(119 days)
No
The summary describes a mechanical access system for neurovascular procedures and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is used to facilitate the insertion and guidance of microcatheters, not to treat a disease or condition itself.
No
Explanation: The device is described as an "Access System" designed for the insertion and guidance of catheters and microcatheters. Its purpose is to facilitate access to blood vessels, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical components (Access Catheter, Delivery Catheter, control wire) and the performance studies include testing for physical properties (tensile strength, kink resistance, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a system of catheters used to facilitate the insertion and guidance of microcatheters into blood vessels in the neurovascular system. This is an interventional medical device used directly within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory analysis.
Therefore, the Route 92 Medical Access System is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Route 92 Medical Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
Product codes
DQY
Device Description
The Route 92 Medical Access System is comprised of an Access Catheter and a Delivery Catheter. The distal portion of the Access Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, singlelumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular system / Neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained in neurovascular interventional techniques
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)
Performance testing included: Dimensional Verification, Luer Integrity, RHV Sealing, Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Air Leakage, Liquid Leakage/Static Burst, Dynamic Burst, Flow, Hydrophilic Coating Integrity, Particulate Recovery, Corrosion Resistance, Simulated Use Testing, Packaging Integrity, and Radiopacity. All samples met the pre-determined acceptance criteria for all tests.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
May 23, 2018
Route 92 Medical, Inc. Kirsten Valley Senior VP QA/RA/CA 1700 South El Camino Real, Suite 206 San Mateo, California 94402
Re: K180201
Trade/Device Name: Route 92 Medical Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 23, 2018 Received: April 24, 2018
Dear Kirsten Valley:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180201
Device Name Route 92 Medical Access System
Indications for Use (Describe)
The Route 92 Medical Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
| 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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K180201
510(K) SUMMARY
510(k) Summary
| Sponsor: | Route 92 Medical
1700 S. El Camino Real, Suite 206
San Mateo, CA 94022
Phone: 650-581-1179
Fax: 650-343-5827 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kirsten Valley |
| Date Prepared: | May 3, 2018 |
| Device Name: | Route 92 Medical Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code DQY, 21 CFR
870.1250) |
| Legally Marketed Predicate Device: | MIVI Mi-EXT Catheter (K163233) |
Device Description
The Route 92 Medical Access System is comprised of an Access Catheter and a Delivery Catheter. The distal portion of the Access Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, singlelumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.
Indications for Use
The Route 92 Medical Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.
Comparison to Predicate Device
The method of action, design, and materials of the Route 92 Medical Access System are equivalent to the MIVI Mi-EXT Catheter as shown in the following table.
| Attribute | Predicate MIVI Mi-EXT Catheter
(K163233) | Subject Route 92 Medical Access
System |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The MIVI 6F Guide Catheter is indicated
for use with compatible guide catheters | The Route 92 Medical Access System
is indicated for use with compatible |
| Attribute | Predicate MIVI Mi-EXT Catheter
(K163233) | Subject Route 92 Medical Access
System |
| | in facilitating the insertion and guidance
of microcatheters into a selected blood
vessel in the peripheral, coronary and
neuro vascular systems. | guide catheters in facilitating the
insertion and guidance of
microcatheters into a selected blood
vessel in the neurovascular system. |
| Device
Description | Sterile, single-use, variable stiffness,
coil-reinforced catheter with proximal
control wire | Same as predicate device. |
| Targeted
population | Patients requiring use of a microcatheter
in the peripheral, coronary or
neurovascular systems | Patients requiring use of a
microcatheter in the neurovascular
system |
| User | Physicians trained in interventional
techniques | Physicians trained in neurovascular
interventional techniques |
| Anatomical Sites | Peripheral, coronary or neurovascular
systems | Neurovasculature only |
| Method of Action | Delivered through a guide catheter with
support of a microcatheter/delivery
catheter, the device provides a lumen for
the introduction of microcatheters. | Same as predicate device |
| Materials | Polymers and metals commonly used in
the manufacture of medical devices | Same as predicate device |
| Access Catheter | | |
| Inner Diameter | 0.069" | 0.070" (minimum) |
| Outer Diameter | Distal: 0.081"
Proximal: 0.087" | Distal: 0.082"
Proximal: 0.087" |
| Length | 140 - 153cm | 136cm |
| Delivery Catheter | | |
| Inner Diameter | N/A | 0.019" |
| Outer Diameter | N/A | 0.062" |
| Length | N/A | 150cm |
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Non-Clinical Testing
Biocompatibility Testing
The Route 92 Medical Access System is constructed using materials that are commonly used in the medical device industry. All patient contacting components have been evaluated for biocompatibility in accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical Access System is classified per ISO 10993-1 as externally communicating with limited circulating blood contact ( | PASS
All samples met the pre-determined
acceptance criteria |
| Corrosion
Resistance | Tested per ISO 10555-1:2013
Annex A. | PASS
All samples met the pre-determined
acceptance criteria |
| Simulated Use
Testing | Deliverability and compatibility
with accessory devices was
evaluated in a neurovascular model | PASS
All samples met the pre-determined
acceptance criteria |
| Packaging
Integrity | ISO 11607-1 Part 1
ISO 11607-2 Part 2 | PASS
All samples met the pre-determined
acceptance criteria |
| Test | Test Method | Results |
| Radiopacity | Radiopacity of the device was
evaluated in an animal model under
fluoroscopy | PASS
All samples met the pre-determined
acceptance criteria |
7
=
8
Substantial Equivalence
The Route 92 Medical Access System has the same intended use, the same technological characteristics and same method of action as the predicate MIVI Mi-EXT Catheter. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Access System is substantially equivalent to MIVI Mi-EXT Catheter.