(19 days)
Not Found
No
The device description and performance testing focus solely on the mechanical and physical properties of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is indicated for "balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion," which describes a therapeutic action to treat a medical condition.
No
Explanation: The Glider™ PTCA Balloon Dilatation Catheter is used for therapeutic purposes (dilatation of stenotic portions of arteries) rather than for diagnosing a condition.
No
The device description clearly details a physical catheter with a balloon, shaft, hub, and lumens, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical expansion within a blood vessel. This is a medical device used for intervention, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is used for direct treatment within the body.
N/A
Intended Use / Indications for Use
The Glider™ PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Glider™ PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters. Overall catheter length is approximately 135 cm. The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braid reinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The Glider PTCA Balloon Catheter is supplied sterile and intended for single use. The currently cleared Glider PTCA devices include the 2.5 and 3.0mm diameter balloons in lengths of 4.0, 8.0, and 12.0mm. The intent of this submission is to market an expanded size matrix, including 1.5, 2.0, and 3.5mm diameter balloons and 16 and 20mm lengths for all diameters. Additional shelf-life testing has been conducted to support the expanded sizes in this submission; all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544. There is no other change to the Glider PTCA device from the original submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery or bypass graft
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)
The device was subjected to the following performance tests according to FDA Guidance Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010): Dimensional Verification, Balloon Preparation, Deployment & Retraction, Flexibility & Kink, Balloon Rated Burst Pressure (RBP), Balloon Fatigue, Balloon Compliance, Balloon Inflation and Deflation, Catheter Bond Strength, Tip Pull Test, Torque Strength, Radiopacity, Catheter Coating Integrity, Particulate Evaluation, Biocompatibility Testing. No new questions of safety or effectiveness were identified during device testing.
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.
Glider PTCA Balloon Catheter (TriReme Medical) – K111544, Monorail Maverick2 and Maverick XL Monorail (Boston Scientific)-P860019, EMPIRA Rx PTCA Dilatation Catheter (Creganna Tactx Medical)-K110133
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
§ 870.5100 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.
0
of
5. 510(k) Summary
JUN 2 6 2012
Submitter's Name / Contact Person
| Submitter: | TriReme Medical, Inc.
7060 Koll Center Parkway, Suite 300
Pleasanton, CA 94566 U.S.A. |
|-----------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Shiva Ardakani
VP of Regulatory, Quality & Clinical
Phone: (925) 931-1300
Fax: (925) 931-1361 |
| Date Prepared: | June 5, 2011 |
General Information
| Trade Name: | Glider™ PTCA Balloon Catheter |
|---|---|
| Common/Usual Name: | PTCA Catheter |
| Product Code: | LOX |
| Classification Name: | Percutaneous transluminal coronary angioplasty (PTCA) catheter |
| [21 CFR 870.5100(a)] | |
| Predicate Device: | Glider PTCA Balloon Catheter (TriReme Medical) – K111544 |
| Monorail Maverick2 and Maverick XL Monorail (Boston Scientific)-P860019 | |
| EMPIRA Rx PTCA Dilatation Catheter (Creganna Tactx Medical)-K110133 |
Device Description
The Glider™ PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters. Overall catheter length is approximately 135 cm. .
The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braid reinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The Glider PTCA Balloon Catheter is supplied sterile and intended for single use.
The currently cleared Glider PTCA devices include the 2.5 and 3.0mm diameter balloons in lengths of 4.0, 8.0, and 12.0mm. The intent of this submission is to market an expanded size matrix, including 1.5, 2.0, and 3.5mm diameter balloons and 16 and 20mm lengths for all
1
diameters. Additional shelf-life testing has been conducted to support the expanded sizes in this submission; all other mechanical bench testing on these devices has been previously provided and reviewed by FDA with K111544. There is no other change to the Glider PTCA device from the original submission.
Intended Use / Indications
The Glider™ PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Technological Characteristics/Performance Testing/Substantial Equivalence
The Glider™ PTCA Balloon Catheter is substantially equivalent to the predicate device in intended use, indications for use, fundamental scientific technology, and important performance specifications. The device was subjected to the following performance tests according to FDA Guidance Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8,
2010):
- . Dimensional Verification
- Balloon Preparation, Deployment & Retraction ●
- Flexibility & Kink .
- . Balloon Rated Burst Pressure (RBP)
- . Balloon Fatigue
- Balloon Compliance
- Balloon Inflation and Deflation
- Catheter Bond Strength
- . Tip Pull Test
- Torque Strength
- Radiopacity .
- . Catheter Coating Integrity
- o Particulate Evaluation
- . Biocompatibility Testing Including:
- l . Hemolysis Assay Direct Contact
-
- Hemolysis Assay Extract Method
-
- Platelet & Leucocyte Counts
-
- Partial Thromboplastin Time
-
- Thromboresistance
-
- Complement Activation C3a and SC5b-9 Assay
-
- MEM Elution Assay with L-929 Mouse Fibroblast Cells (Cytotoxicity)
-
- Intracutaneous Reactivity Test
-
- Guinea Pig Maximization Sensitization Test
-
- Materials Mediated Rabbit Pyrogen Test
-
- Acute Systemic Injection Test
No new questions of safety or effectiveness were identified during device testing; therefore, the Glider™ PTCA Balloon Catheter is considered substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of a human figure, represented by three overlapping profiles.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 26 2012
TriReme Medical, Inc. c/o Ms. Shiva Ardakani Vice President of Regulatory, Quality & Clinical Affairs 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566
Re: K121681
Trade Name: Glider™ PTCA Balloon Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: II (two) Product Code: LOX Dated: June 5, 2012 Received: June 7, 2012
Dear Ms. Ardakani:
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 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.
3
Page 2 - Ms. Shiva Ardakani
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 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/default.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.
M S Hillemann
r ~ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
K12168
Indications for Use
510(k) Number (XXXXX):
Device Name: Glider™ PTCA Balloon Catheter
Indications for Use:
The Glider™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Common
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D).
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)
M. G. Wilhelm
Division Sign-Off) on of Cardiovascular Devices
510(k) Number K 12
Sit
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