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. 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 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.

AI/ML Overview

The provided text describes the Excipio LV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance. The document is a 510(k) summary for a medical device which focuses on non-clinical testing for safety and performance compared to existing devices.

Therefore, most of the requested information regarding AI/algorithm performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The acceptance criteria themselves are not explicitly detailed as numerical values or specific thresholds in this document. Instead, they are implied to be met by the successful execution and results of the listed non-clinical tests.

Acceptance Criteria Category	Reported Device Performance
Mechanical/Physical Performance	The device met all acceptance criteria and performed similarly to the predicate device for tests including: Visual Inspection, Dimensional Inspection, Kink Resistance, Torsional Strength, Tensile Testing, Simulated Use, and Corrosion Testing. Performance data demonstrate that the device functions as intended and has a performance profile similar to predicate devices.
Material/Biological Performance	The device was found to be biocompatible, demonstrating conformance with tests including: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute System Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, and Thrombogenicity.
Functional Performance	Clot removal testing was performed, and performance data demonstrate that the device functions as intended and has a performance profile similar to predicate devices.
In-vivo Safety (Animal Study)	The 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.

Regarding the AI-specific questions:

Sample size used for the test set and the data provenance: Not applicable; this document does not describe a study involving a test set for AI/algorithm performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For the animal study, the ground truth was established by physician venographic assessment and histopathology. For the bench tests, the ground truth was based on engineering and material science standards/measurements.
The sample size for the training set: Not applicable; this document does not describe a training set for an AI algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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.3801 Lake Boone Trail, Suite 100Raleigh, NC 27607
FDA RegistrationNumber	3011471056
Contact Person:	Mr. Jim ClossickContego Medical, Inc.3801 Lake Boone Trail, Suite 100Raleigh, NC 27607Phone: + 1 305 607 1708Email: jclossick@contegomedical.com
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)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:

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 LVThrombectomyDevice	Excipio SVThrombectomyDevice	Inari MedicalFlowTriever	CAPEREThrombectomySystem
Device	Subject Device	Predicate Device	Reference Device	Reference Device
Manufacturer	Contego Medical	Contego Medical	Inari Medical	Vascular Medcure,Inc
510(k) Number	TBD	K221204	K213402	K203476
Class/ProductCode	II/QEW	II/QEW	II/QEW, KRA	II/QEW, KRA
DeviceClassificationDescription	Peripheralmechanicalthrombectomy withaspiration	Peripheral mechanicalthrombectomy withaspiration	Peripheral MechanicalThrombectomy withaspiration	PeripheralMechanicalThrombectomy
Indications forUse/IntendedUse	Non-surgical removalof emboli and thrombifrom peripheral bloodvessels	Non-surgical removalof soft emboli andthrombi from peripheralblood vessels	• Non-surgical removalof emboli and thrombifrom blood vessels• Injection, infusion,and/or aspiration ofcontrast media andother fluids into orfrom a blood vesselThe FlowTrieverRetrieval/Aspirationsystem is intended foruse in the peripheralvasculature and for thetreatment of pulmonaryembolismTriever Catheters areintended for use intreating clot in transit inthe right atrium but noin conjunction withFlowTriever Catheters	• Non-surgicalremoval of softemboli and thrombifrom blood vessels.• Injection, infusionand/or aspiration ofcontrast media andother fluids intoblood vessel.The CAPEREThrombectomySystem is intendedonly for use in theperipheralvasculature and isnot intended for usein the pulmonaryarteries
Principle ofoperation	Compressed NiTiBasket	Compressed NiTiBasket	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 PROTECTIONExcipio LVThrombectomyDevice	Excipio SVThrombectomyDevice	Inari MedicalFlowTriever	CAPEREThrombectomySystem
Device	Subject Device	Predicate Device	Reference Device	Reference Device
- Thrombectomymechanism			wireform disks	NiTi Basket
Basket Material	Nitinol	Nitinol	Nitinol	Nitinol
Expandeddiameter	25 mm	8 mm max	6-25mm	18mm
Thrombectomymechanismlength	100 mm	40 mm	75mm	114 mm
Vesseldiameters to betreated	10 – 25 mm	4 – 8 mm	6-25 mm	>10mm
Guidewirecompatibility	0.035"	0.014"	0.035"	0.035"
Radiopaquemarkers	Proximal and distal tobasket	Proximal and distal tobasket and on basketcircumference	Proximal and distal towireform disks	Radiopaque Coiledand metallicconstruction
AspirationCatheterdiameter	14F minimum	7F or 8F	16, 20, and 24Fr	Catheter is integratedwith product
Sterilization	EO	EO	EO	EO
CatheterUsable 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.

Regulation Number and Section

§ 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).