(81 days)
The Asahi Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
The Asahi Guide Wire Extension accessory is used to elongate the working length of compatible Asahi PTCA and Peripheral extendable wires. The stainless-steel Asahi Guide Wire Extension has an outer diameter of 0.014" (0.36mm) and a length of 150cm. Its distal end bears preformed elastic connecting tube. The product is specially designed to use with Asahi PTCA and Peripheral extendable guide wires. This product is a non-invasive medical device, and it is not contact with tissue and body fluids.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi Guide Wire Extension.
Based on the provided 510(k) summary, the device is a simple mechanical accessory used to extend the working length of guide wires. The submission focuses on substantial equivalence to predicate devices rather than a complex performance study with quantitative acceptance criteria typically seen for AI/ML devices or diagnostic tools.
Therefore, many of the requested fields (e.g., sample sizes for test/training sets, expert consensus, MRMC studies) are not applicable or not provided in this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence: Made of same materials as predicate devices for similar indications. | "The Asahi Guide Wire Extension accessory is made of the same materials that have been used in other predicate devices that are labeled for the similar indications." (Page 1) |
| Dimensional Equivalence: Dimensional specifications equivalent to predicate devices. | "The dimensional specifications are equivalent to those listed for the currently cleared predicate devices." (Page 1) |
| Functional Equivalence: Meets predetermined performance criteria for its intended use (extending guide wire working length during angioplasty).** | "Enclosed within this submission is performance data that demonstrates that the Asahi Guide Wire Extension accessory meets all predetermined performance criteria." (Page 1) (Note: Specific, quantifiable criteria are not detailed in this summary.) |
| Substantial Equivalence to Predicate Devices: Overall characteristics are substantially equivalent to specified predicate and other marketed devices. | "The Asahi Guide Wire Extension accessory characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." (Page 1) |
| Safety and Effectiveness: Demonstrated safety and effectiveness for its intended use. | The FDA's 510(k) clearance implies that the device has been determined to be substantially equivalent to a legally marketed predicate device, thereby demonstrating its safety and effectiveness for the stated indications. (Pages 2-3) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This device is a mechanical accessory. The "performance data" mentioned would typically involve engineering tests (e.g., tensile strength, fatigue, material compatibility) rather than a clinical "test set" with patient data. The summary does not specify any clinical study sample sizes or data provenance.
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 / Not Provided: For a mechanical accessory seeking 510(k) clearance based on substantial equivalence, clinical ground truth established by experts is not typically required in the same way it would be for a diagnostic or AI/ML device. The "ground truth" here is the physical and functional performance of the device itself, assessed through engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: As no clinical test set with patient data is described, an adjudication method for expert review is irrelevant.
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: No MRMC study was done. This device is a mechanical medical accessory, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Performance Standards/Specifications: The "ground truth" for this device would be its ability to meet predetermined physical and mechanical performance criteria (e.g., strength, durability, compatibility with specified guide wires, reliable extension function) as demonstrated through bench testing and material characterization. This is established against industry standards and internal specifications, and its equivalence to predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided: No training set is relevant for a mechanical medical device in this context.
9. How the ground truth for the training set was established
- Not Applicable: No training set is relevant.
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510(K) SUMMARY
510(K) Summary 9.0
JAN 1 2 2009
x3145
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 CORRESPONDENT Yoshi Terai 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: voshi@asahi-intecc.com
TRADE NAME:
Asahi Guide Wire Extension (accessory)
COMMON NAME: Classification
NAME:
DEVICE
Wire, Guide, Catheter
Guide Wire Extension
Class 2 per 21 CFR §870.1330
CLASSIFICATION:
PRODUCT CODE DQX
PREDICATE DEVICE:
Asahi JoWire Neo's PTCA Guide Wire - K022762 Asahi Treasure 12 Peripheral Guide Wire - K061984.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Asahi Guide Wire Extension accessory is used to elongate the working length of compatible Asahi PTCA and Peripheral extendable wires. The stainless-steel Asahi Guide Wire Extension has an outer diameter of 0.014" (0.36mm) and a length of 150cm. Its distal end bears preformed elastic connecting tube. The product is specially designed to use with Asahi PTCA and Peripheral extendable guide wires. This product is a non-invasive medical device, and it is not contact with tissue and body fluids.
000040
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INDICATION FOR USE:
The Asahi Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
TECHNICAL CHARACTERISTICS:
The Asahi Guide Wire Extension accessory is made of the same materials that have been used in other predicate devices that are labeled for the similar indications. The dimensional specifications are equivalent to those listed for the currently cleared predicate devices.
Performance Data:
Enclosed within this submission is performance data that demonstrates that the Asahi Guide Wire Extension accessory meets all predetermined performance criteria.
SUMMARY/CONCLUSION:
The Asahi Guide Wire Extension accessory characteristics are substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use.
በሰብ በ / የ
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asahi Intecc Co., Ltd. c/o Asahi Intecc USA, Inc. Mr. Yoshi Terai President, CEO 2500 Red Hill Ave, Suite 210 Santa Ana, CA 92705
Re: K083145
Trade/Device Name: Asahi Guide Wire Extension Common Name: Guide Wire Catheter Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: December 12, 2008 Received: December 12, 2008
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
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.
JAN 1 2 2009
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.
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
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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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.
R. Vahner
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): 上の8ろしくら
Device Name: Asahi Guide Wire Extension
Indications for Use:
The Asahi Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
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)
R.Lachner
(Division Sign-Off) Division of Cardiovascular Devices
Page
510(k) Number_K083145
§ 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.