(25 days)
No
The 510(k) summary describes a physical catheter system and its mechanical properties. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
No
The device facilitates the insertion and guidance of microcatheters, but it does not directly treat or diagnose a disease or condition itself.
No
Explanation: The device is an access system for facilitating the insertion and guidance of microcatheters, which are tools used in interventional procedures rather than for diagnosis. Its description focuses on mechanical properties and performance, not on generating diagnostic information.
No
The device description explicitly states it is comprised of physical components (Support Catheter and Delivery Catheter) which are hardware.
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.
- Device Description and Intended Use: The Route 92 Medical Full Length 070 Access System is a medical device used to facilitate the insertion and guidance of microcatheters within the neurovascular system. It is a physical tool used during a medical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic results.
Therefore, this device falls under the category of a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Route 92 Medical Full Length 070 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 070 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 catheter. Both 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)
Performance testing included: Dimensional Verification, Luer Integrity, Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Air Leakage, Liquid Leakage, Static Burst, Dynamic Burst, Hydrophilic Coating Integrity, and Simulated Use Testing. All samples met the pre-determined acceptance criteria for each test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Route 92 Medical Full Length 088 Access System K210635
Reference Device(s)
Route 92 Medical Delivery Catheter K190431
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
October 4, 2022
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 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.
Route 92 Medical Kirsten Valley Chief Operating Officer 155 Bovet Road, Suite 100 San Mateo, California 94402
Re: K222743
Trade/Device Name: Route 92 Medical Full Length 070 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: September 8, 2022 Received: September 9, 2022
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 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,
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) K222743
Device Name
Route 92 Medical Full Length 070 Access System
Indications for Use (Describe)
The Route 92 Medical Full Length 070 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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3
510(k) Summary K222743
| Sponsor: | Route 92 Medical
155 Bovet Road, Suite 100
San Mateo, CA 94402 |
|------------------------|---------------------------------------------------------------------------------|
| Contact: | Kirsten Valley
(650) 581-1179 |
| Date Prepared: | October 3, 2022 |
| Device Name: | Route 92 Medical Full Length 070 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 088 Access System
K210635 |
| Reference Device: | Route 92 Medical Delivery Catheter
K190431 |
Device Description
The Route 92 Medical Full Length 070 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 catheter. Both 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 070 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 070 Access System are equivalent to the Predicate Device as shown in the following table.
4
| Attribute | Predicate Device
Route 92 Medical Full Length 088
Access System (K210635) | Subject Device
Route 92 Medical Full Length 070
Access System (K222743) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Route 92 Medical Full Length
088 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 Route 92 Medical Full Length
070 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. |
| 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 | 8 months | 6 months |
| Support Catheter | | |
| Inner Diameter | 0.088" | 0.070" |
| Outer Diameter | 0.101" | 0.084" |
| Length | 132 cm and 125 cm | 132 cm |
| Delivery Catheter | | |
| Inner Diameter | 0.019" | Same |
| Outer Diameter | Distal: 0.080"
Proximal: 0.062" | 0.062" |
| Length | 151 cm | Same |
Non-Clinical Testing
Biocompatibility Testing
5
The patient-contacting materials were unchanged compared to the predicate device; therefore, no additional biocompatibility testing was required.
Performance Testing
The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Full Length 070 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 | ||
| Test | Test Method | Results |
| 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 | ||
| 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 070 Access System has the same intended use, the same technological characteristics and same method of action as the predicate device. Differences between the subject and predicate devices do not raise new concerns of safety and effectiveness of the device. The successful completion of performance testing demonstrates that the Route 92 Medical Full Length 070 Access System is substantially equivalent to the predicate device.