(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "Peripheral Support Catheter" intended to facilitate the placement of guidewires, exchange guidewires, and assist in the delivery of contrast media. Its primary function is supportive, not to directly treat or cure a disease or condition.
No
The device is described as a "Peripheral Support Catheter" intended to "provide support to facilitate the placement of guide wires" and "assist in the delivery of contrast media". These functions are interventional (supporting other procedures or delivery of substances), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly details a physical catheter with multiple layers, a hub, tip, coating, and markers, 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 describes a device used within the body (in the peripheral vasculature) to facilitate guide wire placement and deliver contrast media. This is an in vivo application.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for therapeutic or procedural support as this catheter is.
N/A
Intended Use / Indications for Use
The CROSSWALK™ Peripheral Support Catheter is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. The CROSSWALK™ Peripheral Support Catheter is also intended to assist in the delivery of contrast media into the peripheral vasculature.
Product codes
DQY
Device Description
The ASAHI CROSSWALK™ Peripheral Support Catheters (PSC) are a single lumen catheter with a three layer construction that is composed of a braid reinforced polymer shaft over a PTFE liner. The catheter also has a proximal female hub, a distal radiopaque atraumatic tip, hydrophilic coating and tungsten loaded radiopaque markers on the distal outer surface of the catheter.
There are three sizes in the family, a 0.035", 0.018" and 0.014" quidewire compatible models, whereas the 0.018" and 0.014" models are designed to fit into the 0.035" model for additional proximal support.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Laboratory testing was performed on the ASAHI CROSSWALK™ Peripheral Support Catheter to determine substantial equivalence. The following tests were performed:
- Visual Inspection
- Corrosion Resistance
- Force Break
- Liquid Leak
- Air Leak
- Radio-Detectability
- Torque Transmission
- Torque Durability
- Slide Durability
- Kink Resistance
- Flow Test
- Dimensions
- Coating Integrity
In the in vitro bench tests demonstrated that the ASAHI CROSSWALK™ Peripheral Support Catheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended, and is substantially equivalent to the predicate devices.
All bench testing of the ASAHI CROSSWALK'™ Peripheral Support Catheter was performed on finished sterilized product. The acceptance criteria were based on ISO10555-1. Tests not conducted per ISO10555-1 were conducted using in-house validated procedures with internally developed acceptance criteria.
All ASAHI CROSSWALK™ Peripheral Support Catheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria. Testing shows that the ASAHI CROSSWALK™ Peripheral Support Catheter is equivalent to the predicate ASAHI Corsair Armet.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 29, 2019
Asahi Intecc Co., Ltd. Cynthia Valenzuela Director, Regulatory Affairs 3002 Dow Avenue, Suite 212 Tustin, California 92780
Re: K192782
Trade/Device Name: ASAHI CROSSWALK Peripheral Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2019 Received: September 30, 2019
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
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) 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 (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-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-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,
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
2
Indications for Use
510(k) Number (if known) K192782
Device Name
ASAHI CROSSWALKTM Peripheral Support Catheter
Indications for Use (Describe)
The CROSSWALK™ Peripheral Support Catheter is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. The CROSSWALK™ Peripheral Support Catheter is also intended to assist in the delivery of contrast media into the peripheral vasculature.
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
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 CROSSWALK™ Peripheral Support Catheter
K192782 510(K)
| DATE PREPARED: | 30SEP2019 |
|---|---|
| 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 | |
| TRADE NAME: | ASAHI CROSSWALK™ Peripheral Support Catheter |
| DEVICE CLASSIFICATION: | Class II, 21CFR§870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE: | DQY, Catheter, Percutaneous |
| PREDICATE DEVICE(S): | Primary Predicate: |
| ASAHI Corsair Armet (K161362) |
Intended Use/Indications for Use
The CROSSWALK™ Peripheral Support Catheter is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. The CROSSWALK™ Peripheral Support Catheter is also intended to assist in the delivery of contrast media into the peripheral vasculature.
4
Device Description:
The ASAHI CROSSWALK™ Peripheral Support Catheters (PSC) are a single lumen catheter with a three layer construction that is composed of a braid reinforced polymer shaft over a PTFE liner. The catheter also has a proximal female hub, a distal radiopaque atraumatic tip, hydrophilic coating and tungsten loaded radiopaque markers on the distal outer surface of the catheter.
There are three sizes in the family, a 0.035", 0.018" and 0.014" quidewire compatible models, whereas the 0.018" and 0.014" models are designed to fit into the 0.035" model for additional proximal support.
Comparison with Predicate Device:
A comparison of the ASAHI CROSSWALK™ Peripheral Support Catheter and predicate devices show that the technological characteristics of the ASAHI CROSSWALK™ such as components. design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.
The intended use/indications of the Subject Device are a subset of the predicate. There are specific design features of the Subject Device that are similar to the predicate which has demonstrated equivalence for these similar features.
| Name of Device | ASAHI Corsair Armet | ASAHI CROSSWALK™ |
|---|---|---|
| 510(K) | K161362 | Current Application |
| Intended Use and Indications | The ASAHI Corsair Armet is | |
| intended to provide support to | ||
| facilitate the placement | ||
| of guide wires in the peripheral | ||
| vasculature, and can be used | ||
| to exchange one guide wire for | ||
| another. The ASAHI Corsair | ||
| Armet is also intended to assist | ||
| in the delivery of contrast | ||
| media into the peripheral | ||
| vasculature. This device should | ||
| not be used in coronary | ||
| vasculature or | ||
| neurovasculature. | The CROSSWALK™ is | |
| intended to provide support to | ||
| facilitate the placement of guide | ||
| wires in the peripheral | ||
| vasculature, and can be used to | ||
| exchange one guide wire for | ||
| another. The CROSSWALK™ | ||
| is also intended to assist in the | ||
| delivery of contrast media into | ||
| the peripheral vasculature. | ||
| Target Body Location | Peripheral | |
| Hydrophilic Coating | Yes | |
| Effective Length | 600-1500mm | 900-1700mm |
| Nominal Outer Diameter | Distal: 0.75mm | |
| Proximal: 0.83mm | Distal | |
| 014: 0.0285in (0.724mm) | ||
| 018: 0.0330in (0.838mm) | ||
| 035: 0.0550in (1.397mm) | ||
| Proximal | ||
| 014: 0.0350in (0.889mm) | ||
| 018: 0.0350in (0.889mm) | ||
| 035: 0.0550in (1.397mm) |
5
| Catheter Shaft Material | Polyamide-elastomer | Polyamide/Polyamide-elastomer |
|---|---|---|
| Distal Tip Length | 1.2mm | 1.0cm (10mm) |
| Single Use | Yes | |
| Sterilization | Ethylene Oxide | |
| SAL | 10-6 | |
| Shelf life | 3 Years | 1 Year |
NON CLINICAL TESTING / PERFORMANCE DATA;
Non Clinical Laboratory testing was performed on the ASAHI CROSSWALK™ Peripheral Support Catheter to determine substantial equivalence. The following tests were performed:
- Visual Inspection ●
- Corrosion Resistance ●
- Force Break ●
- Liquid Leak ●
- Air Leak ●
- Radio-Detectability ●
- Torque Transmission
- Torque Durability
- Slide Durability ●
- Kink Resistance ●
- Flow Test ●
- Dimensions ●
- Coating Integrity ●
In the in vitro bench tests demonstrated that the ASAHI CROSSWALK™ Peripheral Support Catheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended, and is substantially equivalent to the predicate devices.
All bench testing of the ASAHI CROSSWALK'™ Peripheral Support Catheter was performed on finished sterilized product. The acceptance criteria were based on ISO10555-1. Tests not conducted per ISO10555-1 were conducted using in-house validated procedures with internally developed acceptance criteria.
All ASAHI CROSSWALK™ Peripheral Support Catheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria. Testing shows that the ASAHI CROSSWALK™ Peripheral Support Catheter is equivalent to the predicate ASAHI Corsair Armet.
6
BIOCOMPATIBILITY:
The Biological Safety of the ASAHI CROSSWALK™ Peripheral Support Catheter was verified in accordance with the ISO10993-1, Biological Evaluation of Medical Devices. The testing was performed by independent laboratories. The results provided assurance that the peripheral support catheters have a safe biocompatibility profile.
CONCLUSION:
The ASAHI CROSSWALK™ Peripheral Support Catheter has identical intended use, the same 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.
Therefore, the ASAHI CROSSWALK™ Peripheral Support Catheter is substantially equivalent to the predicate device.