(172 days)
The Gladiator Elite Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Gladiator Elite Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Gladiator Elite is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y- connector manifold with luer lock fittings. There are radiopaque marker bands located under the balloon shoulders to aid in positioning the system during the procedure. A coating is applied to the balloon to enhance insertion and withdrawal performance. The tip of the catheter is gradually tapered to facilitate advancement of the catheter through the stenosis.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Gladiator Elite PTA Balloon Dilatation Catheter:
The document (K132810) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for a novel device. Therefore, the information you're requesting regarding acceptance criteria, sample sizes, ground truth establishment, and expert involvement is not explicitly detailed in this type of submission.
Instead, the submission states that "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence." This means the testing aims to show the new device performs similarly to the predicate device, or meets established industry standards for such devices, rather than meeting specific performance metrics against a clinical ground truth.
Here's what can be extracted based on the provided text, and where the requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state numerical "acceptance criteria" for each test in the way you might expect for a novel device's clinical performance. Instead, it lists types of tests performed to demonstrate that the device performs equivalently to the predicate and is safe for its intended use. The "reported device performance" is implicitly that the device passed these tests and was deemed substantially equivalent.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Meets established safety standards for biological interaction (e.g., non-sensitizing, non-toxic, non-hemolytic, non-pyrogenic). | Passed all listed biocompatibility tests: Guinea Pig Maximization Sensitization, Intracutaneous Reactivity, In vitro Hemocompatibility Assay, Acute Systemic Injection, Hemolysis Assay: Direct Contact Method, Materials Mediated Rabbit Pyrogen, Complement Activation C3a and SC5b-9 Assay, Ames Mutagenicity, Mouse Lymphoma, In vitro Cytotoxicity: MEM Elution, Partial Thromboplastin Time (PTT), USP Physicochemical Test for Plastics, Natural Rubber Latex. |
| In-vitro Performance: Functions as intended mechanically and dimensionally, demonstrating durability and ease of use consistent with similar devices. | Passed all listed in-vitro performance tests: Balloon Compliance, Balloon Multiple Inflation, Balloon Nominal Diameter, Burst in a Stent, Rated Burst Pressure, Balloon Multiple Inflation in a Stent, Balloon Burst Mode, Initial Sheath Insertion Force, Proximal Bond Tensile, Sheath Withdrawal, Balloon Protector (Wingtool) Removal Force, Crossing Profile, Particulate Release. |
| Substantial Equivalence: Device materials, configuration, packaging, technology, manufacturing, sterilization, and intended use are substantially equivalent to the predicate device, with "no new safety or performance issues." | The device was found substantially equivalent to the Gladiator PTA Balloon Dilatation Catheter (K113681) based on the comprehensive testing performed. |
Missing Information Details:
Due to the nature of a 510(k) submission for a substantially equivalent device, many of the requested details for a performance study are not applicable or not provided.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the in-vitro or biocompatibility tests. These typically involve a number of units sufficient to meet statistical confidence for engineering and biological testing standards, but a specific "test set" in the context of clinical images or patient data is not relevant here.
- Data Provenance: Not applicable. The data is from laboratory (bench) and in-vitro biocompatibility testing, not human subjects or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable: This device is a PTA Balloon Dilatation Catheter. The "tests" relate to its physical and biological properties. Ground truth in the sense of expert consensus on an imaging finding or clinical outcome is not relevant to this type of device submission. Experts involved would be engineers, material scientists, and toxicologists conducting and interpreting the tests according to established protocols.
4. Adjudication Method for the Test Set
- Not Applicable: There is no "adjudication method" in the sense of multiple readers reviewing clinical data. The tests performed are objective laboratory measurements and standardized biological assays.
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
- No: This is a physical medical device (a catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No: This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: Established biological safety standards and validated laboratory test methodologies (e.g., ISO 10993 series for biological evaluation of medical devices).
- For In-vitro Performance: Engineering specifications, device design parameters, industry standards for balloon catheters, and performance characteristics of the predicate device (K113681).
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" as this is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: There is no "training set" for this physical device.
In summary: The provided document is a 510(k) summary for a physical medical device (catheter) seeking substantial equivalence to a predicate. The "study" described consists of bench testing and biocompatibility testing designed to show the new device performs similarly and safely compared to the predicate, and meets general regulatory and industry standards. It does not involve clinical trials, AI, or human reader performance evaluations in the way one might see for diagnostic software or novel therapeutic devices.
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ﻬﺎ
A3-1
510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | |
|---|---|---|
| Contact NameandInformation | Beth TorokPrincipal Regulatory Affairs Specialist | |
| Phone: 763-494-1273Fax: 763-494-2222e-mail: beth.torok@bsci.com | ||
| Date Prepared | 06 September 2013 | |
| ProprietaryName | Gladiator™ Elite PTA Balloon Dilatation Catheter | |
| Common Name | Percutaneous Catheter | |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal | |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter | |
| PredicateDevice(s) | Gladiator PTA Balloon DilatationK11368111 January 2012Catheter | |
| DeviceDescription | Gladiator Elite is an over-the-wire balloon catheter with a dual lumen shaftdesign. One lumen is used to pass the catheter over 0.035" guidewires.The second lumen communicates with the balloon and is used to inflateand deflate the balloon during the procedure. The guidewire lumen and theballoon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fittings. There are radiopaque markerbands located under the balloon shoulders to aid in positioning the systemduring the procedure. A coating is applied to the balloon to enhanceinsertion and withdrawal performance. The tip of the catheter is graduallytapered to facilitate advancement of the catheter through the stenosis. | |
| IntendedUse/Indicationsfor Use | The Gladiator Elite Balloon Dilatation Catheter is indicated forPercutaneous Transluminal Angioplasty (PTA) in the peripheralvasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian,and renal arteries and for the treatment of obstructive lesions of native orsynthetic arteriovenous dialysis fistulae.The Gladiator Elite Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheralvasculature. | |
| Comparison ofTechnologicalCharacteristics | The Gladiator Elite PTA Balloon Dilatation Catheter incorporatessubstantially equivalent device materials, catheter configuration, packaging,fundamental technology, manufacturing processes, sterilization processand intended use as those featured in the Boston Scientific predicatedevice. | |
| Characteristic | Proposed compared to Predicate | |
| Components | Same components, configuration, design and function. | |
| Materials | Same materials. Balloon contains an additional materialnot new to the device. | |
| Packaging | Same packaging materials and configuration. | |
| SterilizationMethod/SAL | Same method and level of assurance. | |
| GuidewireCompatibility | Same compatibility. | |
| Balloon Diameters &Lengths | Same sizes. | |
| Effective Length | Same length catheters. | |
| Rated BurstPressure (RBP) | Same RBP. |
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Comparison to Predicate Device:
Performance Data
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility tests support the Gladiator Elite PTA Balloon Dilatation Catheter;
| Guinea Pig MaximizationSensitization | Intracutaneous Reactivity |
|---|---|
| In vitro Hemocompatibility Assay | Acute Systemic Injection |
| Hemolysis Assay: Direct ContactMethod | Materials Mediated RabbitPyrogen |
| Complement Activation C3a andSC5b-9 Assay | Ames Mutagenicity |
| Mouse Lymphoma | In vitro Cytotoxicity: MEM Elution |
| Partial Thromboplastin Time(PTT) | USP Physicochemical Test forPlastics |
| Natural Rubber Latex |
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| The following in-vitro performance tests were completed; | ||
|---|---|---|
| Balloon Compliance | Balloon Multiple Inflation | |
| Balloon Nominal Diameter | Burst in a Stent | |
| Rated Burst Pressure | Balloon Multiple Inflation in aStent | |
| Balloon Burst Mode | Initial Sheath Insertion Force | |
| Proximal Bond Tensile | Sheath Withdrawal | |
| Balloon Protector (Wingtool) RemovalForce | Crossing Profile | |
| Particulate Release | ||
| Conclusion | Based on the indications for use, technological characteristics, safety andperformance testing, the Gladiator Elite PTA Balloon Dilatation Catheterhas been shown to be appropriate for its intended use and is considered tobe substantially equivalent to the Gladiator PTA Balloon Dilatation Catheteras submitted in K113681. |
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Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Boston Scientific Corporation c/o Ms. Anne V. Rossi Regulatory Affairs Fellow One Scimed Place Maple Grove, MN 55311-1566
Re: K132810
Trade/Device Name: Gladiator 19 Elite PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: January 24, 2014 Received: January 27, 2014
Dear Ms. Rossi,
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. The gencral 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 complics 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Anne V. Rossi
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K132810
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
.
Gladiator™ Elite Over-the-Wire PTA Balloon Dilatation Catheter Device Name:
Indications for Use:
The Gladiator Elite Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illiac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Gladiator Elite Balloon Dilatation Catheter is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Boston Scientific Corporation
§ 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).