(207 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a catheter, with no mention of AI or ML.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is described as assisting in procedures (placement of guide wires, delivery of contrast media), rather than directly treating a medical condition.
No
Explanation: The device is intended to facilitate the physical placement of guide wires and delivery of contrast media, not to diagnose medical conditions.
No
The device description clearly outlines physical components like a distal tip, shaft tube, protector, and connector, and the performance studies focus on physical properties and mechanical performance, indicating it is a hardware device.
Based on the provided information, the ASAHI Corsair Armet is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the placement of guide wires and assist in the delivery of contrast media within the peripheral vasculature. This is an in vivo application, meaning it is used inside a living organism.
- Device Description: The description details a catheter designed to be inserted 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 the device being used to analyze biological samples (blood, urine, tissue, etc.) or provide diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ASAHI Corsair Armet's function is procedural and therapeutic (facilitating access and delivery), not diagnostic.
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 neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
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.
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)
Non clinical laboratory testing was performed on the 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 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): 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.
ASAHI Corsair Microcatheter (K151103)
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.
ASAHI Fubuki 043 (K141981), ASAHI Tornus Support Catheter (K051772), ASAHI PTCA Guide Wire Marker Wire (K022762)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
ASAHI Intecc Co., Ltd. % Ms. Candace Cederman Senior Regulatory Affairs Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K152249
Trade/Device Name: ASAHI Corsair Armet Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 9, 2016 Received: February 11, 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) K152249
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 neuro vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 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 green, sans-serif font. The company name is written in all capital letters and includes a comma between "CO" and "LTD".
1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 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 Armet
510(k) 152249
| DATE PREPARED: | February 25, 2016 |
|---|---|
| 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 Armet |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY- Catheter, Percutaneous |
| PREDICATE DEVICES: | Primary Predicates: |
| ASAHI Corsair Microcatheter (K151103) |
Reference Devices:
ASAHI Fubuki 043 (K141981)
ASAHI Tornus Support Catheter (K051772)
ASAHI PTCA Guide Wire Marker Wire (K022762) |
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 neuro vasculature.
5
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.
Comparison with predicate devices:
Comparisons of the ASAHI Corsair Armet and predicate devices show that the technological characteristics of the ASAHI Corsair Armet such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.
The intended use/indications of the Subject Device are a subset of the primary predicates. There are specific design features of the Subject device that are similar to the primary predicate but not identical. Additional reference devices have been used to demonstrate equivalence for these similar features.
| Name of Device | ASAHI Corsair Armet | ASAHI Corsair Microcatheter |
|---|---|---|
| 510(k) | Current Application | K151103 |
| 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 neuro vasculature. | 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 | |
| Target Body Location | Peripheral | Peripheral, Coronary |
| Hydrophilic coating | Yes | |
| Effective Length | 600-1500 mm | 900 - 1500mm |
| Nominal OD | Distal : 0.75mm
Proximal : 0.83 mm | Distal : 0.75mm
Proximal : 1.0mm |
| Catheter Shaft Material | Polyamide-elastomer | Polyamide-elastomer |
| Single Use | Yes | |
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Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the 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 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 ASAHI Corsair Armet was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates and reference devices, the biocompatibility of the ASAHI Corsair Armet was verified to be the same as those of the predicates and reference devices.
CONCLUSION:
The ASAHI Corsair Armet has identical intended use, a subset of the indications, 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 Armet is substantially equivalent to the predicate devices.