(422 days)
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI ULTIMATEbros 3 PTCA Guide Wire is not to be used in the cerebral blood vessel.
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with platinum-nickel coil. The coil part (distal end) of the guide wire has a radiopaque to achieve visibility. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available as a pre shaped "J ". A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.
The provided text describes a 510(k) summary for a medical device, the ASAHI ULTIMATEbros 3 PTCA Guide Wire. However, it does not include the detailed information required to fill out the requested table and sections regarding acceptance criteria and a study proving the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices, outlining:
- Device Description: Physical characteristics and materials.
- Intended Use: Facilitating PTCA and PTA procedures, not for cerebral blood vessels.
- Technical Characteristics: Comparison to predicate devices, highlighting minor modifications in coating and dimensions.
- Performance Data: Lists various in vitro bench tests (tensile strength, torque strength, tip flexibility, coating adherence, etc.) and biocompatibility tests (systemic toxicity, hemolysis, cytotoxicity, etc.) that were conducted or leveraged from predicate devices.
- Conclusion: The device is substantially equivalent to specified predicate devices.
Missing Information:
Crucially, the document states that these tests were conducted and demonstrates that the device "performs as intended," but it does not report:
- Specific acceptance criteria for each performance test (e.g., minimum tensile strength, maximum turns to failure).
- The reported device performance values against those criteria.
- Details of any specific study (like a clinical trial or even a detailed bench test report with specific numeric results) that explicitly presents the acceptance criteria and the device's performance against them.
- Any information related to clinical studies, sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance in a clinical context. The performance data mentioned are bench and biocompatibility tests, not clinical efficacy or diagnostic performance.
Because the requested information for the acceptance criteria and the study proving it is not present in the provided text, I cannot complete the table or the other sections. The document serves as a regulatory submission for substantial equivalence based on technical and bench testing, not a detailed performance study with explicit acceptance criteria and results.
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510(K) SUMMARY
9.0 510(K) SUMMARY
SEP - 9 2011 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 463-0024 Japan Official Yoshi Terai Correspondent 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 ASAHI ULTIMATEbros 3 PTCA Guide Wire Trade Name: Common Name: Guide Wire Classification NAME: Wire, Guide, Catheter Class 2 per 21 CFR §870.1330 DEVICE CLASSIFICATION: Product Code DQX PREDICATE DEVICE: Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762 Asahi - JoWire Asahi PTCA Guide Wire - 510(k) K031277 Asahi - ASAHI PTCA Guide Wire - 510(k) K070945 Asahi - ASAHI PTCA Guide Wire J shape series - 510(k) K043422 Asahi - ASAHI PTCA Guide Wire Confianza Pro - 510(k) K041531 Asahi - ASAHI PTCA Guide Wire - 510(k) K032615
Description of the Device Subject to Premarket Notification:
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with platinumnickel coil. The coil part (distal end) of the guide wire has a radiopaque to achieve visibility. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available as a pre shaped "J ".
A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.
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Indication for Use:
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI ULTIMATEbros 3 PTCA Guide Wire is not to be used in the cerebral blood vessel.
TECHNICAL CHARACTERISTICS:
Comparisons of the ASAHI ULTIMATEbros 3 PTCA 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 device modification for the ASAHI ULTIMATEbros 3 PTCA Guide Wire is modification in the quide wire coating - application of hydrophilic coating and additional PTFE coating, minor dimensional changes in distal core wire tip of the guide wire and addition of J tip shape of the guide wire.
The ASAHI ULTIMATEbros 3 PTCA 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:
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.
The biocompatibility testing as listed below was leveraged from predicate devices with identical materials and manufacturing process.
This submission contains reference to predicate ASAHI devices that use the same materials as used in the subject device, and also includes evaluations that the test results of biocompatibility for materials of the predicate devices are able to apply to the subject device. And In vitro bench testing and shelf-life testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility and integrity (particulate testing) as listed below were conducted on the subject device -ASAHI ULTIMATEbros 3 PTCA Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI ULTIMATEbros 3 PTCA Guide Wire performs as intended.
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 in PTCA Balloon Catheter Particulate testing
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Biocompatibility: 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 ASAHI ULTIMATEbros 3 PTCA Guide Wire characteristics are substantially equivalent to the specified predicate devices 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 Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Asahi Intecc USA, Inc. c/o Mr. Yoshi Terai President, CEO 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
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Re: K101986
K101760
Trade/Device Name: ASAHI ULTIMATEbros 3 PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guidewire Regulatory Class: Class II Product Code: DQX Dated: August 25, 2011 Received: September 8, 2011
Dear Mr. Terai:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your Section 710(t) promation is substantially equivalent (for the indications
referenced above and have determined the device is devices merketed in interst referenced and nave decemblied the actrosed predicate devices marketed in interstate for use stated in the encrosule) to tegary manoned povice Amendments, or to commerce prof to May 20, 1970, the charmers with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general segetration, listing o You may, therefore, market the device, subject to the girlstration, listing of
general controls provisions of the Act include requirements michaeading and general controls provisions of the rict meration station related to contract light adulteration. Please note: CDRH does not evaluate information related to contract liability. adulteration. Flease note: CDICT does not overaliate and mot be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
If your device is classified (See above) into times regulations affecting your device can be
may be subject to additional controls. Existing major regulations affecting your may be subject to addinonal comrous. Existing mayor of 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I cacral Regarations) our device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualite of a substitution with other requirements of the Act
that FDA has made a determination that your device artern legencies. You must that FDA nas made a decemination and Journer Federal agencies. You must in the must in the statistian and listing or any Federal statures and regirances and united to: registration and listing (21
comply with all the Act's requirements, including, but not anserting of medical comply with all the Act Stequirements, included be reporting (reporting of medical
CFR Part 807); labeling (21 CFR Part 800); medical developments as CFR Part 807); labeling (21 CFR Pall 801); medical de responsing (* 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (2005) (2000) (2006) (2006) (2006) and 121, time Act): 21 CFR 1000-1050. forth in the quality systems (QS) regulation (21 CFR Parvels)
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
r for for If you desire specific advice tor your device offices/CDRH/Offices/ucm I I S809.htm for for for for for for for for for for for for go to http://www.fda.gov/Aboutf1DACEMers/CDTCS/Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDH)'s) Office of Compliance (2)CFR Part the Center for Devices and Radiological Health s (CDTC of OEFrican of (CLCR Pat
note the regulation entitled, "Misbranding by reference to premarket notification" (2 note the regulation entitled, "Misbranding by relective to premation in the MDR regulation (21
807.97). For questions regarding the reporting of adverse events under the MDR CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office
ed to the may be the states and the interest Partnerket http://www.ida.gov/MedicalDooloodson of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational only of its possiblements as and the manner
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Simall Manazave at its Internet address (800) 638-2041 of (501) 790-7100 of at institution
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
LL
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT 2.0
101986 510(k) Number (if known): ر
Device Name: ASAHI ULTIMATEbros 3 PTCA Guide Wire
Indications for Use:
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is intended to facilitate the placement of The ASATT OLLINA (1 2016-01-16 perculaneous transluminal coronary angioplasty Dalloon difatation Cathelers dunny poroutunious any (PTA). The ASAHI ULTIMATEbros 3 PTCA Guide Wire is not to be used in the cerebral blood vessel.
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)
LL
ion Sign-Off) vision of Cardiovascular Devices
510(k) Number K10/986
Page . of
§ 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.