(205 days)
The ASAHI SION 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 SION PTCA Guide Wire is not to be used in the cerebral blood vessel.
The ASAHI SION 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 lengths. The extension wire is connected to the end of the guide wire outside the body. 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 tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the quide wire is coated with PTFE.
The provided text describes the ASAHI SION PTCA Guide Wire, a medical device, and its regulatory clearance process, including performance data. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested for AI/ML devices.
The document states: "In vitro bench testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility and integrity (particulate testing) etc were conducted on the ASAHI SION PTCA Guide Wire, This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI SION PTCA Guide Wire performs.as intended." This indicates that performance testing was done, but the specifics of what constitutes "performing as intended" (i.e., the acceptance criteria) and the detailed results against those criteria are not provided.
Furthermore, the document does not describe an AI/ML device, a clinical study with human readers, or the establishment of ground truth by expert consensus or pathology, as typically would be expected for the detailed questions about an AI/ML study. It is a traditional medical device (guide wire) submission.
Therefore, I cannot populate most of the requested fields. I will fill in what can be inferred from the text and note where information is not available or not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength (meets specifications) | Bench testing demonstrated performance as intended. |
| Torque Strength (meets specifications) | Bench testing demonstrated performance as intended. |
| Torqueability (meets specifications) | Bench testing demonstrated performance as intended. |
| Tip Flexibility (meets specifications) | Bench testing demonstrated performance as intended. |
| Coating Adherence (meets specifications) | Bench testing demonstrated performance as intended. |
| Catheter Compatibility (meets specifications) | Bench testing demonstrated performance as intended. |
| Integrity (e.g., particulate testing) (meets) | Bench testing demonstrated performance as intended. |
| Biocompatibility (proven) | Components have a long history of use and are proven biocompatible. |
| Substantial Equivalence to Predicates | Determined to be substantially equivalent by FDA. |
Explanation: The document states that "In vitro bench testing... were conducted... that demonstrates that the ASAHI SION PTCA Guide Wire performs as intended." However, the specific quantitative acceptance criteria (e.g., "tensile strength must be >X Newtons") and the exact measured values are not disclosed in this summary. The performance is described qualitatively as meeting its intended function and being substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for each individual bench test. The document mentions "bench testing" without providing specific numbers of guide wires tested.
- Data Provenance: Not explicitly stated, but implies in-house laboratory testing ("In vitro bench testing... were conducted on the ASAHI SION PTCA Guide Wire"). No information on geographical origin of data or retrospective/prospective nature as this is not a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. This is not an AI/ML device that generates outputs requiring expert interpretation or ground truth establishment based on clinical data. The performance verification is through engineering bench tests against established physical and material properties.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
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
- No. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
- Not Applicable/Engineering Specifications. For this type of traditional medical device, the "ground truth" for performance is defined by established engineering and material specifications, regulatory standards, and comparison to predicate devices, rather than expert consensus on clinical data or pathology outcomes.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is not an AI/ML device.
{0}------------------------------------------------
KIDG578
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.comSEP 2.2 2010 |
| TRADE NAME: | ASAHI SION PTCA Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATIONNAME: | Wire, Guide, Catheter |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PREDICATE DEVICE: | Asahi - SUOH PTCA Guide Wire - 510(k) K083904Asahi -Asahi PTCA Guide Wire - 510(k) K070945Asahi - JoWire Neo's PTCA Guide Wire - 510(k) K022762 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: ·
The ASAHI SION 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 lengths. The extension wire is connected to the end of the guide wire outside the body. 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 tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the quide wire is coated with PTFE.
{1}------------------------------------------------
Indication for Use:
The ASAHI SION 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 SION PTCA Guide Wire is not to be used in the cerebral blood vessel.
TECHNICAL CHARACTERISTICS:
Comparisons of the ASAHI SION 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 ASAHI SION PTCA Guide Wire is similar in design - device dimensional specifications and manufacturing process, and intended use, 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. Furthermore, this submission contains reference to a predicate ASAHI device that uses the same materials as used in the subject device. In vitro bench testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence, catheter compatibility and integrity (particulate testing) etc were conducted on the ASAHI SION PTCA Guide Wire, This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI SION PTCA Guide Wire performs.as intended.
SUMMARY/CONCLUSION:
The ASAHI SION PTCA Guide Wire characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.
{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 a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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 Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
SEP 2222010
Re: K100578
Trade/Device Name: ASAHI SION PTCA Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: September 17, 2010 Received: September 20, 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. Ilsting 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
regulation (21 CFR Part 803), please go to
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
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D/Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT
INDICATIONS FOR USE STATEMENT 2.0
510(k) Number (if known): _ _ 100578
Device Name: ASAHI SION PTCA Guide Wire
SEP 22 2010
1100528
ي
Indications for Use:
The ASAHI SION 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 SION 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 _
of
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CD, Office of Device/Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K100578
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.