(108 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of software, algorithms, or data processing that would indicate AI/ML. The mention of radioscopy is for visualization, not for automated analysis or decision-making by the device itself.
No
The device is a guide wire used to facilitate the placement of other therapeutic devices (balloon dilatation catheters), but it does not directly provide therapy itself.
No
The device is described as a guide wire intended to facilitate the placement of balloon dilatation catheters for PTCA/PTA procedures, which are interventional treatments. It does not gather information for diagnosis.
No
The device description clearly details a physical guide wire with a core wire, coil assembly, coatings, and radiopaque distal portion, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This is an interventional procedure performed in vivo (within the body).
- Device Description: The description details a physical guide wire used to navigate within blood vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis of specimens.
The mention of radioscopy is for visualizing the device's position within the body during the procedure, not for analyzing a specimen.
N/A
Intended Use / Indications for Use
ASAHI PTCA Guide Wires are 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 neurovasculature.
Product codes
DQX
Device Description
The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire. and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wire: ASAHI SUOH® 03. The distal portion of the guidewire has a hydrophilic coating, and the proximal portion of the guidewire is coated with PTFE. The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available Asahi Intecc extension wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary and Peripheral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical laboratory testing was performed on the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 to determine substantial equivalence. The following testing/assessments were performed:
- . Tensile Strength
- Torque Strength ●
- Torqueability
- Tip Flexibility
- Coating Adhesion/ Coating Integrity
- Catheter Compatibility ●
- Particulate Testing / Coating Integrity ●
The in vitro bench tests demonstrated that the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Asahi Intecc Co., Ltd. % Candace Cederman Senior Regulatory Affairs Consultant Cardiomed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, Maryland 21228
Re: K162842
Trade/Device Name: Asahi PTCA Guide Wire Asahi SUOH 03 Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 29, 2016 Received: December 30, 2016
Dear Ms. Cederman:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
Page 2 - Candace Cederman
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Fernando Agnel
Fernando Aguel-S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162842
Device Name ASAHI® PTCA Guide Wire ASAHI SUOH® 03
Indications for Use (Describe)
ASAHI PTCA Guide Wires are 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 neurovasculature.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
ASAHI INTECC CO.,LTD.
1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463-0024 Japan Tel. +81-52-768-1211 Fax. +81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi
510(k) Summary [as required by 21 CFR 807.92(c)]
ASAHI® PTCA Guide Wire ASAHI SUOH® 03 510(k) __
| DATE PREPARED: | October 7, 2016 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 1703 Wakita-cho, Moriyama-ku | |
| Nagoya, Aichi 463-0024, Japan | |
| CONTACT | 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: ASAHI.ra-fda@ASAHI-intecc.com | |
| TRADE NAME: | ASAHI® PTCA Guide Wire |
| • ASAHI SUOH® 03 | |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | DQX- Catheter Guide Wire |
| PREDICATE DEVICES: | ASAHI® PTCA Guide Wire: |
| • ASAHI® SION® blue (K122468) | |
| • ASAHI® SUOH® (K083904) | |
| REFERENCE DEVICES: | ASAHI® PTCA Guide Wire: |
| • ASAHI RG3 (K141339) | |
| ASAHI® Neurovascular Guide Wire: | |
| • ASAHI CHIKAI black, 300cm (K141751) |
Intended Use/Indications for Use ASAHI® PTCA GUIDE WIRE: ASAHI SUOH® 03
ASAHI PTCA Guide Wires are 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 neurovasculature.
4
Device Description:
The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire. and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wire: ASAHI SUOH® 03. The distal portion of the guidewire has a hydrophilic coating, and the proximal portion of the guidewire is coated with PTFE. The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available Asahi Intecc extension wire.
Comparison with predicate device:
Comparisons of the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 and predicate devices show that the technological characteristics of the Subject device such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices. The intended use of the Subject Device and its predicates are the same.
| | ASAHI® PTCA Guide
Wire:
ASAHI SUOH 03 | ASAHI® PTCA
Guide Wire:
ASAHI SUOH | ASAHI® PTCA
Guide Wire:
ASAHI SION blue |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Device | | | |
| | | | |
| 510(k) | Current Application | K083904 | K122468 |
| Intended Use and
Indications | 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
neurovasculature. | intended to facilitate
the placement of
balloon dilatation
catheters during
percutaneous
transluminal coronary
angioplasty (PTCA)
and percutaneous
transluminal
angioplasty (PTA).
The Asahi SUOH
PTCA Guide Wires
are not to be used in
the cerebral blood
vessel. | 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
vessels. |
| Target Body
Location | Coronary and Peripheral | | |
| Overall Lengths | 190cm and 300cm | 180cm and 300cm | 180cm and 300cm |
| Nominal OD | 0.014 in | | |
| Outer Coil Material | Platinum-Nickel, Stainless Steel | | |
| Core Wire Material | Stainless Steel | | |
| Distal Coating | Hydrophilic coating | | |
| Proximal Coating | PTFE | | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | | |
| Shelf Life | 3 Years | | |
5
Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 to determine substantial equivalence. The following testing/assessments were performed:
- . Tensile Strength
- Torque Strength ●
- Torqueability
- Tip Flexibility
- Coating Adhesion/ Coating Integrity
- Catheter Compatibility ●
- Particulate Testing / Coating Integrity ●
The in vitro bench tests demonstrated that the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate devices.
BIOCOMPATIBILITY:
The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 was compared to the predicate and reference devices. Based on similarities of the materials used the subject device to its predicates / reference devices, the in biocompatibility of the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 was verified to be the same as those of the predicates / reference devices.
CONCLUSION:
The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 has identical intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference devices. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 is substantially equivalent to the predicate device.