(89 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML.
No
The device is a guide wire intended to facilitate the placement of balloon dilatation catheters, not to directly treat a condition. While it is used in therapeutic procedures (PTCA/PTA), it is an accessory device, not a therapeutic device itself.
No
Explanation: The device, ASAHI PTCA Guide Wire, is described as a tool to facilitate the placement of balloon dilatation catheters during angioplasty procedures. Its function is to guide other medical devices, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like a core wire, coils, and coatings, 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 is to facilitate the placement of balloon dilatation catheters during PTCA and PTA procedures. This is a direct intervention within the body for therapeutic purposes.
- Device Description: The device is a physical guide wire used to navigate within blood vessels.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Input Imaging Modality: The device is used in conjunction with radioscopy, which is an imaging technique used to visualize the device's position during the procedure, not to analyze biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
DQX
Device Description
The product, ASAHI PTCA Guide Wire ASAHI Gaia (hereafter ASAHI Gaia), is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The basic structure of ASAHI Gaia consists of a tapered core wire and coils. There are currently three models of the ASAHI Gaia:
- ASAHI Gaia First ●
- ASAHI Gaia Second ●
- . ASAHI Gaia Third
Each of these models share similar design characteristics and have the same maximum outside diameter. The models differ in the distal diameter.
The ASAHI Gaia consists of a tapered core wire and two distal coils: an inner and outer coil. The outer coil is radiopaque so as to be easily confirmed of its position under radioscopy. The distal part of the ASAHI Gaia is tapered. The distal tip of the ASAHI Gaia is available straight or pre-shaped.
In addition, coatings are applied on the surface of the product. The distal part is coated with hydrophilic polymer, and the proximal part is coated with PTFE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Gaia to determine substantial equivalence. The following testing assessments were performed:
- . Tensile Strength
- Torque Strength .
- Torqueablity .
- Tip Flexibility .
- Coating Adhesion/Integrity .
- . Catheter Compatibility
- Coating Integrity and Acute Particulate Characterization .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K101986, K100578, K122469, K041531, K043422
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Premarket Notification ASAHI PTCA Guidewire ASAHI Gaia
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 Gaia
510(k) K133865
| 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: asahi.ra-fda@asahi-intecc.com |
| DEVICE NAME: | ASAHI PTCA Guide Wire ASAHI Gaia |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §870.1330 |
| CLASSIFICATION NAME: | Catheter, Guide, Wire |
| PRODUCT CODE | DQX- Catheter Guide Wire |
| PREDICATE DEVICES: | K101986 - ASAHI UltimateBros3 PTCA Guide Wire
K100578 - ASAHI SION PTCA Guide Wire
K122469 - ASAHI SION J PTCA Guide Wire
K041531 - ASAHI PTCA Guide Wire Confianza Pro
K043422 - ASAHI PTCA Guide Wire, J Shape series (ASAHI
Confianza Pro J) |
| DATE PREPARED: | March 7, 2014 |
.
1
Premarket Notification ASAHI PTCA Guidewire ASAHI Gaia
INTENDED 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.
DESCRIPTION:
The product, ASAHI PTCA Guide Wire ASAHI Gaia (hereafter ASAHI Gaia), is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The basic structure of ASAHI Gaia consists of a tapered core wire and coils. There are currently three models of the ASAHI Gaia:
- ASAHI Gaia First ●
- ASAHI Gaia Second ●
- . ASAHI Gaia Third
Each of these models share similar design characteristics and have the same maximum outside diameter. The models differ in the distal diameter.
The ASAHI Gaia consists of a tapered core wire and two distal coils: an inner and outer coil. The outer coil is radiopaque so as to be easily confirmed of its position under radioscopy. The distal part of the ASAHI Gaia is tapered. The distal tip of the ASAHI Gaia is available straight or pre-shaped.
In addition, coatings are applied on the surface of the product. The distal part is coated with hydrophilic polymer, and the proximal part is coated with PTFE.
COMPARISON TO PREDICATE DEVICES:
Comparisons of the ASAHI PTCA Guide Wire ASAHI Gaia and predicate devices show that the technological characteristics of the ASAHI Gaia such as the intended use, components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate devices. The Gaia guidewire combines the torqueability and crossability of two predicate devices, therefore allowing for more choice for the physician.
NON CLINICAL TESTING / PERFORMANCE DATA:
Non clinical laboratory testing was performed on the ASAHI Gaia to determine substantial equivalence. The following testing assessments were performed:
- . Tensile Strength
- Torque Strength .
2
Premarket Notification ASAHI PTCA Guidewire ASAHI Gaia
- Torqueablity .
- Tip Flexibility .
- Coating Adhesion/Integrity .
- . Catheter Compatibility
- Coating Integrity and Acute Particulate Characterization .
BIOCOMPATIBILITY:
The ASAHI Gaia was compared to the predicate devices. Based on similarities of the materials used in the subject device to its predicates, the biocompatibility of the ASAHI Gaia was verified to be the same as those of predicates.
CONCLUSION:
The ASAHI Gaia has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and is as safe and effective as its predicates.
Therefore, the ASAHI PTCA Guide Wire is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized, flowing lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2014
Asahi Intecc USA Inc. c/o Semih Oktav, PhD President CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K133865
Trade/Device Name: ASAHI PTCA Guide Wire - ASAHI Gaia Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 18, 2013 Received: December 19, 2013
Dear Dr. Oktay:
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
4
Page 2 - Semih Oktay
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
M. A. Hillman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification ASAHI PTCA Guide Wire ASAHI Gaia
Indications for Use
510(k) Number (if known): K133865
Device Name:
ASAHI PTCA Guide Wire ASAHI Gaia
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.
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)
M. A. Heileman
Page 1 of 1
Asahi Intecc Co., Ltd