(18 days)
The ASAHI Treasure Floppy Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
The ASAHI Treasure Floppy Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a stainless steel and platinum-nickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature. 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 medical device, the ASAHI Treasure Floppy Peripheral Guide Wire, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of device performance metrics with numerical values, statistical analysis, or clinical outcomes.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various bench testing and biocompatibility assessments.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Functional Bench Testing: | Not explicitly defined in numerical terms in the provided document. The implied acceptance criterion is that the device "meets all predetermined performance criteria", and "performs as intended", often by being comparable to predicate devices. | Bench testing was conducted for: - Tensile Strength - Turns to Failure (Torque Strength) - Torqueability (Torque Response) - Tip Flexibility - Coating Adhesion - Slipping Ability of Guide Wire in PTA Balloon Catheter - Particulate testing The document states: "Enclosed within this submission is performance data that demonstrates that the ASAHI Treasure Floppy Peripheral Guide Wire meets all predetermined performance criteria. ... This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Treasure Floppy Peripheral Guide Wire performs as intended." |
| Biocompatibility Testing: | Not explicitly defined in numerical terms in the provided document. The implied acceptance criterion is that the device materials are "proven to be biocompatible" and are consistent with predicate devices. | Biocompatibility testing included: - 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 The document states: "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." Biocompatibility testing was "leveraged from predicate devices with identical materials and manufacturing process." |
Key takeaway for this section: The document states that the device meets predetermined performance criteria, but the actual, quantifiable acceptance criteria and the detailed numerical results showing how it meets them are not provided in this summary. The evaluation relies on demonstrating substantial equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document mentions "bench testing" and "shelf-life testing" but does not give the number of units tested for each parameter.
- Data Provenance: The studies were in vitro bench testing and shelf-life testing. The country of origin for the data is not specified, but the applicant is from Japan, and the US correspondent is in Santa Ana, CA. Given it's a 510(k) submission to the FDA, results would be expected to be presented to US regulatory standards. The testing is retrospective in the sense that it's performed on manufactured devices for regulatory submission, not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the studies described are bench tests and biocompatibility assessments, not studies involving human interpretation where medical experts establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as above.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study (comparing human readers with and without AI assistance) is not mentioned or relevant for this type of device (guide wire).
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was it done? No. This is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
- For mechanical/functional bench testing: The "ground truth" would be established by validated test methods and specifications (e.g., a certain force in Newtons for tensile strength, a certain number of turns for torque strength, etc.).
- For biocompatibility testing: The "ground truth" is established by standard ISO and FDA-recognized biological evaluation tests to determine the device's interaction with the biological system. In many cases, these are in vitro or in vivo (animal) studies, not human data.
- The document explicitly states that biocompatibility data was "leveraged from predicate devices with identical materials and manufacturing process," implying that the ground truth for biocompatibility was previously established for those materials.
8. Sample Size for the Training Set
This information is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above.
{0}------------------------------------------------
KIIOS
MAR 1 8 2011
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 Treasure Floppy Peripheral Guide Wire |
| COMMON NAME: | Guide Wire |
| CLASSIFICATIONNAME: | Wire, Guide, Catheter |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PREDICATE DEVICE: | Asahi - ASAHI Treasure 12 Peripheral Guide Wire - 510(k) K061984Asahi - ASAHI Astato XS 20 Peripheral Guide Wire - 510(k) K103057Asahi - JoWire Neo's PTCA Guide Wire – 510(k) K022762Asahi - ASAHI PTCA Guide Wire - 510(k) K070945 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ASAHI Treasure Floppy Peripheral Guide Wire is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with a stainless steel and platinum-nickel coil. The coil part (distal end) of the guide wire is radiopaque to achieve visibility. The distal end of the coil part is a straight configuration and is easily bendable with the vessel curvature.
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.
CONFIDENTIAL Asahi Intecc February 24, 2011
のお気になると、それではなくてしました。 この時間では、 この時間ではない
{1}------------------------------------------------
510(K) Summary
Indication for Use:
The ASAHI Treasure Floppy Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
TECHNICAL CHARACTERISTICS:
This submission represents minor dimensional specifications and the addition of a PTFE coating. All other specifications are equivalent to those listed for the currently cleared predicate devices.
Comparisons of the ASAHI Treasure Floppy Peripheral 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 Treasure Floppy Peripheral 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 Treasure Floppy Peripheral 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.
And In vitro bench testing and shelf-life testing, including tensile strength, torque strength, torqueability, tip flexibility, coating adherence and catheter compatibility as listed below were conducted on the ASAHI Treasure Floppy Peripheral Guide Wire. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI Treasure Floppy Peripheral Guide Wire performs as intended.
The biocompatibility testing as listed below was leveraged from predicate devices with identical materials 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 in PTA Balloon Catheter Particulate testing
CONFIDENTIAL Asahi Intecc February 24, 2011
{2}------------------------------------------------
510(K) SUMMARY
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:
ਰੇ.
The ASAHI Treasure Floppy Peripheral Guide Wire characteristics are substantially equivalent to the specified predicate device and other currently marketed devices for the same indication for use.
CONFIDENTIAL Asahi Intecc February 24, 2011
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. To the left of the graphic, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the edge of the logo.
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 Ave. Suite 210 Santa Ana, CA 92705
MAR 1 8 2011
Re: K110553
Trade/Device Name: Treasure Floppy Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: February 24 2011 Received: February 28, 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.
{4}------------------------------------------------
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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE STATEMENT
2.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K1 0553
Device Name: ASAHI Treasure Floppy Peripheral Guide Wire
Indications for Use:
The ASAHI Treasure Floppy Peripheral Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
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)
Image /page/5/Figure/11 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". There is a signature on the left side of the image. The text "Page of" is on the right side of the image. The number "K110 553" is written near the bottom of the image.
§ 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.