(318 days)
No
The summary describes a physical catheter for pressure measurement and does not mention any software, algorithms, or data processing that would suggest AI/ML.
No.
The device is used to measure physiological parameters (pressure), not to treat or diagnose a disease.
Yes
The device is indicated for "measuring pressure in the right heart," which provides information that can be used to diagnose various cardiac conditions.
No
The device description clearly states it is an "intravascular catheter with a balloon at the distal tip," indicating it is a physical hardware device, not software only.
Based on the provided information, the NuCath™ Wedge Pressure Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The NuCath™ Wedge Pressure Catheter is an intravascular catheter used to directly measure pressure within the right heart. This is an in vivo measurement, meaning it's performed inside the living body.
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient. It's a direct measurement tool.
Therefore, the NuCath™ Wedge Pressure Catheter falls under the category of a medical device used for direct physiological measurement, not an in vitro diagnostic.
N/A
Intended Use / 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).
Product codes
DQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
- Balloon Preparation
- Diameter and Profile
- Radio-detectability
- Catheter Body Maximum Pressure
- Hubs/Luers
- Bond Strength (Peak Tensile Force)
- Tip Pulling and Torquing
- Minimum Burst Strength
- Repeated Balloon Inflation (Balloon Fatigue)
- Balloon Inflation and Deflation
- Balloon Deflatability
- Balloon Distensibility (Compliance)
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
- ASTM F640-12, Standard Test Methods for Determining Radiopacity for Medical Use
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.