(231 days)
No
The description focuses on the physical components and materials of a guide catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guide catheter used to facilitate the delivery of other interventional devices for neurovascular therapy, rather than providing therapy itself.
No
The device is a guide catheter designed to facilitate the delivery of interventional devices and contrast media, not to diagnose a condition.
No
The device description clearly outlines physical components made of polymer resin, stainless steel, tungsten, and PTFE, indicating it is a hardware device (catheter and dilator kit). There is no mention of software as a component or the primary function.
Based on the provided text, 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 guide interventional devices and for injection of contrast media within the neurovasculature. This is a direct intervention on the patient's body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes:
| Product Name | Outer diameter of Catheter |
|---|---|
| ASAHI FUBUKI 043 | 4.2 Fr |
| ASAHI FUBUKI 6Fr | 6 Fr |
| ASAHI FUBUKI 7Fr | 7 Fr |
| ASAHI FUBUKI 8Fr | 8 Fr |
The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes:
| Product Name | Outer diameter of Catheter | Outer diameter of Dilator Shaft (mm) |
|---|---|---|
| ASAHI FUBUKI Dilator Kit 4Fr | 6 Fr | 1.75 |
| ASAHI FUBUKI Dilator Kit 5Fr | 7 Fr | 2.00 |
| ASAHI FUBUKI Dilator Kit 6Fr | 8 Fr | 2.21 |
The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter.
The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non clinical laboratory testing was performed on the ASAHI FUBUKI 043 and ASAHI FUBUKI to determine substantial equivalence. The following testing and assessments were performed:
- Corrosion resistance
- Force at break
- Liquid leakage under pressure
- Air leakage into hub assembly during aspiration
- Leak and damage under high static pressure
- Radio-detectability
- Kink resistance
- Appearance/Dimensions
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2015
Asahi Intecc Co., Ltd. % Mr. H. Semih Oktay President CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228
Re: K141981
Trade/Device Name: ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 5, 2015 Received: February 6, 2015
Dear Mr. Oktay,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S 同公
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141981
Device Name ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters
Indications for Use (Describe)
The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for ASAHI INTECC CO., LTD. The logo features a stylized red "A" symbol on the left, followed by the company name in dark teal. The text is in a clear, sans-serif font, making it easily readable. The logo appears to be professionally designed and conveys a sense of corporate identity.
1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.+81-52-768-1211 Fax.+81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi
510(k) Summary [as required by 21 CFR 807.92(c)]
ASAHI FUBUKI 043 and ASAHI FUBUKI
510(k) K141981
| APPLICANT | Asahi Intecc Co., Ltd.
1703 Wakita-cho, Moriyama-ku
Nagoya, Aichi 463-0024
Japan |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Yoshi Terai
President, CEO
Asahi Intecc USA, Inc.
2500 Red Hill Avenue, Suite 210
Santa Ana, CA 92705
Tel: (949) 756-8252
FAX: (949) 756-8165
e-mail: asahi.ra-fda@asahi-intecc.com |
| TRADE NAMES: | ASAHI FUBUKI 043
ASAHI FUBUKI |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION
NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY |
| PREDICATE
DEVICES: | K090335, HD Guide Catheter
K962362, Envoy Guide Catheter
K980453, GUIDER Softip Guiding Catheter |
| REFERENCE
DEVICES: | K083127, Asahi Corsair Microcatheter
K132556, SheathLess Eaucath Coronary Guide Catheter
K061601, Precious Guide Catheter |
| DATE PREPARED: | February 5th , 2015 |
4
INDICATION FOR USE/INTENDED USE:
ASAHI FUBUKI Intended Use:
This product is intended to be used to guide interventional devices for Neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the Neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this product other than for use in the Neurovasculature.
ASAHI FUBUKI 043 Intended Use:
This catheter is intended to be used to guide interventional devices for Neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular procedure in the Neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this catheter other than for use in the Neurovasculature.
DESCRIPTION:
ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes:
| Product Name | Outer diameter of Catheter |
|---|---|
| ASAHI FUBUKI 043 | 4.2 Fr |
| ASAHI FUBUKI 6Fr | 6 Fr |
| ASAHI FUBUKI 7Fr | 7 Fr |
| ASAHI FUBUKI 8Fr | 8 Fr |
The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes:
| Product Name | Outer diameter of Catheter | Outer diameter of Dilator Shaft (mm) |
|---|---|---|
| ASAHI FUBUKI Dilator Kit 4Fr | 6 Fr | 1.75 |
| ASAHI FUBUKI Dilator Kit 5Fr | 7 Fr | 2.00 |
| ASAHI FUBUKI Dilator Kit 6Fr | 8 Fr | 2.21 |
The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter.
The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.
5
COMPARISON TABLE WITH PREDICATE DEVICES:
Comparisons of the ASAHI FUBUKI 043 and ASAHI FUBUKI with the predicate devices show that the technological characteristics of the ASAHI FUBUKI 043 AND ASAHI FUBUKI such as the intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate devices. A comparison of the ASAHI FUBKI 043 and the ASAHI FUBUKI to the predicate devices is provided in the table below.
| Device Name | ASAHI
FUBUKI 043 | ASAHI
FUBUKI | HD Guide
Catheter | Envoy | GUIDER
Softip
Guiding
Catheter | Device Name
Comparison
Criteria | ASAHI
FUBUKI 043 | ASAHI
FUBUKI | HD Guide
Catheter | Envoy | GUIDER
Softip
Guiding
Catheter |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------|---------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Comparison
Criteria | | | | | | Tip Shape | Straight | Straight
Angled | Unknown | Straight
Multipurpose
C
Multipurpose
D
Modified
Cerebral
(Burke)
Headhunter 1
Simmons 2 | 40° Angle
Multipurpose
Straight |
| Manufacturer | ASAHI INTECC
CO., LTD. | ASAHI INTECC
CO., LTD. | Concentric | Cordis | Schneider | Primary
catheter
material | Polyurethane
Polyamide | Polyurethane
Polyamide | Polyamide
elastomer | Nylon
Polyurethane | Unknown |
| Indications for
Use | This catheter is
intended to be used to
guide interventional
devices for
Neurovascular
therapy to a lesion or
a procedural site for a
percutaneous
intravascular
procedure in the
Neurovasculature.
This catheter is also
intended to be used
for injection of
contrast media.
Do not use this
catheter other than
for use in the
Neurovasculature. | This product is
intended to be used
to guide
interventional
devices for
Neurovascular
therapy to a lesion
or a procedural site
for a percutaneous
intravascular
procedure in the
Neurovasculature.
This catheter is also
intended to be used
for injection of
contrast media.
Do not use this
product other than
for use in the
Neurovasculature. | The HD Guide
Catheter is
indicated for use in
facilitating the
insertion and
guidance of an
occlusion catheter,
infusion catheter or
other appropriate
microcatheter into
a selected blood
vessel in the
peripheral,
coronary and
neurovascular
systems. It may
also be used as a
diagnostic
angiographic
catheter. | The Envoy
Guiding
Catheter is
intended to
use in the
peripheral,
coronary and
neurovasculat
ure for the
intravascular
introduction
of
interventional
/ diagnostic
devices. | The SCHNEIDER
GUIDER Softip
Guiding Catheter
are designed for
introduction of
interventional
devices. They are
intended to
facilitate the
placement of
interventional
devices into the
peripheral and
coronary systems
and, in additional
for the XF models,
into the
neurovascular
system. | Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene
Oxide | Ethylene Oxide |
| Labeled Shaft
Outer
Diameter | 4.2 Fr | 6Fr, 7Fr, 8 Fr | 3.9Fr - 5.2 Fr | 5Fr, 6Fr | 5Fr, 6 Fr, 7 Fr, 8
Fr, 9 Fr | | | | | | |
| Inner Diameter | 4.2 Fr : 1.10mm
(0.043 in) | 6Fr : 1.80mm
(0.071 in)
7Fr : 2.05mm
(0.081 in)
8Fr : 2.28mm
(0.090 in) | Not Provided | 5Fr : 1.4mm
(0.056 in)
6Fr : 1.8mm
(0.070 in) | 5 Fr : 1.35mm
(0.053 in)
6 Fr : 1.63mm
(0.064 in)
7 Fr : 1.85mm
(0.073 in)
8 Fr : 2.18 mm
(0.086 in)
9 Fr : 2.51mm
(0.099 in) | | | | | | |
| Catheter
Effective
Length | 1200mm - 1300mm | 800mm - 1100mm | 1150mm -
1360mm | 900, 1000mm | 900, 1000mm | | | | | | |
6
NON CLINICAL TESTING / PERFORMANCE DATA:
Non clinical laboratory testing was performed on the ASAHI FUBUKI 043 and ASAHI FUBUKI to determine substantial equivalence. The following testing and assessments were performed:
- Corrosion resistance ●
- Force at break
- Liquid leakage under pressure ●
- Air leakage into hub assembly during aspiration
- Leak and damage under high static pressure ●
- Radio-detectability
- Kink resistance ●
- Appearance/Dimensions .
BIOCOMPATIBILITY:
7
The ASAHI FUBUKI 043 and ASAHI FUBUKI was compared to the predicate devices. Based on similariites of the materials used in the subject devcie to its predicates, the biocompatibiity of the ASAHI FUBUKI 043 and ASAHI FUBUKI was verified to be the same as those of the predicates.
CONCLUSION:
The ASAHI FUBUKI 043 and ASAHI FUBUKI has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices.
Therefore, the ASAHI FUBUKI 043 and ASAHI FUBUKI are substantially equivalent to the predicate devices.