(71 days)
No
The device description and performance studies focus on the physical properties and functionality of a guide catheter, with no mention of AI/ML, image processing, or data analysis.
No
The device is described as providing a pathway for other therapeutic and diagnostic devices, rather than being therapeutic itself.
No
The device is a guide catheter intended to provide a pathway for other therapeutic and diagnostic devices. It does not perform diagnostic functions itself.
No
The device description clearly states it consists of a "Catheter" and "Dilator," which are physical components intended for insertion into vasculature. The performance studies also focus on physical properties and biocompatibility of these components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway through which therapeutic and diagnostic devices are introduced" into the coronary vascular system. This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description details a catheter inserted into vasculature, a hub, and a dilator. This aligns with an invasive medical device used for access, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the SheathLess Eaucath Coronary Guide Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The SheathLess Eaucath Coronary Guide Catheter is intended for use in coronary vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
The SheathLess Eaucath Coronary Guide Catheter consists of a "Catheter" and · "Dilator". The catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector. This product is being offered in two sizes: 6.5Fr and 7.5Fr.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary vascular system
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 SheathLess Eaucath Coronary Guide Catheter to determine substantial equivalence. The following testing/assessments were performed: Performance test/evaluation summary: Corrosion resistance, Force at break, Liquid leakage under pressure test, Air leakage into hub assembly during aspiration, Kinking short term test, Coating integrity / Particulate Evaluation, Radiopacity, Dimensional Verification. Biocompatibility: Cytotoxicity, Intracutaneous / Irritation, Sensitization, Systemic Toxicity, In Vitro Hemolysis, In Vivo Thromboresistance, Plasma Recalcification Time Coagulation, C3a Complement Activation, SC5b-9 Complement Activation, Pyrogen. Package integrity: Visual inspection, Seal strength test. Sterilization: Ethylene oxide sterilization evaluation, EO residuals, Endotoxin.
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.
K021256, K022764, K023402, K972484, K091188, K092372
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
OCT 2 4 2013
Premarket Notification SheathLess Eaucath Coronary Guide Catheter
ASAHI INTECC CO.,LTD.
1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel.+81-52-768-1211 Fax.+81-52-768-1221 Branch office : 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)]
SheathLess Eaucath Coronary Guide Catheter
510(k) _____
APPLICANT
Asahi Intecc Co., Ltd. 1703 Wakita-cho, Moriyama-ku Nagoya, Aichi 463-0024 Japan
Owner/Operator Number: 3003775027
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: yoshi.terai@asahi-intecc.com
SheathLess Eaucath Coronary Guide Catheter
Trade Name:
Common Name: Guide Catheter
Class 2 per 21 CFR §870.1250 DEVICE
Classification:
CLASSIFICATION Catheter, Percutaneous NAME:
PRODUCT CODE DQY
PREDICATE DEVICES:
K021256 6F Launcher Guide Catheter (Medtronic Vascular) K022764 7F Launcher Guide Catheter (Medtronic Vascular) K023402 8F Launcher Guide Catheter (Medtronic Vascular) K972484 ACS Viking Catheter (Guidant Corp.) K091188 ASAHI ZenyteEX Guiding Catheter (ASAHI Intecc Co., Ltd. K092372 Heartrail III Guiding Catheter (Terumo Medical Corp.)
- K051601 Pinnacle Destination (Terumo Medical Corp.)
Date Prepared: July 25, 2013
Asahi Intecc Co., Ltd
1
INTENDED USE:
The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.
DESCRIPTION:
The SheathLess Eaucath Coronary Guide Catheter is intended for use in coronary vascular applications and is designed to provide a pathway through which medical instruments, such as balloon catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.
The SheathLess Eaucath Coronary Guide Catheter consists of a "Catheter" and · "Dilator". The catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector. This product is being offered in two sizes: 6.5Fr and 7.5Fr.
Comparison Table With Predicate Devices:
Comparisons of the SheathLess Eaucath Coronary Guide Catheter and predicate devices show that the technological characteristics of the SheathLess Eaucath such as intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the current marketed predicate devices.
Non Clinical Testing / Performance Data:
Non clinical laboratory testing was performed on the SheathLess Eaucath Coronary Guide Catheter to determine substantial equivalence. The following testing/assessments were performed:
Performance test/evaluation summary:
- Corrosion resistance .
- . Force at break
- Liquid leakage under pressure test .
- . Air leakage into hub assembly during aspiration
- . Kinking short term test
- . Coating integrity / Particulate Evaluation
- . Radiopacity
- Dimensional Verification .
Biocompatibility:
- Cytotoxicity .
- Intracutaneous / Irritation .
- Sensitization .
- Systemic Toxicity .
2
Premarket Notification SheathLess Eaucath Coronary Guide Catheter
- . In Vitro Hemolysis
- . In Vivo Thromboresistance
- Plasma Recalcification Time Coagulation .
- . C3a Complement Activation
- . SC5b-9 Complement Activation
- Pyrogen .
Package integrity:
- . Visual inspection
- . Seal strength test
Sterilization:
- Ethylene oxide sterilization evaluation .
- EO residuals .
- Endotoxin .
CONCLUSION:
The SheathLess Eaucath Coronary Guide Catheter has the same intended use and 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, and is as safe and effective as its predicate.
Therefore, the SheathLess Eaucath Coronary Guide Catheter is substantially equivalent to the predicate devices.
3
Public Health Service
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is depicted with a modern, abstract design, consisting of three curved lines. The text is written in a bold, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
October 24, 2013 -
Asahi Intecc Co., Ltd. C/O Semih Oktay CardioMed LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K132556
Trade/Device Name: SheathLess Eaucath Coronary Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 23, 2013 Received: August 26, 2013
Dear Semih Oktay:
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.
4
Page 2- Semih Oktay
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. Zillicherm
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification SheathLess Eaucath Coronary Guide Catheter
Indications for Use
| 510(k) Number (if known): | K132556 |
|---|---|
| Device Name: | SheathLess Eaucath Coronary Guide Catheter |
| Indications for Use: |
The SheathLess Eaucath Coronary Guide Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced. The guide catheter is intended to be used in the coronary vascular system.
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Lillehemann
Page 1 of 1
Asahi Intecc Co., Ltd