(148 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No
The device is used to facilitate the placement and exchange of guide wires and assist in the delivery of contrast media, which are diagnostic or procedural assist functions, not therapeutic.
No
The device is a microcatheter intended to provide support for guide wire placement and exchange, and to assist in the delivery of contrast media. It is an interventional device, not one used for diagnosis.
No
The device description clearly details physical components like a distal tip, shaft tube, vascular connector, hydrophilic coating, PTFE inner lumen, and reinforcing wires, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used within the body (in vivo) to facilitate procedures in the coronary and peripheral vasculatures. IVDs are used to examine specimens from the body (in vitro), such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an in vivo device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this microcatheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
Product codes
DOY, DQY
Device Description
The ASAHI Caravel consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Caravel has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculatures
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 Caravel to determine substantial equivalence. The following testing/assessments were performed:
- Appearance/Dimensions
- Corrosion Resistance
- Force at Break
- Liquid Leakage under Pressure
- Air Leakage
- Leak and Damage under High Static Pressure
- Radio-Detectability
- Slide Durability
- Kink Resistance
- Shaft Flexibility
The in vitro bench tests demonstrated that the ASAHI Caravel met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.
The ASAHI Caravel was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed: Cytotoxicity
- Intracutaneous Study
- Sensitization
- Systemic Toxicity
- Hemolysis
- In Vivo Thromboresistance
- Partial Thromboplastin Time
- C3a Complement Activation
- Sc5b-9 Complement Activation
- USP Pyrogen
Key Metrics
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Asahi Intecc Co. Ltd. c/o Candace Cederman CardioMed Device Consultants LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228
Re: K152447
Trade/Device Name: Asahi Caravel Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 18, 2015 Received: December 22, 2015
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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152447
Device Name ASAHI Caravel
Indications for Use (Describe)
This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
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 pata 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 nurmber."
3
1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463 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 Caravel
510(k) K152447
| DATE PREPARED: | August 26, 2015 |
|---|---|
| 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 | |
| TRADE NAME: | ASAHI Caravel |
| DEVICE CLASSIFICATION: | Class 2 per 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE | DQY- Catheter, Percutaneous |
| PREDICATE DEVICES: | ASAHI Corsair Microcatheter (K151103) |
Intended Use/Indications for Use
This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.
Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.
4
DESCRIPTION:
The ASAHI Caravel consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Caravel has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.
The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
COMPARISON WITH PREDICATE DEVICES:
Comparisons of the ASAHI Caravel and predicate devices show that the technological characteristics of the ASAHI Caravel 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/indications of the Subject Device are a subset of the primary predicates. There are specific design features of the Subject device that are similar to the primary predicate but not identical. Additional reference devices have been used to demonstrate equivalence for these similar features.
| Name of Device | ASAHI Caravel | ASAHI Corsair Microcatheter |
|---|---|---|
| 510(k) | Current Application | K151103 |
| Intended Use and | ||
| Indications | This microcatheter is intended to | |
| provide support to facilitate the | ||
| placement of guide wires in the | ||
| coronary | ||
| and peripheral | ||
| vasculatures, and can be used to | ||
| exchange one guide wire for | ||
| another. | ||
| This microcatheter is also intended | ||
| to assist in the delivery of contrast | ||
| media into the coronary and | ||
| peripheral vasculatures. | ||
| Do not use this microcatheter other | ||
| than for use in the coronary and | ||
| peripheral vasculatures. | The ASAHI Corsair Microcatheter is | |
| intended to provide support to | ||
| facilitate the placement of Guide | ||
| wires in the coronary and peripheral | ||
| vasculatures and can be used to | ||
| exchange one guide wire for | ||
| another. | ||
| The Corsair Microcatheter is also | ||
| intended to assist in the delivery of | ||
| contrast media into the coronary, | ||
| peripheral, | ||
| and | ||
| abdominal | ||
| vasculatures. | ||
| Sterilization | Provided sterile via Ethylene Oxide to SAL10-6 | |
| Target Body | ||
| Location | Peripheral, Coronary | Coronary, Peripheral |
| Abdominal (contrast media only) | ||
| Hydrophilic | ||
| coating | Yes | |
| Effective Length | 1350 – 1500 mm | 900 - 1500mm |
| Nominal OD | Distal : 0.62mm, Proximal : 0.85 | |
| mm | Distal : 0.75mm, Proximal : 1.0mm | |
| Catheter Shaft | ||
| Mat'l | Polyamide | |
| Polyamide-elastomer Polyurethane | Polyamide-elastomer |
5
Non Clinical testing / Performance Data:
Non clinical laboratory testing was performed on the ASAHI Caravel to determine substantial equivalence. The following testing/assessments were performed:
- Appearance/Dimensions ●
- Corrosion Resistance ●
- Force at Break ●
- Liquid Leakage under Pressure ●
- Air Leakage ●
- Leak and Damage under High Static Pressure ●
- Radio-Detectability
- Slide Durability ●
- Kink Resistance ●
- Shaft Flexibility ●
The in vitro bench tests demonstrated that the ASAHI Caravel met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.
BIOCOMPATIBILITY:
The ASAHI Caravel was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed: Cytotoxicity
- Intracutaneous Study ●
- Sensitization ●
- o Systemic Toxicity
- Hemolysis
- o In Vivo Thromboresistance
- Partial Thromboplastin Time ●
- C3a Complement Activation ●
- Sc5b-9 Complement Activation ●
- USP Pyrogen o
CONCLUSION:
The ASAHI Caravel has identical intended use, a subset of the indications, and the same or 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 Caravel is substantially equivalent to the predicate devices.