(112 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon guide catheter system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device facilitates the insertion and guidance of another intravascular catheter and provides temporary vascular occlusion, which are procedural aids rather than direct therapeutic treatments.
No
The device is a balloon guide catheter system used to facilitate the insertion and guidance of other intravascular catheters and provide temporary vascular occlusion. Its function is interventional and supportive, not diagnostic, as it does not gather information to identify or characterize a medical condition.
No
The device description clearly outlines multiple hardware components including a catheter, syringe, introducer, hub extension, and stopcock.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter system designed for insertion into blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is an interventional medical device used during procedures within the patient's vascular system.
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 intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQY, MJN
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 Neurovascular 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 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 087 Balloon Guide Catheter System has successfully completed the following relevant performance testing demonstrating that the device is suitable for its intended use.
- 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. 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.
- Packaging Visual Inspection: 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.
- Visual Surface Requirements: 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.
- Dimensional Inspection: 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.
- Inflation Volume vs Balloon Diameter: 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.
- Balloon Burst Volume: To demonstrate that the Balloon is capable of withstanding an injection volume of 1.0 CC. 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.
- Tip Deflection, FG 00100: 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.
- Torque Testing: 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.
- Peak Tensile: 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.
- Flow Rate: 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.
- Small Bore Connector Compliance with Standard: 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.
- Corrosion Resistance: 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.
- Radiopacity: 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.
- Hub Extension Liquid Leakage Under Pressure: 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.
- Hub Extension Hub Aspiration Air Leakage: 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.
- Particulates, Coating Integrity: This study was conducted to determine the quantity and size of particles generated during simulated use. 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.
- Liquid Leakage Under Pressure: 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.
- Hub Aspiration Air Leakage: 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.
- Balloon Inflation Fatigue: 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.
- Simulated Use: Evaluation of device performance under simulated use conditions 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.
- Flex Fatigue: 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.
- Simulated Use Evaluation of the Q'Apel Balloon Guide Catheter: Simulated use under invitro conditions in a cerebral vascular model. Reference Standard: N/A. Results: Pass, All samples met the pre-determined acceptance criteria.
Biocompatibility Testing Summary:
- Cytotoxicity: Tested in accordance with ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro toxicity, Neutral Red Uptake Method. Results: Pass, Noncytotoxic according to the predetermined acceptance criteria.
- Intracutaneous Irritation: Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization. Results: Pass, Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria.
- Sensitization: Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices - Part 10 Tests for Irritation and Skin Sensitization, Kligman Maximization Test. Results: Pass, did not elicit a sensitization response according to the predetermined acceptance criteria.
- Systemic Toxicity: Tested in accordance with ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity. Results: Pass, Test requirements for systemic toxicity were met according to the predetermined acceptance criteria.
- Material Mediated Pyrogenicity: Tested in accordance with ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity and USP 40 Pyrogen Test. Results: Pass, Nonpyrogenic, met the predetermined acceptance criteria.
- Hemolysis: Tested in accordance with ASTM F756-17, Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, Tests for Hemolytic Properties, Direct and Indirect Methods. Results: Pass, Non-hemolytic, met the predetermined acceptance criteria.
- In Vitro Hemocompatibility: Tested in accordance with ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, Hemocompatibility, Direct Contact Method. Results: Pass, Not expected to result in adverse effects in vivo, met the predetermined acceptance criteria.
- Complement Activation: Tested in accordance with ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, SC5b-9 Complement Activation. Results: Pass, Does not activate the complement system, met the predetermined acceptance criteria.
- Un-activated Partial Thromboplastin Time: Tested in accordance with ISO 10994-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood and ASTM F2382-04, Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (UPTT). Results: Pass, Does not have an effect on coagulation of human plasma, met the predetermined acceptance criteria.
- Thrombogenicity: Tested in accordance with ISO 10994-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood. Results: Pass, Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria.
No animal or clinical studies were required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 15, 2019
Q'Apel Medical LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255
Re: K190749
Device Name: 087 Balloon Guide Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, MJN Dated: June 12, 2019 Received: June 14, 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. Assistant Director 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)
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 intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.
| 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 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: | July 15, 2019 |
| Device Trade Name: | 087 Balloon Guide Catheter System |
| Classification: | Class II |
| Classification Name: | Percutaneous Catheter |
| Product Code(s): | DQY, MJN |
| Regulation Number(s): | 870.1250 |
| Predicate Devices: | Concentric Medical, FlowGate2™ (K153729) |
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 neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.
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
4
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 Neurovascular Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.
Performance Testing Summary:
The 087 Balloon Guide Catheter System has successfully completed the following relevant performance testing demonstrating that the device is suitable for its intended use.
| 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 | |||
| Balloon Burst Volume, | To demonstrate that the Balloon is capable of withstanding an injection volume of 1.0 CC. | 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 | |||
| Performance Test Summary | |||
| Study Name | Description | Reference Standard | Results |
| 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 |
| 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 |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Particulates, Coating
Integrity | This study was conducted to
determine the quantity and size of
particles generated during
simulated use | 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 |
| Simulated Use | Evaluation of device performance
under simulated use conditions
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 |
| 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 |
| Simulated Use Evaluation
of the Q'Apel Balloon
Guide Catheter | Simulated use under invitro
conditions in a cerebral vascular
model | N/A | Pass
All samples met
the pre-determined
acceptance criteria |
5
6
No animal or clinical studies were required to demonstrate substantial equivalence.
7
Biocompatibility Testing Summary
Categorized as Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hours), per ISO 10993-1, the following testing was conducted:
| Test Name | Test Method | Results |
|---|---|---|
| Cytotoxicity | Tested in accordance with ISO 10993-5, Biological | |
| Evaluation of Medical Devices - Part 5: Tests for in vitro toxicity, Neutral Red Uptake Method | Pass | |
| Noncytotoxic according to the | ||
| predetermined acceptance criteria | ||
| Intracutaneous | ||
| Irritation | Tested in accordance with ISO 10993-10, Biological | |
| Evaluation of Medical Devices - Part 10: Tests for | ||
| Irritation and Skin Sensitization | Pass | |
| Test requirements for | ||
| intracutaneous reactivity were met | ||
| according to the predetermined | ||
| acceptance criteria | ||
| Sensitization | Tested in accordance with ISO 10993-10, Biological | |
| Evaluation of Medical Devices - Part 10 Tests for | ||
| Irritation and Skin Sensitization, Kligman | ||
| Maximization Test | Pass | |
| did not elicit a sensitization | ||
| response according to the | ||
| predetermined acceptance criteria | ||
| Systemic Toxicity | Tested in accordance with ISO 10993-11, Biological | |
| Evaluation of Medical Devices - Part 11: Tests for | ||
| Systemic Toxicity | Pass | |
| Test requirements for systemic | ||
| toxicity were met according to the | ||
| predetermined acceptance criteria | ||
| Material Mediated | ||
| Pyrogenicity | Tested in accordance with ISO 10993-11, Biological | |
| Evaluation of Medical Devices - Part 11: Tests for | ||
| Systemic Toxicity and USP 40 Pyrogen Test | Pass | |
| Nonpyrogenic, met the | ||
| predetermined acceptance criteria | ||
| Hemolysis | Tested in accordance with ASTM F756-17, | |
| Standard Practice for Assessment of Hemolytic | ||
| Properties of Materials and ISO 10993-4, Biological | ||
| Evaluation of Medical Devices - Part 4: Selection of | ||
| Tests for Interactions with Blood, Tests for | ||
| Hemolytic Properties, Direct and Indirect Methods | Pass | |
| Non-hemolytic, met the | ||
| predetermined acceptance criteria | ||
| In Vitro | ||
| Hemocompatibility | Tested in accordance with ISO 10993-4, Biological | |
| Evaluation of Medical Devices - Part 4: Selection of | ||
| Tests for Interactions with Blood, | ||
| Hemocompatibility, Direct Contact Method | Pass | |
| Not expected to result in adverse | ||
| effects in vivo , met the | ||
| predetermined acceptance criteria | ||
| Complement | ||
| Activation | Tested in accordance with ISO 10993-4, Biological | |
| Evaluation of Medical Devices - Part 4: Selection of | ||
| Tests for Interactions with Blood, SC5b-9 | ||
| Complement Activation | Pass | |
| Does not activate the complement | ||
| system, met the predetermined | ||
| acceptance criteria | ||
| Un-activated Partial | ||
| Thromboplastin Time | Tested in accordance with ISO 10994-4, Biological | |
| Evaluation of Medical Devices - Part 4: Selection of | ||
| Tests for Interactions with Blood and ASTM F2382- | ||
| 04, Standard Test Method for Assessment of | ||
| Intravascular Medical Device Materials on Partial | ||
| Thromboplastin Time (UPTT) | Pass | |
| Does not have an effect on | ||
| coagulation of human plasma, met | ||
| the predetermined acceptance | ||
| criteria | ||
| Thrombogenicity | Tested in accordance with ISO 10994-4, Biological | |
| Evaluation of Medical Devices - Part 4: Selection of | ||
| Tests for Interactions with Blood | Pass | |
| Demonstrates similar | ||
| thromboresistance characteristics | ||
| as the control device, met the | ||
| predetermined acceptance criteria |
8
Predicate Device Comparison
The following table provides a comparison of the key characteristics of the 087 Balloon Guide Catheter System to the predicate device.
| Comparison Chart | |||
|---|---|---|---|
| Feature | Subject Device | ||
| 087 Balloon Guide | |||
| Catheter System | Predicate device | ||
| the 8F FlowGate2TM | |||
| Balloon Guide Catheter | Comparison | ||
| Regulatory Clearance/ | |||
| Approval Reference | K190749 | K153729 | NA |
| FDA Classification | Class II | Class II | Same |
| Product Code(s) | DQY | DQY | Same |
| Regulation Number | 870.1250 | 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Percutaneous Catheter | Same |
| Anatomical Locations | Peripheral and neuro | ||
| vasculature | Peripheral and neuro | ||
| vasculature | Same | ||
| Material | Commonly used medical | ||
| grade plastics and | |||
| stainless steel, | Commonly used | ||
| medical grade plastics | |||
| and stainless steel | Similar, difference | ||
| does not raise new | |||
| questions regarding | |||
| safety and efficacy, | |||
| confirmed through | |||
| biocompatibility and | |||
| performance testing | |||
| Reinforced Catheter | |||
| Shaft Reinforcement | Stainless steel coil | ||
| reinforced | Stainless steel braid | ||
| reinforced | Similar, minor | ||
| difference does not | |||
| raise new questions | |||
| regarding safety and | |||
| efficacy, both | |||
| devices have | |||
| reinforced catheter | |||
| walls | |||
| Injection Port | Yes | Yes | Same |
| Radiopacity | Yes, shaft is visible due | ||
| to coil reinforcement, | |||
| distal tip Pt-Ir marker | |||
| bands | Yes, shaft material | ||
| contains barium sulfate, | |||
| distal tip Pt-Ir marker | |||
| band | Similar, minor | ||
| difference does not | |||
| raise new questions | |||
| regarding safety and | |||
| efficacy, both | |||
| devices are | |||
| radiopaque | |||
| Marker Band Locations | 0.06-in (1.5mm) from the | ||
| distal tip edge (distal of | |||
| the balloon) | |||
| 0.66-in (16.8mm) from | |||
| the distal tip edge | |||
| (proximal of the balloon) | .08-in (2mm) from the | ||
| distal tip edge | Similar, minor | ||
| difference does not | |||
| raise new questions | |||
| regarding safety and | |||
| efficacy, both | |||
| devices utilize | |||
| radiopaque marker | |||
| bands | |||
| Compliant Balloon | Yes, low durometer | ||
| urethane | Yes, silicone | Similar, material | |
| differences do not | |||
| Comparison Chart | |||
| Feature | Subject Device | ||
| 087 Balloon Guide | |||
| Catheter System | Predicate device | ||
| the 8F FlowGate2TM | |||
| Balloon Guide Catheter | Comparison | ||
| raise new questions | |||
| of safety and | |||
| efficacy, both | |||
| materials are used | |||
| for compliant | |||
| balloons for | |||
| intravascular use | |||
| Labeled Shaft Outer | |||
| Diameter | 0.110-in (max) | ||
| (2.79mm) | |||
| 8Fr | 0.106 in | ||
| (2.7mm) | |||
| 8Fr | Similar, minor | ||
| differences do not | |||
| raise new questions | |||
| of safety and | |||
| efficacy | |||
| Labelled Shaft Inner | |||
| Dimension | .087-in | ||
| (2.21mm) | |||
| 6.6Fr | 0.084-in | ||
| (2.11mm) | |||
| 6.4Fr | Similar, minor | ||
| differences do not | |||
| raise new questions | |||
| of safety and | |||
| efficacy | |||
| Effective length | 90, 95, 100 cm | ||
| (35.4, 37.4, 39.4 in) | 90cm, 100cm | ||
| (35.4, 39.4 in) | Same | ||
| Tip Shape | Straight | Straight | Same |
| Maximum Balloon | |||
| Volume | 0.6ml | 0.6ml | Same |
| Injection Port | Yes | Yes | Same |
| Radiopaque | Distal Tip has radiopaque | ||
| marker bands, stainless | |||
| steel reinforcement in the | |||
| catheter shaft renders the | |||
| shaft visible on | |||
| fluoroscopy | Distal Tip has a | ||
| radiopaque marker | |||
| band, stainless steel | |||
| reinforcement in the | |||
| catheter shaft renders | |||
| the shaft visible on | |||
| fluoroscopy | Same | ||
| Coating | Hydrophilic Coating – | ||
| Proximal to the balloon, | |||
| on the distal Portion | None | Difference does not | |
| raise new questions | |||
| of safety and | |||
| efficacy. | |||
| Hydrophilic | |||
| coatings are | |||
| commonly used to | |||
| lubricate vascular | |||
| catheters. Both | |||
| devices do not have | |||
| coating on the | |||
| balloon region | |||
| Internal Construction | Multi Lumen catheter | ||
| wall | Coaxial lumen | Differences do not | |
| raise new questions | |||
| of safety and | |||
| efficacy | |||
| Comparison Chart | |||
| Feature | Subject Device | ||
| 087 Balloon Guide | |||
| Catheter System | Predicate device | ||
| the 8F FlowGate2TM | |||
| Balloon Guide Catheter | Comparison | ||
| Reinforced Shaft | Stainless steel reinforced | ||
| shaft | Stainless steel | ||
| reinforced shaft | Same | ||
| Accessories Supplied | 3-Way Stopcock, Peel | ||
| Away Sheath, Hub | |||
| extension, 1ml Syringe | Dilator, Rotating | ||
| Hemostasis Valve, | |||
| Tuohy Borst Valve | |||
| with sideport, Peel | |||
| Away Sheaths, Luer- | |||
| Activated Valves | Similar, minor | ||
| differences do not | |||
| raise new questions | |||
| of safety and | |||
| efficacy. | |||
| How Supplied | Sterile, single use | Sterile, single use | Same |
| Sterilization Method | EtO | EtO | Same |
| Sterility Assurance | |||
| Level | 10-6 | 10-6 | Same |
| efficacy. Both | |||
| designs are intended | |||
| to create a pathway | |||
| to the side arm for | |||
| balloon inflation |
9
10
Conclusion:
Q'Apel Medical LLC concludes through a review of the benchtop assessments, the comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility that the 087 Balloon Guide Catheter System is substantially equivalent to the predicate device, the FlowGate2™ Balloon Guide Catheter. Any differences are minor and do not raise different questions of safety and effectiveness.