(73 days)
The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.
The Medtronic FlexCath™ Select Steerable Sheath is a sterile, single-use, percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and exchange 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. A dilator is packaged with the FlexCath Select. The handle incorporates a deflection mechanism and a deflection wire that is integrated into the catheter shaft. This allows the sheath to be deflected to provide additional maneuverability to catheters that are advanced through the sheath into the right or left chamber of the heart. The FlexCath Select sheath is comprised of two (2) main sections: the shaft and the handle.
The provided FDA 510(k) summary (K163268) for the Medtronic FlexCath™ Select Steerable Sheath and Dilator describes modifications to an existing predicate device (K142684). The assessment for this device focuses on demonstrating substantial equivalence through bench testing, rather than an AI/ML driven study with comprehensive acceptance criteria and ground truth evaluations typically found in software as a medical device (SaMD) clearances.
Therefore, the requested information regarding acceptance criteria, study details like sample sizes, data provenance, expert qualifications, and MRMC studies, and ground truth establishment is largely not applicable in the context of this specific medical device clearance, which is for a physical medical device with minor material and manufacturing process changes.
However, I can extract information related to the bench testing performed to ensure the modified device remains substantially equivalent to its predicate.
Here's a summary of the available information and an explanation of why some of the requested details are not present in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Bench testing was completed to support the proposed modifications to the FlexCath Select. Performance testing verified that the subject device performs as designed and is suitable for the intended use." and "All results demonstrate that the properties and performance of the modified FlexCath Select are suitable for the intended use."
While specific numerical acceptance criteria (e.g., "leak rate must be less than X%") are not explicitly detailed in this summary, the criteria would typically be established based on the predicate device's performance, industry standards, and risk analysis for such devices. The "reported device performance" is that the device met these unstated acceptance criteria, thus remaining substantially equivalent.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Leak/air ingress performance (Hemostasis valve) meets pre-defined limits | Performance verified |
| Valve performance following insertion/removal cycling (sheath/valve) maintained | Performance verified |
| Dilator insertion/removal force within acceptable range | Performance verified |
| Bond pull force (sheath/hub) meets strength requirements | Performance verified |
| Compatibility with existing systems/catheters | Performance verified |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. For bench testing of physical devices, sample sizes are typically determined statistically to ensure sufficient power for the tests and often involve a certain number of units for each test (e.g., 3, 5, 10 units).
- Data Provenance: The testing was "Bench testing" performed by the manufacturer, Medtronic CryoCath LP, to support the modifications. This is internal testing. The country of origin of data is not explicitly stated but would be derived from the manufacturing/testing location of the applicant (Canada/USA). This is typically prospective testing, meaning the tests were designed and conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a physical device like a steerable sheath, "ground truth" in the AI/ML sense (e.g., consensus among radiologists for image interpretation) is not relevant. The "truth" is determined by objective physical and mechanical measurements according to established engineering and quality control standards. The "experts" involve engineers and technicians conducting the bench tests and evaluating the results against design specifications and predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical or image-based studies. For bench testing of physical properties, the results are typically objective measurements, which do not require adjudication.
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
- Not Applicable. This is a physical medical device, not an AI/ML driven diagnostic or assistive software. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device. There is no algorithm or software component being evaluated in a "standalone" or "human-in-the-loop" manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Objective Measurements. The "ground truth" for this device's performance is based on objective physical and mechanical properties measured during bench testing, compared against predetermined engineering specifications, and the performance of the predicate device. For example, leak rates are measured quantitatively, bond pull forces are measured in Newtons, etc.
8. The sample size for the training set
- Not Applicable. This submission does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI/ML training set, this question is not relevant.
In summary, this 510(k) submission for the FlexCath™ Select Steerable Sheath and Dilator is for a modified physical device, not a software or AI/ML product. The evaluation relies on demonstrating substantial equivalence through standard bench testing of physical characteristics and mechanical performance, rather than clinical or AI/ML-specific studies.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2017
Medtronic CryoCath LP Natalie Sadeghi Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE, Mail Stop MVS46 Mounds View, Minnesota 55112
Re: K163268
Trade/Device Name: FlexCath™ Select Steerable Sheath and Dilator Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 18, 2016 Received: November 21, 2016
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. 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.
{1}------------------------------------------------
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.
incerery,
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) K163268
Device Name
FlexCath™ Select Steerable Sheath and Dilator
Indications for Use (Describe)
The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| Date Summary Prepared: | November 16, 2016 |
|---|---|
| Applicant: | Medtronic CryoCath LP9000 Autoroute TranscanadiennePointe-Claire, QuebecH9R 5Z8, CanadaEstablishment Registration No. 3002648230 |
| Official Correspondent: | Natalie SadeghiSenior Requlatory Affairs SpecialistMedtronic CryoCath LP8200 Coral Sea StreetMounds View, MN 55112Telephone: 763.526.1035Fax: 763.367. 9903Email: natalie.t.sadeghi@medtronic.com |
| Device Trade Name: | FlexCath™ Select Steerable Sheath and Dilator |
| Common Name: | Steerable Sheath and Dilator |
| Classification Name: | Introducer, Catheter |
| Classification & Panel: | Class II, 21 CFR 870.1340, Cardiovascular |
| Product Code: | DYB |
| Predicate Device: | FlexCath® Select™ Steerable Sheath & Dilator(K142684) |
| Device Description: | The Medtronic FlexCath™ Select Steerable Sheath is a sterile,single-use, percutaneous catheter introducer fitted with avalve to allow for introduction, withdrawal, and exchange ofcatheters and wires while minimizing blood loss. A side portwith stopcock is integrated to allow continuous drip infusion,injection through the center lumen, flushing, aspiration, bloodsampling and pressure monitoring. A dilator is packaged withthe FlexCath Select.The handle incorporates a deflection mechanism and adeflection wire that is integrated into the catheter shaft. Thisallows the sheath to be deflected to provide additionalmaneuverability to catheters that are advanced through the |
{4}------------------------------------------------
| sheath into the right or left chamber of the heart. The FlexCath Select sheath is comprised of two (2) main sections: the shaft and the handle. | |
|---|---|
| Intended Use: | Facilitates introducing various cardiovascular catheters into the heart. This is the same intended use as previously cleared for the original FlexCath Select Steerable Sheath and Dilator, predicate device (K142684). |
| Indications for Use: | The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning. The indications for use are the same as previously cleared for the original FlexCath Select Steerable Sheath and Dilator, predicate device (K142684). |
| Comparison ofTechnologicalCharacteristics : | The FlexCath Select Steerable Sheath and Dilator has the following similarities to the predicate device: Same intended useSame indications for useSame fundamental scientific technologySame unidirectional deflectionSame basic sheath and dilator designSame user interfaceSame materials of constructionSame sterilization processSame packaging configurationSame device shelf life The differences between the modified FlexCath Select and the predicate device consist of the following: Minor dimensional changes to hemostasis valve assembly components Modified molding process temperature for the valve seal component Added silicone oil to the entire length of the dilator component; this silicone oil was present on the predicate device hemostasis valve |
{5}------------------------------------------------
These changes do not constitute a change in the fundamental scientific technology for the proposed device; the differences between the modified FlexCath Select and the predicate do not raise new or different questions of safety and effectiveness. The FlexCath Select does not provide a new therapy, and the intended use and indications for use remain equivalent to that of the predicate. The modified FlexCath Select described in this Traditional 510(k) submission is substantially equivalent to the predicate device, reference Table 1.
| Table 1. Substantial Equivalence for FlexCath Select | ||
|---|---|---|
| Characteristic | PREDICATEDEVICE:FlexCath SelectSteerable Sheath(Model 990065)K142684 | SUBJECTDEVICE:FlexCath SelectSteerableSheath (Model990065) |
| Intended Use | ||
| Intended Use | Facilitatesintroducing variouscardiovascularcatheters into theheart. | Same |
| Indications for Use | The FlexCath SelectSteerable Sheath isintended forpercutaneouscatheterintroduction intothe vasculature andinto the chambersof the heart,including the leftside of the heartthrough theinteratrial septum.The sheathdeflection facilitatescatheterpositioning | Same |
| Contraindications | The FlexCath SelectSteerable Sheath iscontraindicated forplacement in theleft atrium orventricle if any ofthe followingconditions apply tothe patient:• The patient hasan intra-atrialseptal patch oroccluder, or hashad othersurgicalintervention in oradjacent to theintra-atrialseptum.• The patient has aleft atrialthrombus.The patient hasknown orsuspected atrialmyxoma. | Same |
| Technology | ||
| Steerable catheterintroducer | Yes | Same |
| Design | ||
| Unidirectional | Yes | Same |
| Hemostasis valve | Yes | Same |
| Deflectable | Yes | Same |
| Side flush porttubing | Yes | Same |
| Stopcock at the endof side port tubing | Yes | Same |
| Handle | Yes | Same |
| Braided Shaft | Yes | Same |
| Sheath OD (inches/French) | 0.170" (13F) | Same |
| Sheath ID (inches/French) | 0.131" (10F) | Same |
| Total length (cm) | 81 cm | Same |
| Usable length (cm) | 65 cm | Same |
| Distal Flush Holes(quantity) | 3 | Same |
| Deflection | ≥ 135°, when loadedwith the FreezorMAX CryoAblationCatheters – Models239F3. 239F5(P010010), or aphased RF PVACModel 990078(G120067). | Same |
| Deflection Reachlength | 5.5cm | Same |
| Guidewire | Not included inpackage | Same |
| Valve seal volume | 0.645cm3 | 0.584cm3 |
| Valve cap ID | 0.171" | 0.140" |
| Valve hub distal ID | 0.412" | 0.420" |
| Strain Relief ID | 0.165" | Same |
| Dilator OD | 0.128" | Same |
| Dilator ID | 0.038" | Same |
| Dilator usablelength (cm) | 82.88 cm (32.63") | Same |
| Dilator total length(cm) | 85.74 cm (33.755" ) | Same |
| Dilator shape | Pre-curved 55° tip | Same |
| Dilator color | Hub – WhiteShaft – White | Same |
| Materials | ||
| Sheath shaft | Pebax with 20%Barium Sulfate,stainless steel braidand PTFE liner | Same |
| Adhesive (shaft tohub -sheath valveassembly) | Loctite 4310 | Same |
| Hemostasis valvematerial (seal) | Medalist MD200,Nusil MED-400silicone fluid | Same |
| Hemostasis huband cap material | Hub: Calibre 2081-15 FC030004 (PolyCarbonate)Cap: PRO-FAX 6523(Polypropylene) | Same |
| Hemostasis valve(stopcock) | Body: MAKROLONRX 1805 451118(Polycarbonate)Handle:HDPEHD6706.17Extension Tube:Polyurethane(Pellethane 2363-80A) | Same |
| Dilator shaft andhub material | Copolyester TPE(Hytrel 7246 with40% BaSO4) | Copolyester TPE(Hytrel 7246 with40% BaSO4)Coating: NuSilMED-400Silicone oil fluid |
| Pouch material | Tyvek/nylonpolyethylene pouch | Same |
| Sterility, Shelf Life | ||
| SterilizationMethod | Ethylene Oxide(EtO) | Same |
| Usage | Single use anddisposable | Same |
| Shelf Life | 2 years | Same |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
Bench testing was completed to support the proposed Performance Data: modifications to the FlexCath Select. Performance testing verified that the subject device performs as designed and is suitable for the intended use.
Testing included:
- Leak/air ingress performance - Hemostasis valve
- Valve performance following insertion/removal cycling -. sheath/valve
- Dilator insertion/removal force
- Bond pull force sheath/hub ●
- . Compatibility verification
Design verification testing was performed to verify that the Conclusion: performance of the modified FlexCath Select remains substantially equivalent to the predicate device. All results demonstrate that the properties and performance of the modified FlexCath Select are suitable for the intended use. There are no differences between devices identified in testing that raised new questions of safety or effectiveness.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).