(145 days)
Not Found
No
The summary describes a mechanical aspiration catheter and tubing system. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies. The performance studies focus on mechanical and biological performance, not algorithmic performance.
Yes
The device is indicated for "non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels," which describes a therapeutic action.
No
The device is described as an aspiration catheter intended for the non-surgical removal of emboli and thrombi, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components: an aspiration catheter and aspiration tubing. There is no mention of software as the primary or sole component.
Based on the provided information, the Excipio® SV Aspiration Catheter and Tubing is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is the "non-surgical removal of fresh, soft emboli and thrombi from peripheral blood vessels." This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a catheter and tubing designed to be inserted into blood vessels for aspiration. This is consistent with an in vivo (within the living body) medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) outside of the body. There is no mention of reagents, assays, or diagnostic measurements.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Excipio® SV Aspiration Catheter and Tubing is a therapeutic device used for direct intervention within the body.
N/A
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.
Product codes
QEW
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.
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
Not Found
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 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
-
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 also performed to assess the biocompatibility of the following biocompatibility tests were performed for the tubing:
- Cytotoxicity
- Sensitization
- Irritation
-
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.
Key results:
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.
The results from the biocompatibility testing performed showed the Excipio SV Aspiration Catheter and Tubing to be biocompatible.
The GLP animal 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
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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
1
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
2
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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3
Image /page/3/Picture/0 description: The image is a logo for Contego Medical. The logo features the company name in a stylized font, with the word "Contego" in a flowing, cursive-like script and the word "Medical" in a more standard font. Below the company name is the tagline "INTEGRATED EMBOLIC PROTECTION" in smaller, all-caps letters. A curved, teal line arches over the word "Contego", adding a visual element to the logo.
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 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 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:
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.
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.
4
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 Aspiration
System
(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-surgical
removal of fresh, soft emboli and
thrombi from peripheral blood
vessels. | Intended for the removal of fresh,
soft emboli and thrombi from
vessels of the peripheral arterial and
venous systems. Not for use in the
coronaries or the neurovasculature |
| Contraindication | Not for use in the coronaries or
the 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 interventional
devices | Materials - Biocompatible.
commonly used for interventional
devices |
| Includes Aspiration Catheter -
Introducer | Yes | Yes |
| Aspiration Catheter - Effective
length: | 7Fr: 120 cm ± 3 cm
8Fr: 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 |
5
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.
6
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.
7
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.