(27 days)
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.
The CAPERE® Thrombectomy System primarily consists of an 12Fr Delivery Catheter and 15Fr Guide 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.
The provided text describes the 510(k) premarket notification for the CAPERE® Thrombectomy System, focusing on its substantial equivalence to a predicate device (K180722). However, it does not contain a specific acceptance criteria table with reported device performance metrics in the format requested.
The document primarily discusses the nonclinical performance testing conducted to support substantial equivalence. It does not detail a clinical study with human patients for AI/device performance evaluation as implied by some of the questions (e.g., MRMC studies, standalone algorithm performance, AI improvement for human readers). The device described is a medical device for thrombectomy, not an AI/ML algorithm requiring ground truth from experts or large datasets for training and testing in the typical sense of AI product evaluation.
Based on the provided information, I can answer the following:
1. A table of acceptance criteria and the reported device performance
The document states that "the CAPERE® Thrombectomy System functioned as intended under the previously established test methods" and "demonstrated that the CAPERE® Thrombectomy System maintained the predicate characteristics." It also mentions "preestablished acceptance criteria" but without listing them explicitly or providing specific numerical results.
However, based on the descriptions of the tests, we can infer some of the implicit acceptance criteria:
| Acceptance Criteria Category | Reported Device Performance (Implicitly Met) |
|---|---|
| Biocompatibility | No differences in materials between subject and predicate device; confirmed biocompatibility. |
| Packaging | Packaging capable of maintaining a sterile barrier and protecting the device after sterilization, simulated handling/shipping, environmental conditioning, and accelerated aging for a 6-month shelf-life. |
| Functional Bench Testing | Compliance with relevant standards (ISO 10555-1 and ISO 594-2) for bond joints; maintained predicate characteristics despite reduced diameter. |
| Simulated Use Testing | Simulated clot retrieved under simulated conditions without capture basket rupture, catheter damage, or other adverse device effect; maintained predicate characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes nonclinical performance testing (bench and simulated use testing) rather than a clinical study with human patient data. Therefore, the concept of a "test set" and "data provenance" in the context of human data is not directly applicable here. The testing involved device components and simulated clots. No information is provided regarding the specific number of devices or simulated clots used for each test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. The study described is nonclinical performance testing of a physical medical device, not an AI algorithm evaluated against expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There was no clinical study with expert readers requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The CAPERE® Thrombectomy System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the nonclinical performance tests would be defined by the engineering and quality standards for device functionality. For example:
- Biocompatibility: Confirmation against established biological safety standards.
- Packaging: Ability to maintain sterility and physical integrity as per accelerated aging and handling protocols.
- Functional Bench Testing: Compliance with ISO standards (e.g., ISO 10555-1 for sterile single-use catheters, ISO 594-2 for conical fittings) and maintenance of mechanical characteristics (e.g., bond strength, dimension).
- Simulated Use Testing: Successful retrieval of simulated clots without device failure (rupture, damage) as per predefined criteria.
8. The sample size for the training set
This question is not applicable. There is no mention of a "training set" for an AI algorithm. The studies are nonclinical performance tests of a physical device.
9. How the ground truth for the training set was established
This question is not applicable.
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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.
March 4, 2020
Vascular Medcure, Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K200314
Trade/Device Name: Capere Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: February 6, 2020 Received: February 6, 2020
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
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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,
Gregory O'Connell 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
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Indications for Use
510(k) Number (if known) K200314
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K200314 - 510(k) SUMMARY
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: February 20, 2020
Name of Device
CAPERE® Thrombectomy System
Common or Usual Name
Embolectomy Catheter
Classification
21 CFR 870.5150, Class II, product code QEW, KRA
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 12Fr Delivery Catheter and 15Fr Guide 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.
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Technological Characteristics
The CAPERE® Thrombectomy System has the same technological characteristics as its Both CAPERE® predicate device CAPERE Thrombectomy Catheter (K180722). Thrombectomy Systems have either the same components or substantially equivalent components (length change). Each device system includes a guide catheter, delivery catheter, and a mechanism for capturing/removing the soft emboli or thrombi. The predicate and CAPERE® Thrombectomy System both use a 12Fr delivery catheter. The CAPERE® Thrombectomy System utilizes a15Fr guide catheter while the predicate utilizes a 20Fr guide catheter. In addition, both systems use 0.035" quidewires during the procedure.
The CAPERE® System includes a Guide Catheter and a Delivery Catheter. In the same manner as the previously cleared device, the Guide Catheter and Delivery Catheter are advanced to the therapy site. The Guide 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 deploved 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 of the Guide Catheter where the clot is captured and can be removed.
The basket design in the CAPERE® Thrombectomy Systems is exactly the same (nitinol, 18mm diameter, 11.4cm length) as the basket design in the predicate.
Therefore, the subject CAPERE® Thrombectorny 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 confirmed as there are no differences between the materials in the CAPERE® Thrombectomy System and the predicate.
- . Packaging of the CAPERE® Thrombectomy System is the same as the predicate, therefore, the predicate package integrity and accelerated aging studies demonstrate 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 594-2) on the bond joints affected by the reduced diameter of the CAPERE® Thrombectomy System with respect to the predicate and demonstrated that the CAPERE® Thrombectomy System maintained the predicate characteristics.
- . Simulated Use Testing was completed to demonstrate that simulated clot can be retrieved under simulated conditions without capture basket rupture, catheter
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damage, or other adverse device effect and confirmed that the predicate characteristics were maintained.
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 and simulated use testing demonstrated that the minor differences between the device and predicate (i.e. device diameter and lengths) 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.
§ 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).