pressure Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: November 18, 2021 Received: November 22, 2021 Dear Jessica Jho: 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 {1}------------------------------------------------ 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 (OS) 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, for LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K213666 Device Name NuCath™ Wedge Pressure Catheter Indications for Use (Describe) The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). | 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." {3}------------------------------------------------ # 510(k) Summary As required by 21 CFR §807.92 | I. | SUBMITTER: | PFM Medical, Inc 1916 Palomar Oaks Way, Suite 150 Carlsbad, CA 92008 | |----|------------------------|----------------------------------------------------------------------------| | | Contact Person: | Jessica Jho Regulatory Affairs PFM Medical JJho@pfmmedicalusa.com | | | Date Summary Prepared: | November 18, 2021 | ## II. DEVICE | Trade or Proprietary Name: | NuCath™ Wedge Pressure Catheter | |----------------------------|-------------------------------------| | Classification Name: | Catheter, Intravascular, Diagnostic | | Device Class: | II | | Regulation Number: | 21 CFR §870.1200 | | Product Code: | DQO | ## III. LEGALLY MARKETED PREDICATE DEVICE | | Predicate Device | | |---------|---------------------------------------|-------------------| | 510(K) | Product Name | Clearance Date | | K864943 | NuMed Balloon Wedge Pressure Catheter | February 20, 1987 | | | Reference Device | | |---------|------------------------------------------------------|------------------| | 510(K) | Product Name | Clearance Date | | K960479 | Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter | October 19, 1996 | ## IV. DEVICE DESCRIPTION The NuCath Wedge Pressure Catheter is an intravascular catheter with a balloon at the distal tip intended to measure pressure in the right heart. {4}------------------------------------------------ ### V. INDICATIONS FOR USE The NuCath Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). ### VI. TECHNOLOGICAL COMPARISON TO PREDICATE The technological features of the subject device, such as intended use, indications for use, design, function and technology, were compared to the predicate device and it was demonstrated that they are substantially equivalent. The following is a summary of the technological characteristics of the subject, predicate and reference devices: {5}------------------------------------------------ | | Subject Device: NuCath Wedge Pressure Catheter | Predicate Device: NuMed Balloon Wedge Pressure Catheter | Reference Device: Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter | Comparison Discussion | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | PFM Medical, Inc. | NuMed, Inc. | Arrow/Teleflex | Not Applicable | | 510(k) Number | Subject of this Review | K864943 | K960479 | Not Applicable | | Indications for Use | The NuCath Balloon Wedge Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). | Sampling blood for oxygen levels and measuring pressures in the right heart | For use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). The second pressure lumen allows infusion of a solution with simultaneous measurement of pressure. The catheter is intended for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording only. | The subject device has the identical indication as the predicate device with the exception of the details specific to "right heart". The information in the parenthesis of the subject device is identical to the reference device and does not add a new intended use as compared to the predicate. | | FDA Product Code | DQO (Catheter, Intravascular, Diagnostic) 21 CFR 870.1200 | DQO (Catheter, Intravascular, Diagnostic) 21 CFR 870.1200 | LDF (Electrode, Pacemaker, Temporary) 21 CFR 870.3680 | The subject device is identical to the predicate. | | Balloon Material | Pebax + TiO2 | Natural Latex | Unknown | Updated materials have successfully passed all required biocompatibility testing and do not add new or increased risk as compared to the predicate device. | | | Subject Device: NuCath Wedge Pressure Catheter | Predicate Device: NuMed Balloon Wedge Pressure Catheter | Reference Device: Arrow Bipolar Pacing/Balloon Wedge Pressure Catheter | Comparison Discussion | | Catheter Base Materials | Pebax, Bismouth Subcarbonate, TiO2, Nylon | Tecoflex polyurethane w/ 20% Barium Sulfate | Unknown | Updated materials have successfully passed all required biocompatibility testing and do not add new or increased risk as compared to the predicate device. | | Catheter Size (French) | 4F, 5F, 6F | 4F, 5F, 6F, 7F | 4F, 5F, 6F, 8F | The French size of the subject devices are identical to the subject device except for the 7F, which is not part of the subject NuCath portfolio. The subject device does not add a worst case configuration as compared to the predicate device. | | Max Inflation Vol. (cc/mL) | 4F = 1.5 5F = 1.5 6F = 2.5 | 4F = .60 5F = .75 6F = 1 7F = 1.25 | 4F = .60 5F = .75 6F = 1 8F = 1.25 | The subject device 6F catheter has a balloon diameter of 10mm, which has been qualified to 2.5cc/mL max inflation volume. The technological difference does not add a new or increased risk to the subject device as compared to the predicate device. | | Sterility | 100% Ethylene Oxide, SAL, 10-6 | 100% Ethylene Oxide, SAL, 10-6 | Unknown | The subject device is identical to the predicate. | | Single Use | Yes | Yes | Yes | The subject device is identical to the predicate | {6}------------------------------------------------ {7}------------------------------------------------ #### VII. PERFORMANCE TESTING A risk analysis per ISO 14971: Medical devices – Application of risk management of medical devices was conducted to assess the risk profile of the subject device. Control mechanisms, including design verification testing, were defined to mitigate the identified risks, to demonstrate that the subject device performs as intended and to evaluate substantial equivalence. Below is a list of non-clinical testing that is included in the submission: | Visual Inspection | Tip Pulling and Torquing | |------------------------------------|-------------------------------------------------| | Balloon Preparation | Minimum Burst Strength | | Diameter and Profile | Repeated Balloon Inflation (Balloon Fatigue) | | Radio-detectability | Balloon Inflation and Deflation | | Catheter Body Maximum Pressure | Balloon Deflatability | | Hubs/Luers | Balloon Distensibility (Compliance) | | Bond Strength (Peak Tensile Force) | | The following standards were referenced in the testing listed above: - ISO 10555-1:2013, Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements [including Amendment 1 (2017)] - ISO 10555-4: 2013, Intravascular Catheters - Sterile and single-use catheters - Part 4: Balloon dilation catheters - 트 ASTM F640-12, Standard Test Methods for Determining Radiopacity for Medical Use - 트 ISO 80369-1: 2018, Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements - . ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for Intravascular or hypodermic applications - . ISO 80369-20: 2015, Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods Additionally, the NuCath Wedge Pressure Catheter were subjected to applicable biocompatibility testing as required per ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The subject device met all predetermined acceptance criteria as defined in the referenced and internal standards. #### VIII. CONCLUSION Based on the information provided in this 510(k) submission, including the indications for use, technological characterizes, and performance testing result, the subject NuCath Wedge Pressure Catheter is substantially equivalent to the predicate device.