(29 days)
Not Found
No
The description focuses on the physical components and function of a catheter, with no mention of AI or ML capabilities.
No
The device is described as assisting in the placement of guide wires and delivery of contrast media, and exchanging guide wires, which are procedural aids rather than direct treatments for a disease or condition.
No
The device is described as a tool to facilitate the placement and exchange of guidewires and assist in the delivery of contrast media, which are interventional and delivery functions, not diagnostic.
No
The device description clearly outlines physical components like a distal tip, shaft tube, protector, and connector, indicating it is a hardware medical device.
Based on the provided information, the ASAHI Corsair Armet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the placement of guide wires and deliver contrast media in the peripheral vasculature. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a catheter-like device designed for insertion into blood vessels. This aligns with an in vivo medical device, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The ASAHI Corsair Armet's function is purely procedural and interventional within the body.
N/A
Intended Use / Indications for Use
The ASAHI Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature. This device should not be used in coronary vasculature or neurovasculature.
Product codes
DQY
Device Description
The ASAHI Corsair Armet consists of a distal tip, a shaft tube that is inserted into vasculature, a protector, and a connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of distal tip and the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair Armet has a tapered shape. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
The primary change in this Special 510(k) involves a minor change in the shape of the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Confirmatory non clinical laboratory testing was performed on the modified ASAHI Corsair Armet to determine substantial equivalence.
The following testing/assessments were performed:
- Appearance/Dimensions
- Corrosion Resistance
- Force at Break
- Liquid Leakage under Pressure
- Air Leakage
- Leak and Damage under High Static Pressure
- Radio-Detectability
- Torque Transmission
- Slide Durability
- Kink Resistance
- . Torque Durability
The in vitro bench tests demonstrated that the modified ASAHI Corsair Armet met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ASAHI Corsair Armet (K152249)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, with three profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June14, 2016
Asahi Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant Cardiomed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K161362
Trade/Device Name: Asahi Corsair Armet Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 13, 2016 Received: May 16, 2016
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
Kenneth J. Cavanaugh -S
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)
Device Name ASAHI Corsair Armet
Indications for Use (Describe)
The ASAHI Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature. This device should not be used in coronary vasculature or 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) |
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3
510(k) Summary
(as required by 21 CFR 807.92)
HI INTECC CO.LI 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
ASAHI Corsair Armet
510(k) _______________________________________________________________________________________________________________________________________________________________________
| DATE PREPARED: | May 13, 2016 |
|---|---|
| APPLICANT | Asahi Intecc Co., Ltd. |
| 1703 Wakita-cho, Moriyama-ku | |
| Nagoya, Aichi 463-0024, Japan | |
| CONTACT | Carroll Councilman, Sr. RA Manager |
| 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 Armet |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY – Catheter, Percutaneous |
| PREDICATE DEVICES: | ASAHI Corsair Armet (K152249) |
Intended Use/Indications for Use
The ASAHI Corsair Armet is intended to provide support to facilitate the placement of quide wires in the peripheral vasculature, and can be used to exchange one quide wire for another.
The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature.
This device should not be used in coronary vasculature or neurovasculature.
Device Description:
The ASAHI Corsair Armet consists of a distal tip, a shaft tube that is inserted into vasculature, a protector, and a connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the
4
outer surface of distal tip and the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair Armet has a tapered shape. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
The primary change in this Special 510(k) involves a minor change in the shape of the distal tip.
Comparison with Predicate Devices:
Comparisons of the modified ASAHI Corsair Armet to its predicate device show that the technological characteristics of the Subject device such as the product performance, intended use/indications, components, materials, sterilization method, shelf life, manufacturing process, and operating principle are identical to the currently marketed predicate devices. There are only minor dimensional variations between the Subject and predicate device.
| Name of Device | ASAHI Corsair Armet | ASAHI Corsair Armet |
|---|---|---|
| 510(k) | Current Application | K152249 |
| Intended Use and Indications | The ASAHI Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. | |
| The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature. | ||
| This device should not be used in coronary vasculature or neurovasculature. | ||
| Target Body Location | Peripheral | |
| Hydrophilic coating | Yes | |
| Effective Length | 600-1500 cm | |
| Nominal Outer Diameter | Distal : 0.75mm | |
| Proximal : 0.83 mm | ||
| Catheter Shaft Material | Polyamide-elastomer | |
| Distal Tip Length | 1.2mm | 2.0mm |
| Single Use | Yes | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 Years |
5
Non Clinical testing / Performance Data:
Confirmatory non clinical laboratory testing was performed on the modified ASAHI Corsair Armet to determine substantial equivalence.
The following testing/assessments were performed:
- Appearance/Dimensions
- Corrosion Resistance ●
- Force at Break
- Liquid Leakage under Pressure ●
- Air Leakage ●
- Leak and Damage under High Static Pressure ●
- Radio-Detectability ●
- Torque Transmission ●
- Slide Durability ●
- Kink Resistance ●
- . Torque Durability
The in vitro bench tests demonstrated that the modified ASAHI Corsair Armet met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.
BIOCOMPATIBILITY:
The modified ASAHI Corsair Armet was compared to the predicate device. Based on the identical materials and manufacturing process used in the subject device to its predicate, the biocompatibility of the modified ASAHI Corsair Armet was verified to be the same as those of the predicate.
CONCLUSION:
The modified ASAHI Corsair Armet 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 modified ASAHI Corsair Armet is substantially equivalent to the predicate device.