(58 days)
No
The summary describes a purely mechanical thrombectomy device with no mention of AI or ML in its operation, design, or performance evaluation.
Yes
The device is indicated for the non-surgical removal of soft emboli and thrombi from peripheral blood vessels, which is a therapeutic intervention.
No
The device is indicated for the "non-surgical removal of soft emboli and thrombi," which describes a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter, braided component, activation wire, handle, and marker bands, indicating it is a hardware-based medical device.
Based on the provided information, the Excipio SV Thrombectomy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "non-surgical removal of soft emboli and thrombi from peripheral blood vessels." This describes a therapeutic intervention performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a mechanical tool (catheter with a basket) used to physically remove blockages from blood vessels. This is a medical device used for treatment, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Excipio SV Thrombectomy Device is a therapeutic device used to treat a condition (thrombi/emboli).
N/A
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.
Product codes
QEW
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
The in vitro bench tests demonstrated that the Excipio SV Thrombectomy Device met all acceptance criteria and performed similarly to the predicate and referenced devices. 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 on the Excipio SV Thrombectomy Device:
- 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.
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.
Key Metrics
Not Found
Predicate Device(s)
ReVive PV Thrombectomy Device (K132281)
Reference Device(s)
Penumbra Indigo Aspiration System (K142870), Fogarty Arterial Embolectomy Catheter (K193379)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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 100 | |
| Raleigh, NC 27607 | |
| FDA RegistrationNumber | 3011471056 |
| Contact Person: | Mr. Jim Clossick |
| Contego Medical, Inc. | |
| 3801 Lake Boone Trail, Suite 100 | |
| Raleigh, NC 27607 | |
| Phone: + 1 305 607 1708 | |
| Email: 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 SV
Thrombectomy
Device | ReVive PT
Thrombectomy
Device | Penumbra Indigo
Aspiration System | Fogarty Arterial
Embolectomy
Catheter |
|--------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Device | Subject Device | Predicate
Device | Reference Device | Reference Device |
| Manufacturer | Contego Medical | Codman & Shurtleff,
Inc. | Penumbra Inc. | Baxter Healthcare
Corp. |
| 510(k) Number | K221204 | K132281 | K142870 | K193379 |
| Class/Product Code | II/ QEW | II/QEW | II/QEW | II/DXE, GCA |
| Device Classification
Description | Peripheral
mechanical
thrombectomy with
aspiration | Peripheral mechanical
thrombectomy with
aspiration | Peripheral
mechanical
thrombectomy with
aspiration | Embolectomy
Catheter |
| Indications for Use | Non-surgical removal
of soft emboli and
thrombi from
peripheral blood
vessels | Indicated for:
non-surgical removal
of emboli and thrombi
from peripheral blood
vessels
non-surgical removal
of thrombi from
synthetic grafts | Removal of fresh,
soft emboli and
thrombi from vessels
in the arterial system | Removal of fresh,
soft emboli and
thrombi from vessels
in the arterial
system. |
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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 SV
Thrombectomy
Device | ReVive PT
Thrombectomy
Device | Penumbra Indigo
Aspiration System | Fogarty Arterial
Embolectomy
Catheter |
|-------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------|
| Device | Subject Device | Predicate
Device | Reference Device | Reference Device |
| | | • temporary use in
peripheral vessel/graft
occlusion
• with aspiration and
with the injection or
infusion of contrast
media and other fluids | | |
| Principle of operation
- Thrombectomy
mechanism | Compressed NiTi
Basket | Compressed NiTi
Basket | Separator (for use in
catheter lumen) | Inflatable Balloon |
| Expanded diameter | 8 mm max | 4.5mm | 1.14 – 2.67 mm | 4 – 14 mm |
| Thrombectomy
mechanism length | 40 mm | 22-28mm | Unknown | Unknown |
| Artery diameters to
be treated | 4 – 8 mm | 1.5 – 5mm | Unknown | 4 – 14 mm |
| Guidewire
compatibility | 0.014" | 0.014" | 0.035" | N/A |
| Radiopaque markers | Proximal and distal to
basket and on basket
circumference | Proximal and distal to
basket | Unknown | Barium added to
catheter for
radiopacity |
| Aspiration Catheter
diameter | 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.