(188 days)
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
The provided text is an FDA 510(k) clearance letter and summary for the Swan-Ganz catheter. It primarily details the regulatory process, device description, and indications for use.
Crucially, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the context of proving device performance against specific metrics. The document explicitly states:
"The subject Swan-Ganz Base and Advanced catheters are identical to the predicate devices cleared in K160084 and K222117 in terms of design, performance specifications, and technological characteristics with the exception of the indications for use statement and other portions of the labeling. The are no changes to the design, technology, performance, materials, or specifications of the devices in this 510(k). The modifications to the subject devices are limited to labeling changes."
This indicates that the current submission (K233824) is for a labeling change only, and therefore, the performance of the device itself (its ability to accurately monitor hemodynamic pressures) would have been established during the clearance of the predicate devices (K160084 and K222117), not in this particular submission.
Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria or a study proving the device meets acceptance criteria related to its performance.
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June 6, 2024
Edwards Lifesciences LLC Bedalin Lugo Rodriguez Regulatory Affairs Manager One Edwards Way Irvine, California 92614
Re: K233824
Trade/Device Name: Swan-Ganz catheter Regulation Number: 21 CFR 870.1240 Regulation Name: Flow-Directed Catheter Regulatory Class: Class II Product Code: DYG, DQE, DQO, KRA Dated: November 30, 2023 Received: December 1, 2023
Dear Bedalin Lugo Rodriguez:
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.
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"
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(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 OS 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.
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 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
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality
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Enclosure
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510(k) - Edwards Lifesciences LLC - Swan-Ganz catheter
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Swan-Ganz catheter
Indications for Use (Describe)
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
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)
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510(k) SUMMARY
| Swan-Ganz Base and Advanced catheters | ||
|---|---|---|
| 510(k) Submitter | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614(949) 250-111 | |
| Contact Person | Bedalin LugoManager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (787) 229-5433Fax: (949) 809 - 2954Email:Bedalin_lugo@edwards.com | Aditi IyengarSr. Manager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 250-3478Fax: (949) 809 - 2954Email:Aditi_Iyengar@edwards.com |
| Date Prepared | November 30, 2023 | |
| Trade Name | Swan-Ganz catheters | |
| Regulation Number/Regulation Name | 21 CFR §870.1240 - Catheter, Flow Directed21 CFR §870.1230 - Catheter, Oximeter, Fiberoptic21 CFR §870.1200 - Catheter, Intravascular, Diagnostic21 CFR §870.1210 – Catheter, Continuous Flush | |
| Product Code | DYG, DQE, DQO and KRA | |
| Regulation Class | Class II | |
| Predicate Device | K160084, K222117 | |
| Reference Device | K231248 | |
| Device Description | The Swan-Ganz catheters are flow-directed pulmonary artery cathetersused to monitor hemodynamic pressures. The Swan-Ganzthermodilution catheters provide diagnostic information to rapidlydetermine hemodynamic pressures and cardiac output when used witha compatible cardiac output computer. | |
| Indications for Use | Swan-Ganz catheters are diagnostic and monitoring tools used forhemodynamic monitoring of adult critically ill patients including butnot limited to post major surgical recovery, trauma, sepsis, burns,pulmonary disease, pulmonary failure, cardiac disease including heartfailure. | |
| Swan-Ganz Base and Advanced catheters | ||
| The subject Swan-Ganz Base and Advanced catheters are identical tothe predicate devices cleared in K160084 and K222117 in terms ofdesign, performance specifications, and technological characteristicswith the exception of the indications for use statement and otherportions of the labeling. | ||
| ComparativeAnalysis | The are no changes to the design, technology, performance, materials,or specifications of the devices in this 510(k). The modifications to thesubject devices are limited to labeling changes. The indications for useand labeling differences were updated to be in compliance with theEuropean Union Medical Device Regulations (EU MDR), ISO20147:2021, ISO 15223-1:2021, and in better alignment with 21 CFR841.20 requirements. These labeling changes provide additionalclarifying details and did not raise any new concerns of safety andeffectiveness or introduce any new clinical uses for the subject devices. | |
| Conclusion | The Swan-Ganz catheters remain safe, effective, and substantiallyequivalent to the predicate devices. |
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§ 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).