(236 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 (Asahi Extension Wire) accessory is used to elongate the working length of compatible Asahi PTCA and Peripheral extendable wires. The stainless-steel Asahi Guide Wire Extension (Asahi Extension Wire) has an outer stainlood clour round of 165cm. Its distal end bears a prefermed elastic connecting tube. The product is specially designed to use with Asahi PTCA and elastio connooting table wires. This product is a non-invasive medical device, and it is not contact with tissue and body fluids.
The provided text describes a 510(k) summary for the Asahi Guide Wire Extension 165cm and its substantial equivalence to a predicate device. This device is a medical accessory and not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML device studies (such as MRMC studies, ground truth establishment for training sets, number of experts for ground truth, etc.) are not applicable.
However, I can extract the information relevant to the device's performance testing and acceptance criteria as described in the summary.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" values in the common format of "must exceed X" or "must be less than Y". Instead, it states that the device "meets all predetermined performance criteria" and performs "as intended" based on the results of the bench testing. For a non-AI medical device like this, substantial equivalence is often demonstrated by showing that the new device performs comparably to the predicate device in relevant tests.
| Performance Test / Evaluation Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench performance evaluation for joint part strength (Extension Wire 165cm and PTCA Guide Wire) | Not explicitly stated, implied to be comparable to predicate. | Device meets all predetermined performance criteria and performs as intended. |
| Bench performance evaluation for tensile strength (Extension Tube and Core Wire of Extension Wire) | Not explicitly stated, implied to be comparable to predicate. | Device meets all predetermined performance criteria and performs as intended. |
| Kink test/evaluation report for Extension wire 165cm (with the predicate device) | Not explicitly stated, implied to be comparable to predicate. | Device meets all predetermined performance criteria and performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "in vitro bench testing" for the performance data.
- Sample Size: Not specified. The document only mentions that evaluations were "conducted on the subject device - Asahi Guide Wire Extension accessory/Asahi Guide Wire Extension 165cm."
- Data Provenance: In vitro bench testing, meaning conducted in a laboratory setting, not from human patients or a specific country of origin in relation to clinical data. The study is a prospective bench test for the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a physical medical device, not an AI/ML device requiring expert ground truth for image or data interpretation. Performance was assessed through objective bench tests.
4. Adjudication Method for the Test Set
Not applicable. This is a physical medical device. The performance was assessed through objective bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI/ML device, so no MRMC study was performed.
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 AI/ML algorithm.
7. The type of ground truth used
For this device, the "ground truth" is established by direct measurement and observation of the device's physical properties and mechanical performance during various bench tests (joint strength, tensile strength, kink resistance) against predetermined engineering specifications and comparison to the predicate device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML device.
{0}------------------------------------------------
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 Guide Wire Extension 165cm |
| COMMON NAME: | Guide Wire Extension |
| CLASSIFICATIONNAME: | Wire, Guide, Catheter |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| PRODUCT CODE | DQX |
| PREDICATE DEVICE: | Asahi Guide Wire Extension - 510(k) K083145 |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Asahi Guide Wire Extension (Asahi Extension Wire) accessory is used to elongate the working length of compatible Asahi PTCA and Peripheral extendable wires. The stainless-steel Asahi Guide Wire Extension (Asahi Extension Wire) has an outer stainlood clour round of 165cm. Its distal end bears a prefermed elastic connecting tube. The product is specially designed to use with Asahi PTCA and elastio connooting table wires. This product is a non-invasive medical device, and it is not contact with tissue and body fluids.
MAR - 7 2011
{1}------------------------------------------------
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 Guide Wire Extension accessory is made of the same materials that have been used in other predicate device that is labeled for the same indication. This submission represents minor dimensional specification changes in length. All other 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.
In vitro bench testing including bench performance evaluation for Joint strength of Extension Wire and PTCA Guide Wire, Joint strength for extension tube and core wire and Kink test/evaluation of Extension wire with the predicate device as listed below were conducted on the subject device - Asahi Guide Wire Extension accessory/Asahi Guide Wire Extension 165cm. This 510(k) notice includes mechanical and functional bench testing that demonstrates that the Asahi Guide Wire Extension accessory performs as intended.
Performance test/evaluation summary:
- Bench performance evaluation for joint part strength of Extension Wire 165cm (Joint 1. strength test of extension wire 165cm and PTCA Guide Wire)
- Bench performance evaluation for tensile strength of Extension Wire 165cm (Joint 2. strength test for extension tube and core wire of Extension Wire)
- Kink test/evaluation report for Extension wire 165cm with the predicate device 3.
SUMMARY/CONCLUSION:
The Asahi Guide Wire Extension accessory characteristics are substantially equivalent to the specified predicate device and other currently marketed devices for the same indication for use.
{2}------------------------------------------------
Image /page/2/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 arranged in a circular pattern around a stylized emblem. The emblem consists of a symbol that resembles an abstract caduceus or a representation of human services, with three distinct lines or strokes forming a shape that could be interpreted as a stylized human figure or a symbol of support and care.
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 2500 Red Hill Avenue, Suite 210 Santa Ana, CA 92705
Re: K101985
Trade Name: Asahi Guide Wire Extension 165 cm Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DQX Dated: January 20, 2011 Received: January 21, 2011
MAR - 7 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.
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
{3}------------------------------------------------
Page 2 - Mr. Yoshi Terai
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
R. Lahner
(Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
2.0 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 上しし 985
Device Name: Asahi Guide Wire Extension 165cm
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)
Duna R. Vahman
Division Sign-Off Division of Cardiovascular Devices
510(k) Number_K 101985
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.