(270 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a steerable guide wire, with no mention of AI or ML capabilities.
No
The device is described as a steerable guide wire intended to facilitate the "placement and exchange of diagnostic and therapeutic devices," rather than being a therapeutic device itself.
No
The "Intended Use / Indications for Use" section states that the product is intended to "facilitate the placement and exchange of diagnostic and therapeutic devices," meaning it aids in the use of diagnostic devices, but is not itself a diagnostic device.
No
The device description clearly outlines a physical guide wire constructed from stainless steel, platinum-nickel coil, and various coatings. This is a hardware device, not software.
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 and exchange of diagnostic and therapeutic devices during intravascular procedures." This describes a tool used during a medical procedure, not a device used to perform tests on samples taken from the body (which is the definition of an IVD).
- Device Description: The description details a physical guide wire used for navigation within blood vessels. This is consistent with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is clearly intended for use in vivo (within the living body) to assist with other procedures, rather than in vitro (in glass/outside the body) to diagnose conditions.
N/A
Intended Use / Indications for Use
This product is intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.
Product codes
DOX, DQX
Device Description
The ASAHI Gladius Mongo18 PV ES is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190cm. 235cm and 300cm length. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available pre shaped. The guide wire is constructed from a stainless-steel core wire with platinum-nickel coil. The coil is soldered to the core wire. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The solder of distal end is Au-Sn and other solder is Ag-Sn. The distal end of the quide wire has a radiopaque tip to achieve visibility. For the models covered by this submission, a hydrophilic coating is applied to the quide wire along the distal structure. The proximal section of the guide wire is coated with PTFE. The purpose of these surface coatings is to provide lubricity when guide wire is passed through percutaneous catheters. The basic structure, construction, and coating of the ASAHI Gladius Mongo18 PV ES are unchanged from that previously described in the predicate ASAHI Gladius (K150445).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular
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
The substantial equivalence of the ASAHI Gladius Mongo18 PV ES was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, June 15, 2018.
- Tensile Strength
- Torque Strenath o
- Torqueability ●
- Tip Flexibility ●
- Coating Integrity ●
- Catheter Compatibility
- Visual Inspection ●
- Corrosion Resistance ●
- Kink Resistance
- Radiopacity
- Dimensional Verification ●
- o Particulate
The in vitro bench tests demonstrated that the ASAHI Gladius Mongo18 PV ES met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device and the reference device.
Key Metrics
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
September 7, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Asahi Intecc Co., LTD. Cynthia Valenzuela Director, Regulatory Affairs 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K213868
Trade/Device Name: ASAHI Gladius Mongo18 PV ES Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX
Dear Cynthia Valenzuela:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter for your device cleared on September 6, 2022. Specifically, FDA is updating this SE Letter due to the clearance date (September 6, 2022) not appearing on the original letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lydia Glaw, OHT2: Office of Cardiovascular Devices, (301) 796-1456, Lydia.Glaw(@fda.hhs.gov.
Sincerely,
Samuel G. Raben -S
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Asahi Intecc Co., LTD. Cynthia Valenzuela Director, Regulatory Affairs 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K213868
Trade/Device Name: ASAHI Gladius Mongo18 PV ES Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: July 6, 2022 Received: July 8, 2022
Dear Cynthia Valenzuela:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
2
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continung-education/cdrl-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Samuel G. Raben -S
for Lydia Glaw
Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
ASAHI Gladius Mongo18 PV ES
Indications for Use (Describe)
This product is intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.
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."
FORM FDA 3881 (6/20)
Page 1 of 1
4
510(K) Summary
[as required by 21CFR § 807.92(c)]
SAHI INTECC CO.,LTD. Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL : +81-561-48-5551 FAX : +81-561-48-5552 http://www.asahi-intecc.co.jp/
ASAHI Gladius Mongo18 PV ES
510(K) K213868
| DATE PREPARED: | 30, August 2022 |
|---|---|
| APPLICANT: | ASAHI INTECC CO., LTD. |
| 3-100 Akatsuki-cho, Seto | |
| Aichi 489-0071, Japan | |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela |
| Director, Regulatory Affairs | |
| ASAHI INTECC USA, INC. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, California 92780 | |
| Phone: (714) 442 0575 | |
| Fax: (949) 377 3255 | |
| Email: cynthiav@asahi-intecc-us.com | |
| ALTERNATE CONTACT: | Mr. Hiroshi Obara |
| Manager, Regutatory, Affairs | |
| ASAHI INTECC CO., INC. | |
| 3-100 Akatsuki-cho | |
| Seto, Aichi, Japan 489-0071 | |
| Email: yoshi@asahi-intecc-us.com | |
| TRADE NAME: | ASAHI Gladius Mongo18 PV ES |
| DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 |
| CLASSIFICATION NAME: | Catheter Guide Wire |
| PRODUCT CODE: | DQX |
| PREDICATE DEVICE(S): | ASAHI Peripheral Guide Wires (K150445) |
| REFERENCE DEVICE(S): | ASAHI PTCA Guide Wire FIELDER XT (K072431) |
| ASAHI PTCA Guide Wires, ASAHI Peripheral Guide | |
| Wires, ASAHI Guide Wire Extension (K163426) | |
| ASAHI PTCA Guide Wire ASAHI Gladius Mongo | |
| (K180784) |
Intended Use/Indications for Use:
This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
5
Description:
The ASAHI Gladius Mongo18 PV ES is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190cm. 235cm and 300cm length. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available pre shaped. The guide wire is constructed from a stainless-steel core wire with platinum-nickel coil. The coil is soldered to the core wire. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The solder of distal end is Au-Sn and other solder is Ag-Sn. The distal end of the quide wire has a radiopaque tip to achieve visibility. For the models covered by this submission, a hydrophilic coating is applied to the quide wire along the distal structure. The proximal section of the guide wire is coated with PTFE. The purpose of these surface coatings is to provide lubricity when guide wire is passed through percutaneous catheters. The basic structure, construction, and coating of the ASAHI Gladius Mongo18 PV ES are unchanged from that previously described in the predicate ASAHI Gladius (K150445).
Accessory
There are no accessories packed with ASAHI Gladius Mongo18 PV ES.
| Predicate | Device Name | 510(K) Number |
|---|---|---|
| Primary Predicate | ASAHI Gladius | K150445 |
| Reference Device | FIELDER XT | K072431 |
| Reference Device | ASAHI PTCA Guide Wires, | |
| ASAHI Peripheral Guide Wires, | ||
| ASAHI Guide Wire Extension | K163426 | |
| Reference Device | ASAHI Gladius Mongo | K180784 |
Comparison with Predicate Device and Reference Device:
The subject device has the following similarities to those which previously received 510(k) clearance.
- Have the same intended use and indications for use
- . Use the same operating principle;
- Incorporate the same basic designs; and ●
- Incorporate the same materials ●
6
| Name of Devices | ASAHI Gladius Mongo18 PV ES | ASAHI Gladius |
|---|---|---|
| Subject | Predicate | |
| K213868 | K150445 | |
| ASAHI INTECC | ASAHI INTECC | |
| 510(k) | ||
| Manufacturer | ||
| Classification Regulation | 21 CFR 830.1330, Cardiovascular | |
| Common Name | Catheter Guide Wire | |
| Product Code | DQX | |
| Class | II | |
| Intended Use | Guide wire for percutaneous intervention | |
| Indications for Use | This product is intended to facilitate the placement and | |
| exchange of diagnostic and therapeutic devices during | ||
| intravascular procedures. This device is intended for peripheral | ||
| vascular use only. | This product is intended to facilitate the placement and | |
| exchange of diagnostic and therapeutic devices during | ||
| intravascular procedures. This device is intended for peripheral | ||
| vascular use only. | ||
| Nominal OD | 0.46mm (0.018inch) | 0.36mm (0.014inch) |
| 0.46mm (0.018inch) | ||
| Overall Length | 190cm, 235cm, 300cm | 190cm, 235cm,300cm |
| Outer Coil | Pt-Ni | Pt-Ni and SUS |
| Tapered Core Wire | SUS | SUS |
| Inner Structure | SUS Coil | SUS Coil |
| Tip Shape | Straight, Pre-shape | Straight, Pre-shape |
| Coating | Hydrophilic | |
| Hydrophobic | Hydrophilic | |
| Hydrophobic | ||
| Sterilization | Provided sterile via Ethylene Oxide to SAL 10-6 | Provided sterile via Ethylene Oxide to SAL 10-6 |
Comparison with Predicate Device
7
Non Clinical Testing / Performance Data:
The substantial equivalence of the ASAHI Gladius Mongo18 PV ES was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, June 15, 2018.
- Tensile Strength
- Torque Strenath o
- Torqueability ●
- Tip Flexibility ●
- Coating Integrity ●
- Catheter Compatibility
- Visual Inspection ●
- Corrosion Resistance ●
- Kink Resistance
- Radiopacity
- Dimensional Verification ●
- o Particulate
The in vitro bench tests demonstrated that the ASAHI Gladius Mongo18 PV ES met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device and the reference device.
BIOCOMPATIBILITY:
The ASAHI Gladius Monqo 18 PV ES was compared to the predicate and reference devices. Based on similarities of the materials used in the subject device to its predicate and reference, the biocompatibility of the ASAHI Gladius Mongo18 PV ES was verified to be the same as those of the predicate and reference devices.
CONCLUSION:
The ASAHI Gladius Mongo18 PV ES has similar intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate device. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI Gladius Mongo18 PV ES is substantially equivalent to the predicate device.