(250 days)
No reference devices were used in this submission.
No
The device description focuses on the physical components and materials of a catheter and its accessories. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device facilitates the introduction of diagnostic agents or therapeutic devices but is not itself a therapeutic device.
No
The device is a Distal Access Catheter, used to facilitate the introduction of diagnostic agents or therapeutic devices. It is a tool for accessing anatomical sites, not a diagnostic device itself.
No
The device description clearly details physical components such as a catheter, introducer sheath, hemostatic valve, and shaping mandrel, all made of various materials. It also describes manufacturing processes and packaging, indicating it is a physical medical device, not software-only.
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 for "general intravascular use, including the neuro and peripheral vasculature." It is used to "facilitate introduction of diagnostic agents or therapeutic devices." This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. It describes components like a lumen, reinforcement, coating, and radiopaque markers, all consistent with an invasive medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The device's function is mechanical and procedural.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.
Product codes
QJP, DQY
Device Description
The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.
The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively.
A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.
The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.
A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter.
The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neuro and peripheral 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)
Bench Testing and Sterility:
The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. The testing demonstrates that the in vitro behavior of the device is well characterized within design specifications.
Key results include:
- Surface Inspection: The surface integrity is suitable for intended clinical use.
- Surface Contamination: The surface integrity is suitable for intended clinical use.
- Dimensional Verification: The device met the dimensional and physical specifications.
- Distal Tip: Distal tip is suitable for intended clinical use.
- Radio Detectability: Device radiopacity is suitable for intended clinical use.
- Corrosion Resistance: Corrosion resistance is suitable for intended clinical use and met requirements of ISO 10555-1.
- Peak Tensile Force: Peak tensile force is suitable for intended clinical use and met requirements of ISO 10555-1.
- Fluid leakage at > 46 psi: Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Air Leakage: Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Guaging: The device hub met the requirements of ISO 80369-7.
- Separation Force: The device hub met the requirements of ISO 80369-7.
- Unscrewing Torque: The device hub met the requirements of ISO 80369-7.
- Stress Cracking: The device hub met the requirements of ISO 80369-7.
- Ease of Assembly: The device hub met the requirements of ISO 80369-7.
- Resistance to Overriding: The device hub met the requirements of ISO 80369-7.
- Particulate: The amount and size of particles from the subject device was comparable to the predicate device.
- Static Burst Pressure: Device integrity is suitable for intended clinical use and met requirements of ISO 10555-1.
- Lubricity and Durability: The device exhibits no coating cracking or separation, and is equivalent to the predicate device.
- Equipment Interface: The device is compatible with the accessories as specified.
- Tip Shapeability: Shapeability of the distal tip after steam shaping is equivalent to predicate device.
- Kink Resistance: The device is resistant to kinking around relevant radii turns.
- Simulated Use: Device performs as intended under simulated use conditions.
- Torque Response: Device torque response is equivalent to the predicate device.
- Torque Strength: Device torque strength is equivalent to the predicate device.
- Pushability/Retractability: Device pushability/retractability is equivalent to the predicate device.
- Catheter Stiffness: The catheter stiffness is equivalent to the predicate device.
- Catheter Flexural Fatigue: The catheter flexural fatigue is equivalent to the predicate device.
- Dynamic Burst: The device met the test acceptance criteria.
- Flow Rate: The device can withstand flow rates suitable for intended clinical use.
- Ethylene Oxide Residue: Ethylene Oxide Residue met the acceptance criteria per ISO 10993-7:2008.
- Sterility: Sterility of the catheter met the acceptance criteria per ISO 11135:2014.
- Bacterial Endotoxins: Bacterial endotoxins met the acceptance criteria per USP .
Biocompatibility:
The biocompatibility evaluation for the Distal Access Catheter was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58.
Key results include:
- Cytotoxicity Test (ISO 10993-5): Non-cytotoxic.
- Skin Sensitization Test (ISO 10993-10): No significant evidence of skin sensitization.
- Intracutaneous Reactivity Test (ISO 10993-10): Non-irritant.
- Acute Systemic Toxicity Test (ISO 10993-11) Intravenous: No significant evidence of systemic toxicity.
- Acute Systemic Toxicity Test (ISO 10993-11) Intraperitoneal: No significant evidence of systemic toxicity.
- Hemolytic Properties Test (ASTM F756): No influence on hemolytic properties.
- Partial Thromboplastin Time (PTT) Test (ISO 10993-4): No effect on PTT.
- In Vivo Thrombogenicity Test (ISO 10993-4): Equivalent to the control article.
- Pyrogen Test (ISO 10993-11): Non-pyrogenic.
- Complement Activity (C3a, SC5b-9) Test (ISO 10993-4): Equivalent to the negative control group.
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.
No reference devices were used in this submission.
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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2022
Guangzhou Easycess Medical Co., Ltd Xingcheng Liu Manager of Registration Affairs Department Room 701, Building B4, 11 Kaiyuan Avenue, Huangpu District, Guangzhou. 510530 China
Re: K213065
Trade/Device Name: Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: April 28, 2022 Received: May 5, 2022
Dear Xingcheng Liu:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Naira Muradyan, 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) K213065
Device Name Distal Access Catheter
Indications for Use (Describe)
The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.
| Type of Use (Select one or both, as applicable) |
|---|
| Option 1 |
| Option 2 |
X 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 K213065
I. SUBMITTER
Guangzhou Easycess Medical Co., Ltd Room 701, Building B4, 11 Kaiyuan Avenue, Huangpu District, Guangzhou, China, 510530 Phone: 020-31603990 Fax: 020-31603675 Contact Person: Xingcheng Liu Date of Preparation: May 30th, 2022
II. DEVICE
Name of Device: Distal Access Catheter Common or Usual Name: Distal Access Catheter Classification Name: Percutaneous catheter (21 CFR 870.1250) Regulatory Class: II Product Code: QJP, DQY
III. PREDICATE DEVICE
Primary predicate device: SOFIA PLUS/Distal Access Catheter (K150366) Secondary predicate device: SOFIA Distal Access Catheter (K131482, K142014) These predicate devices have not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.
The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively.
A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal
4
end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.
The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.
A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter.
The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.
V. INDICATIONS FOR USE
The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH
THE PREDICATE DEVICE
Technological Comparison:
| Device name | | SOFIA PLUS/Distal
Access Catheter
(K150366, Primary
predicate device) | SOFIA Distal Access
Catheter
(K131482, K142014,
Secondary predicate
device) | Distal Access Catheter
(K213065, Subject
device) |
|-------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | The SOFIA PLUS
/Distal Access Catheters
are indicated for general
intravascular use,
including the neuro and
peripheral vasculature.
It can be used to
facilitate introduction of
diagnostic and
therapeutic agents. It is
not intended for use in
coronary arteries. | The SOFIA Distal
Access Catheter is
intended for general
intravascular use,
including the neuro
and peripheral
vasculature. It can be
used to facilitate the
introduction of
diagnostic and
therapeutic agents. It is
not intended for use in
coronary arteries. | The Distal Access
Catheter is indicated
for general
intravascular use,
including the neuro and
peripheral vasculature.
It can be used to
facilitate introduction
of diagnostic agents or
therapeutic devices. It
is not intended for use in
coronary arteries. |
| | Catheter
inner layer | PTFE, polyolefin
elastomer | PTFE, polyolefin
elastomer | PTFE |
| Material | Catheter
middle
layer | Stainless steel braid/coil | Stainless steel
braid/coil | Same |
| | Catheter
outer layer | Polyurethane elastomer,
polyether block amide
(Pebax) and polyamide | Polyurethane
elastomer, polyether
block amide (Pebax)
and polyamide | Same |
| | Marker | Platinum/Iridium | Platinum/Iridium | Same |
| | Hub | Nylon | Nylon | PC |
| Device name | | SOFIA PLUS/Distal Access Catheter
(K150366, Primary predicate device) | SOFIA Distal Access Catheter
(K131482, K142014, Secondary predicate device) | Distal Access Catheter
(K213065, Subject device) |
| Strain Relief | | Polyurethane | Polyurethane | Pebax |
| Introducer | | Pebax | Pebax | PTFE |
| Shaping Mandrel | | Stainless steel | Stainless steel | Same |
| Hemostatic Valve | | Not applicable | Not applicable | PC |
| Catheter Size | | 6F | 5F | 5F 6F |
| Inner Diameter (ID) | | 0.070 inch (1.78 mm) | 0.055 inch (1.4 mm) | 5F: 0.056" (1.42mm)
6F: 0.071" (1.80mm) |
| Outer Diameter (OD) | | 0.0825 inch (2.1 mm) | 0.068 inch (1.7 mm) | 5F: 0.068" (1.73mm)
6F: 0.083" (2.11mm) |
| Effective Length | | 115-135 cm | 115-125 cm | 115-135cm |
| Coating | | Hydrophilic coating
(Hydak®) | Hydrophilic coating
(Hydak®) | Hydrophilic coating (Polyamide) |
| Tip Configuration | | Steam shapeable by user | Steam shapeable by user | Same |
| Guidewire Compatibility | | 0.035 inch | 0.035 inch or 0.038 inch | 0.035 inch |
| Accessories | | Introducer sheath and shaping mandrel | Introducer sheath and shaping mandrel | Introducer sheath, shaping mandrel and hemostatic valve |
| Method of Supply | | Sterile and single use | Sterile and single use | Same |
| Sterilization Method | | Ethylene Oxide | Ethylene Oxide | Same |
| Packaging Configuration | | Catheter placed into a HDPE dispenser tube.
Dispenser tube, introducer and shaping mandrel placed on a polyethylene packaging card that is
inserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box. | Catheter placed into a HDPE dispenser tube.
Dispenser tube, introducer and shaping mandrel
placed on a polyethylene packaging card that is
inserted into a Tyvek® pouch. Pouch and IFU placed in bleached sulfate carton box. | Catheter placed into a HDPE dispenser tube.
Dispenser tube, introducer, shaping mandrel and hemostatic valve
placed on a polyethylene packaging card that is
inserted into a Tyvek/PE/PET pouch.
Pouch and IFU placed in bleached sulfate carton box. |
5
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
. Bench Testing and Sterility
The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. The testing demonstrates that the in vitro behavior of the device is well characterized within design specifications. The results of bench testing and sterility
6
evaluation are listed in the table below:
| Test | Specification | Conclusion |
|---|---|---|
| Surface | ||
| Inspection | The external surface of the catheter shall be free | |
| from extraneous matter. The external surface of | ||
| the catheter, including the distal end, shall be | ||
| free from process and surface defects which | ||
| could cause trauma to vessels during use. | The surface integrity is | |
| suitable for intended clinical | ||
| use. | ||
| Surface | ||
| Contamination | The test article shall be free from surface | |
| contaminants from uncured coating surface | ||
| particulates > 0.02 mm², embedded particulates. | ||
| The distal tip shall be smooth and tapered. PTFE | ||
| inner layer not delaminated. | The surface integrity is | |
| suitable for intended clinical | ||
| use. | ||
| Dimensional | ||
| Verification | The device shall meet the specified dimensional | |
| requirements, including catheter OD, catheter | ||
| ID, effective length, length of distal tip and total | ||
| length of accessories. | The device met the | |
| dimensional and physical | ||
| specifications. | ||
| Distal Tip | The distal tip shall be smooth, rounded, tapered, | |
| or similarly finished to minimize trauma to | ||
| vessels during use. | Distal tip is suitable for | |
| intended clinical use. | ||
| Radio | ||
| Detectability | The tip of the catheter should be visible under | |
| fluoroscopy. | Device radiopacity is suitable | |
| for intended clinical use. | ||
| Corrosion | ||
| Resistance | Metallic components of the catheter intended for | |
| fluid path contact shall show no signs of | ||
| corrosion. | Corrosion resistance is suitable | |
| for intended clinical use and | ||
| met requirements of ISO | ||
| 10555-1. | ||
| Peak Tensile | ||
| Force | 6F Catheter force at break ≥15N for distal | |
| section and hub/catheter junction. | ||
| 5F Catheter force at break ≥10N for distal | ||
| section and hub/catheter junction. | Peak tensile force is suitable | |
| for intended clinical use and | ||
| met requirements of ISO | ||
| 10555-1. | ||
| Fluid leakage | ||
| at > 46 psi | No liquid leakage from hub and catheter shaft at | |
| 46 psi for 30 seconds. | Device integrity is suitable for | |
| intended clinical use and met | ||
| requirements of ISO 10555-1. | ||
| Air Leakage | No air leakage at hub into syringe when negative | |
| pressure was applied for 15 seconds. | Device integrity is suitable for | |
| intended clinical use and met | ||
| requirements of ISO 10555-1. | ||
| Guaging | The plane of the maximum diameter at the | |
| opening of the female conical fitting shall lie | ||
| between the two limit planes of the gauge. | The device hub met the | |
| requirements of ISO 80369-7. | ||
| Separation | ||
| Force | The mating parts separation force is greater than | |
| 35 N. | The device hub met the | |
| requirements of ISO 80369-7. | ||
| Unscrewing | ||
| Torque | Test article luer remains attached after applying | |
| an unscrewing torque not less than 0.02 N·m for | ||
| a minimum of 10 seconds. | The device hub met the | |
| requirements of ISO 80369-7. | ||
| Stress | ||
| Cracking | No stress cracks on the test article hub. | The device hub met the |
| requirements of ISO 80369-7. | ||
| Ease | ||
| of | ||
| Assembly | Components fit together securely with no | |
| resistance observed between the test article luer | ||
| and reference fitting. | The device hub met the | |
| requirements of ISO 80369-7. | ||
| Resistance to | ||
| Overriding | Test article luer does not override reference | |
| fitting threads. | The device hub met the | |
| requirements of ISO 80369-7. | ||
| Particulate | The amount of particulate matter that comes off | |
| the device during simulated use testing shall be | ||
| determined and compared to the predicate | ||
| device. | The amount and size of | |
| particles from the subject | ||
| device was comparable to the | ||
| predicate device. | ||
| Static | ||
| Burst | ||
| Pressure | The catheter was tested to evaluate the burst | |
| pressure under static conditions per ISO 10555- | ||
| 1:2013(E) Annex F. | Device integrity is suitable for | |
| intended clinical use and met | ||
| requirements of ISO 10555-1. | ||
| Lubricity and | ||
| Durability | tester. The frictional force shall be equivalent to | |
| the predicate device and be less than 0.3N. | coating cracking or separation, | |
| and is equivalent to the | ||
| predicate device. | ||
| Equipment | ||
| Interface | The catheter shall be compatible with 0.035" | |
| guidewire, ≥ 0.088" ID guide catheter/ | ||
| introducer sheath, ≤ 0.027" OD microcatheters, | ||
| and common hemostatic valve. | The device is compatible with | |
| the accessories as specified. | ||
| Tip | ||
| Shapeability | The distal tip should be steam shapeable and | |
| equivalent to the predicate devices. | Shapeability of the distal tip | |
| after steam shaping is | ||
| equivalent to predicate device. | ||
| Kink | ||
| Resistance | No kinks when wrapped around pin gauges of | |
| clinical use relevant radii. | ||
| No kinks noted during simulated use testing. | ||
| Shall be equivalent to the predicate devices. | The device is resistant to | |
| kinking around relevant radii | ||
| turns. | ||
| Simulated Use | The catheter should reach various target | |
| locations in the tortuous vessel model; the | ||
| catheter could be delivered and retracted | ||
| smoothly with a 0.035" guidewire in the model; | ||
| no device damage or defects after simulated use. | Device performs as intended | |
| under simulated use | ||
| conditions. | ||
| Torque | ||
| Response | The torque response of the catheter should be no | |
| worse than the predicate device. | Device torque response is | |
| equivalent to the predicate | ||
| device. | ||
| Torque | ||
| Strength | No catheter breakage after 50 rotations. | Device torque strength is |
| equivalent to the predicate | ||
| device. | ||
| Pushability/ | ||
| Retractability | The pushability/retractability of the catheter in | |
| the tortuous vessel model shall be not worse than | ||
| the predicate device. | Device pushability/ | |
| retractability is equivalent to | ||
| the predicate device. | ||
| Catheter | ||
| Stiffness | The catheter stiffness shall be equivalent to the | |
| predicate devices. | The catheter stiffness is | |
| equivalent to the predicate | ||
| device. | ||
| Catheter | ||
| Flexural | ||
| Fatigue | No flexural fatigue following repeated bending | |
| during simulated use testing and repeated hoop | ||
| stress following pressure and air aspiration | ||
| testing. | The catheter flexural fatigue is | |
| equivalent to the predicate | ||
| device. | ||
| Dynamic | ||
| Burst | The catheter shall not burst under dynamic | |
| pressure of 300 psi for 30 seconds. | The device met the test | |
| acceptance criteria. | ||
| Flow Rate | The catheter should withstand manual injection | |
| of contrast media and saline at the clinically | ||
| relevant flow rates. | The device can withstand flow | |
| rates suitable for intended | ||
| clinical use. | ||
| Ethylene | ||
| Oxide Residue | The residual amount of ethylene oxide in a | |
| single package should not exceed 10µg/g. | Ethylene Oxide Residue met | |
| the acceptance criteria per ISO | ||
| 10993-7:2008. | ||
| Sterility | The product shall be sterile. | Sterility of the catheter met the |
| acceptance criteria per ISO | ||
| 11135:2014. | ||
| Bacterial | ||
| Endotoxins | Endotoxin content shall not be greater than 2.15 | |
| EU/ kit. | Bacterial endotoxins | |
| met | ||
| the acceptance criteria per USP |
|
| Biocompatibility Test | Result | Conclusion |
| Cytotoxicity Test (ISO 10993-5)
MTT Method, MEM with 10% FBS extract | The cell viability of 100%
test article extract was
95.5%. | Non-cytotoxic |
| Skin Sensitization Test (ISO 10993-10)
Guinea Pig Maximization Test, 0.9% Sodium
Chloride Injection Extract and Sesame Oil
Extract | The positive rate of the test
article was 0%. | No significant
evidence of skin
sensitization |
| Intracutaneous Reactivity Test (ISO 10993-
10)
0.9% Sodium Chloride Injection Extract and
Sesame Oil Extract | The final test article score
was calculated to be 0. | Non-irritant |
| Acute Systemic Toxicity Test (ISO 10993-11)
Intravenous 0.9% Sodium Chloride Injection
Extract and Sesame Oil Extract | Body weight data were
acceptable and equivalent
between the corresponding
test and control treatment
groups. | No significant
evidence of
systemic
toxicity |
| Acute Systemic Toxicity Test (ISO 10993-11)
Intraperitoneal Sesame Oil Extract | Body weight data were
acceptable and equivalent
between the corresponding
test and control treatment
groups. | No significant
evidence of
systemic
toxicity |
| Hemolytic Properties Test (ASTM F756)
Direct and Extract Contact Method Rabbit
Blood | The hemolysis index was
0.44% (direct contact) and
0.00 (indirect contact). | No influence on
hemolytic
properties |
| Partial Thromboplastin Time (PTT) Test (ISO
10993-4)
In vitro Human Blood | No significant differences
between the sample group
and the negative group. | No effect on
PTT |
| In Vivo Thrombogenicity Test (ISO 10993-4)
Non-anticoagulated venous implant (NAVI)
Model | No significant differences
between the test and control
articles. | Equivalent to
the control
article |
| Pyrogen Test (ISO 10993-11)
0.9% Sodium Chloride Injection Extract Rabbit | No rabbit shows an
individual rise in temperature
of 0.5 °C or more. | Non-pyrogenic |
| Complement Activity (C3a, SC5b-9) Test (ISO
10993-4)
In vitro Test | No significant difference
between the sample group
and negative control group. | Equivalent to
the negative
control group |
7
• Г Biocompatibility
The biocompatibility evaluation for the Distal Access Catheter was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58. The results of testing are listed in the table below:
8
VIII. CONCLUSIONS
The data presented in this submission demonstrate the technological similarity and substantial equivalence of the Distal Access Catheter when compared with the predicate devices SOFIA PLUS/Distal Access Catheter(K150366) and SOFIA Distal Access Catheter (K131482, K142014).
The subject and predicate devices,
- . have the same indications for use,
- . use the same operating principle,
- . incorporate the same basic design,
- . are packaged and sterilized using similar materials and processes.
In summary, the Distal Access Catheter described in this submission is substantially equivalent to the predicate devices.