(144 days)
Not Found
No
The document describes a catheter for hemodynamic monitoring and does not mention any AI or ML capabilities. The "IQ" in the name appears to be a product line designation, not an indicator of intelligence.
No
The device is a diagnostic tool used for hemodynamic monitoring and measuring various physiological parameters, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly lists "Diagnosis of cardiac tamponade" and "Differential diagnosis of mitral regurgitation and ventricular septal rupture" as primary indications. Additionally, the description highlights its ability to "continuously monitor the patient's balance between oxygen delivery and consumption as well as the ability to help investigate the root cause of an imbalance through analysis of the components of stroke volume." These functions are characteristic of a diagnostic device.
No
The device description clearly describes a physical catheter with lumens and ports for pressure monitoring and blood sampling. It is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "hemodynamic monitoring" and is used in combination with "clinical pressure monitoring equipment" and a "compatible cardiac output computer." It measures pressures within the heart and pulmonary artery and cardiac output. While it allows for "Blood Sampling" as a secondary indication, the primary purpose is direct physiological measurement within the patient's body.
- Device Description: The description reinforces that the catheters are used to "monitor the hemodynamic status of critically ill and injured patients" by measuring pressures and cardiac output. It also mentions "pulmonary artery blood sampling for laboratory analysis," but this is a function of the catheter itself, not the primary diagnostic method performed by the device.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device is used in vivo (within the body) to directly measure physiological parameters.
Therefore, the Swan-Ganz IQ Pulmonary Arterial catheter is a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes:
- Acute heart failure
- Severe hypovolemia
- Complex circulatory situations
- Medical emergencies
- Adult respiratory distress syndrome
- Gram negative sepsis
- Drug intoxication
- Acute renal failure
- Hemorrhagic pancreatitis
- Intra and post-operative management of high risk patients
- History of pulmonary or cardiac disease
- Fluid shifts (e.g., extensive intra-abdominal operations)
- Management of high-risk obstetrical patients
- Diagnosed cardiac disease
- Toxemia
- Premature separation of placenta
- Cardiac output determinations
- Differential diagnosis of mitral regurgitation and ventricular septal rupture
- Diagnosis of cardiac tamponade
Secondary indications include the following:
- Blood Sampling
- Infusion of saline and dextrose solutions
Intended Use- Swan-Ganz IQ catheter:
The Swan-Ganz IQ catheter (model AIQSGF8) is for use in patients who require hemodynamic monitoring. It is intended to be used in combination with clinical pressure monitoring, equipment to measure right heart and pulmonary artery pressures, and with a compatible cardiac output computer to measure intermittent cardiac output. Model AIOSGF8 also measures mixed venous oxygen saturation.
Product codes (comma separated list FDA assigned to the subject device)
DYG
Device Description
The Edwards Swan-Ganz catheters are used to monitor the hemodynamic status of critically ill and injured patients. The existing catheters give clinicians the ability to measure right heart pressures, pulmonary artery occlusion pressure ("wedge"), sample mixed venous blood from the pulmonary artery, as well as measure cardiac output through thermodilution when used with a bedside physiologic monitor and pressure transducers.
The Edwards Swan-Ganz product line is comprised of Standard (Base) and Advanced Technology monitoring catheters. The standard Swan-Ganz catheter measures: right heart pressures, thermodilution cardiac output (room temperature and chilled) and provides a mechanism for pulmonary artery blood sampling for laboratory analysis.
The subject Swan-Ganz IO catheter combines from the existing Advanced catheter design (model 777F8) and the Paceport catheter design (model 780F75M). Using the 777F8 model as the base design, the new catheter modifies the design to remove the thermal filament functionality and replaces it with an additional port which will allow for pressure monitoring at the right ventricular level. The RV port is utilized just like the Swan-Ganz Paceport Oximetry catheter model 780F75M.
Just like the existing advanced catheters, the Swan-Ganz IQ catheter provides the same functionality as the standard and Advanced Technology Swan-Ganz catheters by providing the ability to continuously monitor the patient's balance between oxygen delivery and consumption as well as the ability to help investigate the root cause of an imbalance through analysis of the components of stroke volume (preload, afterload, and contractility).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary Artery, Right Heart, Right Ventricular
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)
The Swan-Ganz IQ catheter has successfully passed functional and performance testing including packaging, shelf life, sterilization, biocompatibility and bench testing, which included frequency response testing, pressure tubing pull testing and lumen burst pressure testing per ISO 10555-1:2013 and IEC 60601:2015 Amd.1:2020.
The subject Swan-Ganz IQ catheter has successfully passed all functional and performance testing including verification and validation, sterilization, shelf life, biocompatibility and bench testing. Completion of all performance verification and validation activities demonstrated that the subject device meets its predetermined design and performance specifications. Verification activities performed confirmed that the differences in the features and design did not adversely affect the safety and effectiveness of the subject device. The testing performed demonstrates that the subject Swan-Ganz IQ (model AIQSGF8) is substantially equivalent to the predicate Swan-Ganz catheter predicate devices models 777F8 and 780F75M (K160084, cleared May 3, 2016).
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.
Not Found
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
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
December 9, 2022
Edwards Lifesiences, LLC Michelle Ducca Manager, Regulatory Affairs 1 Edwards Way Irvine, California 92614
Re: K222117
Trade/Device Name: Swan-Ganz IQ Pulmonary Arterial catheter Regulation Number: 21 CFR 870.1240 Regulation Name: Flow-Directed Catheter Regulatory Class: Class II Product Code: DYG Dated: November 4, 2022 Received: November 7, 2022
Dear Michelle Ducca:
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,
Robert T. Kazmierski -S
for
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) K222117
Device Name
Swan-Ganz IQ Pulmonary Arterial Catheter
Indications for Use (Describe)
The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes:
- · Acute heart failure
- Severe hypovolemia
- Complex circulatory situations
- · Medical emergencies
- · Adult respiratory distress syndrome
- · Gram negative sepsis
- · Drug intoxication
- Acute renal failure
- · Hemorrhagic pancreatitis
- · Intra and post-operative management of high risk patients
- History of pulmonary or cardiac disease
- · Fluid shifts (e.g., extensive intra-abdominal operations)
- · Management of high-risk obstetrical patients
- · Diagnosed cardiac disease
- · Toxemia
- · Premature separation of placenta
- · Cardiac output determinations
- · Differential diagnosis of mitral regurgitation and ventricular septal rupture
- · Diagnosis of cardiac tamponade
Secondary indications include the following:
- · Blood Sampling
- · Infusion of saline and dextrose solutions
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 2015691 |
| Contact
Person: | Michelle Ducca
Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
michelle_ducca@edwards.com
Telephone: (949) 250-4113 |
| Date: | July 15, 2022 |
| Trade Name: | Swan-Ganz IQ catheter (subject) |
| Common
Name: | Cardiovascular Diagnostic Catheters |
| Classification
Name: | Flow-directed catheter 21 CFR 870.1240 |
| Product
Code: | DYG, Class II |
| Predicate
Device(s): | The Edwards Swan-Ganz catheters (Models 777F8 and 780F75M),
manufactured by Edwards Lifesciences, K160084 cleared May 3, 2016, is
being utilized for substantial equivalence due to the same basic device
functionality, similar indications and intended use, labeling and principle of
operation as the subject device. |
| Device
Description: | The Edwards Swan-Ganz catheters are used to monitor the hemodynamic status
of critically ill and injured patients. The existing catheters give clinicians the
ability to measure right heart pressures, pulmonary artery occlusion pressure
("wedge"), sample mixed venous blood from the pulmonary artery, as well as
measure cardiac output through thermodilution when used with a bedside
physiologic monitor and pressure transducers.
The Edwards Swan-Ganz product line is comprised of Standard (Base) and
Advanced Technology monitoring catheters. The standard Swan-Ganz catheter |
510(k) Summary – Swan-Ganz IQ catheter model AIQSGF8
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measures: right heart pressures, thermodilution cardiac output (room temperature and chilled) and provides a mechanism for pulmonary artery blood sampling for laboratory analysis.
The subject Swan-Ganz IO catheter combines from the existing Advanced catheter design (model 777F8) and the Paceport catheter design (model 780F75M). Using the 777F8 model as the base design, the new catheter modifies the design to remove the thermal filament functionality and replaces it with an additional port which will allow for pressure monitoring at the right ventricular level. The RV port is utilized just like the Swan-Ganz Paceport Oximetry catheter model 780F75M.
Just like the existing advanced catheters, the Swan-Ganz IQ catheter provides the same functionality as the standard and Advanced Technology Swan-Ganz catheters by providing the ability to continuously monitor the patient's balance between oxygen delivery and consumption as well as the ability to help investigate the root cause of an imbalance through analysis of the components of stroke volume (preload, afterload, and contractility).
Indications Indications for Use - Swan-Ganz IQ catheter: for Use: The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes: • Acute heart failure • Severe hypovolemia · Complex circulatory situations • Medical emergencies · Adult respiratory distress syndrome · Gram negative sepsis • Drug intoxication • Acute renal failure · Hemorrhagic pancreatitis • Intra and post-operative management of high risk patients • History of pulmonary or cardiac disease · Fluid shifts (e.g., extensive intra-abdominal operations) · Management of high-risk obstetrical patients • Diagnosed cardiac disease
- Toxemia
- Premature separation of placenta
- Cardiac output determinations
- · Differential diagnosis of mitral regurgitation and ventricular septal rupture
- Diagnosis of cardiac tamponade
Secondary indications include the following:
- Blood Sampling
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- · Infusion of saline and dextrose solutions
Intended Use: Intended Use- Swan-Ganz IQ catheter:
Device:
The Swan-Ganz IQ catheter (model AIQSGF8) is for use in patients who require hemodynamic monitoring. It is intended to be used in combination with clinical pressure monitoring, equipment to measure right heart and pulmonary artery pressures, and with a compatible cardiac output computer to measure intermittent cardiac output. Model AIOSGF8 also measures mixed venous oxygen saturation.
Comparison The following technological similarities exist between the subject and predicate to Predicate devices:
The scientific technology and materials of the subject device are unchanged from the legally marketed predicate devices. Both the subject and predicate devices provide the same hemodynamic pressure monitoring and provides intermittent cardiac output, mixed venous oxygen saturation and stroke volume. The modified Swan-Ganz catheter device is identical to the predicate devices in terms of indications for use and has the same overall intended use without the thermodilution functions.
The following technological differences exist between the subject and predicate devices:
- . Thermal filament removed: The currently cleared predicate catheter model 777F8 (K160084 cleared May 3, 2016) has been modified to remove the components relating to the thermal filament including white heater extension tubing.
- . Additional port: An additional port has been implemented to replace the thermal filament with extension tubing (violet) to allow for pressure monitoring from the right ventricular level. The same RV port for pressure monitoring is already available in the existing predicate device model 780F75M (K160084 cleared May 3, 2016).
- Addition of y-connector as tether point on thermistor extension tubing . (yellow) along with short white extension tubing for EEPROM connector.
These differences are not a fundamental change in scientific technology and have no impact to the indications for use or overall intended use.
The existing Swan-Ganz catheter product line includes IFU's for the Pacing, Base and Advanced models. An additional separate IFU for the Swan-Ganz IQ catheter model will be added to the Swan-Ganz product line, which includes the same Indication for Use and the same overall Intended Use as the predicate
7
devices (K160084), an updated image, and removal of thermal filament functionality and associated bolus thermodilution parameters (CCO, EDV, RVEF) in the Instructions for Use.
Performance The Swan-Ganz IQ catheter has successfully passed functional and Data: performance testing including packaging, shelf life, sterilization, biocompatibility and bench testing, which included frequency response testing, pressure tubing pull testing and lumen burst pressure testing per ISO 10555-1:2013 and IEC 60601:2015 Amd.1:2020.
- The subject Swan-Ganz IQ catheter has successfully passed all functional and Conclusions performance testing including verification and validation, sterilization, shelf life, biocompatibility and bench testing. Completion of all performance verification and validation activities demonstrated that the subject device meets its predetermined design and performance specifications. Verification activities performed confirmed that the differences in the features and design did not adversely affect the safety and effectiveness of the subject device. The testing performed demonstrates that the subject Swan-Ganz IQ (model AIQSGF8) is substantially equivalent to the predicate Swan-Ganz catheter predicate devices models 777F8 and 780F75M (K160084, cleared May 3, 2016).