Excipio LV Thrombectomy Device

K223897 · Contego Medical, Inc. · QEW · Feb 17, 2023 · Cardiovascular

Device Facts

• Record ID: K223897
• Device Name: Excipio LV Thrombectomy Device
• Applicant: Contego Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Feb 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Excipio LV Thrombectomy Device is indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels.

Device Story

Excipio LV Thrombectomy Device is a mechanical thrombus displacement catheter used in peripheral blood vessels. It features a distal nitinol braided basket that expands to match target vessel diameters (10-25mm). The device is operated by a physician under fluoroscopic guidance; the basket is deployed and retracted via a proximal handle activation wire. It is designed for use in conjunction with a separate aspiration catheter (minimum 14F). The basket's wire thickness provides radiopacity for visualization. By mechanically displacing thrombus, the device facilitates removal via aspiration, potentially restoring blood flow in peripheral vessels. It is a sterile, single-use device.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical bench testing (visual, dimensional, kink resistance, torsional strength, tensile, simulated use, corrosion, compatibility, clot removal) and an acute GLP swine model study. The animal study demonstrated safety in peripheral veins with no perforations, dissections, or gross thrombosis/emboli, and confirmed vessel patency via venography and histopathology.

Technological Characteristics

Nitinol braided basket; 10-25mm expanded diameter; 100mm mechanism length; 125cm usable length; 0.035" guidewire compatibility; 14F minimum aspiration catheter requirement. Radiopaque via basket wire thickness. EO sterilization. Mechanical displacement principle. Standalone device.

Indications for Use

Indicated for non-surgical removal of emboli and thrombi from peripheral blood vessels in patients requiring mechanical thrombectomy.

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

• Excipio SV Thrombectomy Device (K221204)

Reference Devices

• Inari Medical FlowTriever (K213402)
• Capere Thrombectomy System (K203476)

Submission Summary (Full Text)

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February 17, 2023

Contego Medical Inc. Jim Clossick Vice President of Regulatory Affairs 3801 Lake Boone Trail, Suite 100 Raleigh, North Carolina 27607

Re: K223897

Trade/Device Name: Excipio LV Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: December 27, 2022 Received: December 28, 2022

Dear Jim Clossick:

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

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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) 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,

Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2023.02.17
11:39:22 -05:00'

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) K223897

Device Name Excipio LV Thrombectomy Device

#### Indications for Use (Describe)

The Excipio LV Thrombectomy Device indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> <b> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image shows the logo for Contego Medical. The logo features the company name in a stylized font, with the word "Contego" in black and "Medical" in blue. A blue swoosh appears above the word "Contego". Below the company name, the words "INTEGRATED EMBOLIC PROTECTION" are written in smaller, gray font.

# 510(k) Summary [as required per 21 CFR 807.92]

Image /page/3/Picture/3 description: The image shows the logo for Contego Medical. The logo features the company name in a combination of black and blue text, with the word "Contego" in black and "Medical" in blue. Above the company name is a blue swoosh. Below the company name is the text "INTEGRATED EMBOLIC PROTECTION" in smaller, black font.

K223897 510(k)

| Date Prepared | December 27, 2022 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Contego Medical, Inc.<br>3801 Lake Boone Trail, Suite 100<br>Raleigh, NC 27607 |
| FDA RegistrationNumber | 3011471056 |
| Contact Person: | Mr. Jim Clossick<br>Contego Medical, Inc.<br>3801 Lake Boone Trail, Suite 100<br>Raleigh, NC 27607<br>Phone: + 1 305 607 1708<br>Email: [e-mail] |
| Proprietary Name: | Excipio LV Thrombectomy Device |
| Common Name: | Embolectomy Aspiration Device |
| Device Classification: | Class II per 21 CFR §870.5150 |
| Classification Name: | Catheter, Embolectomy |
| Product Code: | QEW |
| Predicate Device: | Excipio SV Thrombectomy Device (K221204) |
| Reference Devices: | Inari Medical FlowTriever (K213402)<br>Capere Thrombectomy System (K203476) |

#### Intended Use/Indications for Use:

The Excipio LV Thrombectomy Device is indicated for the non-surgical removal of emboli and thrombi from peripheral blood vessels.

### Device Description:

The Excipio LV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The device will be sold as a sterile, single use device.

### Thrombectomy Catheter:

The Thrombectomy Catheter is a mechanical thrombus displacement device with a nitinol braided component (basket) at the distal end that can be opened and closed via an activation wire that attaches to the distal end of the braid and attaches to a proximal

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Image /page/4/Picture/1 description: The image shows the logo for Contego Medical. The logo features the company name in a combination of black and teal lettering. Below the company name is the text "INTEGRATED EMBOLIC PROTECTION" in smaller, teal font.

handle. The operator can open the braided component to a diameter that best matches the target vessel (10-25mm in diameter). The thickness of the basket wires enhance the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

### Comparison with Predicate Devices:

A comparison of the Excipio LV Thrombectomy Device with the predicate and reference devices show that the technological characteristics of the subject device such as the indication for use, principle of operation, design, and sterilization method, are similar to the currently marketed predicate device and reference device. The intended use of the subject device falls within the indication for use/intended use of the predicate device and reference devices. In addition, the subject device treats vessels within the range of reference devices. The expanded diameter, thrombectomy mechanism and its size, and aspiration catheters used are similar for the subject device in comparison to predicate and reference devices.

| Device Name | Excipio LV<br>Thrombectomy<br>Device | Excipio SV<br>Thrombectomy<br>Device | Inari Medical<br>FlowTriever | CAPERE<br>Thrombectomy<br>System |
|-----------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Subject Device | Predicate Device | Reference Device | Reference Device |
| Manufacturer | Contego Medical | Contego Medical | Inari Medical | Vascular Medcure,<br>Inc |
| 510(k) Number | TBD | K221204 | K213402 | K203476 |
| Class/Product<br>Code | II/QEW | II/QEW | II/QEW, KRA | II/QEW, KRA |
| Device<br>Classification<br>Description | Peripheral<br>mechanical<br>thrombectomy with<br>aspiration | Peripheral mechanical<br>thrombectomy with<br>aspiration | Peripheral Mechanical<br>Thrombectomy with<br>aspiration | Peripheral<br>Mechanical<br>Thrombectomy |
| Indications for<br>Use/Intended<br>Use | Non-surgical removal<br>of emboli and thrombi<br>from peripheral blood<br>vessels | Non-surgical removal<br>of soft emboli and<br>thrombi from peripheral<br>blood vessels | • Non-surgical removal<br>of emboli and thrombi<br>from blood vessels<br>• Injection, infusion,<br>and/or aspiration of<br>contrast media and<br>other fluids into or<br>from a blood vessel<br>The FlowTriever<br>Retrieval/Aspiration<br>system is intended for<br>use in the peripheral<br>vasculature and for the<br>treatment of pulmonary<br>embolism<br>Triever Catheters are<br>intended for use in<br>treating clot in transit in<br>the right atrium but no<br>in conjunction with<br>FlowTriever Catheters | • Non-surgical<br>removal of soft<br>emboli and thrombi<br>from blood vessels.<br>• Injection, infusion<br>and/or aspiration of<br>contrast media and<br>other fluids into<br>blood vessel.<br>The CAPERE<br>Thrombectomy<br>System is intended<br>only for use in the<br>peripheral<br>vasculature and is<br>not intended for use<br>in the pulmonary<br>arteries |
| Principle of<br>operation | Compressed NiTi<br>Basket | Compressed NiTi<br>Basket | Self-expanding | Expanding |

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Image /page/5/Picture/0 description: The image shows the logo for Contego Medical. The logo features the company name in a sans-serif font, with the word "Contego" in a darker shade of blue than the word "Medical." A curved line in a lighter shade of blue arches over the word "Contego." Below the company name, the words "INTEGRATED EMBOLIC PROTECTION" are printed in a smaller font.

| Device Name | INTEGRATED EMBOLIC PROTECTION<br>Excipio LV<br>Thrombectomy<br>Device | Excipio SV<br>Thrombectomy<br>Device | Inari Medical<br>FlowTriever | CAPERE<br>Thrombectomy<br>System |
|--------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------|---------------------------------------------------|
| Device | Subject Device | Predicate Device | Reference Device | Reference Device |
| - Thrombectomy<br>mechanism | | | wireform disks | NiTi Basket |
| Basket Material | Nitinol | Nitinol | Nitinol | Nitinol |
| Expanded<br>diameter | 25 mm | 8 mm max | 6-25mm | 18mm |
| Thrombectomy<br>mechanism<br>length | 100 mm | 40 mm | 75mm | 114 mm |
| Vessel<br>diameters to be<br>treated | 10 – 25 mm | 4 – 8 mm | 6-25 mm | >10mm |
| Guidewire<br>compatibility | 0.035" | 0.014" | 0.035" | 0.035" |
| Radiopaque<br>markers | Proximal and distal to<br>basket | Proximal and distal to<br>basket and on basket<br>circumference | Proximal and distal to<br>wireform disks | Radiopaque Coiled<br>and metallic<br>construction |
| Aspiration<br>Catheter<br>diameter | 14F minimum | 7F or 8F | 16, 20, and 24Fr | Catheter is integrated<br>with product |
| Sterilization | EO | EO | EO | EO |
| Catheter<br>Usable length | 125 cm | 165 cm | 115 cm | |

## Non-Clinical Testing/Performance Data:

Non-clinical laboratory testing was performed on the Excipio LV Thrombectomy Device to determine substantial equivalence. The following testing/assessments were performed:

- Visual Inspection
- Dimensional Inspection
- Kink Resistance
- Torsional Strength ●
- Tensile Testing ●
- Simulated Use .

The in vitro bench tests demonstrated that the Excipio LV Thrombectomy Device met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and has a performance profile that is similar to the predicate devices.

- Corrosion Testing
- Compatibility Testing .
- . Clot removal testing

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Image /page/6/Picture/0 description: The image shows the logo for Contego Medical. The word "Contego" is written in black, and the word "Medical" is written in blue. Above the word "Contego" is a blue swoosh. Below the two words is the phrase "Integrated Embolic Protection".

## Biocompatibility:

Biocompatibility evaluation of the Excipio LV Thrombectomy Device was performed. The following aspects of biocompatibility tests were addressed:

- Cytotoxicity
- Sensitization ●
- Intracutaneous Irritation ●
- Acute System Toxicity ●
- Material Mediated Pyrogenicity ●
- Hemolysis
- Complement Activation .
- Thrombogenicity (performed on subject devices) ●

The results from the evaluation performed showed the Excipio LV Thrombectomy Device to be biocompatible. Biocompatibility testing was leveraged from the predicate device.

# GLP Animal Study:

The study provides evidence that the Excipio LV Thrombectomy Device was safe to use in the peripheral veins in the acute swine model as evidenced by no perforations, transmural dissections, or gross thrombosis or emboli, and patent vessels after treatment when assessed by the physician in the blood vessel venographically and through histopathology.

# Conclusion:

The Excipio LV Thrombectomy Device has the same intended use and the same or similar technological characteristics such as design, sterilization method, and operating principles as the predicate and reference devices. Performance data demonstrates that the device functions as intended. The conclusions drawn from the nonclinical test demonstrate that the Excipio LV Thrombectomy Device is substantially equivalent to the predicate and reference devices.