(88 days)
The ASAHI Tornus support catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
The ASAN Tomas Support Satheton is a device that is intended to provide additional support to a stochable galactine in accessing discrete regions of the coronary and penpheral vasculature. The formas ettempting to cross difficult lesions. The full metal spiral shaft that provides the user with a device that has excllent torqability and pushability during intravascular procedures.
This document describes the safety and effectiveness of the Tornus Support Catheter, a medical device manufactured by Asahi Intecc Co., Ltd. The submission is a 510(k) premarket notification to the FDA, asserting that the Tornus Support Catheter is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
- Table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific, quantifiable acceptance criteria in a table format, nor does it present detailed reported device performance against such criteria. Instead, it relies on a general statement of "substantial equivalence" to predicate devices. The performance data section broadly mentions:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | "long history of use in medical devices and are proven to be biocompatible for use in the vasculature." |
| Mechanical and Functional Performance | "mechanical and functional bench test that demonstrates the Tornus performs as intended." |
| Material equivalence | "made of the same materials that have been used in other Asahi products that are labeled for use in the vasculature." |
| Dimensional equivalence | "dimensional and guidewire compatibility specifications are the equivalent to those listed for the currently cleared predicate devices." |
| Indication for Use equivalence | "substantially equivalent to the specified predicate devices and other currently marketed devices for the same indication for use." |
- Sample size used for the test set and the data provenance
The document does not specify a sample size for any clinical test set. The studies mentioned are "mechanical and functional bench tests." There is no indication of human subject testing, and therefore no information about data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. No human-based test set or associated ground truth establishment by experts is mentioned for this device submission. The evaluation is based on bench testing and comparison to predicate devices, not clinical outcomes or expert adjudication of data.
- Adjudication method for the test set
This information is not applicable/not provided as there is no human-based test set that would require adjudication.
- 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
An MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (a support catheter). This device is not an AI-powered diagnostic tool, but rather a physical interventional device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical catheter, not an algorithm. Therefore, "standalone" algorithm performance is irrelevant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" implicitly would be engineering specifications and established performance characteristics of the predicate devices, which the Tornus Support Catheter is intended to match. There is no biological or clinical ground truth described.
- The sample size for the training set
This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The product development likely involved engineering design and testing, but not in the machine learning sense of a training set.
- How the ground truth for the training set was established
This information is not applicable/not provided as there is no training set in the context of this device's development.
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SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
O
This 510(k) summary of safety and effectiveness information is being submitted in
t and except and encome and essee - LCM CED 807 02 This 510(K) summary of Sarety and Sheety 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.1301 Dove Street, Suite 350Newport Beach, CA 92660Tel: (949) 756-8252FAX (949) 756-8165e-mail: yoshi@asahi-intecc.com |
| TRADE NAME: | Tornus Support Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATIONNAME: | Percutaneous Catheter |
| DEVICECLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| PRODUCT CODE | DQY |
| PREDICATE DEVICE: | XTRAK Support Catheter (K032660)ILT Support Catheter (K012169) |
Description of the Device Subject to Premarket Notification:
DESCRIFTION or rests support catheter is a device that is intended to provide additional The ASAN Tomas Support Satheton in accessing discrete regions of the coronary and support to a stochable galactine in the catheter contains a full metal spiral shaft that penpheral vasculature. The formas ettempting to cross difficult lesions. The full metal provides the user with a device that has excllent torqability and pushability during intravascular procedures.
INDICATION FOR USE:
The ASAHI Tornus support catheter is intended to be used in conjunction with a The AOAl If Torniao Support cathere regions of the vasculature and for guidewire exchange.
TECHNICAL CHARACTERISTICS:
The Asahi Tornus support catheter is made of the same materials that have been used in other Asahi products that are labeled for use in the vasculature. The dimensional in other Asam producte that wire use compatibility specifications are the equivalent to those listed for the currently cleared predicate devices.
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Performance Data:
9
PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in All components that come in be biocompatible for use in the vasculature. This medical devices and are proven to be blocompatible for about with the first of the comment of that
510(k) notice includes mechanical and functional bench that demonstrates th 510(K) notice includes meonamour and forms as intended.
SUMMARY/CONCLUSION:
SUMMARY/CONCLUSION.
The ASAHI Tornus support catheteristics are substantially equivalent to the specified The ASAH Tornus support catheteristics are Substantially of the same indication for use.
predicate devices and other currently marketed devices for the same indication for us
Bench testing demonstrates that the device functions as intended.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a symbol with three stylized human figures, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.
SEP 26 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asahi Intecc USA, Inc. c/o Mr. Yoshi Terai President, CEO 1301 Dove Street, Suite 350 Newport Beach, CA 92660
Re: K051772
Tornus Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: September 14, 2005 Received: September 14, 2005
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 Please be advised that FDA s issualice of a succession requirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a decermination and Jointinered by other Federal agencies. You must or any Federal statutes and regulations daminders. by J not limited to: registration and listing (21 comply will an the Act 3 requirements, morealing, were and acturing practice requirements as set CFK Part 807), labeling (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (section (over device as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket notification. THC PDA miding of caseballians 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 If you desire spoonie aarree 10. J 276-0120. Also, please note the regulation entitled, Contact the Office of Compullier as (21 ) = 1 minimation" (21CFR Part 807.97). You may obtain Misoraliung by reference to promantee no promantee act from the Division of Small biller gelleral information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donna R. Vachner
Br.
Di
\ 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):
Device Name: ASAHI Tornus Support Catheter
Indications for Use:
The ASAHI Tornus support catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.
中
Prescription Use
(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)
Donna R. Vachner
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K051772
Page
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).