(260 days)
Not Found
No
The device description and intended use focus on the mechanical function of a microcatheter for guidewire placement and delivery of agents. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The "Intended Use" section states that the device is intended to assist in the delivery of "therapeutic agents, such as occlusion coils" into the vasculature.
No
The device is primarily intended to provide support for guide wire placement and for the delivery of diagnostic and therapeutic agents, not to perform diagnosis itself.
No
The device description clearly outlines physical components like a catheter, tubes, connectors, and a radiopaque marker, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) to facilitate procedures in the coronary and peripheral vasculature. It's about delivering wires, agents, and coils directly into blood vessels.
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a person's health. This device does not perform any such analysis of specimens.
The ASAHI Stride Microcatheter is a medical device used for interventional procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ASAHI Stride Microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature and can be used to exchange one guidewire for another. The Asahi Stride Microcatheter is also intended to assist in the delivery of diagnostic agents, such as contrast media and therapeutic agents, such as occlusion coils into the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
Asahi Stride Microcatheter consists of catheter (soft tip tube and shaft tube), protector tube, strain relief, hub connector, and radiopaque marker in the soft tip tube. The proximal shaft is reinforced with a stainless steel braid wire to enhance pushability. The device is provided in a 2.2 Fr size with lengths ranging from 105 cm to 150 cm. The device also comes with both straight and angled tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary 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)
This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI Stride Microcatheter performs as intended.
Bench testing demonstrates that the device functions as intended.
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.
Boston Scientific Tracker Excel - 14 (K050599), Cordis Transit/Rapid Transit/Spedster/Prowler (K972518), ASHAI Tomus Support Catheter (K051772)
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
X 062885
JUN 1 8 2007
9.0 510(K) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Asahi Intecc Co., Ltd. APPLICANT 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan OFFICIAL Yoshi Terai Correspondent President, CEO Asahi Intecc USA. Inc. 1301 Dove Street, Suite 350 Newport Beach, CA 92660 Tel: (949) 756-8252 FAX (949) 756-8165 e-mail: yoshi@asahi-intecc.com Trade Name: Stride Microcatheter COMMON NAME: Microcatheter Classification NAME: . Percutaneous Catheter DEVICE Class 2 per 21 CFR §870.1250 CLASSIFICATION: PRODUCT CODE DQY PREDICATE DEVICE: Boston Scientific Tracker Excel - 14 (K050599) Cordis Transit/Rapid Transit/Spedster/Prowler (K972518) ASHAI Tomus Support Catheter (K051772)
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
Asahi Stride Microcatheter consists of catheter (soft tip tube and shaft tube), protector tube, strain relief, hub connector, and radiopaque marker in the soft tip tube. The proximal shaft is reinforced with a stainless steel braid wire to enhance pushability. The device is provided in a 2.2 Fr size with lengths ranging from 105 cm to 150 cm. The device also comes with both straight and angled tips.
Indication for Use:
The ASAHI Stride Microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculature and can be used to exchange one guidewire for another. The Asahi Stride Microcatheter is also intended to assist in the delivery of diagnostic agents, such as contrast media and therapeutic agents, such as occlusion coils into the coronary and peripheral vasculature.
1
TECHNICAL CHARACTERISTICS:
The ASAHI Stride Microcatheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.
.
Performance Data:
ತಿ.
All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device. This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI Stride Microcatheter performs as intended.
SUMMARY/CONCLUSION:
The ASAHI Stride Microcatheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.
Bench testing demonstrates that the device functions as intended.
2
Public Health Service
U
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asahi Intecc USA, Inc. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660
JUN 1 8 2007
Re: K062885 Stride Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DQY Dated: March 20, 2007 Received: March 30, 2007
Dear Mr. Terai:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Yoshi Terai
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely wours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 INDICATIONS FOR USE STATEMENT
11062885 510(k) Number (if known): _
Device Name: Stride Microcatheter
Indications for Use:
The ASAHI Stride Microcatheter is intended to provide support to facilitate the placement of quide wires in the coronary and peripheral vasculature and can be used to exchange one guidewire for another. The Asahi Stride Microcatheter is also intended to assist in the delivery of diagnostic agents, such as contrast media and therapeutic agents, such as occlusion coils into the coronary and peripheral vasculature.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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CONFIDENTIAL Asahi Intecc September 12, 2006
NEEDED)
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