CAPERE Thrombectomy System

K192935 · Vascular Medcure, Inc. · QEW · Nov 15, 2019 · Cardiovascular

Device Facts

• Record ID: K192935
• Device Name: CAPERE Thrombectomy System
• Applicant: Vascular Medcure, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Nov 15, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Percutaneous thrombectomy system; includes 8Fr funnel catheter and 6Fr delivery catheter. Delivered via transfemoral or jugular venous access. Mechanism: nitinol wire basket deployed at therapy site by retracting outer sheath; basket retracted and extended to surround/capture clot; clot-loaded delivery catheter retracted into funnel catheter for removal. Side port allows optional aspiration or fluid injection. Used in clinical setting by physicians. Benefits: mechanical removal of soft emboli/thrombi without surgery.

Clinical Evidence

Bench testing only. Functional testing performed on bond joints per ISO 10555-1 and ISO 594-2. Simulated use testing confirmed successful clot retrieval without basket rupture or catheter damage.

Technological Characteristics

Components: 8Fr funnel catheter, 6Fr delivery catheter, nitinol wire basket (10mm diameter, 11.4cm length). Compatible with 0.014" guidewires. Mechanical capture principle. Materials/specs: ISO 10555-1, ISO 594-2. No software or electronic components.

Indications for Use

Indicated for non-surgical removal of soft emboli and thrombi from peripheral vasculature; also for injection, infusion, or aspiration of contrast media and fluids. Not for use in pulmonary arteries.

Regulatory Classification

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.

Predicate Devices

• CAPERE® Thrombectomy System (K183179)

Submission Summary (Full Text)

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November 15, 2019

Vascular Medcure, Inc. % Ms. Janice Hogan Regulatory Counsel Hogan & Lovells US LPP 1735 Market Street. Suite 2300 Philadelphia, Pennsylvania 19103

# Re: K192935

Trade/Device Name: CAPERE Thrombectomy System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY Dated: October 17, 2019 Received: October 17, 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

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

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) K192935

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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### 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: November 12, 2019

# Name of Device

CAPERE® Thrombectomy System

#### Common or Usual Name

Embolectomy Catheter

#### Classification

21 CFR 870.5150, Class II, product code QEY

# Predicate Devices

CAPERE® Thrombectomy System (K183179)

#### 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.

#### Technological Characteristics

The CAPERE® Thrombectomy System has the same technological characteristics as its predicate device CAPERE Thrombectomy Catheter (K183179). Both CAPERE® Thrombectorny Systems have either the same components or substantially equivalent

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components (length change). Each device system includes a funnel catheter, delivery catheter, and a mechanism for capturing/removing the soft emboli or thrombi. The predicate and CAPERE® Thrombectomy System both use an 8Fr funnel catheter and a 6Fr. delivery catheter. In addition, both systems use 0.014" guidewires during the procedure. The only change is an increase of 21cm in the working catheter length.

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 of 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® 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.

- . 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 increased length 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 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 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 pre

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established acceptance criteria. Testing demonstrated that the device performs as intended. The CAPERE® is substantially equivalent to its predicate devices.