(64 days)
Not Found
No
The document describes a mechanical steerable sheath and dilator with modifications to the hemostasis valve. There is no mention of AI, ML, image processing, or any computational analysis of data for diagnosis or treatment.
No
The device is an introducer sheath designed to facilitate the placement of catheters into the heart and vasculature, not to treat a condition itself. Its function is to provide access and maneuverability for other catheters.
No
Explanation: The device is described as a steerable sheath and dilator intended for percutaneous catheter introduction and positioning within the heart. Its features facilitate the delivery and manipulation of other catheters but do not include any functions for diagnosis, such as imaging, signal acquisition, or analysis of physiological data.
No
The device is a physical medical device (sheath and dilator) used for percutaneous catheter introduction. The 510(k) summary describes material and design changes to a hardware component (hemostasis valve) and includes performance testing related to physical properties and biocompatibility.
Based on the provided information, the FlexCath Advance Steerable Sheath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "percutaneous catheter introduction into the vasculature and into the chambers of the heart." This describes a device used within the body for a procedural purpose (introducing catheters), not for examining specimens outside the body to diagnose conditions.
- Device Description: The description details a physical device used for accessing and navigating within the circulatory system and heart chambers. It focuses on mechanical functions like deflection, valve operation, and fluid management.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information based on such analysis. The purpose is purely procedural.
IVD devices are specifically designed to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FlexCath Advance Steerable Sheath does not fit this definition.
N/A
Intended Use / Indications for Use
The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
Product codes (comma separated list FDA assigned to the subject device)
DRA
Device Description
The FlexCath Advance Steerable Sheath and Dilator is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Advance Steerable Sheath and Dilator can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This premarket notification presents proposed design and material changes to the hemostasis valve component, located within the handle section. Product performance requirement changes related to the updated hemostasis valve are also being implemented for the subject device. All other aspects of the device (overall design/technology, labeling, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance Steerable Sheath and Dilator cleared under K183174.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature and into the chambers of the heart.
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)
Performance testing (bench) was completed in support of the proposed modifications. The results of the design verification testing completed in support of the proposed changes demonstrate that the modified FlexCath Advance Steerable Sheath and Dilator in scope of this premarket notification meets all applicable product requirements.
The following design verification tests were successfully completed in support of the modified FlexCath Advance (subject device). All acceptance criteria were met, demonstrating compliance with the applicable product requirements:
Pressure decay and vacuum testing
Kink testing
Pull force testing
Insertion and retraction force testing
All design verification testing was performed on final finished product incorporating the proposed design and material changes.
Biocompatibility of the subject device was assessed via the following testing, in accordance with ISO 10993-1:2018:
Cytotoxicity testing
Sensitization testing
Irritation or Intracutaneous Reactivity testing
Systemic Toxicity testing (acute)
Pyrogenicity testing (Material-mediated)
Hemocompatibility (Hemolysis, Complement Activation)
The following additional hemocompatibility testing and safe history of use was leveraged from the predicate device:
Thrombogenicity in vivo
Coagulation, PTT test
Platelets
Hematology
The results of the biocompatibility testing completed and leveraged support the conclusion that the subject device is biologically safe as guided by ISO 10993-1:2018 for use in its intended application.
A sterilization qualification study was conducted for adoption of the modified FlexCath Advance (subject device) into the existing, validated EO sterilization cycle. The following tests were performed:
EO Residual testing
Bioburden testing
Bacterial endotoxin testing
Qualification testing results for EO residuals, bioburden, and bacterial endotoxin met their respective acceptance criteria with valid assays conducted by qualified laboratories.
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.
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
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
November 13, 2020
Medtronic CryoCath LP Matthew Lobeck Pr. Regulatory Affairs Specialist 8200 Coral Sea Street NE, MVS 46 Mounds View, Minnesota 55112
Re: K202620
Trade/Device Name: FlexCath Advance Steerable Sheath and Dilator Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: September 9, 2020 Received: September 10, 2020
Dear Matthew Lobeck:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202620
Device Name
FlexCath Advance Steerable Sheath and Dilator
Indications for Use (Describe)
The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5.0 510(k) Summary
Date Summary Prepared:
Applicant: Medtronic CryoCath LP 9000 Autoroute Transcanadienne Point-Claire, Quebec H9R 5Z8, Canada Establishment Registration No. 3002648230 Official Correspondent: Matthew Lobeck Principal Regulatory Affairs Specialist Medtronic 8200 Coral Sea Street Mounds View, MN 55112 Work: 763.514.9515 Mobile: 612-202-5925 Fax: 763.367.9903 Email: matthew.lobeck@medtronic.com Device Trade Name: FlexCath Advance Steerable Sheath and Dilator Common Name: Steerable Sheath and Dilator Classification Name: Catheter, Steerable Classification & Panel: Class II, 21 CFR 870.1280, Cardiovascular Product Code: DRA Predicate Device: FlexCath Advance Steerable Sheath and Dilator - K183174 Device Description: The FlexCath Advance Steerable Sheath and Dilator is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Advance Steerable Sheath and Dilator can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included
September 9th, 2020
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with each sheath.
| | This premarket notification presents proposed design and
material changes to the hemostasis valve component, located
within the handle section. Product performance requirement
changes related to the updated hemostasis valve are also
being implemented for the subject device. All other aspects
of the device (overall design/technology, labeling, etc.)
remain unchanged and are identical as compared to the
predicate device, the FlexCath Advance Steerable Sheath and
Dilator cleared under K183174. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Facilitates introducing various cardiovascular catheters into
the heart.
The intended use is unchanged with the proposed
modifications and remains the same as that previously
cleared under K183174. |
| Indications for Use: | The FlexCath Advance Steerable Sheath is intended for
percutaneous catheter introduction into the vasculature and
into the chambers of the heart. The sheath deflection
facilitates catheter positioning.
The indications for use are unchanged with the proposed
modifications and remains the same as that previously
cleared under K183174. |
| Comparison of
Technological
Characteristics: | The modified FlexCath Advance Steerable Sheath and
Dilator features the following similarities with the predicate
device:
Same intended use Same indications for use Same product labeling Same fundamental scientific technology Same unidirectional deflection Same shaft and dilator design and materials Same user interface Same sterilization processes Same packaging configuration The differences between the modified FlexCath Advance
Steerable Sheath and Dilator and predicate devices involve
the following: |
| | Dimensional changes to the design of the hemostasis valve component Material change to the hemostasis valve component Addition of silicone oil to the hemostasis valve. Updates to product performance requirements related to the modified hemostasis valve |
| | The proposed changes do not constitute a change in the fundamental scientific technology for the subject device and do not raise new or different questions of safety and effectiveness. The subject device does not provide a new therapy, and the intended use and indications for use remain unchanged and identical to the predicate. The modified subject device described in this 510(k) submission is substantially equivalent to the predicate device. |
| Performance Data: | Performance testing (bench) was completed in support of the proposed modifications. The results of the design verification testing completed in support of the proposed changes demonstrate that the modified FlexCath Advance Steerable Sheath and Dilator in scope of this premarket notification meets all applicable product requirements. |
| | The following design verification tests were successfully completed in support of the modified FlexCath Advance (subject device). All acceptance criteria were met, demonstrating compliance with the applicable product requirements: |
| | Pressure decay and vacuum testing Kink testing Pull force testing Insertion and retraction force testing |
| | All design verification testing was performed on final finished product incorporating the proposed design and material changes. |
| | Biocompatibility of the subject device was assessed via the following testing, in accordance with ISO 10993-1:2018: |
| | Cytotoxicity testing Sensitization testing Irritation or Intracutaneous Reactivity testing Systemic Toxicity testing (acute) |
| • | Pyrogenicity testing (Material-mediated) |
| • | Hemocompatibility (Hemolysis, Complement Activation) |
| ○ | The following additional hemocompatibility testing and safe history of use was leveraged from the predicate device: |
| ■ | Thrombogenicity in vivo |
| ■ | Coagulation, PTT test |
| ■ | Platelets |
| ■ | Hematology |
| The results of the biocompatibility testing completed and leveraged support the conclusion that the subject device is biologically safe as guided by ISO 10993-1:2018 for use in its intended application. | |
| A sterilization qualification study was conducted for adoption of the modified FlexCath Advance (subject device) into the existing, validated EO sterilization cycle. The following tests were performed: | |
| • | EO Residual testing |
| • | Bioburden testing |
| • | Bacterial endotoxin testing |
| Qualification testing results for EO residuals, bioburden, and bacterial endotoxin met their respective acceptance criteria with valid assays conducted by qualified laboratories. | |
| Conclusion: | There are no changes to the intended use, indications for use, or fundamental scientific technology between the subject and predicate devices. Design verification testing was completed to verify that the performance of the modified FlexCath Advance Steerable Sheath and Dilator. All results demonstrate the properties and performance of the modified FlexCath Advance Steerable Sheath and Dilator are suitable for the intended use. There are no differences between devices identified in testing that raised new questions of safety or effectiveness, and the subject device is considered substantially equivalent to the legally marketed predicate device. |
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