(309 days)
ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral 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 ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral 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. The Catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector for the joint portion of the first 2 sections. The tube body section consists of soft tip, soft tube and shaft. The tube body itself is constructed of a polyamide elastomer. The shaft is reinforced by stainless steel braid, and it consists of two layers. The distal portion of the tube is made soft in order to easily bend.
The provided text is a 510(k) summary for a medical device called the ASAHI ZenyteEX Guiding Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way that would typically be done for a novel AI/software device.
Therefore, much of the requested information (such as sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance for an algorithm, and ground truth establishment for a training set) is not applicable to this type of device submission as described in the provided document.
However, I can extract the relevant information regarding acceptance criteria and the type of study performed to show the device meets these criteria.
Acceptance Criteria and Device Performance for ASAHI ZenyteEX Guiding Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compatibility with patient contact (materials) | "All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device." (Implies successful completion.) |
| Technical/Dimensional | Dimensional specifications equivalence to predicate devices | "The dimensional specifications are equivalent to those listed for the currently cleared predicate devices." |
| Material Composition | Use of same materials as predicate devices | "The ASAHI ZenyteEX Guiding Catheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications." |
| Functional Performance | Mechanical and Functional Bench Testing | "This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI ZenyteEX Guiding Catheter performs as intended." (Implies successful performance.) |
| Substantial Equivalence | Equivalence to specified predicate devices for same indication for use | "The ASAHI ZenyteEX Guiding Catheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." |
| Intended Use | Ability to provide a pathway for medical instruments | "Bench testing demonstrates that the device functions as intended." (Supports the intended use.) |
2. Sample Sizes Used for the Test Set and Data Provenance
Not applicable. This is a physical medical device (guiding catheter), not a software or AI device requiring a "test set" of data. The "testing" refers to physical and material testing. The document does not specify sample sizes (e.g., number of catheters tested) for the mechanical, functional, or biocompatibility bench tests. Data provenance is also not applicable in the context of data for an AI/software device; the provenance here would be the manufacturing site (Japan).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is a physical device, there is no "ground truth" in the context of expert review of data. Performance is evaluated via engineering, material, and biocompatibility testing.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" as would be used for diagnostic output from an AI/software device. Performance is determined by meeting pre-defined physical and chemical specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI/software diagnostic aid.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the context of expert consensus, pathology, or outcomes data. For a physical device like this, the "ground truth" for performance is established through adherence to engineering specifications, material properties, and regulatory standards demonstrated via bench testing.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a physical medical device, not an AI/software device that requires a training set.
{0}------------------------------------------------
510(K) SUMMARY
9.0 510(K) SUMMARY
্রী
FEB 2 6 2010
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Asahi Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024Japan |
|---|---|
| OFFICIALCORRESPONDENT | Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi.terai@asahi-intecc.com |
| TRADE NAME: | ASAHI ZenyteEX Guiding Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATIONNAME: | Catheter, Percutaneous |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| PRODUCT CODE | DQY |
| PREDICATE DEVICE: | K023402 & K022764 - Medtronic Launcher Guide CatheterK972484 - ACS Viking Guiding CatheterK061601 - Precious Guide CatheterK020028 - Mach 1 Guide Catheter |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral 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. The Catheter consists of a tube, which is to be inserted into vasculature, a proximal hub/connector, and strain relief/protector for the joint portion of the first 2 sections. The tube body section consists of soft tip, soft tube and shaft. The tube body itself is constructed of a polyamide elastomer. The shaft is reinforced by stainless steel braid, and it consists of two layers. The distal portion of the tube is made soft in order to easily bend.
{1}------------------------------------------------
INDICATION FOR USE:
ASAHI ZenvteEX Guiding Catheter is intended for use in coronary or peripheral 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.
TECHNICAL CHARACTERISTICS:
The ASAHI ZenyteEX Guiding Catheter is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.
PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device. This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI ZenyteEX Guiding Catheter performs as intended.
SUMMARY/CONCLUSION:
The ASAHI ZenyteEX Guiding Catheter characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.
Bench testing demonstrates that the device functions as intended
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. To the right of the text is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Asahi Intecc Co., Ltd. c/o Mr Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
FEB 2 6 2010
Re: K091188
Trade/Device Name: ASAHI ZenyteEX Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: January 20, 2010 Received: January 27, 2010
Dear Mr. Terai:
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.
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.
{3}------------------------------------------------
Page 2 - Mr Yoshi Terai
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Dura R. Lachner
W
- Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
2.0 INDICATIONS FOR USE STATEMENT
041188 510(k) Number (if known):
Device Name: ASAHI ZenyteEX Guiding Catheter
Indications for Use:
ASAHI ZenyteEX Guiding Catheter is intended for use in coronary or peripheral 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.
Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Image /page/4/Picture/17 description: The image is a black and white drawing with a few distinct lines and shapes. The lines are thin and appear to be hand-drawn. The shapes are abstract and do not resemble any recognizable objects. The drawing is simple and minimalist, with a focus on line and form. The overall impression is one of simplicity and abstraction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
huma D. Vicher
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K 69 II
Page _ of _
§ 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).