(10 days)
Not Found
No
The summary explicitly states that the changes are limited to Instructions for Use updates and that all other aspects of the device (design/technology, performance specifications, etc.) remain unchanged from the predicate device. There is no mention of AI or ML in the device description or the "Mentions AI, DNN, or ML" section.
No.
The device facilitates percutaneous catheter introduction and positioning, but it does not directly treat a disease or condition.
No
Explanation: The device is described as an introducer sheath used for percutaneous catheter introduction, withdrawal, and positioning. Its function is to facilitate the placement of other catheters, not to diagnose a medical condition itself.
No
The device description clearly describes a physical, sterile, single-use percutaneous introducer with a shaft, handle, valve, side-port, and dilator. The submission is for updates to the Instructions for Use, not a software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 in vivo (within the body) for accessing and navigating anatomical structures.
- Device Description: The description details a physical device (sheath, valve, side-port, handle, dilator) used for introducing and manipulating catheters within the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly an invasive medical device used for procedural access and support within the cardiovascular system.
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 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 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 FlexCath Advance Steerable 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 updates to the Instructions for Use (IFU) manual; changes resulting in the subject device are limited to these IFU updates only. All other aspects of the device (design/technology, performance specifications, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance originally cleared under K123591.
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)
No performance testing (bench, animal or clinical) was required to support the proposed IFU updates. The existing performance data previously submitted under K123591 remains valid and applicable for this subject device.
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 26, 2018
Medtronic CryoCath LP Natalie Sadeghi Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE MVS 46 Mounds View, Minnesota 55112
Re: K183174
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: November 15, 2018 Received: November 16, 2018
Dear Natalie Sadeghi:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Wilhelm
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)
K183174
Device Name
FlexCath Advance TM 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) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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3
5.0 510(k) Summary
| Date Summary Prepared: | November 12, 2018 |
|---|---|
| Applicant: | Medtronic CryoCath LP |
| 9000 Autoroute Transcanadienne | |
| Pointe-Claire, Quebec | |
| H9R 5Z8, Canada | |
| Establishment Registration No. 3002648230 | |
| Official Correspondent: | Natalie Sadeghi |
| Principal Regulatory Affairs Specialist | |
| Medtronic CryoCath LP | |
| 8200 Coral Sea Street | |
| Mounds View, MN 55112 | |
| Telephone: 763.526.1035 | |
| Fax: 763.367.9903 | |
| Email: natalie.t.sadeghi@medtronic.com | |
| Device Trade Name: | FlexCath Advance™ Steerable Sheath and Dilator |
| Common Name: | Steerable Sheath and Dilator |
| Classification Name: | Steerable Catheter |
| Classification & Panel: | Class II, 21 CFR 870.1280, Cardiovascular |
| Product Code: | DRA |
| Predicate Device: | FlexCath Advance™ Steerable Sheath and Dilator |
| (K123591) | |
| Device Description: | The FlexCath Advance Steerable Sheath 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 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
FlexCath Advance Steerable 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 updates to the Instructions for Use (IFU) manual; changes resulting in the subject device are limited to these IFU updates only. All other aspects of the device (design/technology, performance specifications, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance originally cleared under K123591. |
| Intended Use: | Facilitates introducing various cardiovascular catheters into the heart. |
| | The intended use is unchanged with the proposed IFU update and remains the same as previously cleared under K123591. |
| 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 is unchanged with the proposed IFU update and remains the same as previously cleared under K123591. |
| Comparison of
Technological
Characteristics: | There are no changes to the predicate device specifications or technological characteristics associated with the proposed IFU update. Compared to the predicate, the subject device features the: |
| | Same intended use Same indications for use Same fundamental scientific technology Same unidirectional deflection Same sheath and dilator design Same user interface Same materials of construction Same sterilization process Same packaging configuration and labels The differences between the subject device and the predicate device are limited to the IFU content only. The updates to the |
| | US IFU were proposed to align with recent updates for the |
| | across the global labeling. The subject device design
technology, performance characteristics, materials, shelf life
and sterilization process are all unchanged with this IFU
update. |
| | The proposed IFU updates do not constitute a change in the
fundamental scientific technology for the proposed 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 FlexCath
Advance featuring the updated IFU as described in this 510(k)
submission is substantially equivalent to the predicate device. |
| Performance Data: | No performance testing (bench, animal or clinical) was
required to support the proposed IFU updates. The existing
performance data previously submitted under K123591
remains valid and applicable for this subject device. |
| Conclusion: | This premarket notification is limited to updates to the
FlexCath Advance Instructions for Use manual, to align the
global labeling for the FlexCath Advance sheath. There are no
changes to the device specifications or technological
characteristics. The IFU update for the subject device does
not raise any new questions of safety or effectiveness as
compared to the device as previously cleared under K123591. |
4
510(k) Summary of Safety and Effectiveness
-FlexCath Advance Japan package insert to ensure consistency
5