(30 days)
Flow Gate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Like the predicate device, the 8F FlowGate2™ Balloon Guide Catheter is a coaxial- lumen, braidreinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.
The provided text describes a 510(k) premarket notification for the 8F FlowGate2™ Balloon Guide Catheter. It outlines the acceptance criteria and testing performed to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that all performed tests "Met established acceptance criteria." However, it does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a list of tests and a blanket statement of compliance.
| Test | Reported Device Performance |
|---|---|
| Modifications to catheter shaft | |
| Catheter Simulated Use (Retriever/Microcatheter Compatibility) | Met established acceptance criteria. |
| Catheter Kink Resistance, Variables (Test Kink Resistance) | Met established acceptance criteria. |
| Catheter Tip Flexibility (Catheter/Vessel Interaction) | Met established acceptance criteria. |
| Torque Transmission | Met established acceptance criteria. |
| High Pressure Leak | Met established acceptance criteria. |
| Distal Shaft Trackability | Met established acceptance criteria. |
| Lumen Compatibility | Met established acceptance criteria. |
| 6F Dilator Accessory | |
| Dimensional Verification | Met established acceptance criteria. |
| Dilator Shape Retention | Met established acceptance criteria. |
| Air Leak Resistance | Met established acceptance criteria. |
| Liquid Leak Resistance | Met established acceptance criteria. |
| Tensile Strength | Met established acceptance criteria. |
| High Pressure Leak | Met established acceptance criteria. |
| Catheter/Vessel Interaction (Catheter Tip Flexibility) | Met established acceptance criteria. |
| Kink Resistance | Met established acceptance criteria. |
| Tuohy Borst Valve with Sideport Accessory | |
| Hub Gauging | Met established acceptance criteria. |
| Liquid Leakage | Met established acceptance criteria. |
| Air Leakage | Met established acceptance criteria. |
| Separation Force | Met established acceptance criteria. |
| Unscrewing Torque | Met established acceptance criteria. |
| Ease of Assembly | Met established acceptance criteria. |
| Resistance to Overriding | Met established acceptance criteria. |
| Stress Cracking | Met established acceptance criteria. |
| Catheter Simulated Use (Tuohy Borst Valve with Sideport seal over devices and wires) | Met established acceptance criteria. |
| Biocompatibility | Met biological safety requirements per EN ISO 10993-1: 2009 for externally communicating medical devices with circulating blood contact for less than 24 hours. |
| Sterilization | Adopted into a validated sterilization process in accordance with ISO 11135:2007 and AAMI TIR 28:2009. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes (number of devices or cases) used for the verification and validation (test set) activities. It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily bench testing performed on manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study described is a technical verification and validation of a medical device's physical and functional properties, not a clinical study involving human assessment of data requiring expert ground truth establishment in the typical sense (e.g., for diagnostic accuracy).
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective technical assessments (e.g., measuring leak resistance, tensile strength, kink resistance), not subjective assessments requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. This submission is for a percutaneous catheter, not a diagnostic or AI-assisted interpretation device that would typically involve human readers. The study focuses on demonstrating the substantial equivalence of the new device to existing predicate devices through material, design, and performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is not an algorithm or AI system. It is a physical medical device (catheter). The testing focuses on the physical and functional performance of the device itself.
7. The Type of Ground Truth Used:
The "ground truth" for the tests performed is based on established engineering principles, industry standards (e.g., ISO 11135, EN ISO 10993-1), and internal performance specifications determined through design and risk assessment processes. For instance, for "High Pressure Leak," the ground truth is a pass/fail criterion based on whether the device exhibits leakage under specific pressure. These are objective measures rather than subjective expert consensus, pathology, or outcomes data in the context of diagnostic performance.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27,2016
Concentric Medical, Inc. Mr. Shazia Hakim Senior Regulatory Affairs Specialist 301 East Evelyn Avenue Mountain View, California 94041
Re: K153729
Trade/Device Name: 8F FlowGate Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 22, 2015 Received: December 28, 2015
Dear Mr. Hakim:
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 yours,
William J. Heetderks -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153729
Device Name 8F FlowGate Balloon Guide Catheter
Indications for Use (Describe)
Flow Gate Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
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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510(k) Summary
| Device Trade Name: | 8F FlowGate2™ Balloon Guide Catheter |
|---|---|
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter, 21CFR 870.1250 Class II |
| Product Code: | DQY |
| Submitter: | Concentric Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 510 - 413-2636Fax 510 - 413-2588Facility Registration #2954917 |
| Contact: | Shazia HakimSenior Regulatory Affairs Specialist |
Date Prepared: December 22, 2015
Predicate Device:
| Primary Predicate Device | |
|---|---|
| K131492(clearance grantedOctober 3, 2013) | Modified FlowGate™ BalloonGuide Catheter |
| Reference Predicate Device | |
| K122581(clearance grantedNovember 21, 2012) | Concentric Balloon GuideCatheter |
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Device Description
Like the predicate device, the 8F FlowGate2™ Balloon Guide Catheter is a coaxial- lumen, braidreinforced, variable stiffness catheter designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Modified FlowGate™ Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label.
Accessories
The 8F FlowGate2™ Balloon Guide Catheter is packaged with a Dilator, Rotating Hemostasis Valve, Tuohy Borst Valve with Sideport, Peel Away Sheaths, Luer-Activated Valve, and Extension tubing.
Indications for Use
The Indications for Use are the same as the predicate devices and are as follows:
FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Technological Characteristics and Product Feature Comparison
The subject device, 8F FlowGate2™ Balloon Guide Catheter is substantially equivalent to the predicate devices in terms of:
- indications for use
- fundamental scientific technology
- fundamental design
- materials and processes for packaging and sterilization of devices
A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below.
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| Product Feature Comparison of Subject Device with Predicate Devices (K122581, K131492) | ||||
|---|---|---|---|---|
| Feature | Reference Predicate Device (K122581) | Primary Predicate Device (K131492) | Subject Device | Rationale for difference (if applicable) |
| Indications for Use | The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. | Same except for product name as “FlowGate Balloon Guide Catheter” | Same as predicate device (K131492) | Not applicable |
| Feature | Reference PredicateDevice (K122581) | PrimaryPredicate Device(K131492) | Subject Device | Rationale fordifference (ifapplicable) |
| Device Description | The Concentric BalloonGuide Catheters arecoaxial-lumen, braid-reinforced, variablestiffness catheters designedfor use in facilitating theinsertion and guidance ofan intravascular catheterinto a selected blood vesselin the peripheral and neurovascular systems. Aradiopaque marker isincluded on the distal endfor angiographicvisualization. A compliantballoon is mounted on thedistal end to providetemporary vascularocclusion duringangiographic procedures. Abifurcated luer hub on theproximal end allowsattachments for flushing,inflation and aspiration.Balloon Guide Catheterdimensions and maximumrecommended ballooninflation volume areindicated on product label. | Same except forproduct name as"FlowGateBalloon GuideCatheter" | Same aspredicate device(K131492) | Not applicable |
| Target Population | Patients undergoingpercutaneousinterventional procedures | Same | Same | Not applicable |
| Anatomical Sites | Peripheral and neurovasculature | Same | Same | Not applicable |
| Regulatory Status | ||||
| Regulation Number | 21CFR 870.1250 | Same | Same | Not applicable |
| Regulation Name | Percutaneous Catheter | Same | Same | Not applicable |
| Feature | Reference PredicateDevice (K122581) | PrimaryPredicate Device(K131492) | Subject Device | Rationale fordifference (ifapplicable) |
| Regulatory Class | II | Same | Same | Not applicable |
| Product Code | DQY | Same | Same | Not applicable |
| Materials | ||||
| Outer Jacket-Proximal Shaft | Purple Pebax® 7233Barium sulfate | Same | Same | Not applicable |
| Outer Jacket- DistalShaft | Blue Pebax 6333Barium sulfate | Same | Same | Not applicable |
| Inner Jacket-Proximal Shaft | White Polyamide BlendBarium sulfate | Same | Same | Not applicable |
| Inner Jacket -Proximal Transition | Natural Pebax 7233Barium sulfate | Same | Same | Not applicable |
| Inner Jacket -Proximal Mid Shaft | Natural Pebax 5533,Barium sulfate | Same | Same | Not applicable |
| Inner Jacket -Distal Mid Shaft | Natural Pebax 4033 | Same | Same | Not applicable |
| Inner Jacket -Distal Shaft | White Pebax 2533,Barium sulfate | Same | Same | Not applicable |
| Distal Tip | White Pebax 2533,Barium sulfate | White Pebax3533White Pebax2533Barium sulfate | Same aspredicate device(K131492) | Not applicable |
| Balloon Material | NuSil MED 4035 siliconeelastomer | NuSil MED 4025siliconeelastomer | Same aspredicate device(K131492) | Not applicable |
| Balloon BondAdhesive | Loctite 4011 CyanoacrylateLoctite 3974 UV Adhesive | Same | Same | Not applicable |
| Feature | Reference PredicateDevice (K122581) | PrimaryPredicate Device(K131492) | Subject Device | Rationale fordifference (ifapplicable) |
| Braid | 304V Stainless Steel | Same | Same | Not applicable |
| Braid distal endsecurement | Loctite UV Adhesive | Loctite 4014Cyanoacrylate | Same aspredicate device(K131492) | Not applicable |
| Liner | Etched PTFE | Same | Same | Not applicable |
| Marker Band | 90% Platinum/10% Iridium | Same | Same | Not applicable |
| Luer Hub Adhesive | Loctite 3321 UV Adhesive | Same | Same | Not applicable |
| 2-Arm Luer Hub | Polyurethane | Same | Same | Not applicable |
| Strain Relief | White Pebax 4033White Polyolefin | White Pebax4033White Polyolefin | Same aspredicate device(K131492) | Not applicable |
| Labeled ShaftOuter Diameter | 8F (2.7mm) | Same | Same | Not applicable |
| Labeled Shaft InnerDiameter | 6.4F (0.084 inch /2.1 mm) | Same | Same | Not applicable |
| Maximum outerdiameter alongeffective length | 0.108 inch | Same | Same | Not applicable |
| Effective Lengths | 100 cm and 90 cm | 95 cm and 85 cm | Same aspredicate device(K131492) | Not applicable |
| RadiopaqueMarker Locationfrom Distal Tip | 2 mm | 0.75 mm | Same aspredicate device(K131492) | Not applicable |
| RadiopaqueMarker Length | 0.020 inch | Same | Same | Not applicable |
| Feature | Reference PredicateDevice (K122581) | PrimaryPredicate Device(K131492) | Subject Device | Rationale fordifference (ifapplicable) |
| Accessory DevicesProvided | Dilator (1)Rotating Hemostasis Valve(1)Tuohy Borst Valve withsideport (1)Peel Away Sheaths (2)Luer-Activated Valve (1) | Same aspredicatedevice,with addition ofExtensionTubing (1) | Same aspredicatedevice, K131492except formodified Dilatortip shape andTuohy BorstValve withSideport withsmaller ID | The 6F Dilatorand Tuohy BorstValve withSideport havebeen modifiedto meet userpreferences.Bench testinghasdemonstratedthat thecompatibility ofmodified 6FDilator andTuohy BorstValve withSideport withthe subjectdevice does notaffect the safetyandeffectiveness ofthe device. |
| Tuohy Borst Valvewith Sideiportmaterial | ABS bodypolypropylene capPVC tubingpolycarbonate luersilicone sealLDPE washer/ring | Same | Same aspredicatedevice, K131492except forPolycarbonatebodypolycarbonateсарPVC tubingpolycarbonateluersilicone sealPTFEwasher/ring | The Tuohy BorstValve withSideport hasbeen modifiedto meet userpreferences.Bench testinghasdemonstratedthat thecompatibility ofmodified TuohyBorst Valve withSideport withthe subjectdevice does notaffect the safetyandeffectiveness ofthe device. |
| Feature | Reference PredicateDevice (K122581) | PrimaryPredicate Device(K131492) | Subject Device | Rationale fordifference (ifapplicable) |
| Dilator Shaftmaterial | Blue PebaxBarium sulfateBismuth subcarbonate (attip only) Stainless Steelbraid wire | Same | Same | Not applicable |
| Dilator Hubmaterial | White Polycarbonate | Same | Same | Not applicable |
| Dilator Strain ReliefSleeve material | Green Pebax | Same | Same | Not applicable |
| Dilator adhesivematerials | Cyanoacrylate | Same | Same | Not applicable |
| Dilator Shaft OuterDiameter (nominal) | 0.072 inch (distal), 0.078inch (proximal) | Same | Same | Not applicable |
| Dilator InnerDiameter (nominal) | 0.041 inch (distal), 0.050"(proximal) | Same | Same | Not applicable |
| Dilator EffectiveLength (nominal) | 123 cm | Same | Same | Not applicable |
| Dilator Distal TipAngle | 60° | Same | Same | Not applicable |
| Feature | Reference PredicateDevice (K122581) | PrimaryPredicate Device(K131492) | Subject Device | Rationale fordifference (ifapplicable) |
| Dilator Distal TipLength | 1.40 inch | Same | 0.67 inches | The tip shape ofthe 6F Dilatorhas beenshortened tomeet userpreferences.Bench testinghasdemonstratedthat thecompatibility ofthe shorterdistal tip lengthof the 6F Dilatorwith the subjectdevice does notaffect the safetyandeffectiveness ofthe device. |
| Packaging | ||||
| Materials andConfiguration | Polyethylene tubes forcatheter and dilator, HDPEsterile prep card andpackaging card, Tyvek andLLDPE/Nylon Film Pouch,Chipboard carton | Same | Same | Not applicable |
| SterilizationMethod | 100% EtO | Same | Same | Not applicable |
| How Supplied | Sterile, Single Use | Same | Same | Not applicable |
Product Feature Comparison of Subject Device with Predicate Devices (K122581, K131492)
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Concentric Medical, Inc.
Premarket Notification, Special 510(k) 8F FlowGate²™ Balloon Guide Catheter
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{8}------------------------------------------------
{9}------------------------------------------------
Concentric Medical, Inc.
Premarket Notification, Special 510(k) 8F FlowGate²™ Balloon Guide Catheter
{10}------------------------------------------------
Concentric Medical, Inc. Premarket Notification, Special 510(k) 8F FlowGate²™ Balloon Guide Catheter
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Concentric Medical, Inc. Premarket Notification, Special 510(k) 8F FlowGate²™ Balloon Guide Catheter
{12}------------------------------------------------
Risk Assessment
Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. Concentric Medical, Inc. has determined that the modifications to the predicate devices raise no new questions of safety or effectiveness.
Results of verification and validation testing have demonstrated the subject device is substantially equivalent to the predicate devices. Furthermore, the modifications did not result in any new failure modes nor were there any changes to existing failure modes.
Testing Summary
The results of verification and validation testing conducted on the subject device demonstrate that it performs as designed, and is suitable for its intended use. Specifically, the following tests were performed on the subject device:
| Test | Conclusions |
|---|---|
| Modifications to catheter shaft | |
| Catheter Simulated Use (Retriever/Microcatheter Compatibility) | Met established acceptance criteria. |
| Catheter Kink Resistance, Variables (TestKink Resistance) | Met established acceptance criteria. |
| Catheter Tip Flexibility (Catheter/Vessel Interaction) | Met established acceptance criteria. |
| Torque Transmission | Met established acceptance criteria. |
| High Pressure Leak | Met established acceptance criteria. |
| 6F Dilator Accessory | Met established acceptance criteria. |
| Dimensional Verification | Met established acceptance criteria. |
| Dilator Shape Retention | Met established acceptance criteria. |
| Air Leak Resistance | Met established acceptance criteria. |
| Liquid Leak Resistance | Met established acceptance criteria. |
| Tensile Strength | Met established acceptance criteria. |
| High Pressure Leak | Met established acceptance criteria. |
| Catheter/Vessel Interaction (Catheter Tip Flexibility) | Met established acceptance criteria. |
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| Test | Conclusions |
|---|---|
| Kink Resistance | Met established acceptance criteria. |
| Distal Shaft Trackability | Met established acceptance criteria. |
| Lumen Compatibility | Met established acceptance criteria. |
| Tuohy Borst Valve with Sideport Accessory | |
| Hub Gauging | Met established acceptance criteria. |
| Liquid leakage | Met established acceptance criteria. |
| Air Leakage | Met established acceptance criteria. |
| Separation Force | Met established acceptance criteria. |
| Unscrewing Torque | Met established acceptance criteria. |
| Ease of Assembly | Met established acceptance criteria. |
| Resistance to Overriding | Met established acceptance criteria. |
| Stress Cracking | Met established acceptance criteria. |
| Catheter Simulated Use (Tuohy Borst Valvewith Sideport seal over devices and wires) | Met established acceptance criteria. |
Biocompatibility
Biocompatibility testing was completed for the previously cleared devices under K122581 and K131492. These results apply to the subject device because it uses the same materials and processes as previously cleared predicate devices. Biocompatibility testing was conducted on the accessories packaged with the previously cleared devices under K131492, which included the modified Tuohy Borst Valve with Sideport to be packaged with the proposed 8F FlowGate² BGC in compliance with EN ISO 10993-1. The results demonstrate that the subject device with its accessories meet biological safety requirements per EN ISO 10993-1: 2009 for externally communicating medical devices with circulating blood contact for less than 24 hours.
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Sterilization and Shelf life
The subject device, including its accessories, are sterilized by 100% EtO and have been adopted into a validated sterilization process in accordance with the principles of ISO 11135:2007, ("Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices") and AAMI TIR 28:2009 ("Product Adoption and Process Equivalency for Ethylene Oxide Sterilization") without deviations.
Summary of Substantial Equivalence
The subject device is substantially equivalent to the predicate devices with regard to device design, materials, intended use, and patient population. The conclusions drawn from the risk assessments, verification and validation testing conducted demonstrate that the subject device performs as designed and has an equivalent performance profile as the predicate devices.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).