(114 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.
No.
The device is a guide wire intended to facilitate the placement of balloon dilatation catheters, which are the therapeutic devices used in PTCA and PTA procedures, not a therapeutic device itself.
No
The device is a guide wire used to facilitate the placement of other catheters, not to diagnose a condition.
No
The device description clearly details a physical guide wire made of core wire, coil assembly, and coatings. The performance studies also focus on physical properties like tensile strength, torque strength, and coating adhesion, which are characteristic of a hardware device, not software.
No, 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 describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical guide wire used within the body.
- Anatomical Site: The anatomical site is the "Coronary and Peripheral vasculature," which are parts of the patient's circulatory system.
- Input Imaging Modality: The input imaging modality is "Radioscopy," which is used to visualize the device's position within the patient's body during the procedure.
- Performance Studies: The performance studies are bench tests evaluating the physical properties and performance of the guide wire itself, not tests on biological samples.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description. It is a medical device used in vivo (within the living body) during a medical procedure.
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 Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil 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 the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. 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 vasculature
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
Non-clinical laboratory testing was performed on the ASAHI® PTCA Guide Wire ASAHI Gladius Mongo to to determine substantial equivalence. The following testing/assessments were performed:
- Tensile Strength
- Torque Strength
- Torqueability
- TipFlexibility
- Coating Adhesion
- Catheter Compatibility
- Particulate Testing/ Coating Integrity
- Lubricity Testing
The in vitro bench tests demonstrated that the ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the devices functions as intended, and have a safety and effectiveness profile that is similar to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K163426, K162842, K141339, K133865, K122469, K101986, K043422, K141751, K150445
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 18, 2018
Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 3168 Braverton Street, Suite 200 Edgewater, Maryland 21037
Re: K180784
Trade/Device Name: ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 20, 2018 Received: June 21, 2018
Dear Candace 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Michael John -S 2018.07.18 15:29:55 -04'00'
for 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)
Device Name
ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
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.
3-100 Akatsuki-cho, Seto, Aichi 489-0071 Japan Tel. +81-561-48-5551 Fax. +81-561-48-5552 Branch o ffice : Tokyo, Nagoya, Osaka, Hong Kong, EU, S ingapore, Beijin g, Ind ia, Middle Eastern Research Facilitie s and Factorie s: Osaka, Seto, Thail and, Hanoi
510(k) Summary [as required by 21 CFR 807.92(c)]
ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES
510(k) 180784
| DATE PREPARED: | July 18, 2018 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 3-100 Akatsuki-cho | |
| Seto, Aichi 489-0071, 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@ASAH-lintecc.com | |
| TRADE NAME: | ASAHI® PTCA Guide Wire: |
| ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES | |
| 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® Fielder XT-A (K153106) | |
| REFERENCE DEVICES: | ASAHI®Guide Wire Family (K163426) |
| ASAHI® PTCA Guide Wire | |
| • ASAHI SUOH 03 (K162842) | |
| • ASAHI RG3 (K141339) | |
| • ASAHI Gaia (K133865) | |
| • ASAHI SION (K122469) | |
| • ASAHI ULTIMATEbros 3 (K101986) | |
| • ASAHI Grand Slam (K043422) | |
| ASAHI®Chikai Guide Wires (K141751) | |
| ASAHI®Peripheral Guide Wire ASAHI Gladius | |
| (K150445) |
INTENDED USE/INDICATIONS FOR USE
ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 (ES)
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 Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil 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 the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. 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 Gladius Mongo 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.
| Name of Device | ASAHI® PTCA Guide Wire ASAHI
Gladius Mongo 14 and ASAHI
Gladius Mongo 14 ES | ASAHI® PTCA Guide Wire
ASAHI Fielder XT-A |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | Subject | Predicate |
| 510(k) | TBD | K153106 |
| Intended Use and
Indications | 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. | |
| Target Location | Coronary and Peripheral vasculature | |
| Nominal OD | 0.36mm (0.014 inch) | |
| Overall Lengths | 190cm and 300cm | |
| Outer Coil Material | ASAHI Gladius Mongo 14:
Platinum-Nickel, Stainless Steel
ASAHI Gladius Mongo 14 ES:
Platinum-Nickel | Platinum-Nickel |
| Inner Coil Material | Stainless Steel | |
| Core Wire Material | Stainless Steel | |
| Undercoating | Polyurethane | |
| Outer Distal Coating | Hydrophilic coating | |
| Proximal Coating | PTFE | |
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Shelf Life | 3 years | |
NON-CLINICAL TESTING/ PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the ASAHI® PTCA Guide Wire ASAHI Gladius Mongo to to determine substantial equivalence. The following testing/assessments were performed:
- Tensile Strength
- . Torque Strength
5
- Torqueability
- . TipFlexibility
- . Coating Adhesion
- . Catheter Compatibility
- Particulate Testing/ Coating Integrity .
- . Lubricity Testing
The in vitro bench tests demonstrated that the ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the devices functions as intended, and have a safety and effectiveness profile that is similar to the predicate devices.
BIOCOMPATIBLIITY:
The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo were compared to the predicate and reference devices. Based on similarities of the materials used in the subject device to its predicates / reference devices, the biocompatibility of the ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES were verified to be the same as those of the predicate / reference devices.
CONCLUSION:
The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo have 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 Gladius Mongo 14 and ASAHI Gladius Monqo 14 ES are substantially equivalent to the predicate device.