The Excipio® SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels.

Device Description

The Excipio SV Aspiration Catheter and Tubing consists of an aspiration catheter which is a single, large inner lumen catheter with a hydrophilic coating (20cm outside the distal end) designed to navigate through the peripheral vasculature and provide the maximum luminal area for aspiration. The aspiration catheter will be available in 7F and 8F sizes. Sterile, single use aspiration tubing will be distributed to facilitate a vacuum connection between the aspiration catheter and the collection canister of the vacuum pump.

AI/ML Overview

Since the provided text describes a medical device (catheter and tubing) rather than an AI/ML powered device, the requested information (such as sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) is not applicable or available in the document.

The document discusses the non-clinical testing performed to establish substantial equivalence of the Excipio SV Aspiration Catheter and Tubing to a predicate device.

Here's a summary of the available information based on the provided text, focusing on the acceptance criteria and performance data for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests/Assessments	Reported Device Performance
Excipio SV Aspiration Catheter	Visual Inspection	Met all acceptance criteria
	Dimensional Inspection	Met all acceptance criteria
	Kink Resistance (material property)	Met all acceptance criteria
	Torsional Strength	Met all acceptance criteria
	Tensile Testing	Met all acceptance criteria
	Functional Testing: Vacuum Collapse	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Kink Resistance	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Torque Testing	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Tip Pull	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Proximal Shaft to Luer	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Coating Length	Performed similarly to the predicate device, functioned as intended
	Coating Integrity	Met all acceptance criteria
	Particulate Testing	Met all acceptance criteria
Tubing	Dimensional Inspection	Met all acceptance criteria
	Tensile Testing	Met all acceptance criteria
	Functional Testing: Vacuum Collapse	Performed similarly to the predicate device, functioned as intended
	Functional Testing: Kink Resistance	Performed similarly to the predicate device, functioned as intended
System-level Testing	Simulated Use Testing	Performed similarly to the predicate device, functioned as intended
	Visual Inspection	Met all acceptance criteria
	Tubing Testing	Met all acceptance criteria
	Packaging and Sterile Barrier Testing	Met all acceptance criteria
Biocompatibility (Catheter)	Cytotoxicity, Sensitization, Irritation, Acute System Toxicity, Material Mediated Pyrogenicity, Hemolysis, Complement Activation, Thrombogenicity	Results showed the device to be biocompatible
Biocompatibility (Tubing)	Cytotoxicity, Sensitization, Irritation	Results showed the device to be biocompatible
GLP Animal Study (Porcine)	In vivo thrombogenicity, acute performance, and safety	Usable, non-thrombogenic, raised no new safety questions

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not specified for individual bench tests. The animal study was conducted using a "porcine model," but the number of animals is not provided.
Data Provenance: The "non-clinical laboratory testing" and "in vitro bench tests" were performed, indicating laboratory-generated data. The "GLP animal study (porcine)" indicates live animal data. Countries of origin are not specified for these tests. The data appears to be prospective as it was performed to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The testing described involves objective physical and biological measurements, not expert interpretation of outputs like in AI/ML performance evaluation.

4. Adjudication Method

This information is not applicable and not provided. The testing described involves objective measurements against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not applicable to this medical device submission.

6. Standalone Performance

The document describes "Non-Clinical Testing/Performance Data" and "in vitro bench tests" which evaluate the device's performance properties as a standalone product (i.e., algorithm only without human-in-the loop performance). The animal study also evaluated standalone performance in an in-vivo setting.

7. Type of Ground Truth Used

The "ground truth" for this device type is established by:
- Engineering specifications and standards: For dimensional, strength, and functional tests (e.g., kink resistance, tensile strength, vacuum collapse).
- Validated biological assays: For biocompatibility tests (e.g., cytotoxicity, hemolysis).
- In-vivo observations and measurements: For the GLP animal study (e.g., thrombogenicity, acute performance, safety).

8. Sample Size for the Training Set

This information is not applicable and not provided. There is no AI/ML component described, so no 'training set' is used.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no AI/ML component or training set.

Summary

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May 30, 2023

Contego Medical, Inc. James Clossic Vice President, Regulatory Affairs 3801 Lake Boone Trail Raleigh, North Carolina 27607

Re: K230030

Trade/Device Name: Excipio SV Aspiration Catheter and Tubing Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: April 24, 2023 Received: April 25, 2023

Dear James Clossic:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For
Eleni
Whatley -S
Digitally signed by
Eleni Whatley -S
Date: 2023.05.30
10:38:37 -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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Indications for Use

510(k) Number (if known) K230030

Device Name Excipio® SV Aspiration Catheter and Tubing

Indications for Use (Describe)

The Excipio® SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, 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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K230030 Page 1 of 5

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

510(k) K230030

Date Prepared	May 30, 2023
Applicant:	Contego Medical, Inc.3801 Lake Boone Trail, Suite 100Raleigh, NC 27607
FDA Registration Number	3011471056
Contact Person:	Mr. Nitin MehtaContego Medical, Inc.3801 Lake Boone Trail, Suite 100Raleigh, NC 27607Phone: + 1 805-813-7897Email: nmehta@contegomedical.com
Proprietary Name:	Excipio SV Aspiration Catheter and Tubing
Common Name:	Embolectomy Aspiration Device
Device Classification:	Class II per 21 CFR §870.5150
Classification Name:	Catheter, Embolectomy
Product Code:	QEW
Predicate Device:	Penumbra Indigo Aspiration System (K142870)

Intended Use/Indications for Use:

The Excipio SV Aspiration Catheter and Tubing is indicated for the non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels.

Device Description:

Comparison with Predicate Devices

A comparison of the Excipio SV Aspiration Catheter and the predicate device shows that the technological characteristics of the subject devices such as the design, sterilization method, and operating principles are similar to the currently marketed predicate device.

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Image /page/4/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 company name is a blue swoosh design. Below the company name is the tagline "INTEGRATED EMBOLIC PROTECTION" in smaller, black font.

The intended use of the subject device falls within the intended use of the predicate device.

Device Name	Excipio SV Aspiration Catheter(Subject Device)	Penumbra Indigo AspirationSystem(Predicate Device)
Manufacturer	Contego Medical	Penumbra Inc.
510(k) number	K230030	K142870
Class/Product Code	II/QEW	II/QEW
Indication for Use	Intended for the non-surgicalremoval of fresh, soft emboli andthrombi from peripheral bloodvessels.	Intended for the removal of fresh,soft emboli and thrombi fromvessels of the peripheral arterial andvenous systems. Not for use in thecoronaries or the neurovasculature
Contraindication	Not for use in the coronaries orthe neurovasculature	See Intended Use above
Principle of operation- Thrombectomy mechanism	Vacuum aspiration	Vacuum aspiration
Guidewire compatibility	0.035" or smaller	0.035"
Radiopaque markers	Radiopaque marker band	Radiopaque marker band
Aspiration Catheter diameter	7F or 8F	3F - 8F
Aspiration Catheter Material -Catheter Body	Materials - Biocompatible.commonly used for interventionaldevices	Materials - Biocompatible.commonly used for interventionaldevices
Includes Aspiration Catheter -Introducer	Yes	Yes
Aspiration Catheter - Effectivelength:	7Fr: 120 cm ± 3 cm8Fr: 90 cm ± 2 cm	85 -130cm
Coating	Hydrophilic coating	Hydrophilic coating
Aspiration Tubing Length	270 cm	285 cm
Compatible with Aspiration Pump	Yes (vacuum source)	Yes (vacuum source)
Sterilization	EO	EO

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Image /page/5/Picture/0 description: The image shows the logo for Contego Medical. The logo has the word "Contego" in black and "Medical" in blue. Underneath the words is the phrase "INTEGRATED EMBOLIC PROTECTION" in smaller, gray font. There is a blue swoosh above the word "Contego".

Non-Clinical Testing/Performance Data:

Non-clinical laboratory testing was performed on the Excipio SV Aspiration Catheter and Tubing to determine substantial equivalence. The following testing/assessment were performed:

Excipio SV Aspiration Catheter:

. Visual Inspection
Dimensional Inspection ●
. Kink Resistance
Torsional Strength .
Tensile Testing
. Functional Testing
- Vacuum Collapse
- Kink Resistance
- Torque Testing
- Tip Pull
- . Proximal Shaft to Luer
- Coating Length
Coating Integrity ●
Particulate Testing ●

Tubing:

Dimensional Inspection ●
. Tensile Testing
Functional Testing
- Vacuum Collapse .
- Kink Resistance .
- Visual Inspection .

System-level Testing:

Simulated Use Testing ●
Visual Inspection .
Tubing Testing .
Packaging and Sterile Barrier Testing .

The in vitro bench tests demonstrated that the Excipio SV Aspiration Catheter and Tubing met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and is substantially equivalent to the predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for Contego Medical. The logo features a blue curved line above the word "Contego" in black, with "Medical" in blue to the right. Below the main text, it says "INTEGRATED EMBOLIC PROTECTION" in smaller, all-caps letters.

Biocompatibility:

Testing was performed to assess biocompatibility of the Excipio SV Aspiration Catheter. The following biocompatibility tests were performed:

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

Testing was performed to assess the biocompatibility of the following biocompatibility tests were performed:

. Cytotoxicity
Sensitization .
Irritation ●

The results from the testing performed showed the Excipio SV Aspiration Catheter and Tubing 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 SV Aspiration Catheter.

The study provides evidence that the Excipio SV Aspiration Catheter was usable, nonthrombogenic, 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.

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Image /page/7/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 teal. Above the word "Contego" is a teal swoosh. Below the company name is the tagline "INTEGRATED EMBOLIC PROTECTION" in smaller, black font.

K230030 Page 5 of 5

Conclusion:

The Excipio SV Aspiration Catheter and Tubing has a similar intended use and the same or similar technological characteristics such as design, sterilization method, and operating principles as the predicate device.

Performance data demonstrates that the device functions as intended.

The conclusions drawn from the nonclinical test demonstrate that the Excipio SV Aspiration Catheter and Tubing does not raise new questions of safety and effectiveness compared to the predicate device. Therefore, the Excipio SV Aspiration Catheter and Tubing 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).