The Excipio LV Prime 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 (6-16 mm in diameter). The thickness of the basket wires enhances the radiopacity to facilitate visualization under fluoroscopy without the need for additional radiopaque markers.

AI/ML Overview

Let's break down the information regarding the acceptance criteria and study for the Excipio LV Prime Thrombectomy Device, based on the provided FDA 510(k) clearance letter.

It's important to note that this document is a 510(k) clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described here is primarily a non-clinical bench testing campaign aimed at proving the new device performs similarly and meets a defined set of engineering and performance specifications. There is no clinical study involving human (or animal) subjects described in this document for the Excipio LV Prime Thrombectomy Device. Thus, concepts like "human readers," "AI assistance," "effect size," or "ground truth for training/test set" in the context of clinical outcomes or diagnostic accuracy are not applicable to this type of device and submission.

Acceptance Criteria and Reported Device Performance

The document describes non-clinical laboratory testing performed to support the substantial equivalence. The acceptance criteria for these tests are implicitly that the device met the criteria and functioned as intended, with a performance profile similar to predicate devices. Specific quantitative acceptance criteria or detailed reported performance values are not explicitly stated in this summary. Instead, it broadly states that the device "met all acceptance criteria" and "functioned as intended."

Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Visual Inspection	Device meets visual quality standards.	Met all acceptance criteria.
Dimensional Inspection	Device dimensions conform to design specifications.	Met all acceptance criteria.
Kink Resistance	Device withstands kinking under specified conditions.	Met all acceptance criteria.
Torsional Strength	Device exhibits sufficient torsional strength.	Met all acceptance criteria.
Tensile Testing	Device components meet tensile strength requirements.	Met all acceptance criteria.
Simulated Use	Device performs as expected during simulated operation.	Functioned as intended.
Radial Force	Device exerts appropriate radial force.	Met all acceptance criteria.
Corrosion Testing	Device materials demonstrate resistance to corrosion.	Met all acceptance criteria.
Compatibility Testing	Device is compatible with specified ancillary devices/materials.	Met all acceptance criteria.
Clot removal testing	Device effectively removes clots under specified conditions.	Met all acceptance criteria, functioned as intended, and has a performance profile that is similar to the predicate devices (specific to clot removal effectiveness in vitro).
Biocompatibility	Device materials are biocompatible per ISO 10993-1.	Biocompatible and meets requirements per ISO 10993-1 (leveraging testing from predicate device for Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute System Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity).
Sterilization	Sterilization method is effective and validated.	Assessed through sterilization adoption (leveraged from predicate due to limited device change).
Packaging	Packaging protects device and maintains sterility.	Leveraged from predicate due to limited device change.

Study Details: Non-Clinical Bench Testing

Since this is a thrombectomy device and the submission is for 510(k) clearance based on substantial equivalence, the "study" referred to is a series of in vitro bench tests.

Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the specific number of units tested for each non-clinical test (e.g., how many devices were subjected to kink resistance or tensile testing). This level of detail is typically found in the full 510(k) submission, not the summary.
- Data Provenance: All data is from in vitro bench testing conducted by the manufacturer, Contego Medical, Inc. The country of origin for this testing is not specified, but it would typically be conducted at the manufacturer's facilities or a contracted testing lab. This is by definition retrospective in the sense that the testing is performed before submission for clearance.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For non-clinical bench testing of a medical device, "ground truth" is established by engineering specifications, validated test methods, and industry standards (e.g., ISO standards). There are no "experts" establishing a clinical judgment ground truth in this context. The "experts" involved would be the design engineers, quality engineers, and test technicians who define the test protocols and interpret the results against the defined acceptance criteria.
Adjudication Method for the Test Set:
- None Applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where multiple human readers' opinions need to be reconciled to establish a ground truth. For bench testing, results are typically objective measurements compared directly against predetermined pass/fail criteria.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not done. An MRMC study is relevant to diagnostic imaging devices or other technologies where human interpretation is involved. This device is a mechanical thrombectomy device; its performance is evaluated by its physical characteristics and efficacy in removing thrombus in a lab setting, not by aiding human readers in diagnosis.
Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Not Applicable. This device is an invasive medical device, not a software algorithm. Its use inherently involves a human operator (a clinician) and is not "standalone" in the sense of an unassisted algorithm making decisions.
Type of Ground Truth Used:
- For the non-clinical testing, the "ground truth" is defined by:
  - Engineering specifications and design requirements: For dimensional, kink resistance, torsional strength, tensile, radial force, and corrosion testing.
  - Validated test methods and industry standards (e.g., ISO 10993-1): For biocompatibility, simulated use, and clot removal testing.
  - Manufacturer's internal quality standards.
Sample Size for the Training Set:
- Not Applicable. The concept of a "training set" applies to machine learning algorithms. This device is a physical, mechanical medical device, not an AI/ML system.
How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, there is no training set for this type of device.

Summary

FDA 510(k) Clearance Letter - Excipio LV Prime Thrombectomy Device

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 13, 2025

Contego Medical, Inc.
Nitin Mehta
Director, Regulatory Affairs
3801 Lake Boone Trail
Suite 100
Raleigh, North Carolina 27607

Re: K251485
Trade/Device Name: Excipio LV Prime Thrombectomy Device
Regulation Number: 21 CFR 870.5150
Regulation Name: Embolectomy Catheter
Regulatory Class: Class II
Product Code: QEW
Dated: May 13, 2025
Received: May 14, 2025

Dear Nitin Mehta:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251485 - Nitin Mehta
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assistance/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. O'CONNELL -S
Digitally signed by GREGORY W. O'CONNELL -S
Date: 2025.06.13 08:11:54 -04'00'

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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251485

Device Name: Excipio LV Prime Thrombectomy Device

Indications for Use (Describe):
The Excipio LV Prime Thrombectomy Device is indicated for the nonsurgical 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K251485
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510(K) SUMMARY

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

510(k) K251485
Date Prepared June 12, 2025

Applicant: Contego Medical, Inc.
3801 Lake Boone Trail, Suite 100
Raleigh, NC 27607

FDA Registration Number 3011471056

Contact Person: Mr. Nitin Mehta
Contego Medical, Inc.
3801 Lake Boone Trail, Suite 100
Raleigh, NC 27607
Phone: + 1 805 813 7897
Email: nmehta@contegomedical.com

Proprietary Name: Excipio LV Prime 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 LV Thrombectomy Device (K223897)
Reference Devices: Excipio SV Thrombectomy Device (K221204)

Intended Use/Indications for Use:

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

Device Description:

Thrombectomy Catheter:

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radiopaque markers.

Comparison with Predicate Devices:

A comparison of the Excipio LV Prime Thrombectomy Device (subject device) with the predicate devices shows that the technological characteristics of the subject device are the same, or similar, including the indication for use/intended use, principle of operation, design, sterilization method, and packaging.

There is no change of intended use or fundamental technology between the subject device and predicates. In addition, the subject device treats vessels within the range of the predicate devices. The Excipio LV Prime device performs thrombectomy using the same method as the predicate and reference devices.

A tabular comparison of the technological characteristics between the subject and predicate devices is provided below.

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Device Name	Excipio LV (Prime) Thrombectomy Device	Excipio LV Thrombectomy Device	Excipio SV Thrombectomy Device
Device	Subject Device	Predicate Device	Reference Device
Manufacturer	Contego Medical	Contego Medical	Contego Medical
510(k) Number	TBD	K223897	K221204
Class/Product Code	II/QEW	II/QEW	II/QEW
Device Classification Description	Peripheral mechanical thrombectomy with aspiration	Peripheral mechanical thrombectomy with aspiration	Peripheral mechanical thrombectomy with aspiration
Indications for Use/Intended Use	Non-surgical removal of emboli and thrombi from peripheral blood vessels	Non-surgical removal of emboli and thrombi from peripheral blood vessels	Non-surgical removal of soft emboli and thrombi from peripheral blood vessels
Principle of operation
- Thrombectomy mechanism	NiTi Basket	NiTi Basket	NiTi Basket
Vessel diameters to be treated	6 – 16 mm	10 – 25 mm	4 – 8 mm
Handle – Mechanism of action	Ergonomic handle	Ergonomic handle	Ergonomic handle
Basket Material	Nitinol	Nitinol	Nitinol
Basket diameter (fully expanded)	16 mm	25 mm	8 mm
Basket Braid working length	60 mm ± 5mm	82 mm minimum	34 ± 2mm
Basket Length (closed)	7 cm	10 cm	4.4 cm
Basket (max crossing profile)	0.120" (3.05mm)	0.160" (4.06mm)	0.066" (1.68mm)
Materials of Construction	Nitinol, Polyimide, Pebax, PET, SS, Loctite, Nylon, ABS, Dymax (high level)	Nitinol, Polyimide, Pebax, PET, SS, Loctite, Nylon, ABS, Dymax (high level)	Nitinol, Polyimide, Pebax, PET, SS, Loctite, Nylon, ABS, Dymax (high level)
Thrombectomy device working length	150 cm	125 cm	165 cm
Guidewire compatibility	0.035"	0.035"	0.014"
Radiopaque markers	No radiopaque markers. Basket is radiopaque itself.	No radiopaque markers. Basket is radiopaque itself.	Proximal and distal to basket and on basket circumference
Recommended Aspiration Catheter diameter	9.1 Fr inside diameter (minimum)	12.6 Fr inside diameter minimum	6.3 Fr inside diameter minimum
Aspiration Source	Vacuum (-28 in Hg)	Vacuum (-28 in Hg)	Vacuum (-28 in Hg)
Shelf Life	2 years	2 years	2 years
Sterilization	EO, Single Use device	EO, Single Use device	EO, Single Use device

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Non-Clinical Testing/Performance Data:

In accordance with Contego's Risk Analysis process, non-clinical laboratory testing was performed on the Excipio LV Prime Thrombectomy Device to support the substantial equivalence of Excipio LV Prime device.

The following testing/assessments were performed:

Visual Inspection
Dimensional Inspection
Kink Resistance
Torsional Strength
Tensile Testing
Simulated Use
Radial Force
Corrosion Testing
Compatibility Testing
Clot removal testing

The in vitro bench tests demonstrated that the Excipio LV Prime Thrombectomy Device met all acceptance criteria, functioned as intended and has a performance profile that is similar to the predicate devices.

Biocompatibility

Biocompatibility evaluation of the Excipio LV Prime Thrombectomy Device was performed. The following aspects of biocompatibility tests were leveraged from the predicate device:

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

The results from the evaluation performed showed the Excipio LV Prime Thrombectomy Device to be biocompatible and meets requirements per ISO 10993-1.

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Sterilization and Packaging

Due to the limited nature of the device change, packaging testing was leveraged, and sterilization was assessed through sterilization adoption.

Conclusion:

The Excipio LV Prime Thrombectomy Device has the same intended use and the same or similar technological characteristics such as design, sterilization method, and operating principles as Contego's own legally marketed predicate and reference devices. None of the differences between the subject device and predicates raise any new questions of safety or effectiveness.

The conclusions drawn from the nonclinical tests demonstrate that the Excipio LV Prime 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).