(147 days)
Not Found
No
The device description focuses on mechanical components and manual manipulation, with no mention of AI or ML capabilities.
No.
The device is intended for the retrieval of foreign objects from the cardiovascular system, which is an interventional procedure rather than a therapeutic treatment.
No
This device is designed to retrieve foreign objects from the cardiovascular system, making it a therapeutic device rather than a diagnostic one. Its function is to remove existing problems, not to identify or diagnose them.
No
The device description clearly outlines physical components such as a shaft, snare, inner rod, and torquer, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Captus Vascular Retrieval System Function: The description clearly states that the Captus Vascular Retrieval System is intended for use within the cardiovascular system to retrieve foreign objects. This is an in vivo procedure, meaning it's performed inside the living body.
The device is a surgical tool used for intervention within the body, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Captus Vascular Retrieval System is intended for use in the cardiovascular system to retrieve foreign objects, including, but not limited to guide wires, coils, balloons, catheters, and filters.
Product codes (comma separated list FDA assigned to the subject device)
MMX
Device Description
The Captus Vascular Retrieval System consists of a flexible polyetheretherketone (PEEK) and Pebax shaft with a nitinol Braided Loop Snare (BLS) on the distal end. The device is designed to capture and retrieve foreign objects from the cardiovascular system. The lumen of the 120 cm long flexible snare shaft contains an inner rod that is secured to the BLS using an ultra-high molecular weight polyethylene (UHMWPE) braided suture. The external torquer is attached to the proximal end of the shaft and supports BLS manipulation. During the procedure, once the distal end has been positioned near the foreign object, the torquer can be turned clockwise (in relation to the shaft) in order to cinch the BLS. This feature allows the foreign object to be more firmly secured before its retrieval.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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)
No FDA performance standards have been established for the Captus System. The following tests were performed to demonstrate safety based on current industry standards:
The following tests were performed to demonstrate biocompatibility of the device: cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility (direct and indirect hemolysis, complement activation, platelet and leukocyte counts, partial thromboplastin time), and material mediated pyrogenicity. Additionally, a thrombogenicity assessment of the device was performed in an ovine model.
The following tests were performed to demonstrate design verification and performance of the device: total length, outer shaft length, BLS outer working length (open), BLS outer diameter (open), BLS inner working length (open), outer shaft (outside diameter), inner shaft (outside diameter), maximum number of turns on torquer, appearance, cross-hair symmetry, distal bond tensile strength, joint strength, torque tensile strength, leak, torque location, and junction tensile strength. Corrosion resistance was performed as well as simulated use testing comparing the subject and predicate devices. A feasibility study documenting the retrieval of various foreign bodies from the vascular system was performed to demonstrate that the device is appropriate with the stated indications.
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.
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2017
Avantec Vascular Corporation % Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, California 92104
Re: K170987
Trade/Device Name: Captus Vascular Retrieval System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: July 28, 2017 Received: July 31, 2017
Dear Allison Komiyama:
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. Isting 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 (DICE) 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" (21 CFR 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 (DICE) 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.
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
Indications for Use
510(k) Number (if known)
Device Name Captus Vascular Retrieval System
Indications for Use (Describe)
The Captus Vascular Retrieval System is intended for use in the cardiovascular system to retrieve foreign objects, including, but not limited to guide wires, coils, balloons, catheters, and filters.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for "AVANTEC VASCULAR". The logo features a stylized letter "A" in blue, with a yellow swoosh above it. The words "AVANTEC" and "VASCULAR" are written in blue, with "VASCULAR" appearing below "AVANTEC" and including the trademark symbol.
510(k) Summary K170987
DATE PREPARED
August 28, 2017
MANUFACTURER AND 510(k) OWNER
Avantec Vascular Corporation 605 W. California Avenue, Sunnyvale, CA 94086, USA Telephone: +1 (408) 329-5489 Fax: Official Contact: Nicholas deBeer, Director of R&D
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
Captus Vascular Retrieval System
COMMON NAME
Device, Percutaneous Retrieval
DEVICE CLASSIFICATION
Embolectomy catheter (21 CFR 870.5150, Product Code MMX Class II)
PREMARKET REVIEW
ODE/DCD/ICDB Cardiovascular Panel
INDICATIONS FOR USE
The Captus Vascular Retrieval System is intended for use in the cardiovascular system to retrieve foreign objects, including, but not limited to guide wires, coils, balloons, catheters, and filters.
DEVICE DESCRIPTION
The Captus Vascular Retrieval System consists of a flexible polyetheretherketone (PEEK) and Pebax shaft with a nitinol Braided Loop Snare (BLS) on the distal end. The device is designed to
4
Image /page/4/Picture/1 description: The image shows the logo for "AVANTEC VASCULAR". The logo is in blue, with a yellow swoosh above the "A" in AVANTEC. The word "VASCULAR" is in a smaller font size and is located below the word "AVANTEC". The TM symbol is located to the right of the word "VASCULAR".
capture and retrieve foreign objects from the cardiovascular system. The lumen of the 120 cm long flexible snare shaft contains an inner rod that is secured to the BLS using an ultra-high molecular weight polyethylene (UHMWPE) braided suture. The external torquer is attached to the proximal end of the shaft and supports BLS manipulation. During the procedure, once the distal end has been positioned near the foreign object, the torquer can be turned clockwise (in relation to the shaft) in order to cinch the BLS. This feature allows the foreign object to be more firmly secured before its retrieval.
PREDICATE DEVICE IDENTIFICATION
The Captus System is substantially equivalent to the following predicates:
| 510(k)
Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|------------------|------------------------------------------------------------------|----------------------|
| K112185 | FourSnare Vascular Retrieval Snare / Cook Inc. | ✓ |
| K092343 | EN Snare Endovascular Snare System / Merit Medical Systems, Inc. | |
| K151497 | EN Snare Endovascular Snare System / Merit Medical Systems, Inc. | |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Captus System. The following tests were performed to demonstrate safety based on current industry standards:
The following tests were performed to demonstrate biocompatibility of the device: cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility (direct and indirect hemolysis, complement activation, platelet and leukocyte counts, partial thromboplastin time), and material mediated pyrogenicity. Additionally, a thrombogenicity assessment of the device was performed in an ovine model.
The following tests were performed to demonstrate design verification and performance of the device: total length, outer shaft length, BLS outer working length (open), BLS outer diameter (open), BLS inner working length (open), outer shaft (outside diameter), inner shaft (outside diameter), maximum number of turns on torquer, appearance, cross-hair symmetry, distal bond tensile strength, joint strength, torque tensile strength, leak, torque location, and junction tensile strength. Corrosion resistance was performed as well as simulated use testing comparing the subject and predicate devices. A feasibility study documenting the retrieval of various foreign bodies from the vascular system was performed to demonstrate that the device is appropriate with the stated indications.
5
Image /page/5/Picture/1 description: The image shows the logo for "AVANTEC VASCULAR". The logo is in blue, with a yellow swoosh above the "A" in AVANTEC. The word "VASCULAR" is in a smaller font size and is located below the word "AVANTEC". The TM symbol is located to the right of the word "VASCULAR".
EQUIVALENCE TO PREDICATE DEVICES
Avantec believes that the Captus System is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has identical indications for use as K112185 and similar design and dimensions as the devices cleared in K092343 and K151497. It uses similar or identical materials as the devices cleared in K112185 and K151497. The subject device has similar technological characteristics to the devices cleared in K112185, K092343, and K151497 and has undergone testing to ensure the device is substantially equivalent to the predicates.
CONCLUSION
Based on the testing performed, including biocompatibility, design validation, corrosion testing, usability testing, and feasibility testing, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Captus System are assessed to be substantially equivalent to the predicate devices.