(28 days)
The ASAHI PTCA Guide Wire, X-treme is 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 vessel.
The Asahi PTCA Guide Wire, X-treme is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 190cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made of soft to easy bend with the vessel curve, and is available with a straight tip. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil – not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this guide wire is coated with PTFE.
The provided text describes a 510(k) summary for the Asahi PTCA Guide Wire, X-treme. However, it does not contain the detailed information typically associated with acceptance criteria and a study that proves a device meets those criteria, especially for AI/ML-driven devices.
The document pertains to a medical device (a guide wire) that is explicitly stated to not be an AI/ML device. The "Performance Data" section briefly mentions "mechanical and functional bench testing that demonstrates that the ASAHI PTCA Guide Wire, X-treme performs as intended." This indicates that the safety and effectiveness were demonstrated through bench tests, not through clinical studies involving human or AI-assisted performance metrics.
Therefore, most of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document as it is specific to AI/ML device evaluations.
Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI PTCA Guide Wire, X-treme performs as intended." It also claims: "The ASAHI PTCA Guide Wire, X-treme is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use."
However, specific numerical acceptance criteria (e.g., tensile strength greater than X, friction coefficient less than Y) and the corresponding measured performance values are not provided in this summary. The "summary/conclusion" states the device "functions as intended" and is "substantially equivalent" to predicate devices, implying it met the criteria, but the criteria themselves are not listed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document (e.g., tensile strength, flexibility, lubricity, torqueability, tip deflection.) | "Performs as intended" based on mechanical and functional bench testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The testing was "mechanical and functional bench testing," which would involve physical samples of the guide wire, but the number of samples tested is not stated.
- Data Provenance: Not applicable in the context of clinical data provenance. The testing was conducted by Asahi Intecc Co., Ltd. (Japan).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is not an AI/ML diagnostic device.
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 (expert consensus, pathology, outcomes data, etc)
- For mechanical/functional bench testing, the "ground truth" would be established engineering specifications, standards (e.g., ISO for medical devices), or predicate device performance characteristics. No expert consensus, pathology, or outcomes data is relevant for this type of device testing.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that undergoes training.
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510(K) SUMMARY 9.0
K07243/
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 | SEP 26 2007 |
|---|---|---|
| OFFICIALCORRESPONDENT | Yoshi TeraiPresident, CEOAsahi Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi@asahi-intecc.com | |
| TRADE NAME: | Asahi PTCA Guide Wire, X-treme | |
| COMMON NAME: | Guide Wire | |
| CLASSIFICATIONNAME: | Catheter Guide Wire | |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1330 | |
| PRODUCT CODE | DQX | |
| PRIMARYPREDICATE DEVICE: | Asahi PTCA Guide Wire, Fielder - K052022Asahi PTCA Guide Wire, Fielder FC- K063819 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Asahi PTCA Guide Wire, X-treme is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 190cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made of soft to easy bend with the vessel curve, and is available with a straight tip. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil – not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this guide wire is coated with PTFE.
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INDICATION FOR USE:
The ASAHI PTCA Guide Wire, X-treme is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and diffation outhotels anning perciolasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
TECHNICAL CHARACTERISTICS:
The ASAHI PTCA Guide Wire, X-treme is of the same materials as the predicate devices. The dimensional specifications and design of the device ensures compatibility for the intended use.
PERFORMANCE DATA:
This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI PTCA Guide Wire, X-treme performs as intended.
SUMMARY/CONCLUSION:
The ASAHI PTCA Guide Wire, X-treme characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.
Bench testing demonstrates that the device functions as intended.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 26 2007
Asani Intecc Co., Ltd. c/o Mr. Yoshi Terai President, CEO Asahi Intecc USA, Inc. 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
Re: K072431
Asahi PTCA Guide Wire, X-treme Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: August 21, 2007 Received: August 29, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
B. Yummumo 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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2.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 长072431
Device Name: ASAHI PTCA Guide Wire, X-treme
Indications for Use:
The ASAHI PTCA Guide Wire, X-treme is 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 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)
B/Bummena
510(k) Numbe
Page
000015
§ 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.