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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NuCath Wedge Pressure Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance results in the way one might expect for a de novo submission or a clinical trial.

However, I can extract the information relevant to acceptance criteria and the study that proves the device meets the acceptance criteria by interpreting the "performance testing" section as the "study" conducted.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with quantitative acceptance criteria values and corresponding quantitative performance values for each test. Instead, it states: "The subject device met all predetermined acceptance criteria as defined in the referenced and internal standards." This implies the tests were conducted with pass/fail criteria, and the device passed all of them.

Below is a table listing the performance tests conducted, with the understanding that the "Reported Device Performance" is implicit as meeting the (unspecified) acceptance criteria for each test.

Acceptance Criteria (Defined by Referenced and Internal Standards)	Reported Device Performance
Visual Inspection	Met criteria
Balloon Preparation	Met criteria
Diameter and Profile	Met criteria
Radio-detectability	Met criteria
Catheter Body Maximum Pressure	Met criteria
Hubs/Luers	Met criteria
Bond Strength (Peak Tensile Force)	Met criteria
Tip Pulling and Torquing	Met criteria
Minimum Burst Strength	Met criteria
Repeated Balloon Inflation (Balloon Fatigue)	Met criteria
Balloon Inflation and Deflation	Met criteria
Balloon Deflatability	Met criteria
Balloon Distensibility (Compliance)	Met criteria
Biocompatibility testing (per ISO 10993-1)	Met criteria

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

Sample Size for Test Set: The document does not specify the exact sample sizes used for each performance test. It lists the types of tests performed.
Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (PFM Medical, Inc.). This implies the data is prospective in the sense that the tests were conducted specifically for this submission, and the country of origin would be where the manufacturer's testing facilities are located (implied to be the US based on the Carlsbad, California address).

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance and design verification testing is established by engineering specifications, recognized standards (e.g., ISO, ASTM), and internal company standards. There are no "experts" in the sense of clinical reviewers establishing ground truth for a test set in this type of submission; rather, the data is compared against predefined technical criteria.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for medical image analysis where multiple readers evaluate cases and a consensus or tie-breaking mechanism is needed. For non-clinical bench testing, the results are objectively measured and compared against established engineering and material specifications.

5. If a Multi Reaser Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation of results, like imaging software) to assess the impact of a device on human reader performance. The NuCath Wedge Pressure Catheter is a physical diagnostic catheter, and its performance evaluation focuses on its physical and functional attributes.

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

Yes, the performance testing described is essentially a "standalone" evaluation of the device itself (algorithm only performance). The tests listed (e.g., burst strength, inflation/deflation, radiodetectability) assess the device's technical specifications and physical integrity without human interaction being part of the primary performance metric for the device's basic function. The device's primary function is to measure pressure, and the tests verify the components that enable this function.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the NuCath Wedge Pressure Catheter is based on:

Engineering Specifications: Designed values and tolerances for dimensions, material properties, and functional characteristics.
Referenced Standards: International and national standards such as ISO 10555-1, ISO 10555-4, ASTM F640-12, ISO 80369 series, and ISO 10993-1. These standards define test methods and often acceptable performance ranges for specific aspects of medical devices.
Internal Standards: Manufacturer's own established quality and performance criteria.

These form the objective criteria against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This question is not applicable. The NuCath Wedge Pressure Catheter is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. The "development" of the device involves engineering design, material selection, and manufacturing processes, not data-driven training.

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

This question is not applicable as there is no "training set" for this physical device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K213666

Device Name NuCath™ Wedge Pressure Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary As required by 21 CFR §807.92

I.	SUBMITTER:	PFM Medical, Inc1916 Palomar Oaks Way, Suite 150Carlsbad, CA 92008
	Contact Person:	Jessica JhoRegulatory AffairsPFM MedicalJJho@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.

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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:

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	Subject Device:NuCath Wedge PressureCatheter	Predicate Device:NuMed Balloon WedgePressure Catheter	Reference Device:Arrow Bipolar Pacing/BalloonWedge 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
Indicationsfor Use	The NuCath Balloon WedgeCatheter is indicated formeasuring pressure in the rightheart (including central venouspressure, right ventriclepressure, pulmonary arterypressure, and pulmonary arterywedge pressure).	Sampling blood for oxygenlevels and measuring pressuresin the right heart	For use in sampling blood foroxygen levels and measuringpressure in the right heart(including central venouspressure, right ventriclepressure, pulmonary arterypressure, and pulmonary arterywedge pressure). The secondpressure lumen allows infusionof a solution with simultaneousmeasurement of pressure. Thecatheter is intended fortemporary use inelectrophysiology studies forintracardiac simulation and/orECG recording only.	The subject device has theidentical indication as thepredicate device with theexception of the details specificto "right heart". The informationin the parenthesis of the subjectdevice is identical to thereference device and does notadd a new intended use ascompared to the predicate.
FDA ProductCode	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 tothe predicate.
BalloonMaterial	Pebax + TiO2	Natural Latex	Unknown	Updated materials havesuccessfully passed all requiredbiocompatibility testing and donot add new or increased risk ascompared to the predicatedevice.
	Subject Device:NuCath Wedge PressureCatheter	Predicate Device:NuMed Balloon WedgePressure Catheter	Reference Device:Arrow Bipolar Pacing/BalloonWedge Pressure Catheter	Comparison Discussion
CatheterBaseMaterials	Pebax, Bismouth Subcarbonate,TiO2, Nylon	Tecoflex polyurethane w/ 20%Barium Sulfate	Unknown	Updated materials havesuccessfully passed all requiredbiocompatibility testing and donot add new or increased risk ascompared to the predicatedevice.
Catheter Size(French)	4F, 5F, 6F	4F, 5F, 6F, 7F	4F, 5F, 6F, 8F	The French size of the subjectdevices are identical to thesubject device except for the 7F,which is not part of the subjectNuCath portfolio. The subjectdevice does not add a worstcase configuration as comparedto the predicate device.
Max InflationVol. (cc/mL)	4F = 1.55F = 1.56F = 2.5	4F = .605F = .756F = 17F = 1.25	4F = .605F = .756F = 18F = 1.25	The subject device 6F catheterhas a balloon diameter of10mm, which has been qualifiedto 2.5cc/mL max inflationvolume. The technologicaldifference does not add a newor increased risk to the subjectdevice as compared to thepredicate device.
Sterility	100% Ethylene Oxide, SAL, 10-6	100% Ethylene Oxide, SAL, 10-6	Unknown	The subject device is identical tothe predicate.
Single Use	Yes	Yes	Yes	The subject device is identical tothe predicate

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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 (BalloonFatigue)
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.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).