(172 days)
Not Found
No
The description focuses on the mechanical aspects of a balloon catheter and does not mention any AI/ML components or functionalities.
Yes
This device is a balloon dilatation catheter used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in the peripheral vasculature and for post-dilatation of stents, which are direct therapeutic interventions.
No
The device is a balloon dilatation catheter used for therapeutic procedures (angioplasty and post-dilatation of stents), not for diagnosing conditions.
No
The device description clearly details a physical catheter with a balloon, lumens, guidewire compatibility, radiopaque markers, and a coating, indicating it is a hardware device.
Based on the provided information, the Gladiator Elite Balloon Dilatation Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for a medical procedure (Percutaneous Transluminal Angioplasty) performed within the patient's body to treat vascular conditions. IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The description details a physical catheter with a balloon designed for insertion into blood vessels. This aligns with a therapeutic medical device, not a diagnostic test performed on a sample.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Gladiator Elite Balloon Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
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)
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 Maximization Sensitization
In vitro Hemocompatibility Assay
Hemolysis Assay: Direct Contact Method
Complement Activation C3a and SC5b-9 Assay
Mouse Lymphoma
Partial Thromboplastin Time (PTT)
Natural Rubber Latex
Intracutaneous Reactivity
Acute Systemic Injection
Materials Mediated Rabbit Pyrogen
Ames Mutagenicity
In vitro Cytotoxicity: MEM Elution
USP Physicochemical Test for Plastics
The following in-vitro performance tests were completed;
Balloon Compliance
Balloon Nominal Diameter
Rated Burst Pressure
Balloon Burst Mode
Proximal Bond Tensile
Balloon Protector (Wingtool) Removal Force
Particulate Release
Balloon Multiple Inflation
Burst in a Stent
Balloon Multiple Inflation in a Stent
Initial Sheath Insertion Force
Sheath Withdrawal
Crossing Profile
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
§ 870.1250 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).
0
ﻬﺎ
A3-1
510(k) Summary
per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Name
and
Information | Beth Torok
Principal Regulatory Affairs Specialist | |
| | Phone: 763-494-1273
Fax: 763-494-2222
e-mail: beth.torok@bsci.com | |
| Date Prepared | 06 September 2013 | |
| Proprietary
Name | 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 | |
| Predicate
Device(s) | Gladiator PTA Balloon Dilatation
K113681
11 January 2012
Catheter | |
| Device
Description | 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. | |
| Intended
Use/Indications
for Use | 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. | |
| Comparison of
Technological
Characteristics | The Gladiator Elite PTA Balloon Dilatation Catheter incorporates
substantially equivalent device materials, catheter configuration, packaging,
fundamental technology, manufacturing processes, sterilization process
and intended use as those featured in the Boston Scientific predicate
device. | |
| | | |
| Characteristic | Proposed compared to Predicate | |
| Components | Same components, configuration, design and function. | |
| Materials | Same materials. Balloon contains an additional material
not new to the device. | |
| Packaging | Same packaging materials and configuration. | |
| Sterilization
Method/SAL | Same method and level of assurance. | |
| Guidewire
Compatibility | Same compatibility. | |
| Balloon Diameters &
Lengths | Same sizes. | |
| Effective Length | Same length catheters. | |
| Rated Burst
Pressure (RBP) | Same RBP. | |
1
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 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 |
2
| 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 a | |
| Stent | ||
| Balloon Burst Mode | Initial Sheath Insertion Force | |
| Proximal Bond Tensile | Sheath Withdrawal | |
| Balloon Protector (Wingtool) Removal | ||
| Force | Crossing Profile | |
| Particulate Release | ||
| Conclusion | Based on the indications for use, technological characteristics, safety and | |
| performance testing, the Gladiator Elite PTA Balloon Dilatation Catheter | ||
| has been shown to be appropriate for its intended use and is considered to | ||
| be substantially equivalent to the Gladiator PTA Balloon Dilatation Catheter | ||
| as submitted in K113681. |
3
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
4
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
5
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