(207 days)
ASAHI PTCA GUIDE WIRES are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA GUIDE WIRES are not to be used in the cerebral blood vessels.
The ASAHI SION blue PTCA Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm lengths. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and there is a safety wire for which is soldered to the inner and outer coils and the core wire. The 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 ". Silicone and hydrophilic coatings are applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire.
The provided text describes a medical device, the ASAHI SION blue PTCA Guide Wire, and its 510(k) summary for FDA clearance. It outlines the performance data used to demonstrate substantial equivalence to predicate devices, but does not describe an AI medical device or a study involving AI. Therefore, I will extract information related to the device's acceptance criteria and the study proving it meets those criteria, as much as possible for a non-AI medical device.
Key Missing Information for AI Devices:
The document is for a physical medical device (guide wire) and therefore does not contain information about:
- Sample size used for the test set and the data provenance for an AI model.
- Number of experts used to establish ground truth for an AI model's test set.
- Adjudication method for an AI model's test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study for AI.
- Standalone (algorithm only) performance for AI.
- Sample size and ground truth establishment for a training set in AI.
Here's the information extracted from the provided text, focusing on the acceptance criteria and the study performed for the ASAHI SION blue PTCA Guide Wire:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test/Evaluation | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Tests | ||
| Tensile Strength | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Turns to Failure (Torque Strength) | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Torqueability (Torque Response) | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Tip Flexibility | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Coating Adhesion | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Slipping Ability of Guide Wire with PTCA Balloon Catheter | Met predetermined performance criteria (details not specified) | Performance data "demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended." (Specific numerical results not provided in this summary) |
| Particulate Evaluation | Demonstrated acceptable levels of particulates. (Specific criteria not detailed, but states "conducted with a combination assessment with the subject device itself and data leveraged from the predicate devices with identical product material and manufacturing process.") | Demonstrated acceptable particulate levels, leveraged from subject device assessment and identical predicate device data. (Conclusions of meeting criteria are implicit in the "summary/conclusion" of substantial equivalence) |
| Biocompatibility Tests | Acceptable biocompatibility for use in the vasculature (details from predicate devices not specified in this summary). The materials have a "long history of use in medical devices and are proven to be biocompatible for use in the vasculature." The biocompatibility tests listed below were leveraged from predicate devices with identical materials and manufacturing processes, implying the predicate devices met these criteria. | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." (i.e., met criteria by leveraging predicate device data). |
| Systemic Toxicity Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| In Vitro Hemolysis Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Intracutaneous Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Cytotoxicity Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Sensitization Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Pyrogen Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Plasma Recalcification Time | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| Coagulation Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| In Vivo Thromboresistance Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| C3a Complement Activation Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
| SC5b-9 Complement Activation Study | Leveraged from predicate devices (criteria met by predicate) | Biocompatibility "established by the successful use of the same materials and manufacturing process in currently 510(k) approved Asahi Guide Wire products." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in this summary. The text mentions "in vitro bench testing" and "particulate evaluation was conducted with a combination assessment with the subject device itself and data leveraged from the predicate devices." For biocompatibility, testing was "leveraged from the predicate devices."
- Data Provenance: The company, Asahi Intecc Co., Ltd., is based in Japan. The testing described (in vitro bench testing) would likely have been conducted by the manufacturer or a contract lab. The data related to predicate devices are from previously cleared 510(k) devices by Asahi Intecc. This would be considered retrospective for the predicate data and likely prospective for the specific bench tests conducted on the ASAHI SION blue device. The country of origin of the data is not specified beyond the company's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This summary describes a physical medical device and its performance in bench testing, not an AI model requiring expert ground truth or interpretation of images/data. The "truth" in this context is based on engineering specifications and established test methodologies.
4. Adjudication Method for the Test Set
- Not applicable. This is a physical device tested against engineering and biocompatibility standards, not an AI model where human adjudication of results is typical.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No such study was done or described. This is a premarket notification for a physical medical device, not an AI-assisted diagnostic or therapeutic tool.
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
- For mechanical/physical tests: The ground truth is the established engineering specifications and performance standards for guide wires, and comparison to the performance of equivalent predicate devices.
- For biocompatibility: The ground truth is established biocompatibility standards for medical devices and successful use of identical materials and manufacturing processes in previously cleared predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This summary is for a physical medical device, not an AI model that uses a training set. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no "training set" in the context of this device.
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MAR 8 2013
- 510(K) Summary
9.0 510(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-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 SION blue PTCA Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATIONNAME: | Wire, Guide, Catheter |
| DEVICE | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION:PRODUCT CODE | DQX - Catheter Guide Wire |
| PREDICATEDEVICE: | 1. Asahi Intecc - ASAHI SION PTCA Guide Wire - 510(k) K1005782. Asahi Intecc - JoWire Neo's PTCA Guide Wire - 510(k) K022762 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ASAHI SION blue PTCA Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm lengths. The guide wire is constructed from a stainless steel core wire with platinum-nickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and there is a safety wire for which is soldered to the inner and outer coils and the core wire. The 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 ". Silicone and hydrophilic coatings are applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire.
Asahi Intecc
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Indication for Use:
ASAHI PTCA GUIDE WIRES are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA GUIDE WIRES are not to be used in the cerebral blood vessels.
TECHNICAL CHARACTERISTICS:
Comparisons of the ASAHI SION blue PTCA Guide Wire and predicate devices show that the technological characteristics, the materials and the manufacturing processes used in the SION blue device are the same as those used in the previously 510(k) cleared Asahi predicate devices.
This submission represents a change to the tip configuration from a straight tip design to a pre-shaped J design and silicone coating application of the guide wire tip with minor dimensional changes of the quide wire.
PERFORMANCE DATA:
Enclosed within this submission is performance data that demonstrates that the ASAHI SION blue PTCA Guide Wire meets all predetermined performance criteria and performs as intended.
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 strength, torqueability, tip flexibility, coating adherence and catheter compatibility as listed below were conducted on the ASAHI SION blue PTCA Guide Wire. And the particulate evaluation was conducted with a combination assessment with the subject device itself and data leveraged from the predicate devices with identical product material and manufacturing process.
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 PTCA Balloon Catheter Particulate evaluation
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. The biocompatibility testing as listed below was leveraged from the predicate devices with identical materials and manufacturing process.
Biocompatibility/evaluation: Systemic Toxicity Study In Vitro Hemolysis Study Intracutaneous Study
Asahi Intecc
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Cytotoxicity Study Sensitization Study Pyrogen Study Plasma Recalcification Time Coagulation Study In Vivo Thromboresistance Study C3a Complement Activation Study SC5b-9 Complement Activation Study The Children Comments of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Child
SUMMARY/CONCLUSION:
The ASAHI SION blue 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a globe, signifying the department's mission to protect and promote the health and well-being of all Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2013
Asahi Intecc USA, Inc. c/o Mr. Yoshi Terai 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
Re: K122468
Trade/Device Name: ASAHI SION blue PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 17, 2013 Received: February 13, 2013
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.
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
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Page 2 - Mr. Yoshi Terai
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),-pleasego 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Owen-P.Faris -S
for 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
510(k) Number (if known):
Device Name: ASAHI SION blue PTCA Guide Wire
Indications for Use:
ASAHI PTCA GUIDE WIRES are intended to facilitate the placement of balloon dilatation catheters during perculaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA GUIDE WIRES are not to be used in the cerebral blood vessels.
Prescription Use_ X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
Owen P. Faris -S
2013.03.08
13:52:05 -05'00'
Page of
Asahi Intecc
§ 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.