(84 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 consists of a 12Fr Delivery Catheter and a 20Fr Guide Catheter. The 12Fr Delivery Catheter consists of a nitinol basket that comes in two different sizes (10 mm and 18 mm). The 20Fr Guide Catheter consists of an inner and outer guide and an inner and outer introducer. The CAPERE™ Thrombectomy System is delivered percutaneously via transfernoral 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 extract thrombus but does have a side port in the guide catheter that allows aspiration or injection of saline or fluids if needed.
The provided text describes a medical device, the CAPERE™ Thrombectomy System, and its regulatory clearance by the FDA based on a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full premarket approval (PMA) process that would typically involve extensive clinical trials with human subjects.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in human subjects, specifically for an AI/ML medical device. The data provided focuses on:
- Nonclinical performance testing: Biocompatibility, package integrity, accelerated aging, functional bench testing (visual inspection, dimensional testing, guidewire compatibility, catheter trackability, etc.).
- Simulated Use Testing: Demonstrating clot retrieval without device damage under simulated conditions.
- In vivo testing in an animal model: Evaluating acute and chronic performance, handling, vascular safety, and clinical outcomes compared to a predicate device.
Key reasons why the provided document cannot fulfill the request:
- No AI/ML Component: The CAPERE™ Thrombectomy System is a mechanical device (embolectomy catheter system with a nitinol basket), not an AI/ML driven device. The request specifically asks about "device meets the acceptance criteria" in the context of an AI/ML study, which is not applicable here.
- No Human Clinical Performance Study: The 510(k) submission for this device does not describe a human clinical trial to establish performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. The "performance data" section refers to non-clinical and animal studies.
- No Ground Truth Generation: Since there's no human clinical performance study, there's no mention of expert consensus, pathology, or outcomes data used to establish ground truth for a test set.
- No Multi-Reader Multi-Case (MRMC) Study: This type of study is relevant for evaluating the impact of AI on human readers, which is not discussed for this mechanical device.
To directly answer your prompt based only on the provided text, I must state that the information is not present for an AI/ML device.
However, if we interpret "acceptance criteria" and "study" in the context of this 510(k) submission for a mechanical device, we can infer what constitutes "meeting the criteria" for regulatory clearance.
Here's an attempt to structure an answer, while clearly highlighting what information is not available due to the nature of the provided document:
Acceptance Criteria and Device Performance (Based on 510(k) for a Mechanical Device)
The provided document (K180722 510(k) for CAPERE™ Thrombectomy System) describes the non-clinical and animal testing conducted to demonstrate substantial equivalence to predicate devices, which served as the "acceptance criteria" for its regulatory clearance. It does not describe an AI/ML-driven device or human clinical performance studies with metrics like sensitivity, specificity, or reader improvement. Therefore, the information requested regarding AI/ML device performance (like accuracy, F1 score, MRMC study results, etc.) is not present in this document.
The "acceptance criteria" for this device were met by successfully completing a battery of non-clinical and animal tests, demonstrating that the device functions as intended and is safe and effective when compared to its predicates.
1. Table of Acceptance Criteria and Reported Device Performance (Inferred from the document for a mechanical device):
| Acceptance Criteria Category (Inferred) | Specific Tests / Performance Metrics (Reported) | Description of "Meeting Criteria" |
|---|---|---|
| Biocompatibility | ISO 10993 Compliance | Patient-contacting components established as biocompatible. |
| Packaging & Sterilization | ISO 11607-1, ASTM D4332-14, ASTM D4169-16, ASTM F88/F88M-15, ASTM F2096-11, ASTM 1980-16 | Package integrity and accelerated aging studies completed, ensuring sterility and shelf-life. |
| Functional Bench Testing | ISO 10555-1, ISO 80369 (formerly ISO 594-1) compliance, including: visual inspection, dimensional testing, guidewire compatibility, catheter trackability, radio-detectability, kink resistance, luer compatibility, force to deploy/recapture basket, leak test, tensile, corrosion resistance, flexibility, funnel deployment/recapture force, torsion, basket resistance to rupture. | "In all instances, the CAPERE™ Thrombectomy System functioned as intended." All tests passed. |
| Simulated Use Testing | Retrieval of simulated clot in simulated conditions. | Demonstrated clot retrieval without "filter rupture, catheter damage, or other adverse device effect." |
| In Vivo Performance | Animal Model Study: Evaluation of acute and chronic overall performance and handling, regional and downstream vascular safety, clinical pathologic, and overall in-life clinical outcomes compared to predicate device. | "Evaluate and establish the substantial equivalence... to the predicate device." Results supported substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (for a mechanical device, relevant to animals/bench): The document does not specify exact "sample sizes" (e.g., number of animals, number of bench test iterations) for each test. For instance, it mentions "in vivo testing in an animal model" without detailing the number of animals.
- Data Provenance: Not explicitly stated for each test beyond "nonclinical performance testing" and "in vivo testing in an animal model." Specific country of origin or whether data was retrospective/prospective is not mentioned. Given the nature of a 510(k), these studies are typically conducted by the manufacturer as prospective engineering/animal tests.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable for a mechanical device 510(k) submission. The concept of "ground truth" established by experts (e.g., radiologists for image interpretation tasks) is primarily relevant for AI/ML devices or diagnostic accuracy studies on human data. The assessment of this mechanical device relied on engineering specifications and animal model observations.
4. Adjudication Method for the Test Set:
- Not applicable for a mechanical device 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation of data is involved.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This type of study is relevant for evaluating the impact of AI assistance on human readers, which is not applicable to this mechanical medical device.
6. Standalone (Algorithm Only) Performance:
- Not applicable. The CAPERE™ Thrombectomy System is a physical, mechanical medical device. There is no algorithm to assess independently.
7. Type of Ground Truth Used:
- For a mechanical device: The "ground truth" was established by comparing the device's performance against pre-defined engineering specifications, in vitro test protocols, and observations in an animal model, all benchmarked against the performance of predicate devices. There was no "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnoses from human subjects.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. This is a mechanical device, not an AI/ML device that requires a training set with established ground truth.
In summary, the provided FDA 510(k) summary (K180722) details the engineering, in vitro, and animal studies used to demonstrate substantial equivalence for a mechanical thrombectomy system. It does not contain information relevant to AI/ML device performance evaluation, human clinical studies, or associated methodologies like MRMC studies or expert-driven ground truth.
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June 11, 2018
KP Medcure, Inc. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K180722
Trade/Device Name: CAPERE Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 2, 2018 Received: April 2, 2018
Dear Janice 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 medical devices and radiation-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.
Misti L. Malone -S
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) K180722
Device Name CAPERE™ Thrombectomy System
Indications for Use (Describe) The CAPERETM 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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K180722 Page 1 of 3
510(k) SUMMARY
KP Medcure, Inc.'s CAPERE™ Thrombectomy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Samuel Shaolian KP Medcure, Inc. 1500 S. Sunkist Street, Suite H Anaheim, CA 92806 Office: 657-549-5175 Cell: 949-378-4742
Date Prepared: March 19, 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
Infusion Aspiration Catheter System (K143563) (Primary Predicate)
MSD Embolectomy Basket (K991093) (Reference Predicate)
Fogarty Venous Thrombectomy Catheter (510(k)-Unknown) (Reference Predicate)
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 consists of a 12Fr Delivery Catheter and a 20Fr Guide Catheter. The 12Fr Delivery Catheter consists of a nitinol basket that comes in two different sizes (10 mm and 18 mm). The 20Fr Guide Catheter consists of an inner and outer guide and an inner and outer introducer.
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The CAPERE™ Thrombectomy System is delivered percutaneously via transfernoral 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 extract thrombus but does have a side port in the guide catheter that allows aspiration or injection of saline or fluids if needed.
Technological Characteristics
The CAPERE™ Thrombectomy System has similar technological characteristics as its predicate devices. Both the CAPERE™ Thrombectomy System and the primary predicate device have similar components. Each device system includes a 20F quide catheter, dilator catheter, 12F catheter, and a mechanism for capturing/removing the soft emboli or thrombi. Both the CAPERE™ and its primary predicate use a 20F guide catheter with similar inner diameters (5.8 mm for the CAPERE™ versus 5.9 mm for the primary predicate). In addition, both systems use commercially available 0.035" guidewires during the procedure.
The CAPERE™ System includes a guide catheter and a Delivery Catheter. The Delivery Catheter is advanced distal to the obstruction, and a nitinol basket connected to the catheter is deployed by retracting the outer sheath of the catheter. The Delivery Catheter is inserted into the Guide Catheter, which includes a funnel at its distal tip to cap and contain the embolus within the basket. Comparatively, the primary predicate system similarly includes a dilator catheter (which fits inside the quide catheter), and an embolus disrupt/delivery catheter (Infusion Wireform Catheter). The internal Wireform Catheter has expanding wireform disks attached to its distal end. The Infusion Wireform Catheter is advanced distal to the obstruction, and wireform disks are deployed by retracting the delivery catheter. The predicate disrupts/removes the obstructing material by the withdrawal of the Infusion Wireform Catheter into the quide catheter, similar to the CAPERE™ Svstem.
The basket designs in both the CAPERE™ Thrombectory System and the reference predicate, MSD Embolectomy Basket (K991093) have similar technological characteristics. Similar to the mechanism of the CAPERE™, the MSD Embolectomy Basket's nitinol wire frame component is retracted into the sheath by operation of the handle, which first closes the mouth of the sack, and then configures it for retraction with the frame into the sheath.
Therefore, the subject CAPERE™ Thrombectomy System has very similar technological characteristics as its predicates.
Performance Data
The following nonclinical performance testing has been conducted to support the substantial equivalence of the CAPERE™ Thrombectorny System to its predicate devices. In all instances, the CAPERE™ Thrombectomy System functioned as intended.
- Biocompatibility of the patient-contacting components of the device was established in accordance with ISO 10993.
- . Package integrity and accelerated aging studies were completed per ISO 11607-1, ASTM D4332-14, ASTM D4169-16, ASTM F88/F88M-15, ASTM F2096-11, and ASTM 1980-16.
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- . Functional bench testing was conducted (including demonstrated compliance with relevant standards such as ISO 10555-1 and ISO 80369 (formerly ISO 594-1)).
- Testing included visual inspection, dimensional testing, guidewire . compatibility, catheter trackability, delivery/guide catheter radio-detectability, delivery/guide catheter kink resistance, luer compatibility, force to deploy basket testing, force to recapture basket in quide catheter testing, leak test for all appropriate bonds/joints, tensile testing, corrosion resistance, flexibility testing, funnel deployment force testing, funnel recapture force testing, torsion testing, and basket resistance to rupture testing, packaging validation (ISO 10555-1: 2014, ISO 594-2, ISO 11607-1).
- Simulated Use Testing was completed to demonstrate that simulated clot can be . retrieved under simulated conditions without filter rupture, catheter damage, or other adverse device effect.
- . In vivo testing in an animal model was performed to evaluate and establish the substantial equivalence of the CAPERE™ Thrombectomy System to the predicate device. The purpose of the study was to compare acute and chronic overall performance and handling, regional, and downstream vascular safety, clinical pathologic, and overall in-life clinical outcomes compared to the predicate device.
Substantial Equivalence
The CAPERE™ Thrombectomy System has the same intended use and very similar indications for use, technological characteristics, and principles of operation as its predicate devices. Nonclinical testing, including functional testing, simulated use testing, and in vivo testing in an animal model, demonstrated that the minor differences in technology do not raise new types of safety or effectiveness questions. Thus, the CAPERE™ Thrombectomy System is substantially equivalent to the predicate devices.
Conclusion
KP 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).