(88 days)
No
The summary describes a mechanical catheter system and does not mention any AI or ML components or functions.
No.
The device is used to facilitate the insertion and guidance of microcatheters, not to perform a therapeutic action itself.
No
The device is described as facilitating the insertion and guidance of microcatheters, indicating it is an interventional/therapeutic device, not a diagnostic one. Its function is to deliver other devices, not to diagnose a condition.
No
The device description explicitly states it is comprised of physical components (Support Catheter and Delivery Catheter) made of materials like stainless steel and are hydrophilically coated. The performance studies also focus on physical characteristics and testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the insertion and guidance of microcatheters into blood vessels in the neurovascular system. This is a therapeutic or interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a catheter system designed for physical access within the body. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and procedural within the body.
N/A
Intended Use / Indications for Use
The Route 92 Medical 088 Access System, 110 cm, 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
QJP
Device Description
The Route 92 Medical 088 Access System, 110 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support 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, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 110 cm, 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
Neurovasculature only
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)
Non-Clinical Testing:
Biocompatibility Testing: Evaluated patient contacting components for biocompatibility in accordance with ISO 10993-1. Tests included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen, Hemocompatibility (Complement Activation, Partial Thromboplastin Time, ASTM Hemolysis, Thromboresistance). All tests passed, indicating the device is non-cytotoxic, non-sensitizing, non-irritating, non-pyrogenic, and has acceptable hemocompatibility.
Performance Testing:
A series of tests were conducted to demonstrate the suitability of the device for its intended use:
- Dimensional Verification: Measured device dimensions to confirm conformance to specifications.
- Luer Integrity: Tested per ISO 80369-7:2016.
- RHV Sealing: Tested sealing around the catheter shafts.
- Tensile Strength: Tested tensile strength of catheter sections and bonds.
- Kink Resistance: Evaluated kink resistance.
- Torsion Resistance: Evaluated integrity after rotation.
- Tip Flexibility: Tested tip flexibility.
- Air Leakage: Tested per ISO 10555-1:2013 Annex D.
- Liquid Leakage / Static Burst: Tested per ISO 10555-1:2013 Annex C.
- Dynamic Burst: Mechanical integrity maintained up to specified pressures.
- Hydrophilic Coating Integrity: Evaluated after multiple insertion and withdrawal cycles.
- Particulate Recovery: Tested effluent water after multiple insertion and withdrawal cycles per USP .
- Simulated Use Testing: Evaluated deliverability and compatibility with accessory devices in a neurovascular model.
- Radiopacity: Evaluated in an animal model under fluoroscopy.
- Contrast Delivery: Evaluated in an animal model under fluoroscopy.
- In Vivo Thromboresistance: Evaluated under clinical conditions in the swine model.
- Packaging Integrity: Tested per ISO 11607-1 Part 1 and ISO 11607-2 Part 2.
Results: All samples met the pre-determined acceptance criteria for all performance tests, indicating a PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Route 92 Medical Access System, K180201, Imperative Care Inc. EagleRay Long Sheath, K180169
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 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, 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.
April 18, 2020
Route 92 Medical Inc. Kathy Tansey Senior Director of Regulatory Affairs and Quality Assurance 1700 S. El Camino Real, Suite 206 San Mateo, California 94402
Re: K200121
Trade/Device Name: Route 92 Medical 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: January 17, 2020 Received: January 21, 2020
Dear Kathy Tansey:
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
1
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 (OS) 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 mediation-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,
Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200121
Device Name Route 92 Medical 088 Access System
Indications for Use (Describe)
The Route 92 Medical 088 Access System, 110 cm, 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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3
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 |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Kathy Tansey |
| Date Prepared: | January 17, 2019 |
| Device Name: | Route 92 Medical 088 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code OJP, 21 CFR
870.1250) |
| Primary Predicate Device:
Secondary Predicate Device: | Route 92 Medical Access System, K180201
Imperative Care Inc. EagleRay Long Sheath, K180169 |
Device Description
The Route 92 Medical 088 Access System, 110 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support 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, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 110 cm, 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 088 Access System, 110 cm, 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 the Predicate Device
The method of action, design, and materials of the Route 92 Medical 088 Access System, 110 cm, are equivalent to the Predicate Devices as shown in the following table.
4
| Attribute | Primary Predicate
Route 92 Medical Access
System (K180201) | Secondary Predicate
Imperative Care Inc.
EagleRay Long Sheath
(K180169) | Subject
Route 92 Medical 088
Access System, 110 cm |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The EagleRay Long
Sheath and EagleRay
Access Catheter are
indicated for the
introduction of
interventional devices into
the peripheral, coronary,
and neuro vasculature. | The Route 92 Medical 088
Access System, 110 cm, 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. |
| Device
Description | Sterile, single-use, variable
stiffness, coil-reinforced
catheter with proximal
control wire | Sterile, single-use,
variable stiffness, wire-
reinforced catheter | Sterile, single-use, variable
stiffness, coil-reinforced
catheter with proximal
control wire |
| Targeted
population | Patients requiring use of a
microcatheter in the
neurovascular system | 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
neurovascular interventional
techniques | Physicians trained in
interventional techniques | Physicians trained in
neurovascular interventional
techniques |
| Anatomical
Sites | Neurovasculature only | Peripheral, coronary or
neurovascular systems | Neurovasculature only |
| Materials | Polymers and metals
commonly used in the
manufacture of medical
devices | Polymers and metals
commonly used in the
manufacture of medical
devices | Polymers and metals
commonly used in the
manufacture of medical
devices |
| Support Catheter | | | |
| Inner
Diameter | 0.070" | .088" | 0.088" |
| Outer
Diameter | Distal: 0.082"
Proximal: 0.087" | Distal: 0.106"
Proximal: 0.108" | Distal: 0.101"
Proximal: 0.105" |
| Length | 136cm | 80cm -110cm | 110cm |
| Inner
Diameter | 0.019" | N/A | 0.019" |
| Outer
Diameter | 0.062" | N/A | Distal: 0.080"
Proximal: 0.062" |
| Length | 143cm | N/A | 151cm |
5
Non-Clinical Testing
Biocompatibility Testing
The Route 92 Medical 088 Access System, 110 cm, 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 |
| Simulated Use
Testing | Deliverability and compatibility
with accessory devices was
evaluated in a neurovascular model | PASS
All samples met the pre-determined
acceptance criteria |
| Radiopacity | Radiopacity of the device was
evaluated in an animal model
under fluoroscopy | PASS
All samples met the pre-determined
acceptance criteria |
| Contrast Delivery | Contrast delivery using the
device was evaluated in an
animal model under fluoroscopy | PASS
All samples met the pre-determined
acceptance criteria |
| In Vivo
Thromboresistance | Thromboresistance was evaluated
under clinical conditions in the
swine 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 |
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Substantial Equivalence
The Route 92 Medical 088 Access System, 110 cm, has the same intended use, the same technological characteristics and same method of action as the Predicate Devices. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical 088 Access System, 110 cm, is substantially equivalent to the Predicate Devices.