(138 days)
The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
The Direxion Microcatheter is available in small and large lumens. The Direxion Torqueable Microcatheter (Direxion) is a small lumen microcatheter with a distal outside diameter of 2.5F (0.85 mm), and a maximum outside diameter of 2.7F (0.95 mm). It has an inside diameter of 0.021 in (0.5 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.018 in (0.47 mm).
The Direxion HI-FLO Torqueable Microcatheter (Direxion HI-FLO) is a large lumen microcatheter with a distal outside diameter of 2.9F (1.00 mm), and a maximum outside diameter of 3F (1.05 mm). It has an inside diameter of 0.027 in (0.6 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.021 in (0.53 mm).
The Direxion and Direxion HI-FLO Microcatheters are available in a variety of tip shapes (Straight, Bern, Swan, and J) to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. A radiopaque marker is located at the distal tip to facilitate fluoroscopic visualization. Some Direxion Microcatheters have a second marker 3 cm proximal to the first marker. The distal tip of the microcatheter is steam shapeable. The proximal end incorporates a standard luer with rotating hemostatic valve (RHV) or Y-adapter.
The Direxion and Direxion HI-FLO Microcatheters are available with the following preloaded guidewires:
Fathom-16 Steerable Guidewire
- 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths
Transend 14/18 Steerable Guidewires - 0.014 in (0.37 mm) or 0.018 in (0.47 mm) diameters; 135, 165 or 190 cm lengths
The guidewires have a hydrophilic coating to provide lubricity, which aids in the navigation of distal, tortuous vasculature. The guidewires are radiopaque to allow for visualization under fluoroscopy and the tips are shapeable.
Accessories may include a RHV or Y-adapter, steam shaping mandrel, microcatheter introducer, quidewire introducer and torque device.
This document is a 510(k) summary for the Direxion and Direxion HI-FLO Torqueable Microcatheters. It describes the device, its intended use, and performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria in the way typically expected for a medical device efficacy or performance study with quantified clinical outcomes or statistical analysis.
Instead, this document outlines an equivalence claim based on engineering and performance testing against predetermined acceptance criteria to show that modifications do not introduce new safety or performance issues compared to a legally marketed predicate device.
Here's an analysis based on the provided text, addressing your questions where possible:
Acceptance Criteria and Device Performance Study (as presented in this document)
The document lists various performance characteristics for which testing was conducted. It states that "The Direxion Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, it does not provide a table with specific acceptance criteria values or detailed reported device performance values. It only states that the criteria were met.
1. A table of acceptance criteria and the reported device performance
A table cannot be fully constructed from the provided text as specific numerical acceptance criteria and reported performance values are not detailed. The document only lists the categories of tests performed and a general statement that the device "met the predetermined acceptance criteria."
Implicit acceptance criteria categories based on the text:
| Performance Characteristic | Acceptance Criteria (Not Quantified) | Reported Device Performance (Not Quantified) |
|---|---|---|
| OD/ID Dimensional Requirements | Met specified dimensional tolerances (implied) | Met (stated "met the predetermined acceptance criteria") |
| Guide Catheter Compatibility | Compatible with specified guide catheters (implied) | Met (stated "met the predetermined acceptance criteria") |
| Microcatheter Surface Defects | Within acceptable limits for surface integrity (implied) | Met (stated "met the predetermined acceptance criteria") |
| Microcatheter Coating Length | Met specified coating length requirements (implied) | Met (stated "met the predetermined acceptance criteria") |
| Distal Joint Integrity | Maintained integrity under specified forces/conditions (implied) | Met (stated "met the predetermined acceptance criteria") |
| RO Marker band Tensile | Withstood specified tensile forces (implied) | Met (stated "met the predetermined acceptance criteria") |
| Embolic Coil Compatibility | Compatible with specified embolic coils (implied) | Met (stated "met the predetermined acceptance criteria") |
| Initial Tip Shape | Maintained specified initial tip shapes (implied) | Met (stated "met the predetermined acceptance criteria") |
| Packaging Mandrel Removal Force | Within specified force limits for removal (implied) | Met (stated "met the predetermined acceptance criteria") |
| Sterile Barrier Integrity | Maintained sterile barrier under specified conditions (implied) | Met (stated "met the predetermined acceptance criteria") |
| Device Containment in Packaging | Device remained contained in packaging under specified conditions (implied) | Met (stated "met the predetermined acceptance criteria") |
| Microcatheter System Removal from Packaging | Easily removable from packaging without damage (implied) | Met (stated "met the predetermined acceptance criteria") |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample sizes used for any of the performance tests.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are typically engineering tests performed in a lab setting, not clinical studies.
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 information is not applicable to the type of testing described. The "ground truth" for these engineering and performance tests would be based on design specifications, industry standards, and predicate device characteristics, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the type of testing described (engineering/performance tests). Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human experts.
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
An MRMC comparative effectiveness study was not done. This document is for a medical device (microcatheter), not an AI/software device. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical microcatheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned, the "ground truth" for these engineering and performance tests would be based on design specifications, industry standards, and equivalence to the predicate device's established performance. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as #8.
In summary: This 510(k) document demonstrates substantial equivalence through a series of engineering and performance tests against predetermined acceptance criteria (which are not specifically detailed in the provided text). It is not a clinical study or an AI/MML device submission, so many of the requested categories (expert ground truth, sample sizes for training/test sets, MRMC studies) are not pertinent to this type of regulatory submission. The key takeaway is that the device met internal performance specifications designed to ensure it is as safe and effective as its predicate.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 16, 2017
Boston Scientific Corporation Ms. Liz Johnston Regulatory Affairs Specialist Three Scimed Place Maple Grove, MN 55311
Re: K163701
Trade/Device Name: Direxion and Direxion HI-FLO Torqueable Microcatheters Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: April 17, 2017 Received: April 18, 2017
Dear Ms. Johnston:
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.
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 devicerelated 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" (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 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,
Sincerely,
Fernand Aguel - 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) K163701
Device Name
Direxion and Direxion HI-FLO Torqueable Microcatheters
Indications for Use (Describe)
The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
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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K163701 510(k) Summary
Per 21 CFR 807.92
| Submitter's Name and Address | Boston Scientific CorporationThree Scimed PlaceMaple Grove, MN 55311USA |
|---|---|
| Contract Information | Liz JohnstonRegulatory Affairs SpecialistPhone: 763-494-1676Fax: 763-494-2222Email: Liz.Johnston@bsci.com |
| Date Prepared | 22 December 2016 |
| Proprietary Name | Single Product Configurations:• Direxion™ Torqueable Microcatheter• Direxion™ HI-FLO™ Torqueable MicrocatheterPreloaded Guidewire System Configurations:• Direxion™ Fathom™-16 System Pre-Loaded Torqueable Microcatheter• Direxion™ Transend™-14 System Pre-Loaded Torqueable Microcatheter• Direxion™ HI-FLO™ Fathom™-16 System Pre-Loaded Torqueable Microcatheter• Direxion™ HI-FLO™ Transend™-18 System Pre-Loaded Torqueable Microcatheter |
| Common Name | Continuous Flush Catheters |
| Classification | Class II per CFR 870.1210 |
| Predicate Device | Boston Scientific Direxion Microcatheters:• K142259, KRA, September 10, 2014 |
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Device Description
The Direxion Microcatheter is available in small and large lumens. The Direxion Torqueable Microcatheter (Direxion) is a small lumen microcatheter with a distal outside diameter of 2.5F (0.85 mm), and a maximum outside diameter of 2.7F (0.95 mm). It has an inside diameter of 0.021 in (0.5 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.018 in (0.47 mm).
The Direxion HI-FLO Torqueable Microcatheter (Direxion HI-FLO) is a large lumen microcatheter with a distal outside diameter of 2.9F (1.00 mm), and a maximum outside diameter of 3F (1.05 mm). It has an inside diameter of 0.027 in (0.6 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.021 in (0.53 mm).
The Direxion and Direxion HI-FLO Microcatheters are available in a variety of tip shapes (Straight, Bern, Swan, and J) to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. A radiopaque marker is located at the distal tip to facilitate fluoroscopic visualization. Some Direxion Microcatheters have a second marker 3 cm proximal to the first marker. The distal tip of the microcatheter is steam shapeable. The proximal end incorporates a standard luer with rotating hemostatic valve (RHV) or Y-adapter.
The Direxion and Direxion HI-FLO Microcatheters are available with the following preloaded guidewires:
Fathom-16 Steerable Guidewire
- 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths
Transend 14/18 Steerable Guidewires
- 0.014 in (0.37 mm) or 0.018 in (0.47 mm) diameters; 135, 165 or 190 cm lengths
The guidewires have a hydrophilic coating to provide lubricity, which aids in the navigation of distal, tortuous vasculature. The guidewires are radiopaque to allow for visualization under fluoroscopy and the tips are shapeable.
Accessories may include a RHV or Y-adapter, steam shaping mandrel, microcatheter introducer, quidewire introducer and torque device.
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Intended Use / Indications for Use
The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
Comparison of Technological Characteristics
The Direxion and Direxion HI-FLO Torqueable Microcatheters are similar in fundamental design, function, materials, packaging, sterilization, operating principle, intended use / indication for use and fundamental technology as the predicate device. Modifications were made to the coating length, pre-shaped tips (Bern, J. Swan), and packaging of the Direxion Microcatheter.
Performance Data
The following testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. The Direxion Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing.
- OD/ID Dimensional Requirements
- Guide Catheter Compatibility ●
- Microcatheter Surface Defects ●
- Microcatheter Coating Length ●
- Distal Joint Integrity ●
- RO Marker band Tensile ●
- Embolic Coil Compatibility
- Initial Tip Shape
- Packaging Mandrel Removal Force ●
- Sterile Barrier Integrity ●
- Device Containment in Packaging ●
- Microcatheter System Removal from Packaging ●
Conclusion
Boston Scientific has demonstrated that the modifications to the Direxion Microcatheters are substantially equivalent in fundamental design, technology, function, materials, packaging, operating principle, and intended use / indication for use as the predicate device.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).