The Excipio SV 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 handle. The operator can open the braided component to a diameter that best matches the target vessel (4-8mm in diameter). Proximal and distal marker bands delineate the ends of the basket component, and 4 radiopaque markers delineate the circumference of the basket component to facilitate visualization under fluoroscopy.

AI/ML Overview

The provided document describes the Excipio SV Thrombectomy Device and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical medical device (a thrombectomy device), and the testing described is standard for such a device (e.g., visual inspection, dimensional inspection, biocompatibility, animal study for thrombogenicity).

Therefore, I cannot provide the requested information for the following points as they are not applicable to this physical medical device submission:

A table of acceptance criteria and the reported device performance: This document refers to meeting acceptance criteria for non-clinical lab tests (e.g., kink resistance, tensile testing) and biocompatibility, but it doesn't provide specific quantitative acceptance criteria or detailed reported performance values for these tests in a table format that would be typical for an AI/ML device. It merely states that the device "met all acceptance criteria."
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable to this type of device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) 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 (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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June 23, 2022

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

Re: K221204

Trade/Device Name: Excipio SV Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: April 25, 2022 Received: April 26, 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 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) K221204

Device Name Excipio SV Thrombectomy Device

Indications for Use (Describe)

The Excipio SV Thrombectory Device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels

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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Image /page/3/Picture/0 description: The image shows the logo for Contego Medical. The logo features the company name in a combination of black and blue lettering, with a stylized blue arc above the word "Contego". Below the company name, the tagline "INTEGRATED EMBOLIC PROTECTION" is written in smaller, capitalized letters.

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

510(K) K221204

Date Prepared	April 22, 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 SV Thrombectomy Device
Common Name:	Embolectomy Aspiration Device
Device Classification:	Class II per 21 CFR §870.5150
Classification Name:	Peripheral Mechanical Thrombectomy With Aspiration
Product Code:	QEW
Predicate Device:	ReVive PV Thrombectomy Device (K132281)
Reference Device:	Penumbra Indigo Aspiration System (K142870)Fogarty Arterial Embolectomy Catheter(K193379)

Intended Use/Indications for Use:

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

Device Description:

The Excipio SV Thrombectomy Device consists of a Thrombectomy Catheter to mechanically displace thrombus when used with an aspiration catheter. The Device

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Image /page/4/Picture/0 description: The image shows the logo for Contego Medical. The word "Contego" is in black font, and the word "Medical" is in blue font. Above the word "Contego" is a blue swoosh. Below the words "Contego Medical" is the phrase "INTEGRATED EMBOLIC PROTECTION" in smaller, gray font.

K221204 Traditional 510(k) Summary Excipio SV Thrombectomy Device June 22, 2022

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 handle. The operator can open the braided component to a diameter that best matches the target vessel (4-8mm in diameter). Proximal and distal marker bands delineate the ends of the basket component, and 4 radiopaque markers delineate the circumference of the basket component to facilitate visualization under fluoroscopy.

Comparison with Predicate Devices

A comparison of the Excipio SV Thrombectomy Device and the predicate and reference devices show that the technological characteristics of the subject devices such as the design, sterilization method, and operating principles are similar to the currently marketed predicate and reference devices. The intended use of the subject device falls within the intended use of the predicate device.

Device Name	Excipio SVThrombectomyDevice	ReVive PTThrombectomyDevice	Penumbra IndigoAspiration System	Fogarty ArterialEmbolectomyCatheter
Device	Subject Device	PredicateDevice	Reference Device	Reference Device
Manufacturer	Contego Medical	Codman & Shurtleff,Inc.	Penumbra Inc.	Baxter HealthcareCorp.
510(k) Number	K221204	K132281	K142870	K193379
Class/Product Code	II/ QEW	II/QEW	II/QEW	II/DXE, GCA
Device ClassificationDescription	Peripheralmechanicalthrombectomy withaspiration	Peripheral mechanicalthrombectomy withaspiration	Peripheralmechanicalthrombectomy withaspiration	EmbolectomyCatheter
Indications for Use	Non-surgical removalof soft emboli andthrombi fromperipheral bloodvessels	Indicated for:non-surgical removalof emboli and thrombifrom peripheral bloodvesselsnon-surgical removalof thrombi fromsynthetic grafts	Removal of fresh,soft emboli andthrombi from vesselsin the arterial system	Removal of fresh,soft emboli andthrombi from vesselsin the arterialsystem.

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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 stylized font, with the word "Contego" in black and "Medical" in blue. Above the word "Contego" is a blue curved line. Below the company name is the tagline "INTEGRATED EMBOLIC PROTECTION" in smaller, black font.

K221204 Traditional 510(k) Summary Excipio SV Thrombectomy Device June 22, 2022

Device Name	Excipio SVThrombectomyDevice	ReVive PTThrombectomyDevice	Penumbra IndigoAspiration System	Fogarty ArterialEmbolectomyCatheter
Device	Subject Device	PredicateDevice	Reference Device	Reference Device
		• temporary use inperipheral vessel/graftocclusion• with aspiration andwith the injection orinfusion of contrastmedia and other fluids
Principle of operation- Thrombectomymechanism	Compressed NiTiBasket	Compressed NiTiBasket	Separator (for use incatheter lumen)	Inflatable Balloon
Expanded diameter	8 mm max	4.5mm	1.14 – 2.67 mm	4 – 14 mm
Thrombectomymechanism length	40 mm	22-28mm	Unknown	Unknown
Artery diameters tobe treated	4 – 8 mm	1.5 – 5mm	Unknown	4 – 14 mm
Guidewirecompatibility	0.014"	0.014"	0.035"	N/A
Radiopaque markers	Proximal and distal tobasket and on basketcircumference	Proximal and distal tobasket	Unknown	Barium added tocatheter forradiopacity
Aspiration Catheterdiameter	7F or 8F	N/A	3 – 8F	N/A
Sterilization	EO	E-beam	Unknown	Unknown

Non-Clinical Testing/Performance Data:

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

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

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Image /page/6/Picture/0 description: The image is a 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, all-caps letters.

K221204 Traditional 510(k) Summary Excipio SV Thrombectomy Device June 22, 2022

The in vitro bench tests demonstrated that the Excipio SV Thrombectomy Devicemet all acceptance criteria and performed similarly to the predicate and referencedevices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate and reference devices.

Biocompatibility:

Testing was performed to assess biocompatibility of the Excipio SVThrombectomy Device. The following biocompatibility tests were performed:

Cytotoxicity ●
Sensitization ●
Irritation ●
Acute System Toxicity ●
Material Mediated Pyrogenicity
Hemolysis
Complement Activation ●
Thrombogenicity ●

The results from the testing performed showed the Excipio SV Thrombectomy Device to be biocompatible.

GLP Animal Study:

An acute GLP animal study (porcine) was conducted to evaluate in vivo thrombogenicity and acute performance and safety of the Excipio Device.

The study provides evidence that the Excipio Device was usable, non-thrombogenic, and did not raise any new questions of safety in the peripheral vasculature of the porcine model. Therefore, the device is substantially equivalent to the predicate device.

Conclusion:

The Excipio SV Thrombectomy Device has a similar 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 SV Thrombectomy Device is substantially equivalent to the predicate device.

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).