(101 days)
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.
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).
This document describes the 510(k) premarket notification for the Stingray LP Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.
The document does not describe an AI/ML device or a study involving human readers and AI. The acceptance criteria and testing detailed relate to the physical and biological performance of a medical catheter, not an algorithm.
Therefore, many of the requested categories in your prompt are not applicable to the provided text.
Here's the relevant information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device was subjected to testing according to the requirements of the "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters." It then lists the types of tests performed. The specific numerical acceptance criteria and detailed performance results are not provided in this summary document. It only states that "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."
The categories of tests performed include:
| Test Type | Specific Tests Mentioned (where applicable) |
|---|---|
| Biocompatibility & Chemical | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity, Hemolysis (Direct Contact), Hemolysis (Extract Method), Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, In Vivo Thromboresistance, USP <661> Physicochemical Properties (though not listed under this section, it's a general category that might cover some material characterization) |
| In-vitro Performance | 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 (listed again), Marker Visibility, System Radiopacity, Coating Integrity (Balloon and Shaft), Particulates (Sim Use), Corrosion Resistance |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers generally to "bench testing and biocompatibility testing" without specifying sample sizes for each test or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The device is a physical catheter, and the testing involves engineering and biocompatibility evaluations, not interpretive tasks requiring expert ground truth in the context of AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. See point 3.
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 is not applicable. This document is for a physical medical device (catheter), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" would be established by standardized biological assays and chemical characterization methods. For the in-vitro performance tests, the "ground truth" would be the engineering specifications and performance limits defined for the device based on design requirements and relevant standards. These are concrete, measurable physical and chemical properties, not expert consensus or pathology in the clinical sense.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" as this is not an AI/ML device.
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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.
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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
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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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510(k) Summary
per 21 CFR §807.92
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222 |
|---|---|
| Contact NameandInformation | Kurtis HunsbergerPrincipal Regulatory Affairs SpecialistPhone: 763-494-1204Fax: 763-494-2222e-mail: kurtis.hunsberger@bsci.com |
| Date Prepared | August 24, 2015 |
| ProprietaryName | StingrayTM LP Catheter |
| Common Name | Percutaneous Catheter |
| Product Code | DQY |
| Classification | Class II, 21 CFR Part 870.1250 |
| PredicateDevice | BridgePoint MedicalStingray TM Orienting Balloon CatheterK102725 May 10, 2011 |
| DeviceDescription | The Stingray LP Catheter facilitates the placement, support and steeringof a guidewire into discrete regions of the coronary and peripheralvasculature through the central guidewire lumen or through one of twoside-ports. These side-ports are on opposite sides of the balloon and areidentified by radiopaque markers. The side-ports communicate with thecentral guidewire lumen and facilitate guidewire steering (at an angle tothe central lumen) by allowing the guidewire to exit the Stingray LPCatheter. The Stingray LP Catheter contains a small balloon used forfluoroscopic orientation on the distal tip of a flexible shaft. The distal endof the catheter is hydrophilic coated. The Stingray LP Catheter iscompatible with 6F guide catheters with minimum inner diameter of 0.070in (1.7 mm), and may be used with guidewires ≤0.014 in (0.36 mm). |
| Intended Use /Indications forUse | The Stingray LP Catheter is indicated for directing, steering, controlling,and supporting a guidewire in order to access discrete regions of thecoronary 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 isindicated for use to facilitate the intraluminal placement of conventionalguidewires beyond stenotic coronary lesions (including chronic totalocclusions [CTOs]) prior to PTCA or stent intervention. |
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| Comparison ofTechnologicalCharacteristics | The Stingray™ LP Catheter incorporates substantially equivalent devicematerials and design, packaging materials and design, fundamentaltechnology, manufacturing processes, sterilization process and intendeduse as those featured in the Stingray™ Orienting Balloon CatheterK102725 cleared May 10, 2011. Similarities and differences intechnological characteristics between the predicate and subject deviceare 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 thepredicate Stingray. | ||
| PerformanceData | The Stingray™ LP Catheter was subjected to testing according to therequirements of Guidance for Industry and FDA Staff – Class II SpecialControls for Certain Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheters , September 8, 2010. Bench testing andbiocompatibility testing were performed to support a determination ofsubstantial equivalence. The results of these tests provide reasonableassurance that the proposed device has been designed and tested toassure conformance to the requirements for its intended use. No newsafety or performance issues were raised during the testing; therefore,this device may be considered substantially equivalent to the predicatedevice. | |
| The following biocompatibility and chemical characterization tests werecompleted 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 <661> Physicochemical |
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| 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 / GuidewireMovement | Kink – Distal End of Gradient Outer | |
| Guidewire Movementat 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 safetyand performance testing, the Stingray™ LP Catheter has been shown tobe appropriate for its intended use and is considered to be substantiallyequivalent to the Stingray™ Orienting Balloon Catheter. |
§ 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).