(202 days)
The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.
The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of quidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.
The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.
The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a semi-compliant balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter (1.2 mm) and length (12 mm) at recommended pressures. The Threader™ Micro-Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There is a single radiopaque marker band located in the center of the balloon body to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.
Here's a breakdown of the acceptance criteria and the study information for the Threader™ Micro-Dilatation Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity Hemolysis (Direct Contact & Extract) | Tests completed; no new safety issues raised. |
| Sensitization | Tests completed; no new safety issues raised. | |
| Complement Activation | Tests completed; no new safety issues raised. | |
| Intracutaneous Reactivity | Tests completed; no new safety issues raised. | |
| Coagulation | Tests completed; no new safety issues raised. | |
| Acute Systemic Toxicity | Tests completed; no new safety issues raised. | |
| In Vitro Hemocompatibility | Tests completed; no new safety issues raised. | |
| Materials Mediated Pyrogenicity | Tests completed; no new safety issues raised. | |
| USP Physicochemical | Tests completed; no new safety issues raised. | |
| In-Vitro Performance | Effective Length | Tests completed; no new performance issues raised. |
| Catheter Bond Strength | Tests completed; no new performance issues raised. | |
| Shaft Inner and Outer Diameter | Tests completed; no new performance issues raised. | |
| Tip Pull Test | Tests completed; no new performance issues raised. | |
| Balloon Crossing Profile | Tests completed; no new performance issues raised. | |
| Flexibility and Kink | Tests completed; no new performance issues raised. | |
| Balloon Preparation, Deployment, and Retraction | Tests completed; no new performance issues raised. | |
| Torque Strength | Tests completed; no new performance issues raised. | |
| Withdrawal into a Guide Catheter | Tests completed; no new performance issues raised. | |
| Radiopacity | Tests completed; no new performance issues raised. | |
| Balloon Rated Burst Pressure | Tests completed; no new performance issues raised. | |
| Coating Integrity | Tests completed; no new performance issues raised. | |
| Balloon Fatigue (Repeat Inflations) | Tests completed; no new performance issues raised. | |
| Particulate Evaluation | Tests completed; no new performance issues raised. | |
| Balloon Compliance | Tests completed; no new performance issues raised. | |
| Catheter Body Burst Pressure | Tests completed; no new performance issues raised. | |
| Balloon Inflation/Deflation Time | Tests completed; no new performance issues raised. | |
| Contrast Media Flow Rate | Tests completed; no new performance issues raised. | |
| Overall Equivalence | Conformance to regulatory guidance | The device 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." The results provide reasonable assurance of conformance and substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for the biocompatibility or in-vitro performance tests. It only states that these tests were "completed."
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin. Given the nature of these tests (bench testing and biocompatibility), they are typically conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided in the 510(k) summary. The ground truth for device performance in this context is established through objective physical and chemical testing against engineering specifications and regulatory guidance, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., medical images) requires consensus. The tests described are objective, physical, and chemical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI with human readers, which is not relevant for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device (catheter), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Threader™ Micro-Dilatation Catheter is based on:
- Engineering Specifications: The device's design parameters (e.g., balloon diameter, length, bond strength) are inherent to its design and manufacturing.
- Regulatory Guidance: The "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" provides the established benchmarks and acceptance criteria for these types of devices.
- Predicate Device Performance: The device is compared to legally marketed predicate devices, implying that their established performance serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. "Training set" refers to data used to train AI algorithms, which is not relevant for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
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510(k) Summary
per 21 CFR §807.92
X134031 JIII 2 1 2014
| Submitter'sName andAddress | Boston Scientific CorporationCardiovascular DivisionOne Scimed PlaceMaple Grove, MN 55311Phone: 763-494-1700Fax: 763-494-2222 | ||
|---|---|---|---|
| Contact NameandInformation | Vicky L. HagensPrincipal Regulatory Affairs SpecialistPhone: 763-494-1522Fax: 763-494-2222e-mail: vicky.hagens@bsci.com | ||
| Date Prepared | January 27, 2014 | ||
| ProprietaryName(s) | Threader™ Monorail ™ Micro-Dilatation CatheterThreader™ Over-The-Wire Micro-Dilatation Catheter | ||
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) DilatationCatheter | ||
| Product Code | LOX | ||
| Classification | Class II, 21 CFR Part 870.5100 | ||
| PredicateDevices | Emerge™ PTCA DilatationCatheter (1.20 mm) | K130391 | July 10, 2013 |
| CrossBoss™ Catheter | K102725 | May 10, 2011 | |
| Coyote™ PTA Balloon DilatationCatheter | K111295 | May 31, 2011 | |
| Asahi Corsair Microcatheter | K083127 | February 3, 2009 | |
| DeviceDescription | The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile,single-use, intravascular medical device. The catheter consists of a shaftwith a semi-compliant balloon near the distal tip. The balloon is designedto provide an inflatable segment of known diameter (1.2 mm) and length(12 mm) at recommended pressures. The Threader™ Micro-DilatationCatheter is offered in both Monorail (MR) and Over-The-Wire (OTW)platforms. There is a single radiopaque marker band located in the centerof the balloon body to aid in positioning the system during the procedure.Coatings are applied to the balloon and catheter to enhance insertion andwithdrawal performance. | ||
| Intended Useof Device | The Threader™ Micro-Dilatation Catheter is intended for dilatation ofstenosis in coronary arteries or bypass grafts. |
510(k) Summary . Threader™ Micro-Dilatation Catheter
.
:
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| Indications for Use | The Threader™ Micro-Dilatation Catheters are indicated for pre-dilatationof the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70%stenosis) for the purpose of improving myocardial perfusion.The Threader™ Micro-Dilatation Catheters are intended to providesupport to facilitate the placement of guidewires in the coronaryvasculature. The Threader Over-The-Wire Micro-Dilatation Catheter canalso be used to exchange one guidewire for another.The Threader™ Over-The-Wire Micro-Dilatation Catheter is also intendedto allow hand-injection of contrast media into the coronary vasculature. |
|---|---|
| Comparison ofTechnologicalCharacteristics | The Threader™ Micro-Dilatation Catheter incorporates substantiallyequivalent device materials and design, packaging materials and design,fundamental technology, manufacturing processes, sterilization processand intended use as those featured in the predicate devices: Emerge™PTCA Dilatation Catheter (1.20 mm), K130391 (cleared July 10, 2013);CrossBoss™ Catheter, K102725 (cleared May 10, 2011); Coyote™ PTADilatation Catheter, K111295 (cleared May 31, 2011); and Asahi CorsairMicrocatheter, K083127 (cleared February 3, 2009). |
| PerformanceData | The Threader™ Micro-Dilatation Catheter was subjected to testingaccording to the requirements of Guidance for Industry and FDA Staff –Class II Special Controls for Certain Percutaneous Transluminal CoronaryAngioplasty (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 and,therefore, these devices may be considered substantially equivalent to thepredicate devices.The following biocompatibility and chemical characterization tests werecompleted on the Threader™ Micro-Dilatation Catheter: |
| Cytotoxicity Hemolysis (Direct Contact & Extract)Sensitization Complement ActivationIntracutaneous Reactivity CoagulationAcute Systemic Toxicity In Vitro HemocompatibilityMaterials Mediated Pyrogenicity USP Physicochemical | |
| The following in-vitro performance tests were completed on theThreader™ Micro-Dilatation Catheter: | |
| Effective Length Catheter Bond StrengthShaft Inner and Outer Diameter Tip Pull TestBalloon Crossing Profile Flexibility and KinkBalloon Preparation, Deployment, Torque Strengthand RetractionWithdrawal into a Guide Catheter RadiopacityBalloon Rated Burst Pressure Coating IntegrityBalloon Fatigue (Repeat Inflations) Particulate EvaluationBalloon Compliance Catheter Body Burst PressureBalloon Inflation/Deflation Time Contrast Media Flow Rate |
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Conclusion
1
:
. .
Based on the indications for use, technological characteristics, and safety and performance testing, the Threader™ Micro-Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate devices.
510(k) Summary Threader™ Micro-Dilatation Catheter
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MI) 20993-0002
July 21, 2014
Boston Scientific Corporation Ms. Vicky Hagens Principal Regulatory Affairs Specialist One Scimed Place Maple Grove. Minnesota 55311
Re: K 134031
Trade/Device Name: Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: June 16, 2014 Received: June 17, 2014
Dear Ms. Hagens.
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. Ilisting 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 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
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Page 2 - Ms. Vicky Hagens
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 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/ReportalProblem/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.A. Hillemann
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): K134031
Device Name: Threader™ Monorail™ Micro-Dilatation Catheter Threader™ Over-The-Wire Micro-Dilatation Catheter
Indications for Use:
The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.
The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of quidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.
The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.
Prescription Use × (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)
M. G. Hillemann
§ 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.