(56 days)
ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The ASAHI CHIKAI 10 Neurovascular Guide Wire is a steerable guide wire with a maximum diameter of 0.010 inches (0.26mm) and available in 200 cm and 300 cm maximall attimorer or one is connected to the end of the guide wire outside the body for 200 cm wire. The guide wire is constructed from a stainless steel core wire with for 200 on will be handstainless steel coils. The coil assembly consists of an inner coil and pratinan monor che coil assembly is soldered to the core wire. The coil assembly an outer outli, and the 510k cleared ASAHI CHIKAI Neurovascular Guide Wire with K110584. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available The distar end of the galas into has a made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the quide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
The provided document is a 510(k) Pre-Market Notification for a medical device, specifically a guide wire. It focuses on demonstrating substantial equivalence to predicate devices rather than proving novel diagnostic accuracy or clinical effectiveness for an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies (such as MRMC studies, training set details, and expert qualifications for ground truth establishment) are not applicable or not present in this type of document.
However, I can extract the acceptance criteria and performance data for the device's physical performance as tested in this submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance test. Instead, it states that "ASAHI CHIKAI 10 Neurovascular Guide Wire meets all predetermined performance criteria" and that it "performs as intended." The overall conclusion is that the device is "substantially equivalent" to predicate devices, inferring that its performance matches or is comparable to those predicate devices.
The performance areas evaluated are listed. I will present the evaluated performance aspects and the general statement of conformity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain Tensile Strength | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Turns to Failure (Torque Strength) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Torqueability (Torque Response) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Tip Flexibility | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Coating Adhesion | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Maintain Slipping Ability of Guide Wire with Microcatheter | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Absence of excessive particulates (Particulate Testing) | Meets predetermined performance criteria; Performs as intended; Substantially equivalent to predicate devices. |
| Biocompatibility (various studies: Systemic Toxicity, Hemolysis, etc.) | Established by successful use of same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products; Meets performance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of guide wires or samples used for each in vitro bench test (tensile strength, torque strength, etc.). It generally states that "performance data" was enclosed and that tests "were conducted."
- Data Provenance: The tests are described as "In vitro bench testing," indicating they were conducted in a laboratory setting. The origin of the data is from the manufacturer, Asahi Intecc Co., Ltd. (Japan), as part of their submission to the FDA. The data is prospective in the sense that these tests were specifically conducted for this 510(k) submission to demonstrate device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device submission. The "ground truth" for a medical device's physical and mechanical properties is typically established through standardized engineering and material science testing methods, not by expert consensus on observational data as would be done for an AI/ML diagnostic device.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of cases to establish ground truth in diagnostic studies, which is not what was performed for this guide wire submission.
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
This question is not applicable. This submission is for a physical medical device (guide wire), not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. As stated above, this is not an AI/ML algorithm. The performance tests are for the physical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Standards and Specifications: Tests like tensile strength, torque, and flexibility are measured against defined engineering limits and performance requirements relevant to the intended use.
- Biocompatibility Standards: Biocompatibility is assessed against established ISO standards and material safety profiles for medical devices.
- Comparison to Predicate Devices: Performance is benchmarked against the known characteristics and established safety/effectiveness of legally marketed predicate devices.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of an AI/ML model for this type of physical medical device submission.
9. How the Ground Truth for the Training Set was Established
This question is not applicable due to the absence of a training set for an AI/ML model.
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DEC - 1 2011
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510(K) Summary
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-ku |
|---|---|
| Nagoya, 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 CHIKAI 10 Neurovascular Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATIONNAME: | Wire, Guide, Catheter |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | MOF - Catheter Guide Wire |
| PREDICATE DEVICE: | 1. Asahi - ASAHI CHIKAI Neurovascular Guide Wire - 510(k) K1105842. Micro Therapeutics, Inc. / EV3 - SilverSpeed Hydrophilic Guidewire -510(k) K9932573. Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K0227624. BSC/SciMed Life Systems, Inc. - Transend EX Platinum Guidewire -510(k)K971254Additional referenced 510(k) cleared device:5. Asahi - ASAHI SION PTCA Guide Wire - 510(k) K100578 |
Description of the Device Subject to Premarket Notification:
The ASAHI CHIKAI 10 Neurovascular Guide Wire is a steerable guide wire with a maximum diameter of 0.010 inches (0.26mm) and available in 200 cm and 300 cm maximall attimorer or one is connected to the end of the guide wire outside the body for 200 cm wire. The guide wire is constructed from a stainless steel core wire with for 200 on will be handstainless steel coils. The coil assembly consists of an inner coil and pratinan monor che coil assembly is soldered to the core wire. The coil assembly an outer outli, and the 510k cleared ASAHI CHIKAI Neurovascular Guide Wire with K110584.
with N 1000+.
The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available The distar end of the galas into has a made to bend easily with the vessel curve. A
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510(K) SUMMARY
hydrophilic coating is applied to the distal portion of the quide wire. The proximal section of the guide wire for 300 cm wire is coated with PTFE.
Indication for Use:
ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
TECHNICAL CHARACTERISTICS:
Comparisons of the ASAHI CHIKAI 10 Neurovascular Guide Wire and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the current marketed predicate devices. The ASAHI CHIKAI 10 Neurovascular Guide Wire is similar in design - device dimensional specifications, and intended use, manufacturing process, operating principle, shelf life and sterilization process are the same and materials that have been used in other predicate devices in that its core wire, tip coils and solders remain the same.
Performance Data:
Enclosed within this submission is performance data that demonstrates that the ASAHI CHIKAI 10 Neurovascular Guide Wire meets all predetermined performance criteria. 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 reference to predicate ASAHI devices that use the same materials as used in the subject device.
In vitro bench testing, including tensile strength, torque strenath, torqueability, tip flexibility, coating adherence, catheter compatibility, particulate testing and shelf life testing as listed below were conducted on the ASAHI CHIKAI 10 Neurovascular Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI CHIKAI 10 Neurovascular Guide Wire performs as intended.
The biocompatibility has been established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products.
Performance test/evaluation summary:
Device performance: Tensile Strength Turns to Failure (Torque Strength) Torqueability (Torque Response) Tip Flexibility Coating Adhesion Slipping Ability of Guide Wire with Microcatheter Additional bench testing Particulate testing
Asahi Intecc
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510(K) Summary
p. 3/3
Biocompatibility/evaluation: Systemic Toxicity Study In Vitro Hemolysis Study Intracutaneous Study Cytotoxicity Study Sensitization Study Pyrogen Study Plasma Recalcification Time Coagulation Study In Vivo Thromboresistance Study C3a Complement Activation Study SC5b-9 Complement Activation Study
SUMMARY/CONCLUSION:
The ASAHI CHIKAI 10 Neurovascular Guide Wire characteristics are substantially equivalent to the specified predicate device and other currently marketed devices for the same indication for use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Asahi Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO 2500 Red Hill Ave., Suite 210 Santa Ana, CA 92705
DEC - 1 2011
Re: K112979
Trade/Device Name: ASAHI CHIKAI 10 Neurovascular Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: October 5, 2011 Received: October 12, 2011
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. 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.
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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 (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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Re. Tom m
Malvina B. Eydelman. M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ﺗﻢ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ INDICATIONS FOR USE STATEMENT
KI12979 510(k) Number (if known):
Device Name: ASAHI CHIKAI 10 Neurovascular Guide Wire
Indications for Use:
ASAHI Neurovascular Guide Wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
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)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KII2979
Page of
510(k) Number.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.