(30 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon guide catheter, with no mention of AI or ML.
No.
The device facilitates the insertion and guidance of other catheters; it is not directly listed as providing therapeutic intervention itself, but rather as an accessory to procedures.
No
Explanation: The device is a guide catheter used to facilitate the insertion and guidance of other intravascular catheters and provide temporary vascular occlusion. Its function is interventional, not diagnostic.
No
The device description clearly details a physical catheter with a balloon, radiopaque marker, and luer hub, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the Flow Gate Balloon Guide Catheter is used within the body (in vivo) to facilitate the insertion and guidance of other catheters and provide temporary vascular occlusion during angiographic procedures. It is a tool used during a medical procedure, not a device for analyzing biological samples.
The device is an invasive medical device used for interventional procedures.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral and neuro vasculature
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)
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: 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.
Test: 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.
Distal Shaft Trackability: Met established acceptance criteria.
Lumen Compatibility: Met established acceptance criteria.
Test: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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.
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 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
2
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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3
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 Avenue | |
| Mountain View, CA 94041 | |
| Tel 510 - 413-2636 | |
| Fax 510 - 413-2588 | |
| Facility Registration #2954917 | |
| Contact: | Shazia Hakim |
| Senior Regulatory Affairs Specialist |
Date Prepared: December 22, 2015
Predicate Device:
| Primary Predicate Device | |
|---|---|
| K131492 | |
| (clearance granted | |
| October 3, 2013) | Modified FlowGate™ Balloon |
| Guide Catheter | |
| Reference Predicate Device | |
| K122581 | |
| (clearance granted | |
| November 21, 2012) | Concentric Balloon Guide |
| Catheter |
4
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.
5
| 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 Predicate | |||
| Device (K122581) | Primary | |||
| Predicate Device | ||||
| (K131492) | Subject Device | Rationale for | ||
| difference (if | ||||
| applicable) | ||||
| Device Description | The Concentric Balloon | |||
| Guide Catheters are | ||||
| coaxial-lumen, braid- | ||||
| reinforced, variable | ||||
| stiffness catheters 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. | ||||
| Balloon Guide Catheter | ||||
| dimensions and maximum | ||||
| recommended balloon | ||||
| inflation volume are | ||||
| indicated on product label. | Same except for | |||
| product name as | ||||
| "FlowGate | ||||
| Balloon Guide | ||||
| Catheter" | Same as | |||
| predicate device | ||||
| (K131492) | Not applicable | |||
| Target Population | Patients undergoing | |||
| percutaneous | ||||
| interventional procedures | Same | Same | Not applicable | |
| Anatomical Sites | Peripheral and neuro | |||
| vasculature | 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 Predicate | |||
| Device (K122581) | Primary | |||
| Predicate Device | ||||
| (K131492) | Subject Device | Rationale for | ||
| difference (if | ||||
| applicable) | ||||
| Regulatory Class | II | Same | Same | Not applicable |
| Product Code | DQY | Same | Same | Not applicable |
| Materials | ||||
| Outer Jacket- | ||||
| Proximal Shaft | Purple Pebax® 7233 | |||
| Barium sulfate | Same | Same | Not applicable | |
| Outer Jacket- Distal | ||||
| Shaft | Blue Pebax 6333 | |||
| Barium sulfate | Same | Same | Not applicable | |
| Inner Jacket- | ||||
| Proximal Shaft | White Polyamide Blend | |||
| Barium sulfate | Same | Same | Not applicable | |
| Inner Jacket - | ||||
| Proximal Transition | Natural Pebax 7233 | |||
| Barium 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 Pebax | |||
| 3533 | ||||
| White Pebax | ||||
| 2533 | ||||
| Barium sulfate | Same as | |||
| predicate device | ||||
| (K131492) | Not applicable | |||
| Balloon Material | NuSil MED 4035 silicone | |||
| elastomer | NuSil MED 4025 | |||
| silicone | ||||
| elastomer | Same as | |||
| predicate device | ||||
| (K131492) | Not applicable | |||
| Balloon Bond | ||||
| Adhesive | Loctite 4011 Cyanoacrylate | |||
| Loctite 3974 UV Adhesive | Same | Same | Not applicable | |
| Feature | Reference Predicate | |||
| Device (K122581) | Primary | |||
| Predicate Device | ||||
| (K131492) | Subject Device | Rationale for | ||
| difference (if | ||||
| applicable) | ||||
| Braid | 304V Stainless Steel | Same | Same | Not applicable |
| Braid distal end | ||||
| securement | Loctite UV Adhesive | Loctite 4014 | ||
| Cyanoacrylate | Same as | |||
| predicate 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 4033 | |||
| White Polyolefin | White Pebax | |||
| 4033 | ||||
| White Polyolefin | Same as | |||
| predicate device | ||||
| (K131492) | Not applicable | |||
| Labeled Shaft | ||||
| Outer Diameter | 8F (2.7mm) | Same | Same | Not applicable |
| Labeled Shaft Inner | ||||
| Diameter | 6.4F (0.084 inch /2.1 mm) | Same | Same | Not applicable |
| Maximum outer | ||||
| diameter along | ||||
| effective length | 0.108 inch | Same | Same | Not applicable |
| Effective Lengths | 100 cm and 90 cm | 95 cm and 85 cm | Same as | |
| predicate device | ||||
| (K131492) | Not applicable | |||
| Radiopaque | ||||
| Marker Location | ||||
| from Distal Tip | 2 mm | 0.75 mm | Same as | |
| predicate device | ||||
| (K131492) | Not applicable | |||
| Radiopaque | ||||
| Marker Length | 0.020 inch | Same | Same | Not applicable |
| Feature | Reference Predicate | |||
| Device (K122581) | Primary | |||
| Predicate Device | ||||
| (K131492) | Subject Device | Rationale for | ||
| difference (if | ||||
| applicable) | ||||
| Accessory Devices | ||||
| Provided | Dilator (1) | |||
| Rotating Hemostasis Valve | ||||
| (1) | ||||
| Tuohy Borst Valve with | ||||
| sideport (1) | ||||
| Peel Away Sheaths (2) | ||||
| Luer-Activated Valve (1) | Same as | |||
| predicate | ||||
| device, | ||||
| with addition of | ||||
| Extension | ||||
| Tubing (1) | Same as | |||
| predicate | ||||
| device, K131492 | ||||
| except for | ||||
| modified Dilator | ||||
| tip shape and | ||||
| Tuohy Borst | ||||
| Valve with | ||||
| Sideport with | ||||
| smaller ID | The 6F Dilator | |||
| and Tuohy Borst | ||||
| Valve with | ||||
| Sideport have | ||||
| been modified | ||||
| to meet user | ||||
| preferences. | ||||
| Bench testing | ||||
| has | ||||
| demonstrated | ||||
| that the | ||||
| compatibility of | ||||
| modified 6F | ||||
| Dilator and | ||||
| Tuohy Borst | ||||
| Valve with | ||||
| Sideport with | ||||
| the subject | ||||
| device does not | ||||
| affect the safety | ||||
| and | ||||
| effectiveness of | ||||
| the device. | ||||
| Tuohy Borst Valve | ||||
| with Sideiport | ||||
| material | ABS body | |||
| polypropylene cap | ||||
| PVC tubing | ||||
| polycarbonate luer | ||||
| silicone seal | ||||
| LDPE washer/ring | Same | Same as | ||
| predicate | ||||
| device, K131492 | ||||
| except for | ||||
| Polycarbonate | ||||
| body | ||||
| polycarbonate | ||||
| сар | ||||
| PVC tubing | ||||
| polycarbonate | ||||
| luer | ||||
| silicone seal | ||||
| PTFE | ||||
| washer/ring | The Tuohy Borst | |||
| Valve with | ||||
| Sideport has | ||||
| been modified | ||||
| to meet user | ||||
| preferences. | ||||
| Bench testing | ||||
| has | ||||
| demonstrated | ||||
| that the | ||||
| compatibility of | ||||
| modified Tuohy | ||||
| Borst Valve with | ||||
| Sideport with | ||||
| the subject | ||||
| device does not | ||||
| affect the safety | ||||
| and | ||||
| effectiveness of | ||||
| the device. | ||||
| Feature | Reference Predicate | |||
| Device (K122581) | Primary | |||
| Predicate Device | ||||
| (K131492) | Subject Device | Rationale for | ||
| difference (if | ||||
| applicable) | ||||
| Dilator Shaft | ||||
| material | Blue Pebax | |||
| Barium sulfate | ||||
| Bismuth subcarbonate (at | ||||
| tip only) Stainless Steel | ||||
| braid wire | Same | Same | Not applicable | |
| Dilator Hub | ||||
| material | White Polycarbonate | Same | Same | Not applicable |
| Dilator Strain Relief | ||||
| Sleeve material | Green Pebax | Same | Same | Not applicable |
| Dilator adhesive | ||||
| materials | Cyanoacrylate | Same | Same | Not applicable |
| Dilator Shaft Outer | ||||
| Diameter (nominal) | 0.072 inch (distal), 0.078 | |||
| inch (proximal) | Same | Same | Not applicable | |
| Dilator Inner | ||||
| Diameter (nominal) | 0.041 inch (distal), 0.050" | |||
| (proximal) | Same | Same | Not applicable | |
| Dilator Effective | ||||
| Length (nominal) | 123 cm | Same | Same | Not applicable |
| Dilator Distal Tip | ||||
| Angle | 60° | Same | Same | Not applicable |
| Feature | Reference Predicate | |||
| Device (K122581) | Primary | |||
| Predicate Device | ||||
| (K131492) | Subject Device | Rationale for | ||
| difference (if | ||||
| applicable) | ||||
| Dilator Distal Tip | ||||
| Length | 1.40 inch | Same | 0.67 inches | The tip shape of |
| the 6F Dilator | ||||
| has been | ||||
| shortened to | ||||
| meet user | ||||
| preferences. | ||||
| Bench testing | ||||
| has | ||||
| demonstrated | ||||
| that the | ||||
| compatibility of | ||||
| the shorter | ||||
| distal tip length | ||||
| of the 6F Dilator | ||||
| with the subject | ||||
| device does not | ||||
| affect the safety | ||||
| and | ||||
| effectiveness of | ||||
| the device. | ||||
| Packaging | ||||
| Materials and | ||||
| Configuration | Polyethylene tubes for | |||
| catheter and dilator, HDPE | ||||
| sterile prep card and | ||||
| packaging card, Tyvek and | ||||
| LLDPE/Nylon Film Pouch, | ||||
| Chipboard carton | Same | Same | Not applicable | |
| Sterilization | ||||
| Method | 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)
6
Concentric Medical, Inc.
Premarket Notification, Special 510(k) 8F FlowGate²™ Balloon Guide Catheter
7
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
11
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 (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. |
| 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. |
13
| 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 Valve | |
| with 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.
14
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.