(192 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and its performance in clinical trials. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies.
Yes
The device is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses, which is a therapeutic intervention aimed at treating medical conditions.
No
The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly describes a physical catheter with a balloon, guidewire lumen, radiopaque markers, and positioning marks. It is a hardware device used for balloon dilatation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The Ringer Perfusion Balloon Catheter is a medical device used directly within the body (in vivo) to physically dilate coronary arteries or bypass grafts. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly describes a procedure performed on the patient's anatomy, not an analysis of a biological sample.
- Device Description: The description details a physical catheter with a balloon and guidewire lumen, consistent with an interventional device.
- Performance Studies: The performance studies focus on procedural success, safety during the procedure, and maintenance of blood flow within the body, not on the accuracy of a diagnostic test.
Therefore, the Ringer Perfusion Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.
Product codes
LOX
Device Description
The Ringer perfusion balloon catheter is a rapid exchange catheter with a spiral-shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014" guidewire. The inflated spiral balloon approximates a hollow cylinder. Radiopaque markers at the proximal and distal end of the balloon facilitate visualization and intravascular placement of the catheter prior to inflation. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip. The Ringer perfusion balloon catheter has been sterilized with ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary bypass graft, coronary artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Biocompatibility Tests: The biocompatibility evaluation for the Ringer perfusion balloon catheter device was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, September 2023 and International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The battery of testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Materia Mediated Pyrogenicity, Hemolysis, Complement Activation, and Thrombogenicity.
Bench Tests: Dimensional and Visual Verification, Balloon Preparation, Deployment and Retraction, Balloon Rated Burst Pressure, Balloon Fatigue, Balloon Compliance, Balloon Inflation and Deflation Time, Catheter Bond Strength, Tip Pull Test, Flexibility and Kink, Torque Strength, Radiopacity, ISO 80369 Hub Verification.
Animal Tests: The safety of the Ringer perfusion balloon catheter was evaluated during simulated clinical use in a swine model. The testing was performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.
The primary objective of demonstrating safety of the Ringer perfusion balloon catheter was exhibited in this study in terms of the measured adverse events, procedural data, gross necropsy, histopathology, and clinical observations. Normal, TIMI 3 perfusion was maintained to all vasculature distal to the test article for the duration of inflation. Thrombogenicity scores demonstrated no to minimal thrombus formation. Additionally, no significant visual changes observed from baseline to terminal time points through angiographic evaluation.
Clinical Tests:
Study type: Clinical Trial (G200321, 'Ringer PTCA Study')
Sample size: 60 subjects
Primary Effectiveness Endpoint: Device procedural success consisting of successful delivery, inflation, deflation, and removal of the study device; no vessel perforation, flow-limiting vessel dissection, no reduction in TIMI flow from baseline, and no clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with the study device; achievement of final TIMI flow grade of 3 at the conclusion of the PCI procedure for the target lesion.
Key results: The primary efficacy endpoint was met in 57/60 (95%) of the subjects.
Primary Safety Endpoint: Occurrence of clinically relevant events during prolonged balloon inflations and freedom from MACE at hospital discharge.
Key results: The study primary safety endpoint was met in 95% (57/60) of the subjects.
Secondary Efficacy Endpoint: Successful PCI defined as final residual stenosis ≤20% diameter stenosis (in-stent) or ≤ 50% diameter stenosis (stand-alone balloon) by visual angiographic estimation and freedom from MACE at hospital discharge; maintenance of TIMI-2 or -3 flow into distal coronary bed during study device inflation.
Key results: The secondary efficacy endpoint of successful PCI was met in 93% (56/60) of the subjects.
Secondary Efficacy Endpoint: Tolerance of at least one study device inflation equal to or greater than one minute (prolonged inflation) at target site.
Key results: The secondary safety endpoint of tolerance of at least one Ringer perfusion balloon catheter prolonged inflation at target site was met in 50/60 (83.3%) of subjects.
Summary: Procedural success was achieved in 95% of cases with no serious adverse events attributable to the subject device. Maintenance of TIMI II or III flow into distal coronary bed during Ringer perfusion balloon inflation was achieved in 100% of cases.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
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May 31, 2024
Vascular Solutions LLC Becky Astrup Pr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K233729
Dear Becky Astrup:
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.
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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" (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 QS 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).
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Sincerely,
Brian D. Pullin -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: 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) K233729
Device Name Ringer perfusion balloon catheter
Indications for Use (Describe)
The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.
| 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
[As required by 21 CFR 807.92]
Date Prepared: May 1, 2024
510(k) Number: K233729
Submitter's Name / Contact Person
Manufacturer Vascular Solutions LLC 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812
Contact Person Becky Astrup Pr. Regulatory Product Specialist Tel: 763-762-2601
General Information Trade Name Ringer perfusion balloon catheter Common / Usual Name Catheter Classification Name 21 CFR 870.5100, LOX, Percutaneous Transluminal Coronary Angioplasty Catheters, Class II Predicate Device K153682, Chocolate XD PTCA Balloon Catheter (Vascular Solutions) The Chocolate XD PTCA balloon catheter has not been subject to a design related recall.
Device Description
The Ringer perfusion balloon catheter is a rapid exchange catheter with a spiral-shaped inflatable balloon on the distal end and a wire lumen for delivery over a ≤ 0.014" guidewire. The inflated spiral balloon approximates a hollow cylinder. Radiopaque markers at the proximal and distal end of the balloon facilitate visualization and intravascular placement of the catheter prior to inflation. The catheter shaft has positioning marks located at 95cm (single mark) and 105cm (double mark) from the distal tip. The Ringer perfusion balloon catheter has been sterilized with ethylene oxide.
5
Indications for Use
The Ringer Perfusion Balloon Catheter is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion.
The Indications for Use statement for the Ringer Perfusion Balloon Catheter is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
Comparison of Technological Characteristics with the Predicate Device
The subject device and predicate device have the same intended use and the indications for use for the subject device fall within the intended use of the predicate device. Differences between the subject device indications for use and predicate device indications for use are supported by benchtop, animal, and clinical tests.
The Ringer perfusion balloon catheter and the predicate device have the same technological characteristics with respect to:
- . Conditions of Use
- . General Principles of Operation
- . Cutting/Scoring Features (none)
- Materials ●
- Catheter Shaft Design and Configuration
- Guidewire and Guide Catheter Compatibility ●
- . Balloon Length
The following technological differences exist between the subject and predicate device:
- . Ancillary Device Delivery
- Balloon Design .
- Distal Perfusion Mechanism ●
- Crossing Profile ●
- Balloon Inflation Time
- Radiopaque Markers ●
- Catheter Length ●
- Packaging
- Sterilization ●
- Shelf Life ●
- Balloon Diameter
- Nominal Pressure
- Rated Burst Pressure ●
- Balloon Deflation Time ●
Results of benchtop, animal, and clinical tests demonstrate that the technological characteristics of the subject device do not raise different questions of safety and effectiveness and that the subject device is substantially equivalent to the predicate device.
Performance Data
The following performance data were provided in support of substantial equivalence.
Biocompatibility Tests:
The biocompatibility evaluation for the Ringer perfusion balloon catheter device was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, September 2023
6
and International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA. The battery of testing included the following tests:
- . Cvtotoxicitv
- Sensitization ●
- Irritation
- Acute Systemic Toxicity ●
- Materia Mediated Pyrogenicity
- Hemolysis ●
- Complement Activation ●
- Thrombogenicity ●
The Ringer perfusion balloon catheter is considered an external communicating device contacting circulating blood for a limited duration (