(48 days)
087 Balloon Guide Catheter System K190749
No
The summary describes a physical catheter system and its mechanical performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is indicated for facilitating the insertion and guidance of an intravascular catheter and for temporary vascular occlusion or as a conduit for retrieval devices. While it is used during medical procedures, its primary function is not to directly treat a disease or condition.
No
Explanation: The device is a guide catheter system used to facilitate the insertion and guidance of other catheters and retrieval devices, and to provide temporary vascular occlusion. It does not perform diagnostic functions.
No
The device description clearly outlines multiple physical components including a catheter, syringe, introducer, hub extension, and stopcock. The performance studies also focus on physical characteristics and functionality of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the insertion and guidance of an intravascular catheter and for temporary vascular occlusion within the body (in the peripheral and neurovasculature). It also acts as a conduit for retrieval devices within the body.
- Device Description: The description details a catheter system designed for insertion into blood vessels.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue in a laboratory or clinical setting to diagnose or monitor conditions. This device is an interventional medical device used directly within the patient's body.
N/A
Intended Use / Indications for Use
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:
- .087 Balloon Guide Catheter
- 1cc Inflation Syringe
- 8Fr Peel Away Introducer
- Hub Extension
- Three Way Stopcock
The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neurovasculature
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)
Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data. The 087 Balloon Guide Catheter System has successfully completed the following relevant performance testing to demonstrate substantial equivalence. Testing was performed to evaluate physical integrity, functionality, and performance of the 087 Balloon Guide Catheter. A summary of the tests performed is provided in the table below:
Study Name: Conditioning, Distribution, and Shelf Life Aging Verification
Description: To demonstrate that the product meets the packaging strength and packaging integrity following accelerated aging to a 6-month shelf life equivalent
Reference Standard: ASTM F88 Seal Strength of Flexible Barrier materials ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Packaging Visual Inspection
Description: To demonstrate that the product meets the packaging visual inspection requirements given
Reference Standard: N/A
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Visual Surface Requirements
Description: To demonstrate the product satisfies the visual surface requirements
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Dimensional Inspection
Description: To demonstrate that the product meets the dimensional specifications
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Inflation Volume vs Balloon Diameter
Description: To demonstrate that the product meets the inflation volume vs balloon diameter specifications
Reference Standard: In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Balloon Burst Volume
Description: To demonstrate that the Balloon is capable of withstanding an injection volume of 1.0CC.
Reference Standard: In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Tip Deflection, FG 00100
Description: To demonstrate that the stiffness of the distal end of the product is similar to other marketed devices.
Reference Standard: N/A
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Torque Testing
Description: To demonstrate that the product is capable of 720 degrees of rotation about the central lumen axis without failure.
Reference Standard: N/A
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Peak Tensile
Description: To demonstrate the product satisfies the peak tensile requirements
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Flow Rate
Description: To demonstrate that the flow rate is comparable to the predicate device.
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Small Bore Connector Compliance with Standard
Description: To demonstrate that the product meets the requirements
Reference Standard: ISO 80369-7 2016, Small-bore connectors for liquids and gases in healthcare applications - Part 7, Connectors for intravascular or hypodermic applications.
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Corrosion Resistance
Description: To demonstrate the product satisfies the corrosion resistance requirements
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Radiopacity
Description: To determine the radiopaque characteristics of the device.
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Hub Extension Liquid Leakage Under Pressure
Description: To demonstrate that the product meets the liquid leakage requirements
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Hub Extension Hub Aspiration Air Leakage
Description: To demonstrate that the product meets the liquid leakage requirements
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Particulates, Coating Integrity
Description: This study was conducted to determine the quantity and size of particles generated during simulated use, including use with stent retrievers
Reference Standard: AAMI TIR42:10 Evaluation of particulates associated with vascular medical devices USP Particulate Matter in Injections FDA CTQ: Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices, August 2015
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Liquid Leakage Under Pressure
Description: To demonstrate that the product meets the liquid leakage requirements given in ISO 10555 1.
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Hub Aspiration Air Leakage
Description: To demonstrate that the product meets the hub aspiration air leakage requirements given in ISO 10555-1.
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Balloon Inflation Fatigue
Description: To demonstrate that there is no degradation of the Balloon after 20 inflation cycles.
Reference Standard: In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Flex Fatigue
Description: To demonstrate that the product does not loose structural integrity when used in the tortuous path model.
Reference Standard: ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Kink Resistance
Description: To demonstrate that the product has acceptable kink resistance
Reference Standard: DIN EN 13868:2002, Test methods for kinking of single lumen catheters and medical tubing
Results: Pass All samples met the pre-determined acceptance criteria
Study Name: Simulated Use
Description: Evaluation of device performance under simulated use conditions, including stent retrievers compared to the predicate device
Reference Standard: In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters
Results: Pass All samples met the pre-determined acceptance criteria
The results of these tests provide reasonable assurance that the 087 Balloon Guide Catheter System has been designed and tested to assure conformance to the requirements for its intended use and indications for use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate 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.
Concentric Medical, FlowGate2TM, K153729
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.
087 Balloon Guide Catheter System K190749
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
§ 870.1250 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 31, 2019
Q'Apel Medical LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K192525
Device Name: 087 Balloon Guide Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 12, 2019 Received: September 13, 2019
Dear Michele Lucey:
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
1
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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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,
Xiaolin Zheng, Ph.D. Director (Acting) DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192525
Device Name 087 Balloon Guide Catheter System
Indications for Use (Describe)
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System 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 Traditional 510(k) As required by 21 CFR 807.92
Submitter Information:
| Submitter's Name: | Q'Apel Medical LLC |
|---|---|
| Address: | 330 Wilshire Boulevard |
| Santa Monica CA 90401 | |
| Telephone: | 310-395-3950 |
| Fax: | 310-395-3950 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 17, 2019 |
| Device Trade Name: | 087 Balloon Guide Catheter System |
| Classification: | Class II |
| Classification Name: | Percutaneous Catheter |
| Product Code(s): | DQY |
| Regulation Number(s): | 870.1250 |
| Predicate Device: | Concentric Medical, FlowGate2TM, K153729 |
| Reference Device: | 087 Balloon Guide Catheter System K190749 |
Indication for Use:
The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.
Device Description
The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of:
- . 087 Balloon Guide Catheter
- 1cc Inflation Syringe ●
- 8Fr Peel Away Introducer ●
- Hub Extension
4
- Three Way Stopcock ●
The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.
Nonclinical Performance Testing Summary:
Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data. The 087 Balloon Guide Catheter System has successfully completed the following relevant performance testing to demonstrate substantial equivalence. Testing was performed to evaluate physical integrity, functionality, and performance of the 087 Balloon Guide Catheter. A summary of the tests performed is provided in the table below:
| Performance Test Summary | |||
|---|---|---|---|
| Study Name | Description | Reference Standard | Results |
| Conditioning. | |||
| Distribution, and Shelf | |||
| Life Aging Verification | To demonstrate that the product | ||
| meets the packaging strength and | |||
| packaging integrity following | |||
| accelerated aging to a 6-month | |||
| shelf life equivalent | ASTM F88 Seal | ||
| Strength of Flexible | |||
| Barrier materials | |||
| ASTM F2096 Standard | |||
| Test Method for | |||
| Detecting Gross Leaks | |||
| in Medical Packaging | Pass | ||
| All samples met | |||
| the pre-determined | |||
| acceptance criteria | |||
| Packaging Visual | |||
| Inspection | To demonstrate that the product | ||
| meets the packaging visual | |||
| inspection requirements given | N/A | Pass | |
| All samples met | |||
| the pre-determined | |||
| acceptance criteria | |||
| Visual Surface | |||
| Requirements | To demonstrate the product | ||
| satisfies the visual surface | |||
| requirements | ISO 10555-1:2013 | ||
| Intravascular catheters - | |||
| Sterile and single-use | |||
| catheters - Part 1: | |||
| General requirements | Pass | ||
| All samples met | |||
| the pre-determined | |||
| acceptance criteria | |||
| Dimensional Inspection | To demonstrate that the product | ||
| meets the dimensional | |||
| specifications | ISO 10555-1:2013 | ||
| Intravascular catheters - | |||
| Sterile and single-use | |||
| catheters - Part 1: | |||
| General requirements | Pass | ||
| All samples met | |||
| the pre-determined | |||
| acceptance criteria | |||
| Inflation Volume vs | |||
| Balloon Diameter | To demonstrate that the product | ||
| meets the inflation volume vs | |||
| balloon diameter specifications | In consideration of ISO | ||
| 10555-4:2013 | |||
| Intravascular Catheters |
- Sterile and Single-Use
Catheters - Part 4:
Balloon Dilatation
Catheters | Pass
All samples met
the pre-determined
acceptance criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Balloon Burst Volume, | To demonstrate that the Balloon
is capable of withstanding an
injection volume of 1.0CC. | In consideration of ISO
10555-4:2013
Intravascular Catheters - Sterile and Single-Use
Catheters - Part 4:
Balloon Dilatation
Catheters | Pass
All samples met
the pre-determined
acceptance criteria |
| Tip Deflection, FG 00100 | To demonstrate that the stiffness
of the distal end of the product is
similar to other marketed devices. | N/A | Pass
All samples met
the pre-determined
acceptance criteria |
| Torque Testing | To demonstrate that the product is
capable of 720 degrees of rotation
about the central lumen axis
without failure. | N/A | Pass
All samples met
the pre-determined
acceptance criteria |
| Peak Tensile | To demonstrate the product
satisfies the peak tensile
requirements | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Flow Rate | To demonstrate that the flow rate
is comparable to the predicate
device. | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Small Bore Connector
Compliance with
Standard | To demonstrate that the product
meets the requirements | ISO 80369-7 2016,
Small-bore connectors
for liquids and gases in
healthcare applications - Part 7, Connectors
for intravascular or
hypodermic
applications. | Pass
All samples met
the pre-determined
acceptance criteria |
| Corrosion Resistance | To demonstrate the product
satisfies the corrosion resistance
requirements | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Radiopacity | To determine the radiopaque
characteristics of the device. | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements
ASTM F640-12
Standard Test Methods
for Determining
Radiopacity for
Medical Use | Pass
All samples met
the pre-determined
acceptance criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Hub Extension Liquid
Leakage Under Pressure | To demonstrate that the product
meets the liquid leakage
requirements | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Hub Extension Hub
Aspiration Air Leakage | To demonstrate that the product
meets the liquid leakage
requirements | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Particulates, Coating
Integrity | This study was conducted to
determine the quantity and size of
particles generated during
simulated use, including use with
stent retrievers | AAMI TIR42:10
Evaluation of
particulates associated
with vascular medical
devices
USP Particulate
Matter in Injections
FDA CTQ: Hydrophilic
Coated and
Hydrophobic Coated
Vascular and
Neurological Devices,
August 2015 | Pass
All samples met
the pre-determined
acceptance criteria |
| Liquid Leakage Under
Pressure | To demonstrate that the product
meets the liquid leakage
requirements given in ISO 10555-
-
| ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Hub Aspiration Air
Leakage | To demonstrate that the product
meets the hub aspiration air
leakage requirements given in
ISO 10555-1. | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Balloon Inflation Fatigue | To demonstrate that there is no
degradation of the Balloon after
20 inflation cycles. | In consideration of ISO
10555-4:2013
Intravascular Catheters
- Sterile and Single-Use
Catheters - Part 4:
Balloon Dilatation
Catheters | Pass
All samples met
the pre-determined
acceptance criteria |
| Flex Fatigue | To demonstrate that the product
does not loose structural integrity
when used in the tortuous path
model. | ISO 10555-1:2013
Intravascular catheters -
Sterile and single-use
catheters - Part 1:
General requirements | Pass
All samples met
the pre-determined
acceptance criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Kink Resistance | To demonstrate that the product
has acceptable kink resistance | DIN EN 13868:2002,
Test methods for
kinking of single lumen
catheters and medical
tubing | Pass
All samples met
the pre-determined
acceptance criteria |
| Simulated Use | Evaluation of device performance
under simulated use conditions,
including stent retrievers
compared to the predicate device | In consideration of ISO
10555-4:2013
Intravascular Catheters - Sterile and Single-Use
Catheters - Part 4:
Balloon Dilatation
Catheters | Pass
All samples met the
pre-determined
acceptance criteria |
5
6
7
The results of these tests provide reasonable assurance that the 087 Balloon Guide Catheter System has been designed and tested to assure conformance to the requirements for its intended use and indications for use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate device.
Animal or Clinical Testing: No animal or clinical studies were required to demonstrate substantial equivalence.
Biocompatibility Testing Summary
The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (