(256 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a dual lumen catheter, with no mention of AI or ML technologies.
No.
The device is used to facilitate placement of other interventional devices and to infuse diagnostic or therapeutic agents, but it is not itself a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states that the product is intended "to subselectively infuse/deliver diagnostic or therapeutic agents," which includes diagnostic agents.
No
The device description clearly outlines a physical catheter with multiple lumens, a shaft, tip, connector, hydrophilic coating, and a radiopaque marker. It is a tangible medical 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 clearly describes a device used in vivo (within the body) to access blood vessels, facilitate placement of other devices, and deliver agents. This is a therapeutic and interventional use, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a catheter designed to be inserted into the arterial vasculature. This is consistent with an in vivo device.
- Input Imaging Modality: The use of X-ray fluoroscopy is for visualizing the device's position within the body during the procedure, not for analyzing biological samples.
- Anatomical Site: The specified anatomical sites are within the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
This product is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary arterial vasculature and peripheral vessels, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures, and to subselectively infuse/deliver diagnostic or therapeutic agents. Not for use in the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The ASAHI SASUKE® Dual Lumen Catheter is a sterile single use device designed for use in the arterial vasculature. The ASAHI SASUKE® is a catheter that has two lumens: an over-the-wire lumen that extends across the length of the catheter, and a rapid exchange lumen installed at the distal end. This product consists of a tip, shaft, protector and connector. The surface of the distal section of the shaft of this product is coated with hydrophilic coating. In addition, a radiopaque marker is provided between the tip and the shaft of the product, enabling the user to view the position of the tip under X-ray fluoroscopy. The device packaging includes a needle to flush the lumens prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray fluoroscopy
Anatomical Site
coronary arterial vasculature and peripheral vessels
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 SASUKE® to determine substantial equivalence. The following testing/assessments were performed:
- Appearance/Dimensions ●
- Corrosion Resistance .
- Force at Break ●
- Liquid Leakage under Pressure
- Air Leakage
- Radio-Detectability
- Slide Durability
- Kink Resistance
- Particulate and Coating Integrity testing ●
The in vitro bench tests demonstrated that the ASAHI SASUKE® met all acceptance criteria. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate and reference devices.
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.
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.
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
§ 870.1250 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "HUMAN SERVICES-USA" around the edge. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 22, 2019
Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 1783 Forest Drive #254 Annapolis, Maryland 21401
Re: K182844
Trade/Device Name: ASAHI SASUKE Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 22, 2019 Received: May 24, 2019
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. 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.
1
Page 2
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 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 (QS) 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-continuing-education/cdrh-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-regulatory-assistance/contact-usdivision-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.
for Kenneth Cavanaugh, Ph.D. Director (Acting) DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name ASAHI® SASUKE®
Indications for Use (Describe)
This product is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary arterial vasculature and peripheral vessels, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures, and to subselectively infuse/deliver diagnostic or therapeutic agents. Not for use 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
Image /page/3/Picture/0 description: The image shows the logo for ASAHI INTECC CO.,LTD. The logo features a red stylized "A" on the left, followed by the company name in a dark green sans-serif font. The letters are bold and slightly blurred, giving the logo a modern and professional appearance. The company name is followed by a comma and the letters 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) Summarv
[as required by 21 CFR 807.92(c)]
ASAHI SASUKE®
510(k) K182844
| DATE PREPARED: | June 21, 2019 |
|---|---|
| APPLICANT | ASAHI INTECC CO., LTD. |
| 1703 Wakita-cho, Moriyama-ku | |
| Nagoya, Aichi 463-0024. Japan | |
| CONTACT | Yoshi Terai |
| President/CEO | |
| ASAHI INTECC USA,INC. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, CA 92780 | |
| Tel: (949) 756-8252, FAX: (949) 756-8165 | |
| e-mail: ASAHI.ra-fda@ASAHI-intecc.com | |
| TRADE NAME: | ASAHI SASUKE® |
| DEVICE | |
| CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION | |
| NAME: | Percutaneous Catheter |
| Product Code | DQY- Catheter, Percutaneous |
| PREDICATE DEVICE: | Twin-Pass Dual Access Catheter (K060327) |
| REFERENCE DEVICE | ASAHI Caravel (K152447) |
INDICATIONS FOR USE FOR THE ASAHI SASUKE®
This product is intended to be used in conjunction with steerable quidewires in order to access discrete regions of the coronary arterial vasculature and peripheral vessels, to facilitate placement of guidewires and other interventional devices, for use during two guidewire procedures, and to subselectively infuse/deliver diagnostic or therapeutic agents. Not for use in the neurovasculature.
DESCRIPTION:
The ASAHI SASUKE® Dual Lumen Catheter is a sterile single use device designed for use in the arterial vasculature. The ASAHI SASUKE® is a catheter that has two lumens: an over-the-wire lumen that extends across the length of the catheter, and a rapid exchange lumen installed at the distal end. This product consists of a tip, shaft, protector and connector. The surface of the distal section of the shaft of this product is coated with hydrophilic coating. In addition, a radiopaque
4
marker is provided between the tip and the shaft of the product, enabling the user to view the position of the tip under X-ray fluoroscopy. The device packaging includes a needle to flush the lumens prior to use.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the ASAHI SASUKE® and predicate device show that the technological characteristics of the Subject device such as the design, materials, sterilization method, and operating principle are similar to currently marketed predicate devices. The minor differences between the Subject and predicate device do not raise any new questions of safety or effectiveness.
The indications for use between the Subject Device and its primary predicate are the same.
| Name of Device | ASAHI SASUKE® | Twin-Pass Dual Access
Catheter |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Current Application | K060327 |
| Indications for Use | This product is intended to be
used in conjunction with
steerable guidewires in order to
access discrete regions of the
coronary arterial vasculature
and peripheral vessels, to
facilitate placement of
guidewires and other
interventional devices, for use
during two guidewire
procedures, and to
subselectively infuse/deliver
diagnostic or therapeutic
agents.
Not for use in the
neurovasculature. | The Twin-Pass catheter is
intended to be used in
conjunction with steerable
guidewires in order to access
discrete regions of the coronary
and peripheral arterial
vasculature, to facilitate
placement and exchange of
guidewires and other
interventional devices, for use
during two guidewire
procedures and to
subselectively infuse/deliver
diagnostic or therapeutic
agents. |
| Sterilization | Provided sterile via Ethylene
Oxide | Same |
| Sterility Assurance Level | SAL10-6 | Same |
| Effective Length | 145cm | 135 cm |
| Guidewire Compatibility | 0.014" (0.36mm) | Same |
| Outer Diameter (shaft) | 1.05mm (proximal)
1.08mm (distal) | 0.97mm, 1.14 mm (proximal)
1.19mm, 1.35 mm (distal) |
| Outer Diameter (tip) | Tapered from 0.50 to 0.72mm | 0.66mm |
| Distal Coating | Hydrophilic | Same |
| Single Use | Yes | Same |
| Radiopaque? | Yes, with Marker Band | Same |
Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the ASAHI SASUKE® to determine substantial equivalence. The following testing/assessments were performed:
- Appearance/Dimensions ●
- Corrosion Resistance .
5
- Force at Break ●
- Liquid Leakage under Pressure
- Air Leakage
- Radio-Detectability
- Slide Durability
- Kink Resistance
- Particulate and Coating Integrity testing ●
The in vitro bench tests demonstrated that the ASAHI SASUKE® met all acceptance criteria. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate and reference devices.
BIOCOMPATIBILITY:
The ASAHI SASUKE® was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed:
- . Cytotoxicity
- Intracutaneous ●
- Sensitization ●
- Systemic Toxicity ●
- USP Pyrogen
- Hemolysis
- Sc5b-9 Complement Activation ●
- In Vivo Thrombogenicity
- Partial Thromboplastin Time ●
- Platelet and Leukocyte Binding
Conclusion:
The ASAHI SASUKE® has the same intended use and indications, and the same or similar technological characteristics such as design, materials, sterilization method, performance, and operating principles as the predicate and reference devices. Performance data demonstrates that the device functions as intended.
Therefore, the ASAHI SASUKE® is substantially equivalent to the predicate and reference devices.