(76 days)
Not Found
No
The summary describes a physical catheter system and its performance testing, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is indicated for facilitating the insertion and guidance of other devices, not directly treating a condition.
No
The device is an access system designed to facilitate the insertion and guidance of microcatheters, not to provide information or interpretation for diagnosis.
No
The device description explicitly states it is comprised of physical components (Support Catheter and Delivery Catheter) and describes their physical characteristics and testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to facilitate the insertion and guidance of catheters within the neurovascular system. This is an in vivo procedure, meaning it's performed on a living organism.
- Device Description: The description details a physical catheter system designed for insertion into blood vessels.
- 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 treatment.
IVD devices are specifically designed to be used outside the body to analyze samples. This device is designed for direct use inside the body.
N/A
Intended Use / Indications for Use
The Route 92 Medical Full Length 054 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
QJP
Device Description
The Route 92 Medical Full Length 054 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen, variable stiffness catheters are hydrophilically coated. 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 including Biocompatibility Testing and Performance Testing.
Biocompatibility Testing: The patient-contacting materials were unchanged compared to the predicate device; therefore, no additional biocompatibility testing was required.
Performance Testing:
- Test: Dimensional Verification, Test Method: Device dimensions were measured to confirm conformance to the specifications., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Luer Integrity, Test Method: Tested per ISO 80369-7:2016., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Tensile Strength, Test Method: The tensile strength of the catheter sections and bonds was tested., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Kink Resistance, Test Method: Test specimen segments were formed into a defined bend diameter to evaluate kink resistance., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Torsion Resistance, Test Method: The test specimens were rotated to evaluate integrity after rotation., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Tip Flexibility, Test Method: Test specimens were tested for tip flexibility., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Air Leakage, Test Method: Tested per ISO 10555-1:2013 Annex D., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Liquid Leakage, Test Method: Tested per ISO 10555-1:2013 Annex C., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Static Burst, Test Method: Tested per ISO 10555-1:2013 Annex F., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Dynamic Burst, Test Method: Mechanical integrity was maintained up to the specified pressures., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Hydrophilic Coating Integrity, Test Method: The integrity of the hydrophilic coating was evaluated after multiple insertion and withdrawal cycles., Results: PASS All samples met the pre-determined acceptance criteria
- Test: Simulated Use Testing, Test Method: Deliverability and compatibility with accessory devices were evaluated in a neurovascular model., Results: PASS All samples met the pre-determined acceptance criteria
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
August 15, 2023
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 the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Route 92 Medical Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
Re: K231583
Trade/Device Name: Route 92 Medical Full Length 054 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: July 28, 2023 Received: July 28, 2023
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. 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,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant 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) K231583
Device Name
Route 92 Medical Full Length 054 Access System
Indications for Use (Describe)
The Route 92 Medical Full Length 054 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.
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 K231583
| Sponsor: | Route 92 Medical
155 Bovet Road, Suite 100
San Mateo, CA 94402 |
|------------------------|---------------------------------------------------------------------------------|
| Contact: | Kirsten Valley
(650) 581-1179 |
| Date Prepared: | August 14, 2023 |
| Device Name: | Route 92 Medical Full Length 054 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Catheter, Percutaneous, Neurovasculature (Product Code
QJP, 21 CFR 870.1250) |
| Device Classification: | Class II |
| Predicate Device: | Route 92 Medical Full Length 070 Access System
K222743 |
Device Description
The Route 92 Medical Full Length 054 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen, variable stiffness catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.
Indications for Use
The Route 92 Medical Full Length 054 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 the Predicate Device
The method of action, design, and materials of the Route 92 Medical Full Length 054 Access System are equivalent or similar to the Predicate Device as shown in the following table.
| Attribute | Predicate Device
Route 92 Medical Full Length 070
Access System (K222743) | Subject Device
Route 92 Medical Full Length 054
Access System (K231583) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Route 92 Medical Full Length
070 Access System is indicated for | The Route 92 Medical Full Length
054 Access System is indicated for |
| Attribute | Predicate Device
Route 92 Medical Full Length 070
Access System (K222743) | Subject Device
Route 92 Medical Full Length 054
Access System (K231583) |
| | use with compatible guide catheters in
facilitating the insertion and guidance
of microcatheters into a selected
blood vessel in the neurovascular
system. | 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 | Same |
| Targeted
population | Patients requiring use of a
microcatheter in the neurovascular
system | Same |
| User | Physicians trained in neurovascular
interventional techniques | Same |
| Anatomical
Sites | Neurovasculature only | Same |
| Materials | Polymers and metals commonly used
in the manufacture of medical devices | Same |
| Sterilization | 100% ethylene oxide | Same |
| Shelf Life | 6 months | Same |
| Support Catheter | | |
| Inner
Diameter | 0.070" | 0.054" |
| Outer
Diameter | 0.084" | 0.066" |
| Length | 132 cm | 125 cm and 148 cm |
| Delivery Catheter | | |
| Inner
Diameter | 0.019" | 0.015" |
| Outer
Diameter | 0.062" | 0.048" |
| Length | 151 cm | 167 cm |
4
Non-Clinical Testing
Biocompatibility Testing
The patient-contacting materials were unchanged compared to the predicate device; therefore, no additional biocompatibility testing was required.
Performance Testing
5
The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Full Length 054 Access System is suitable for its intended use.
| Test | Test Method | Results |
|---|---|---|
| Dimensional | ||
| Verification | Device dimensions were measured | |
| to confirm conformance to the | ||
| specifications. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Luer Integrity | Tested per ISO 80369-7:2016. | PASS |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Tensile Strength | The tensile strength of the catheter | |
| sections and bonds was tested. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Kink Resistance | Test specimen segments were | |
| formed into a defined bend | ||
| diameter to evaluate kink | ||
| resistance. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Torsion | ||
| Resistance | The test specimens were rotated to | |
| evaluate integrity after rotation. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Tip Flexibility | Test specimens were tested for tip | |
| flexibility. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Air Leakage | Tested per ISO 10555-1:2013 | |
| Annex D. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Liquid Leakage | Tested per ISO 10555-1:2013 | |
| Annex C. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Static Burst | Tested per ISO 10555-1:2013 | |
| Annex F. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Dynamic Burst | Mechanical integrity was | |
| maintained up to the specified | ||
| pressures. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Hydrophilic | ||
| Coating Integrity | The integrity of the hydrophilic | |
| coating was evaluated after | ||
| multiple insertion and withdrawal | ||
| cycles. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Test | Test Method | Results |
| Simulated Use | ||
| Testing | Deliverability and compatibility | |
| with accessory devices were | ||
| evaluated in a neurovascular model. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria |
6
Conclusions
The Route 92 Medical Full Length 054 Access System has the same intended use, similar technological characteristics and the same method of action as the predicate device. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness of the device. The successful completion of performance testing demonstrates that the Route 92 Medical Full Length 054 Access System is substantially equivalent to the predicate device.