(101 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a catheter and its interaction with guidewires and other devices. There is no mention of AI, ML, or any computational analysis of data for decision-making or guidance.
No.
The device facilitates guidewire placement and steering within the vasculature but itself does not provide a therapeutic effect. It is a tool for accessing and supporting other interventions (PTCA or stent intervention).
No
The device is indicated for directing, steering, controlling, and supporting a guidewire to access regions of the coronary and peripheral vasculature, and to facilitate guidewire placement for PTCA or stent intervention. It is an interventional device, not a diagnostic one.
No
The device description clearly describes a physical catheter with a balloon, guidewire lumen, side-ports, and a flexible shaft, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the Stingray LP Catheter clearly indicates it is a medical device used within the body (in vivo) to facilitate the placement and steering of guidewires in the coronary and peripheral vasculature. It is a tool for interventional procedures, not a test performed on a sample outside the body.
- Intended Use: The intended use is to access and navigate within blood vessels, not to analyze biological samples.
- Device Description: The description focuses on the physical components and function of the catheter for guiding and supporting guidewires.
- Performance Studies: The performance studies mentioned are bench testing and biocompatibility testing, which are typical for in vivo medical devices, not IVDs.
Therefore, the Stingray LP Catheter is an interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.
When used as part of the system consisting of the CrossBossTM Catheter, Stingray LP Catheter, and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
Product codes
DQY
Device Description
The Stingray LP Catheter facilitates the placement, support and steering of a guidewire into discrete regions of the coronary and peripheral vasculature through the central guidewire lumen or through one of two side-ports. These side-ports are on opposite sides of the balloon and are identified by radiopaque markers. The side-ports communicate with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the Stingray LP Catheter. The Stingray LP Catheter contains a small balloon used for fluoroscopic orientation on the distal tip of a flexible shaft. The distal end of the catheter is hydrophilic coated. The Stingray LP Catheter is compatible with 6F guide catheters with minimum inner diameter of 0.070 in (1.7 mm), and may be used with guidewires Physicochemical.
The following in-vitro performance tests were completed on the StingrayTM LP Catheter: Effective Length, Shaft Outer Diameter, Crossing Profile, Delivery, Catheter Torque / Guidewire Movement, Guidewire Movement at Rated Burst Pressure, Withdrawal into a Guide, Two Catheters in a 7F Guide, Rated Burst Pressure (RPB), Balloon Burst Mode, Repeat Inflation, Balloon Dimensional, Inflation and Deflation Time, Full Unit Tensile, Distal Reflow Bond Yield Strength, Kink – Proximal End, Kink – Distal End of Gradient Outer, Kink – Distal End, Catheter Torque, Marker Visibility, System Radiopacity, Coating Integrity (Balloon and Shaft), Particulates (Sim Use), Corrosion Resistance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight. The profiles are depicted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2015
Boston Scientific Corporation Kurtis Hunsberger Principal Regulatory Affairs Specialist, Interventional Cardiology One Scimed Place Maple Grove, MN 55311
Re: K152401
Trade/Device Name: Stingray LP Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 5, 2015 Received: November 6, 2015
Dear Kurtis Hunsberger:
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 mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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
2
Indications for Use
510(k) Number (if known)
Device Name Stingray™ LP Catheter
Indications for Use (Describe)
The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.
When used as part of the system consisting of the CrossBoss™ Catheter, Stingray LP Catheter, and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
| 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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3
510(k) Summary
per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
Fax: 763-494-2222 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Kurtis Hunsberger
Principal Regulatory Affairs Specialist
Phone: 763-494-1204
Fax: 763-494-2222
e-mail: kurtis.hunsberger@bsci.com |
| Date Prepared | August 24, 2015 |
| Proprietary
Name | StingrayTM LP Catheter |
| Common Name | Percutaneous Catheter |
| Product Code | DQY |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate
Device | BridgePoint Medical
Stingray TM Orienting Balloon Catheter
K102725 May 10, 2011 |
| Device
Description | The Stingray LP Catheter facilitates the placement, support and steering
of a guidewire into discrete regions of the coronary and peripheral
vasculature through the central guidewire lumen or through one of two
side-ports. These side-ports are on opposite sides of the balloon and are
identified by radiopaque markers. The side-ports communicate with the
central guidewire lumen and facilitate guidewire steering (at an angle to
the central lumen) by allowing the guidewire to exit the Stingray LP
Catheter. The Stingray LP Catheter contains a small balloon used for
fluoroscopic orientation on the distal tip of a flexible shaft. The distal end
of the catheter is hydrophilic coated. The Stingray LP Catheter is
compatible with 6F guide catheters with minimum inner diameter of 0.070
in (1.7 mm), and may be used with guidewires ≤0.014 in (0.36 mm). |
| Intended Use /
Indications for
Use | The Stingray LP Catheter is indicated for directing, steering, controlling,
and supporting a guidewire in order to access discrete regions of the
coronary and peripheral vasculature.
When used as part of the system consisting of the CrossBossTM Catheter,
Stingray LP Catheter, and Stingray Guidewire, the Stingray LP Catheter is
indicated for use to facilitate the intraluminal placement of conventional
guidewires beyond stenotic coronary lesions (including chronic total
occlusions [CTOs]) prior to PTCA or stent intervention. |
4
| Comparison of
Technological
Characteristics | The Stingray™ LP Catheter incorporates substantially equivalent device
materials and design, packaging materials and design, fundamental
technology, manufacturing processes, sterilization process and intended
use as those featured in the Stingray™ Orienting Balloon Catheter
K102725 cleared May 10, 2011. Similarities and differences in
technological characteristics between the predicate and subject device
are listed below.
Similarities:
Polymer material construction Hydrophilic coating Radiopaque proximal markers Manifold and strain relief Identical balloon segment Ethylene Oxide sterilization Packaging design with same function Differences: | |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | Shaft Outer Diameter: Stingray LP has a lower profile than the
predicate Stingray. | |
| Performance
Data | The Stingray™ LP Catheter was subjected to testing according to the
requirements of Guidance for Industry and FDA Staff – Class II Special
Controls for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters , September 8, 2010. 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; therefore,
this device may be considered substantially equivalent to the predicate
device. | |
| | The following biocompatibility and chemical characterization tests were
completed on the Stingray™ LP Catheter: | |
| | Cytotoxicity | Hemolysis (Extract Method) |
| | Sensitization | Partial Thromboplastin Time |
| | Intracutaneous Reactivity | In Vitro Hemocompatibility |
| | Acute Systemic Toxicity | Complement Activation |
| | Materials Mediated Pyrogenicity | In Vivo Thromboresistance |
| | Hemolysis (Direct Contact) | USP Physicochemical |
5
| | The following in-vitro performance tests were completed on the Stingray™
LP Catheter: | |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| | Effective Length | Inflation and Deflation Time |
| | Shaft Outer Diameter | Full Unit Tensile |
| | Crossing Profile | Distal Reflow Bond Yield Strength |
| | Delivery | Kink – Proximal End |
| | Catheter Torque / Guidewire
Movement | Kink – Distal End of Gradient Outer |
| | Guidewire Movement
at Rated Burst Pressure | Kink – Distal End |
| | Withdrawal into a Guide | Catheter Torque |
| | Two Catheters in a 7F Guide | Marker Visibility |
| | Rated Burst Pressure (RPB) | System Radiopacity |
| | Balloon Burst Mode | Coating Integrity (Balloon and Shaft) |
| | Repeat Inflation | Particulates (Sim Use) |
| | Balloon Dimensional | Corrosion Resistance |
| Conclusion | Based on the indications for use, technological characteristics, and safety
and performance testing, the Stingray™ LP Catheter has been shown to
be appropriate for its intended use and is considered to be substantially
equivalent to the Stingray™ Orienting Balloon Catheter. | |