(60 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a catheter system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates the placement of other interventional devices rather than directly providing a diagnostic or therapeutic function itself.
No
The device is described as an integrated microcatheter guide extension system intended to facilitate placement of interventional devices, not to diagnose a condition.
No
The device description clearly states it consists of two physical catheters (Inner Catheter and Outer Catheter) and describes their physical interaction and use in a medical procedure. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access and facilitate placement of interventional devices within the coronary and/or peripheral vasculature. This is a direct intervention on the patient's body.
- Device Description: The device is a physical catheter system used to extend guide catheters and aid in delivering other devices. It is used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the living body) to analyze samples and provide diagnostic information. This device is clearly used in vivo for a procedural purpose.
N/A
Intended Use / Indications for Use
The CrossFAST™ Integrated Microcatheter Guide Extension System is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Product codes
DQY
Device Description
CrossFAST™ Integrated Microcatheter Guide Extension System (GES) ("Device" or "CrossFAST" (GES") is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. It is intended for use in a cardiac catheterization laboratory by physicians trained in percutaneous, intravascular techniques and procedures.
CrossFAST™ GES consists of two catheters: an Inner Catheter. The Outer Catheter is intended to act as an extension to a traditional guide catheter (i.e., "guide extension") and to facilitate delivery of interventional devices within the target vasculature. The Inner Catheter is intended to be pre-loaded into the user and to provide additional support to the Outer Catheter during delivery. Once assembled, the Inneyond the Outer Catheter tip. After the Outer Catheter has been delivered to the target vasculature, the Inner Catheter is removed from the passage of interventional devices.
The Device is designed for use in vessels larger than 2.5mm and is not for use in the venous system. The Device is single use and provided sterile via Ethylene Oxide (EO) sterilization. The Device is compatible with standard, off-the-shelf 0.014" lumen inner diameter (ID) and minimum 180cm length guidewires and a minimum 100cm length 6F guide is intended for use with a hemostasis valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained in percutaneous, intravascular techniques and procedures. Intended for use in a cardiac catheterization laboratory.
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)
Design Verification/In-Vitro (Bench) Testing:
-
- Packaging/Transportation Testing
-
- Visual and Dimensional Testing
-
- Tensile Testing (including Simulated Use)
-
- Performance Testing:
- · System Preparation & Inspection Testing
- Stent Passage Testing (including Simulated Use)
- · Catheter Kink Resistance Testing
- · Catheter Torque Resistance Testing (including Simulated Use)
- · Contrast Delivery Testing
- · Radiopacity Testing
-
- Track Force Testing (including. Simulated Use)
-
- Particulate Testing (including Simulated Use)
-
- Coating Characterization
- · Baseline Coating Integrity
- · Post Simulated Use Coating Integrity
Biocompatibility Testing:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation/Intracutaneous Toxicity
-
- Acute Systemic Toxicity
-
- Material Mediated Pyrogenicity
-
- Hemocompatibility
- In-vivo Thromboresistance
- ASTM Hemolysis
- Complement Activation
-
- Partial Thromboplastin Time
These tests confirmed that any technological differences between the selected predicate device device does not raise different questions of safety or effectiveness. The test results support that the proposed device is at least as safe and as effective as the predicate device for the same intended use. No clinical testing was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
September 30, 2024
Image /page/0/Picture/1 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 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.
Vantis Vascular, Inc. Angela Thompson Vice President, Quality 2570 N First St., Suite 200 San Jose, California 95131
Re: K242276
Trade/Device Name: CrossFAST™ Integrated Microcatheter Guide Extension System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 1, 2024 Received: August 1, 2024
Dear Angela Thompson:
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.
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).
1
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 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-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 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 Rue"). 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-device-advicecomprehensive-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-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).
2
Sincerely,
Samuel G. Raben -S
for Lydia Glaw 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
Indications for Use (Describe)
The CrossFAST™ Integrated Microcatheter Guide Extension System is intended to be used in conjunction with quide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
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."
4
| 510(k) #: | K242276 |
|---|---|
| ----------- | --------- |
| 510(k) Summary | Prepared on: 2024-09-10 | |
|---|---|---|
| -- | ---------------- | ------------------------- |
Contact Details
| 21 CFR 807.92(a)(1) | |
|---|---|
| Applicant Name | Vantis Vascular, Inc. |
| Applicant Address | 2570 N First St. Suite 200 San Jose CA 95131 United States |
| Applicant Contact Telephone | 510-673-0983 |
| Applicant Contact | Angela Thompson |
| Applicant Contact Email | athompson@vantisvascular.com |
Device Name
| 21 CFR 807.92(a)(2) | |
|---|---|
| Device Trade Name | CrossFAST TM Integrated Microcatheter Guide Extension System (CFM55) |
| Common Name | Percutaneous catheter |
| Classification Name | Catheter, Percutaneous |
| Regulation Number | 870.1250 |
| Product Code(s) | DQY |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | |
|---|---|
| -- | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K183353 | Telescope TM Guide Extension Catheter | DQY |
Device Description Summary
| 21 CFR 807.92(a)(4) | |
|---|---|
| -- | --------------------- |
CrossFAST™ Integrated Microcatheter Guide Extension System (GES) ("Device" or "CrossFAST" (GES") is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. It is intended for use in a cardiac catheterization laboratory by physicians trained in percutaneous, intravascular techniques and procedures.
CrossFAST™ GES consists of two catheters: an Inner Catheter. The Outer Catheter is intended to act as an extension to a traditional guide catheter (i.e., "guide extension") and to facilitate delivery of interventional devices within the target vasculature. The Inner Catheter is intended to be pre-loaded into the user and to provide additional support to the Outer Catheter during delivery. Once assembled, the Inneyond the Outer Catheter tip. After the Outer Catheter has been delivered to the target vasculature, the Inner Catheter is removed from the passage of interventional devices.
The Device is designed for use in vessels larger than 2.5mm and is not for use in the venous system. The Device is single use and provided sterile via Ethylene Oxide (EO) sterilization. The Device is compatible with standard, off-the-shelf 0.014" lumen inner diameter (ID) and minimum 180cm length guidewires and a minimum 100cm length 6F guide is intended for use with a hemostasis valve.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The CrossFAST™ Integrated Microcatheter Guide Extension System is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
5
Indications for Use Comparison
21 CFR 807.92(a)(5)
CrossFAST™ Integrated Microcatheter Guide Extension System GES ("CrossFAST" GES") has the same intended use and Indications for Use as Telescope™ Guide Extension Catheter (K18353). Both devices are intended to be used in a cardiac catheterization laboratory by physicians trained in percutaneous, intravascular procedure. Both devices are for prescription use only. Both devices are similar in size and utilize radiopaque markers. Any differences between Cross AST™ GES and Telescope Guide Extension Catheter (K183353) do not raise any different questions of safety and effectiveness as confirmed through the Performance Testing.
Technological Comparison
21 CFR 807.92(a)(6)
CrossFAST™ Integrated Microcatheter Guide Extension System GES ("CrossFAST™ GES") and Telescope Guide Extension Catheter (K183353) share the same or similar fundamental technological characteristics and principles of operation. Vantis Vascular, hc. has performed comprehensive performance testing to demonstrate that the device meets all required specifications. The performance testing demonstrated that any technological differences between CrossFAST™ GES and Telescope Guide Extension Catheter (K183353) do not raise any different questions of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The technological differences between the subject and predicate device has been evaluated through design tests and biocompatibility tests to provide evidence of substantial equivalence for the CrossFAST™ GES. The following testing conducted is listed below.
Design Verification/In-Vitro (Bench) Testing:
-
- Packaging/Transportation Testing
-
- Visual and Dimensional Testing
-
- Tensile Testing (including Simulated Use)
-
- Performance Testing:
- · System Preparation & Inspection Testing
- Stent Passage Testing (including Simulated Use)
- · Catheter Kink Resistance Testing
- · Catheter Torque Resistance Testing (including Simulated Use)
- · Contrast Delivery Testing
- · Radiopacity Testing
-
- Track Force Testing (including. Simulated Use)
-
- Particulate Testing (including Simulated Use)
-
- Coating Characterization
- · Baseline Coating Integrity
- · Post Simulated Use Coating Integrity
Biocompatibility Testing:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation/Intracutaneous Toxicity
-
- Acute Systemic Toxicity
-
- Material Mediated Pyrogenicity
-
- Hemocompatibility
- In-vivo Thromboresistance
- ASTM Hemolysis
- Complement Activation
-
- Partial Thromboplastin Time
These tests confirmed that any technological differences between the selected predicate device device does not raise different questions of safety or effectiveness. The test results support that the proposed device is at least as safe and as effective as the predicate device for the same intended use.
No clinical testing was conducted to support this 510(k) Premarket Notification. As such, this section is not applicable.
The tests demonstrated that the proposed device functions as intended use and Indications for Use. These results further support that the proposed device performs at least as well as the for the same intended use and confirm that any technological differences do not raise different questions of safety or effectiveness.