(60 days)
No
The description focuses on the physical construction and materials of a microcatheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates placement of guide wires and delivery of contrast media, but does not directly treat a disease or condition.
No
The ASAHI Corsair Microcatheter is explicitly stated to "provide support to facilitate the placement of Guide wires" and "assist in the delivery of contrast media." These are interventional and delivery functions, not diagnostic; it does not analyze or interpret biological data to determine a medical condition or disease.
No
The device description clearly details physical components such as a distal tip, shaft tube, radiopaque marker coil, hydrophilic coating, and reinforcing wires, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- ASAHI Corsair Microcatheter Function: The description clearly states the device's purpose is to facilitate the placement of guide wires, exchange guide wires, and assist in the delivery of contrast media within the body (coronary, peripheral, and abdominal vasculatures). It is an interventional device used directly on the patient.
- No Specimen Analysis: There is no mention of the device being used to analyze any specimens taken from the body.
Therefore, based on the provided information, the ASAHI Corsair Microcatheter is a medical device used for interventional procedures within the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ASAHI Corsair Microcatheter is intended to provide support to facilitate the placement of Guide wires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculatures.
Product codes (comma separated list FDA assigned to the subject device)
DOY, DQY
Device Description
The ASAHI Corsair Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculatures, abdominal vasculatures
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 Corsair Microcatheter to determine substantial equivalence. Torque durability testing was conducted to ensure that the shorter length of the ASAHI Corsair Microcatheter maintained the torque durability within the acceptance criteria. Coating integrity/peel testing confirmed equivalent performance of the Subject device as compared to its predicate. Confirmatory biocompatibility testing was done to ensure that the minor modifications to the coating materials had no negative impact upon biocompatibility of the device.
The in vitro bench test demonstrated that the ASAHI Corsair Microcatheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the Subject device functions as intended and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2015
ASAHI Intecc Co., Ltd. % Ms. Candace Cederman Senior Regulatory Affairs Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, Maryland 21228
Re: K151103
Trade/Device Name: ASAHI Corsair Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: April 23, 2015 Received: April 24, 2015
Dear Ms. Cederman:
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
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
M.A. Hillebrand
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151103
Device Name ASAHI Corsair Microcatheter
Indications for Use (Describe)
The ASAHI Corsair Microcatheter is intended to provide support to facilitate the placement of Guide wires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculatures.
| 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
/akita-cho, Moriyama-ku, Nagoya, Aichi 463 1703 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 Corsair Microcatheter 510(k) K151103
| DATE PREPARED: | April 29, 2015 |
|---|---|
| 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 NAME: | ASAHI Corsair Microcatheter |
| DEVICE | |
| CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION | |
| NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY |
| PREDICATE | |
| DEVICE: | ASAHI Corsair Microcatheter (K083127) |
INTENDED USE/INDICATIONS FOR USE
The ASAHI Corsair Microcatheter is intended to provide support to facilitate the placement of Guide wires in the coronary and peripheral vasculatures and can be used to exchange one guide
4
wire for another. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral, and abdominal vasculatures.
DESCRIPTION:
The ASAHI Corsair Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the ASAHI Corsair Microcatheter and predicate device show that the technological characteristics of the Subject device such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to currently marketed predicate devices. The addition of a shorter length catheter does not raise any new questions of safety or effectiveness.
| Name of Device | ASAHI Corsair Microcatheter | ASAHI Corsair Microcatheter |
|---|---|---|
| 510(k) | Current Application | K083127 |
| Indications for Use | The ASAHI Corsair Microcatheter | |
| is intended to provide support to | ||
| facilitate the placement of Guide | ||
| wires in the coronary and peripheral | ||
| vasculatures and can be used to | ||
| exchange one guide wire for | ||
| another. The Corsair Microcatheter | ||
| is also intended to assist in the | ||
| delivery of contrast media into the | ||
| coronary, peripheral, and abdominal | ||
| vasculatures. | The ASAHI Corsair Microcatheter | |
| is intended to provide support to | ||
| facilitate the placement of Guide | ||
| wires in the coronary and peripheral | ||
| vasculatures and can be used to | ||
| exchange one guide wire for | ||
| another. The Corsair Microcatheter | ||
| is also intended to assist in the | ||
| delivery of contrast media into the | ||
| coronary, peripheral, and abdominal | ||
| vasculatures. | ||
| Sterilization | Provided sterile via Ethylene Oxide | |
| to SAL10-6 | Provided sterile via Ethylene Oxide | |
| to SAL10-6 | ||
| Shelf Life | 2 Years | 2 Years |
| Overall Length | 90 cm / 135 cm/ 150 cm | 135 cm/ 150 cm |
| Nominal OD | 0.93 mm | 0.93 mm |
| Coating Length | 600 mm | 600 mm |
| Coating material | Hydrophilic | Hydrophilic |
The intended use/indications between the Subject Device and its primary predicate are identical.
5
NON CLINICAL TESTING / PERFORMANCE DATA:
Non clinical laboratory testing was performed on the ASAHI Corsair Microcatheter to determine substantial equivalence. Torque durability testing was conducted to ensure that the shorter length of the ASAHI Corsair Microcatheter maintained the torque durability within the acceptance criteria. Coating integrity/peel testing confirmed equivalent performance of the Subject device as compared to its predicate. Confirmatory biocompatibility testing was done to ensure that the minor modifications to the coating materials had no negative impact upon biocompatibility of the device.
The in vitro bench test demonstrated that the ASAHI Corsair Microcatheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the Subject device functions as intended and is substantially equivalent to the predicate device.
BIOCOMPATIBILITY:
The ASAHI Corsair Microcatheter was compared to the predicate and reference devices. The ratios of the coating material were modified slightly from the ASAHI Corsair Microcatheter predicate but are the same as used on the reference ASAHI Fubuki (K141981). Confirmatory testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity (acute), and hemocompatibility) supports that the modifications to the coating material continue to render the device biocompatible.
CONCLUSION:
The ASAHI Corsair Microcatheter has identical intended use and the same or 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.
Therefore, the ASAHI Corsair Microcatheter is substantially equivalent to the predicate device.