(55 days)
Not Found
No
The summary describes a mechanical system for blood flow reversal and embolic protection during carotid procedures, with no mention of AI or ML in its function or design.
Yes
The device is described as introducing "therapeutic devices" and providing "embolic protection," which is a direct therapeutic action to prevent stroke during carotid artery procedures.
No
The device is described as providing vascular access, introduction of diagnostic agents AND therapeutic devices, and embolic protection. While it facilitates the introduction of diagnostic agents, its primary function is protective and therapeutic rather than solely diagnostic.
No
The device description clearly outlines multiple hardware components (sheaths, dilators, flow controller, guidewire) that are physically inserted into the patient and create an arteriovenous shunt. The performance studies also focus on the physical and mechanical properties of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ENROUTE Transcarotid Neuroprotection System is a medical device used during a surgical procedure (carotid artery angioplasty and stenting). Its purpose is to provide access, introduce other devices, and protect against emboli by reversing blood flow and filtering particles. It is an interventional device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure and the device's role within that procedure. It does not mention analyzing biological samples for diagnostic purposes.
- Device Description: The description details the physical components and how they function to create an arteriovenous shunt and filter emboli. This is consistent with an interventional device.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties, sterilization, and shelf life – typical evaluations for a surgical device, not an IVD.
In summary, the ENROUTE Transcarotid Neuroprotection System is a surgical device used for intervention and protection during a carotid artery procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:
- · Adequate femoral venous access
- Common carotid artery reference diameter of at least 6mm
- · Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.
Product codes (comma separated list FDA assigned to the subject device)
NTE
Device Description
The ENROUTE® Transcarotid Neuroprotection System (Modified) is designed to provide direct transcarotid arterial access to the common carotid artery (CCA), provide introduction of diagnostic agents and therapeutic devices, and provide embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis. The ENROUTE Transcarotid NPS (Modified) is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an integrated filter used to capture and contain embolic material liberated during the procedure.
The ENROUTE Transcarotid NPS (Modified) consists of four primary components: the Transcarotid Arterial Sheath with Dilator, the Venous Return Sheath with Dilator, the Flow Controller and a 0.035" Extra Support J-Tip Guidewire. When assembled and inserted into the patient, the components of the ENROUTE Transcarotid NPS (Modified) create an arteriovenous shunt. When used in conjunction with occlusion of the proximal common carotid artery, the ENROUTE Transcarotid NPS (Modified) reverses the direction of blood flow in the internal carotid artery (ICA), shunting embolic particles away from the cerebral circulation, and into the venous circulation. Flow through the arteriovenous shunt is regulated by the Flow Controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.
Anatomical Site
carotid artery, common carotid artery (CCA), internal carotid artery (ICA), femoral venous
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility: Successfully conducted per ISO 10993-1, including Cytotoxicity and Hemocompatibility (Direct and Indirect Contact) on final, finished Arterial Sheath components. All tests received passing scores.
- Design Verification (Bench-Top Testing): Evaluated physical and mechanical properties. All testing met pre-determined acceptance criteria. Tests included Visual Inspection and Dimensional Verification, Dilator Snap Force, Air Leakage During Aspiration, Liquid Leakage Under Pressure, Dilator Peak Tensile Force, Junction Tensile Strength, ISO 80369-7 Small Bore Connector Dimensional and Functional Testing, Simulated Use/Usability.
- Sterilization, Packaging Validation, and Shelf Life: Compliance with ISO 11135:2014 for sterilization. Packaging validation with ISO 11607-1 & ISO 11607-2 and accelerated aged devices established shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
April 11, 2023
Silk Road Medical Denise Aycox Senior Regulatory Affairs Specialist 1213 Innsbruck Drive Sunnyvale, California 94089
Re: K230402
Trade/Device Name: ENROUTE® Transcarotid Neuroprotection System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: February 14, 2023 Received: February 15, 2023
Dear Denise Aycox:
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.
1
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 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.
Misti L. Malone -S
Misti Malone, PhD 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
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Indications for Use
510(k) Number (if known) K230402/S001
Device Name
Enroute Transcarotid Neuroprotection System
Indications for Use (Describe)
The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:
- · Adequate femoral venous access
- Common carotid artery reference diameter of at least 6mm
- · Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.
| 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------- |
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1. 510(k) Summary
1.1. Date of Preparation of 510(k)Summary
February 14, 2023
1.2. Device Trade or Proprietary Name
1.3. Device Trade or Proprietary Name
Enroute Transcarotid Neuroprotection System
1.4. Device Classification
Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Temporary Carotid Catheter for Embolic Capture Commun Name: Percutaneous Catheter Classification Regulation: 870.1250 Product Code: NTE
1.5. Predicate Device
510K Number & Date: K153485 on March 10, 2016 Device Name: Enroute Transcarotid Neuroprotection System
| Predicate Device | ||
|---|---|---|
| 510(k) Number/ Clearance | ||
| Date | Name of Device | Name of Manufacturer |
| K153485 cleared on March 10, | ||
| 2016 | ENROUTE® Transcarotid | |
| Neuroprotection System | Silk Road Medical | |
| 1213 Innsbruck Dr. Sunnyvale, | ||
| CA 94089 |
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1.6. Predicate Device Comparison
| Predicate Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Device Name | ENROUTE® Transcarotid | |
| Neuroprotection | ||
| System | ENROUTE® Transcarotid Neuroprotection System | |
| (Modified) | ||
| Indications For | ||
| Use | The ENROUTE | |
| Transcarotid | ||
| Neuroprotection System | ||
| (ENROUTE Transcarotid | ||
| NPS) is intended to | ||
| provide transcarotid | ||
| vascular access, | ||
| introduction of | ||
| diagnostic agents and | ||
| therapeutic devices, and | ||
| embolic protection | ||
| during carotid artery | ||
| angioplasty and stenting | ||
| procedures for patients | ||
| diagnosed with carotid | ||
| artery stenosis and who | ||
| have appropriate | ||
| anatomy described | ||
| below: | ||
| • Adequate femoral | ||
| venous access | ||
| • Common carotid | ||
| artery reference | ||
| diameter of at least | ||
| 6 mm | ||
| • Carotid bifurcation is | ||
| a minimum of 5 cm | ||
| above the clavicle as | ||
| measured by duplex | ||
| Doppler ultrasound | ||
| (DUS) or | ||
| computerized axial | ||
| tomography (CT) | ||
| angiography or | ||
| magnetic resonance | ||
| (MR) angiography. | SAME | |
| Device Characteristics | ||
| Single Use | Yes | SAME |
| Arterial and | ||
| Venous Sheath | ||
| reinforcement | Sheath body is | |
| reinforced with a ribbon | ||
| coil | SAME | |
| Predicate Comparison | ||
| Device Name | Predicate Device | Subject Device |
| Arterial and | ||
| Venous Sheath | ||
| construction | Sheath body outer | |
| jacket is mostly | ||
| constructed of | ||
| thermoplastic polymer | ||
| layers of various | ||
| densities to enhance | ||
| flexibility | SAME | |
| Arterial Sheath | ||
| Configuration | • Straight | |
| • Angled-Tip | Angled-Tip | |
| Sheath Stopper | ||
| Design | • Removable | |
| • Large Distal Foot | ||
| • Suture Grooves | ||
| • Positive Lock to the | ||
| Sheath | SAME | |
| Venous Return | ||
| Sheath | ||
| components | • Sheath | |
| • Hemostasis Valve | ||
| • Flow Line with | ||
| Stopcock and Quick | ||
| Connect | ||
| • Dilator | All return sheath components remain the same | |
| except that the stopcock now provides indexed | ||
| tactile feedback. | ||
| Arterial Sheath | ||
| Components | • Sheath | |
| • Hemostasis Valve | ||
| • Extension Tubing | ||
| • Arterial Stopcock | ||
| • Dilator | All sheath components remain the same except | |
| that the stopcock now provides indexed tactile | ||
| feedback. | ||
| Guidewire | ||
| Construction | • Core wire 0.035" OD | |
| • 90 cm | ||
| PTFE-coated Nitinol | ||
| with stainless steel coil | ||
| J-Tip. | SAME | |
| Dimensions | ||
| Transcarotid Arterial Sheath | ||
| Working Length | 11 cm | SAME |
| Total Length | 33.2 cm | SAME |
| Inner Diameter | 8 Fr (2.6 mm) | SAME |
| Outer Diameter | 10.5 Fr (3.5 mm) | SAME |
| Venous Return Sheath | ||
| Working Length | 11 cm | K230402/S001 |
| Page 1 of 8 | ||
| SAME | ||
| Total Length | 13.6 cm | SAME |
| Inner Diameter | 8 Fr (2.6 mm) | SAME |
| Predicate Comparison | ||
| Device Name | Predicate Device | Subject Device |
| ENROUTE® Transcarotid | ||
| Neuroprotection | ||
| System | ENROUTE® Transcarotid Neuroprotection System | |
| (Modified) | ||
| Outer Diameter | 10.5 Fr (3.5 mm) | SAME |
| Arteriovenous Shunt | ||
| Total Length | 102 cm ± 2 cm | SAME |
| Packaging and Sterilization | ||
| Packaging | Paperboard card | |
| Nylon/Tyvek pouch | ||
| Paperboard shelf carton | Thermoformed, Plastic tray | |
| Nylon/Tyvek pouch | ||
| Paperboard shelf carton | ||
| Sterilization | Ethylene Oxide (EO) | |
| SAL: 10-6 | SAME | |
| Shelf Life | 6 months at original | |
| submission (now labeled | ||
| for 3-years) | 6 months | |
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1.7. Device Description:
The ENROUTE® Transcarotid Neuroprotection System (Modified) is designed to provide direct transcarotid arterial access to the common carotid artery (CCA), provide introduction of diagnostic agents and therapeutic devices, and provide embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis. The ENROUTE Transcarotid NPS (Modified) is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an integrated filter used to capture and contain embolic material liberated during the procedure.
The ENROUTE Transcarotid NPS (Modified) consists of four primary components: the Transcarotid Arterial Sheath with Dilator, the Venous Return Sheath with Dilator, the Flow Controller and a 0.035" Extra Support J-Tip Guidewire. When assembled and inserted into the patient, the components of the ENROUTE Transcarotid NPS (Modified) create an arteriovenous shunt. When used in conjunction with occlusion of the proximal common carotid artery, the ENROUTE Transcarotid NPS (Modified) reverses the direction of blood flow in the internal carotid artery (ICA), shunting embolic particles away from the cerebral circulation, and into the venous circulation. Flow through the arteriovenous shunt is regulated by the Flow Controller.
1.8. Indications for Use:
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:
7
- Adequate femoral venous access
- Common carotid artery reference diameter of at least 6 mm
- Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography.
1.9. Summary of Performance Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows. Included in this section are descriptions of the testing, which substantiates the safe and effective performance of the subject, ENROUTE® Transcarotid Neuroprotection System (Modified) as well its substantial equivalence to the predicate device:
- Biocompatibility
- . Design Verification (Bench-Top Testing)
- Sterilization, Packaging Validation, and Shelf Life
The subject, ENROUTE® Transcarotid Neuroprotection System (Modified) met all established requirements.
1.9.1. Biocompatibility Testing
The purpose of biocompatibility testing is to demonstrate an absence of harmful effects of patient-contact materials in the subject device, ENROUTE® Transcarotid Neuroprotection System (Modified).
The materials used in the subject, ENROUTE® Transcarotid Neuroprotection System (Modified) are the same as those utilized in the currently marketed predicate device, ENROUTE® Transcarotid Neuroprotection System, with the exception of the new packaging tray. The ENROUTE® Transcarotid Neuroprotection System (Modified) device is manufactured in the same environment as the ENROUTE® Transcarotid Neuroprotection System and uses equivalent manufacturing processes.
Biocompatibility testing was successfully conducted per ISO 10993-1. The studies completed for the ENROUTE® Transcarotid Neuroprotection System (Modified) were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (