(101 days)
CAPERE™ Thrombectomy System (K180722)
Not Found
No
The description focuses on the mechanical aspects of the device (catheters, basket) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Not Found" entries for mentions of AI/ML, image processing, training/test sets, and key metrics further support this conclusion.
Yes
The device is indicated for non-surgical removal of soft emboli and thrombi from blood vessels and is used to capture and mechanically remove emboli and thrombi, which are therapeutic actions.
No
The device is described as a thrombectomy system designed for the non-surgical removal of soft emboli and thrombi from blood vessels, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components (8Fr Delivery Catheter, Funnel Catheter, nitinol wire basket) and describes a mechanical thrombectomy system. The performance studies also focus on hardware-related testing (biocompatibility, package integrity, functional bench testing, simulated use testing, in vivo testing).
Based on the provided information, the CAPERE™ Thrombectomy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- CAPERE™ Thrombectomy System Function: The description clearly states that the CAPERE™ system is used within the body (in vivo) to mechanically remove emboli and thrombi from blood vessels. It is a surgical/interventional device used directly on the patient's anatomy.
The intended use, device description, and performance studies all focus on the physical interaction and removal of material from within the peripheral vasculature, which is the hallmark of an in vivo device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CAPERE™ Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels. o
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. O
The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The CAPERE™ Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE™ Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
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)
The following nonclinical performance testing has been conducted, using the established test methods used in the cleared predicate device, to support the substantial equivalence of the CAPERE™ Thrombectomy System to its predicate device. In all instances, the CAPERE Thrombectomy System functioned as intended under the previously established test methods.
- Biocompatibility of the patient-contacting components of the device was established.
- . Package integrity and accelerated aging studies were completed and demonstrated that the packaging was capable of maintaining a sterile barrier and protecting the device after 2X EO sterilization, simulated handling and shipping, environmental conditioning, and 6-months of accelerated aging in support of a 6-month shelf-life.
- Functional bench testing was conducted (including demonstrated compliance with ● relevant standards such as ISO 10555-1 and ISO 594-1) after 2X EO sterilization, simulated handling and shipping, environmental conditioning and 6-months of aging.
- Simulated Use Testing after 2X EO sterilization, simulated handling and shipping, . environmental conditioning and 6-months of aging was completed to demonstrate that simulated clot can be retrieved under simulated conditions without capture basket rupture, catheter damage, or other adverse device effect.
- Confirmatory In vivo testing in an animal model was performed. Although not strictly required to establish substantial equivalence to the predicate given the minor nature of changes to the predicate (e.q. pre-assembled configuration, smaller diameters), the testing was used to confirm the usability of the system in the pre-assembled 8Fr configuration and gather user feedback on ease of use, etc. in the previously established acute animal model conditions. While, non-GLP, due to the confirmatory nature of the testing, the testing was performed in accordance with all established procedures and methods of the test facility; just without QA audit. The in-vivo testing was also used to confirm that there were no issues with introduction of the delivery catheter to, and deployment of, the funnel and basket, or with the interaction of the system within the vascular blood flow at the treatment site. While all issues were considered low risk, testing was performed out of an abundance of caution and all aspects of the evaluation met the acceptance criteria established by the protocol.
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.
CAPERE™ Thrombectomy System (K180722)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
February 25, 2019
Vascular Medcure, Inc. % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K183179
Trade/Device Name: CAPERE Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: January 28, 2019 Received: January 28, 2019
Dear Ms. Hogan:
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
1
801 and Part 809: 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell 2019.02.25 13:26:14
Gregory O'Connell 205'00' For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183179
Device Name CAPERE Thrombectomy System
Indications for Use (Describe) The CAPERE Thrombectomy System is indicated for:
· Non-surgical removal of soft emboli and thrombi from blood vessels.
- · Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Vascular Medcure, Inc.'s CAPERE™ Thrombectomy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jeffrey P. DuMontelle
Vascular Medcure, Inc.
1500 S. Sunkist Street, Suite H
Anaheim, CA 92806
Office: 657-549-5175
714-915-0886 Cell:
Date Prepared: November 16, 2018
Name of Device
CAPERE™ Thrombectomy System
Common or Usual Name
Embolectomy Catheter
Classification
21 CFR 870.5150, Class II, product code DXE
Predicate Devices
CAPERE™ Thrombectomy System (K180722)
Intended Use / Indications for Use
The CAPERE™ Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels. o
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel. O
The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
Device Description
The CAPERE™ Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE™ Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
4
Technological Characteristics
The CAPERE™ Thrombectomy System has the same technological characteristics as its predicate device CAPERE Thrombectomy Catheter (K180722). Both CAPERE "1" Thrombectomy Systems have either the same components or substantially equivalent components. Each device system includes a funnel or quide catheter, aelivery catheter, and a mechanism for capturing/removing the soft emboli or thrombi. The quide catheter of the predicate uses a 20F guide catheter while the proposed CAPERE™ Thrombectomy System uses an 8Fr funnel catheter. In addition, both systems use guidewires (0.035" for the predicate; 0.014" for the CAPERE™ Thrombectomy System) during the procedure.
The CAPERE "" System includes a Funnel Catheter and a Delivery Catheter. In the same manner as the previously cleared device, the Funnel Catheter and Delivery Catheter are advanced to the therapy site. The funnel catheter is unsheathed, and the Delivery Catheter is then advanced passed the obstruction. A nitinol basket connected to the Delivery Catheter is deployed by retracting the outer sheath of the catheter.
To capture the soft emboli or thrombi ("clot"), the deployed basket is retracted while simultaneously being extended to surround and capture the length of the clot. The Delivery Catheter and clot-load is then retracted into the Funnel Catheter where the clot is captured and can be removed.
The basket design in the CAPERE™ Thrombectomy Systems is exactly the same (nitinol, 10mm diameter, 11.4cm length) as the basket design in the predicate.
Therefore, the subject CAPERE™ Thrombectomy System has the same technological characteristics as its predicate.
Performance Data
The following nonclinical performance testing has been conducted, using the established test methods used in the cleared predicate device, to support the substantial equivalence of the CAPERE™ Thrombectomy System to its predicate device. In all instances, the CAPERE Thrombectomy System functioned as intended under the previously established test methods.
- Biocompatibility of the patient-contacting components of the device was established.
- . Package integrity and accelerated aging studies were completed and demonstrated that the packaging was capable of maintaining a sterile barrier and protecting the device after 2X EO sterilization, simulated handling and shipping, environmental conditioning, and 6-months of accelerated aging in support of a 6-month shelf-life.
- Functional bench testing was conducted (including demonstrated compliance with ● relevant standards such as ISO 10555-1 and ISO 594-1) after 2X EO sterilization, simulated handling and shipping, environmental conditioning and 6-months of aging.
- Simulated Use Testing after 2X EO sterilization, simulated handling and shipping, . environmental conditioning and 6-months of aging was completed to demonstrate that simulated clot can be retrieved under simulated conditions without capture basket rupture, catheter damage, or other adverse device effect.
5
- Confirmatory In vivo testing in an animal model was performed. Although not strictly required to establish substantial equivalence to the predicate given the minor nature of changes to the predicate (e.q. pre-assembled configuration, smaller diameters), the testing was used to confirm the usability of the system in the pre-assembled 8Fr configuration and gather user feedback on ease of use, etc. in the previously established acute animal model conditions. While, non-GLP, due to the confirmatory nature of the testing, the testing was performed in accordance with all established procedures and methods of the test facility; just without QA audit. The in-vivo testing was also used to confirm that there were no issues with introduction of the delivery catheter to, and deployment of, the funnel and basket, or with the interaction of the system within the vascular blood flow at the treatment site. While all issues were considered low risk, testing was performed out of an abundance of caution and all aspects of the evaluation met the acceptance criteria established by the protocol.
Substantial Equivalence
The CAPERE"" Thrombectomy System has the same intended use and indications for use, technological characteristics, and principles of operation as its predicate devices. Nonclinical testing, including functional testing, simulated use testing, and confirmatory in vivo testing in an animal model, demonstrated that the minor differences between the device and predicate (e.g. 8Fr, device length) do not raise new types of safety or effectiveness questions. Thus, the CAPERE™ Thrombectomy System is substantially equivalent to the predicate devices.
Conclusion
Vascular Medcure's CAPERE" is an Embolectomy Catheter, Class II device that has been evaluated in nonclinical testing in accordance with FDA's recognized standards and preestablished acceptance criteria. Testing demonstrated that the device performs as intended. The CAPERE™ is substantially equivalent to its predicate devices.