(115 days)
The Finesse Injectable™ PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Finesse InjectableTM PTA Balloon Dilatation Catheter is an over-the-wire balloon catheter for peripheral indications. The device features a semi-compliant balloon combined with a low-profile tip. The catheter is compatible with 0.014" (0.36 mm) guidewires and has a hydrophilic coating over its distal coaxial segment to facilitate advancement of the catheter to the treatment site. The Finesse Injectable™ PTA Balloon Dilatation Catheter has a working length of 150 cm, and is available with balloon working lengths of 20, 40, 60, 100, and 225 mm. There are two radiopaque marker bands located within the balloon working length (one proximal and one distal). These radiopaque marker bands, in conjunction with fluoroscopy, aid in the placement of the catheter's balloon segment. There is one additional radiopaque marker located distal of the exit holes to aid in locating their position relative to a guiding sheath distal tip. The catheter construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the guidewire and injection of fluids via the catheter's exit holes that are positioned proximal to the balloon. The proximal portion of the catheter comprises a hub that includes an extension tube with a female luer-lock port connected to a balloon inflation/deflation lumen, and a stopcock with female luer-lock port for fluid/contrast injection attached to the side port of a Touhy-Borst adapter that is in communication with the guidewire lumen.
The Finesse™ Injectable PTA Balloon Dilatation Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria for each test. However, it states that "Results from all tests were acceptable" and that the data "demonstrate that the Finesse Injectable™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate devices."
Based on the information provided, a table of acceptance criteria and reported device performance would look like this:
| Performance Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Testing | Demonstrates sterility suitable for a medical device | Acceptable |
| Package Integrity | Maintain package integrity | Acceptable |
| Crossing Profile | Within acceptable limits for PTA catheters | Acceptable |
| Balloon Outer Diameter | Within specification for marketed balloon sizes | Acceptable |
| Tip/Lesion Entry Profile | Suitable for navigating peripheral vasculature | Acceptable |
| Tip ID | Within specification | Acceptable |
| Catheter Useable Length | Within specification (150 cm) | Acceptable |
| Injection Exit Hole Dimensions and Locations | Within specification | Acceptable |
| Marker Band Position | Accurately placed for fluoroscopic guidance | Acceptable |
| Balloon Burst Strength | Withstands specified pressure without bursting | Acceptable |
| Balloon Compliance | Meets specified compliance characteristics | Acceptable |
| Balloon Working Length | Within specification for marketed balloon lengths | Acceptable |
| Inflation/Deflation Time | Meets specified inflation/deflation times | Acceptable |
| Balloon Fatigue | Withstands repeated inflation/deflation cycles | Acceptable |
| Catheter Bond Tensile Strength | Meets specified tensile strength | Acceptable |
| Kink Resistance | Resists kinking during use | Acceptable |
| Balloon Preparation, Deployment, and Retraction | Demonstrates proper function | Acceptable |
| Introducer Sheath Compatibility | Compatible with specified introducer sheaths | Acceptable |
| Torque Tolerance | Withstands specified torque | Acceptable |
| Radiopacity | Sufficient for fluoroscopic visibility | Acceptable |
| Infusion Rate | Meets specified infusion rate | Acceptable |
| Catheter Body Burst Pressure | Withstands specified burst pressure | Acceptable |
| Guidewire Compatibility | Compatible with specified guidewire diameters | Acceptable |
| Coating Integrity | Maintains integrity during use | Acceptable |
| Particulate Generation | Meets acceptable limits for particulate generation | Acceptable |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Bacterial Endotoxin) | Meets ISO 10993-1 requirements | Met all requirements |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test mentioned under "Performance Data." It refers to "Design verification and validation" and "the following tests were conducted," implying a series of laboratory and bench tests.
- Sample size: Not specified.
- Data provenance: The performance data is generated through "Design verification and validation" testing. This typically implies prospective, internal laboratory testing conducted by the manufacturer (Summa Therapeutics, LLC). There is no indication of country of origin for the data or if it was retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The study is a device performance evaluation (bench testing and biocompatibility), not a clinical study involving the establishment of ground truth by experts for diagnostic or treatment effectiveness.
4. Adjudication method for the test set:
This information is not applicable, as it is a device performance study and not a study requiring expert adjudication of clinical outcomes or images.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This is a 510(k) submission for a physical medical device (balloon catheter), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable, as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable in the context of this device performance study. The "ground truth" for this device's evaluation is defined by engineering specifications, material standards, and established test methodologies for evaluating the physical and mechanical properties of balloon catheters and their biological safety.
8. The sample size for the training set:
This information is not applicable. This is a device performance study, not a machine learning or AI algorithm development that would involve training sets.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this type of device submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 26, 2023
Summa Therapeutics, LLC % Elena Jugo Regulatory Consultant Caraballo Consulting 11037 Bitternut Hickory Lane Boynton Beach, Florida 33437
Re: K230263
Trade/Device Name: Finesse™ Injectable PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: May 2, 2023 Received: May 3, 2023
Dear Elena Jugo:
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,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell - S 0ate: 2023.05.26
Gregory O'Connell 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K230263
Device Name
Finesse Injectable™ PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The Finesse Injectable™ PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
| 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.
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}------------------------------------------------
| 5 - 510(k) Summary | |
|---|---|
| Date Summary Prepared: | January 30, 2023 |
| Submitter: | Summa Therapeutics, LLC225 Dyer Street, 2nd FloorProvidence, RI 02903 |
| Primary Submission Contact: | Elena JugoRegulatory ConsultantCaraballo Consulting & Associates1037 Bitternut Hickory LnBoynton Beach, FL 33437Telephone: 1-305-510-4398E-Mail: Elena@Caraballoconsulting.com |
| Secondary Submission Contact: | Timothy Murphy, M.D.CEO, Summa Therapeutics, LLC225 Dyer Street, 2nd FloorProvidence, RI 02903Telephone: 1-401-484-1355E-Mail: tmurphy@summatherapeutics.com |
| Trade Name: | Finesse Injectable™ PTA Balloon Dilatation Catheter |
| Regulation Number: | 21 CFR 820.1250 |
| Device Common orClassification Name: | PTA Dilatation Catheter |
| Product Class: | Class II |
| Product Panel: | Cardiovascular |
| Product Code: | LIT |
| Predicate Device: | K150452, Finesse™ Injectable PTA Balloon Dilatation Catheter |
{4}------------------------------------------------
Reference Predicate Device:
K192318, Bard Peripheral Vascular. Inc. Ultraverse® 014 PTA Balloon Dilatation Catheter
5.1 Device Description
The Finesse InjectableTM PTA Balloon Dilatation Catheter is an over-the-wire balloon catheter for peripheral indications. The device features a semi-compliant balloon combined with a low-profile tip. The catheter is compatible with 0.014" (0.36 mm) guidewires and has a hydrophilic coating over its distal coaxial segment to facilitate advancement of the catheter to the treatment site.
The Finesse Injectable™ PTA Balloon Dilatation Catheter has a working length of 150 cm, and is available with balloon working lengths of 20, 40, 60, 100, and 225 mm. There are two radiopaque marker bands located within the balloon working length (one proximal and one distal). These radiopaque marker bands, in conjunction with fluoroscopy, aid in the placement of the catheter's balloon segment. There is one additional radiopaque marker located distal of the exit holes to aid in locating their position relative to a guiding sheath distal tip. The catheter construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the guidewire and injection of fluids via the catheter's exit holes that are positioned proximal to the balloon. The proximal portion of the catheter comprises a hub that includes an extension tube with a female luer-lock port connected to a balloon inflation/deflation lumen, and a stopcock with female luer-lock port for fluid/contrast injection attached to the side port of a Touhy-Borst adapter that is in communication with the guidewire lumen.
5.2 Indications for Use
The Finesse Injectable™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
5.3 Technological Characteristics and Basis for Substantial Equivalence
The Finesse Injectable TM PTA Balloon Dilatation Catheter, subject of this 510(k) submission, is substantially equivalent in its intended use/indications for use, technology/principal of operation. biocompatibility of materials, sterilization method, packing, and performance to the predicate device, the ComboCath™ OTW PTA Dilation Catheter (Summa Therapeutics, LLC, Providence,
{5}------------------------------------------------
RI), and the reference predicate device, the Bard Peripheral Vascular, Inc. Ultraverse® 014 PTA Balloon Dilatation Catheter (C. R. Bard, Inc., Murray Hill, NJ).
A comparison of the technological characteristics of the subject device and the predicate devices is summarized in Table 5.3.1. All characteristics noted are the same as, or within the range, of the primary predicate device and/or the reference predicate device.
| Parameter | Subject DeviceFinesse Injectable™PTA Balloon DilatationCatheter | Primary PredicateDeviceComboCath™OTWPTA DilatationCatheter510(k) # K150452 | Reference PredicateDeviceUltraverse® 014 and018 PTA BalloonDilatation Catheters510(k) # K192318 | EquivalenceComparison |
|---|---|---|---|---|
| Indications forUse | The Finesse Injectable™PTA Balloon DilatationCatheter is indicated forPercutaneousTransluminalAngioplasty (PTA) in theperipheral vasculature,including iliac, femoral,popliteal, infra-poplitealand renal arteries, andfor the treatment ofobstructive lesions ofnative or syntheticarteriovenous dialysisfistulae. | The ComboCath™ OTWPTA Dilatation Catheteris indicated forPercutaneousTransluminalAngioplasty (PTA) in theperipheral vasculature,including iliac, femoral,popliteal, infra-poplitealand renal arteries, andfor the treatment ofobstructive lesions ofnative or syntheticarteriovenous dialysisfistulae. | Ultraverse® 014 andUltraverse® 018 PTABalloon DilatationCatheters arerecommended for use inpercutaneoustransluminal angioplasty(PTA) of the renal.popliteal, tibial, femoral,and peroneal arteries.These catheters are notfor use in coronaryarteries. | Same as thePrimary Predicate |
| Product Code | LIT | LIT | LIT | Same |
| Regulation No. | 21CFR 870.1250 | 21CFR 870.1250 | 21CFR 870.1250 | Same |
| Classification | Class II | Class II | Class II | Same |
| Design | · Over-the-wire• Two lumen cathetershaft: 1 lumen forballoon inflation and1 lumen for theguidewire andinjection of fluids· Thermoplasticpolymer balloon· Radiopaque markers | · Over-the-wire• Two lumen cathetershaft: 1 lumen forballoon inflation and1 lumen for theguidewire andinjection of fluids· Thermoplasticpolymer balloon· Radiopaque markers | · Over-the-wire· Coaxial lumen· Radiopaque markers | Same as PrimaryPredicate |
| Shaft and BalloonMaterial | Thermoplastic | Thermoplastic | Information not available | Same as PrimaryPredicate |
Table 5.3.1 - Comparison Between the Finesse Injectable™ PTA Balloon Dilatation Catheter and Predicate Devices
{6}------------------------------------------------
| Parameter | Subject DeviceFinesse Injectable™PTA Balloon DilatationCatheter | Primary PredicateDeviceComboCath™OTWPTA DilatationCatheter510(k) # K150452 | Reference PredicateDeviceUltraverse® 014 and018 PTA BalloonDilatation Catheters510(k) # K192318 | EquivalenceComparison |
|---|---|---|---|---|
| Balloon Diameter | 2.0, 2.5, 3.0, 3.5, 4.0 mm | 2.5, 3.0, 3.5, 4.0 mm | 1.5, 2.0, 2.5, 3.0, 3.5,4.0, 5.0, 6.0, 7.0, 8.0, 9.0mm | Within the range ofsizes of theReference Predicate |
| Balloon Length | 20, 40, 60, 100, 225 mm | 40 mm | 20, 40, 60, 80, 100, 120,150, 200, 220, 250, 300mm | Within the range ofsizes of theReference Predicate |
| Working Length | 150 cm | 150 cm | 75, 90, 100, 130, 150,and 200 cm | Same |
| Coating | Hydrophilic Coating | None | Hydrophilic Coating | Same as theReference Predicate |
| GuidewireCompatibility | 0.14 inches | 0.14 inches | 014": 0.14 inches018": 0.14 or 0.18 inches | Same |
| SheathCompatibility | 5 Fr | 5 Fr | 014": 4 Fr, 5 Fr018": 4 Fr, 5 Fr, 6 Fr | Same |
| Single Use Only | Yes | Yes | Yes | Same |
| Sterilization | E-beam Irradiation | E-beam Irradiation | Ethylene Oxide | Same as thePrimary Predicate |
| Packaging | Catheter is packagedinside dispensing coil orpackaging tray; Tyvekpouch; cardboard box | Catheter is packagedinside dispensing coil orpackaging tray; Tyvekpouch; cardboard box | Information not available | Same as thePrimary Predicate |
Table 5.3.1 - Comparison Between the Finesse Injectable™ PTA Balloon Dilatation Catheter and Predicate Devices
5.4 Performance Data
Design verification and validation were performed to ensure that the Finesse Injectable™ PTA Balloon Dilatation Catheter meets its performance specifications and demonstrates substantial equivalence to the predicate devices. There are no known performance standards for this device. The following tests were conducted to demonstrate performance equivalence to the predicate device:
- Sterility Testing ●
- Package Integrity
- Crossing Profile
- Balloon Outer Diameter
- Tip/Lesion Entry Profile
- Tip ID ●
- Catheter Useable Length ●
- Injection Exit Hole Dimensions and Locations .
{7}------------------------------------------------
K230263 Page 5 of 5
- Marker Band Position ●
- Balloon Burst Strength ●
- Balloon Compliance ●
- Balloon Working Length ●
- Inflation/Deflation Time ●
- Balloon Fatigue
- Catheter Bond Tensile Strength
- Kink Resistance
- Balloon Preparation, Deployment, and Retraction
- . Introducer Sheath Compatibility
- Torque Tolerance ●
- . Radiopacity
- Infusion Rate ●
- Catheter Body Burst Pressure ●
- Guidewire Compatibility ●
- Coating Integrity ●
- Particulate Generation ●
Results from all tests were acceptable. The data demonstrate that the Finesse Injectable™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate devices.
5.5 Biocompatibility Testing
The Finesse Injectable™ PTA Balloon Dilatation Catheter was assessed for biocompatibility in accordance with ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process". The Finesse Injectable™ PTA Balloon Catheter has limited contact (< 24 hours), and as such, the following tests were performed to ensure it is biocompatible:
- . Cytotoxicity
- Sensitization .
- Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- . Hemocompatibility
- o Scanning Electron Microscopy
- . Bacterial Endotoxin
The biocompatibility testing met all requirements.
{8}------------------------------------------------
5.6 Conclusion
Review of the verification and validation test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the Finesse Injectable™ PTA Balloon Dilatation Catheter, is substantially equivalent to the primary predicate device, the ComboCath™ OTW PTA Dilatation Catheter, K150452, cleared on August 13, 2015.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).