(106 days)
No
The 510(k) summary describes a mechanical microcatheter with no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on physical and material properties.
No
The device is a medical instrument used for support and delivery, not for treating or curing a medical condition.
No
The device's intended use is to facilitate guide wire placement and exchange, assist in contrast media delivery, and help cross CTOs, all of which are interventional or therapeutic actions, not diagnostic.
No
The device description clearly outlines physical components like a distal tip, shaft tube, wires, and a hydrophilic coating, 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use of the ASAHI Corsair Pro® XS clearly indicate it is a medical device used within the body (in vivo) to facilitate procedures in the coronary and peripheral vasculatures. It is used for guide wire placement, guide wire exchange, and delivery of contrast media.
- Lack of Specimen Analysis: There is no mention of this device being used to collect, prepare, or analyze any specimens from the human body.
Therefore, based on the provided information, the ASAHI Corsair Pro® XS is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product 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.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary total occlusions (CTO).
This device should not be used in neurovasculature.
Product codes
DQY
Device Description
The ASAHI Corsair Pro® XS consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. 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 ASAHI Corsair Pro® XS has a tapered shape and is designed to have increased flexibility towards the distal end. The inner lumen of the catheter is PTFE 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.
As compared to the predicate device, the primary change presented in this 510(k) involves a minor change in the dimensions of the tip and catheter shaft and the structure of inner layer (rope coil) of the catheter shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculatures, coronary, peripheral and abdominal vasculatures. This device should not be used in 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)
Based on a risk analysis to assess the impact of the modification on the device, ASAHI INTECC performed the following confirmatory non-clinical testing on the ASAHI Corsair Pro® XS to determine substantial equivalence.
The following testing/assessments were performed:
- Appearance / Dimensional testing
- Tensile strength
- Corrosion resistance
- Liquid leakage under pressure
- Air leakage into hub assembly during aspiration
- Pressure Resistance (Burst pressure)
- Radio-detectability
- Torque durability
- Slide durability (Lubricity)
- Kink resistance
- Torque transmission
- Flexibility
The in vitro bench tests demonstrated that the ASAHI Corsair Pro® XS 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 Pro® XS was compared to the predicate device. Based on the comparison of materials and manufacturing process used in the subject device to its predicate, the biocompatibility of the ASAHI Corsair Pro® XS was verified to be the same as the predicates.
The following tests were performed:
- Cytotoxicity
- Sensitization
- Intracutaneous Irritation
- Systemic Toxicity
- USP Rabbit Pyrogen, Material Mediated
- Hemolysis
- Partial Thromboplastin Time
- In Vivo Thromboresistance
- Sc5b-9 Complement Activation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ASAHI Corsair Pro® (K171933)
Reference Device(s)
ASAHI Caravel (K152447)
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2018
Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant Cardiomed Device Consultants, LLC 3168 Braverton Street, Suite 200 Edgewater, Maryland 21037
Re: K182420
Trade/Device Name: ASAHI Corsair Pro® XS Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 14, 2018 Received: November 19, 2018
Dear Candace 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Digitally signed by Lydia S. Lydia S. Glaw -S Date: 2018.12.20 Glaw -S 14:35:02 -05'00'
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) K182420
Device Name ASAHI Corsair Pro® XS
Indications for Use (Describe)
This product 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.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary total occlusions (CTO).
This device should not be used in 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) SAHI INTECC CO.,LTD.
3-100 Akatsuki-cho, Seto, Aichi 489-0071 Japan Tel. +81-561-48-5551 Fax. +81-561-48-5552 Branch office: Tokyo, Nagova, Osaka, Hong Kong, EU, Singapore, Beijing, India, Middle Eastern Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi
ASAHI Corsair Pro XS
510(k) K182420
| DATE PREPARED: | December 14, 2018 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 3-100 Akatsuki-cho, | |
| Seto, Aichi 489-0071 Japan | |
| CONTACT | Yoshi Terai. President/CEO |
| ASAHI INTECC USA, Inc. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, CA 92780 | |
| Tel: (949) 756-8252, FAX: (949) 756-8165 | |
| e-mail: ASAHI.ra-fda@ASAHI-intecc.com | |
| TRADE NAME: | ASAHI Corsair Pro® XS |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY - Catheter, Percutaneous |
| PREDICATE DEVICE: | ASAHI Corsair Pro® (K171933) |
| REFERENCE DEVICE: | ASAHI Caravel (K152447) |
Intended Use/Indications for Use
This product 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 quide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary total occlusions (CTO).
This device should not be used in neurovasculature.
Device Description:
The ASAHI Corsair Pro® XS consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. 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 ASAHI Corsair Pro® XS has a tapered shape and is designed to have
4
increased flexibility towards the distal end. The inner lumen of the catheter is PTFE 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.
As compared to the predicate device, the primary change presented in this 510(k) involves a minor change in the dimensions of the tip and catheter shaft and the structure of inner layer (rope coil) of the catheter shaft.
Comparison with Predicate device:
Comparisons of the ASAHI Corsair Pro® XS 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 device. The minor differences between the subject and predicate device do not raise any new questions of safety or effectiveness
| Name of Device | ASAHI Corsair Pro® | ASAHI Corsair Pro® XS |
|---|---|---|
| 510(k) | K171933 | Current Application |
| Intended Use and | ||
| Indications | This product 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. This product is also intended to assist in the delivery of | ||
| contrast media into the coronary, peripheral and abdominal | ||
| vasculatures, and to assist in crossing de novo coronary chronic | ||
| total occlusions (CTO). This device should not be used in | ||
| neurovasculature. | ||
| Target Body Location | Coronary and Peripheral | |
| Hydrophilic coating | Yes | |
| Effective Length | 1350 mm, 1500 mm | |
| Nominal Outer Diameter | Tapered | |
| 0.3 mm to 1.0 mm | Tapered | |
| 0.44 mm to 0.95 mm | ||
| Catheter Shaft Material | Polyamide elastomer & Polyamide | |
| Distal Tip Length | 5 mm | 6.5 mm |
| Single Use | Yes | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 years |
Non Clinical testing / Performance Data:
Based on a risk analysis to assess the impact of the modification on the device, ASAHI INTECC performed the following confirmatory non-clinical testing on the ASAHI Corsair Pro® XS to determine substantial equivalence.
The following testing/assessments were performed:
- Appearance / Dimensional testing
- Tensile strength ●
- . Corrosion resistance
- . Liquid leakage under pressure
- . Air leakage into hub assembly during aspiration
5
- Pressure Resistance (Burst pressure) ●
- Radio-detectability ●
- Torque durability ●
- Slide durability (Lubricity) ●
- Kink resistance
- . Torque transmission
- . Flexibility
The in vitro bench tests demonstrated that the ASAHI Corsair Pro® XS 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 Pro® XS was compared to the predicate device. Based on the comparison of materials and manufacturing process used in the subject device to its predicate, the biocompatibility of the ASAHI Corsair Pro® XS was verified to be the same as the predicates.
The following tests were performed:
- Cytotoxicity ●
- . Sensitization
- Intracutaneous Irritation
- Systemic Toxicity ●
- . USP Rabbit Pyrogen, Material Mediated
- Hemolysis
- Partial Thromboplastin Time ●
- . In Vivo Thromboresistance
- . Sc5b-9 Complement Activation
Conclusion:
The ASAHI Corsair Pro® XS 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 device. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI Corsair Pro® XS is substantially equivalent to the predicate device.