(146 days)
Not Found
No
The summary describes a mechanical access system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an access system for facilitating the insertion and guidance of microcatheters, not for treating any condition or disease.
No
The device is described as an "Access System" that facilitates the "insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system." This function is interventional or procedural, not diagnostic.
No
The device description explicitly states it is comprised of physical components (Support Catheter and Delivery Catheter) and describes performance testing related to physical properties (Tensile Strength, Kink Resistance, etc.), indicating it is a hardware device.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Route 92 Medical Full Length 088 Access System is a catheter system used to facilitate the insertion and guidance of other devices (microcatheters) into blood vessels within the neurovascular system. This is a surgical/interventional tool used directly within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information based on biological markers. Its purpose is purely mechanical and procedural.
Therefore, based on the provided information, the Route 92 Medical Full Length 088 Access System is 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 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.
Product codes
QJP
Device Description
The Route 92 Medical Full Length 088 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 Route 92 Medical Full Length 088 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
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)
Biocompatibility Testing
- Cytotoxicity - ISO MEM Elution:
- Results: The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test as grade was less than 2.
- Conclusions: The test article is non-cytotoxic.
- Sensitization - ISO Guinea Pig Maximization Sensitization Test (Normal Saline and Sesame Oil):
- Results: The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the test.
- Conclusions: The test article did not elicit a sensitization response.
- Irritation - ISO Intracutaneous Reactivity (Normal Saline and Sesame Oil):
- Results: The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 1.0 or less for both sodium chloride and sesame oil test article extracts.
- Conclusions: Requirements of the ISO intracutaneous reactivity test have been met for the test article.
- Acute Systemic Toxicity - ISO Acute Systemic Injection (Normal Saline and Sesame Oil):
- Results: There was no mortality or evidence of systemic toxicity from the extracts injected into mice.
- Conclusions: Requirements of the ISO acute systemic injection test have been met for the test article.
- Pyrogen - Material Mediated Pyrogen (Normal Saline):
- Results: No single animal showed a temperature rise of 0.5℃ or more above its baseline temperature.
- Conclusions: The test article is non-pyrogenic.
- Hemocompatibility - Complement Activation (SC5b-9):
- Results: The concentration of SC5b-9 in the test sample was lower than the concentration in the control sample.
- Conclusions: The test article would not be expected to result in adverse effects in vivo.
- Hemocompatibility - Partial Thromboplastin Time:
- Results: The test article clotting time was not statistically different as compared to the control article.
- Conclusions: The test article is considered to be a non-activator of the intrinsic coagulation pathway.
- Hemocompatibility - ASTM Hemolysis:
- Results: Both the test article in direct contact with blood and the test article extract were non-hemolytic.
- Conclusions: The test article is considered non-hemolytic.
Performance Testing
- Dimensional Verification: All samples met the pre-determined acceptance criteria.
- Luer Integrity: All samples met the pre-determined acceptance criteria.
- Tensile Strength: All samples met the pre-determined acceptance criteria.
- Kink Resistance: All samples met the pre-determined acceptance criteria.
- Torsion Resistance: All samples met the pre-determined acceptance criteria.
- Tip Flexibility: All samples met the pre-determined acceptance criteria.
- Air Leakage: All samples met the pre-determined acceptance criteria.
- Liquid Leakage: All samples met the pre-determined acceptance criteria.
- Static Burst: All samples met the pre-determined acceptance criteria.
- Dynamic Burst: All samples met the pre-determined acceptance criteria.
- Hydrophilic Coating Integrity: All samples met the pre-determined acceptance criteria.
- Particulate Recovery: All samples met the pre-determined acceptance criteria.
- Simulated Use Testing: All samples met the pre-determined acceptance criteria.
- Packaging Integrity: All samples met the pre-determined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Route 92 Medical 088 Access System, K201518
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
July 27, 2021
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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in smaller blue letters below that.
Route 92 Medical Kirsten Valley Chief Operating Officer 155 Bovet Road. Suite 100 San Mateo, California 94402
Re: K210635
Trade/Device Name: Route 92 Medical Full Length 088 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: June 28, 2021 Received: June 29, 2021
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
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,
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) K210635
Device Name
Route 92 Medical Full Length 088 Access System
Indications for Use (Describe)
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.
| 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
K210635 510(k) Summary
| Sponsor: | Route 92 Medical
155 Bovet Road, Suite 100
San Mateo, CA 94402
Phone: 650-581-1179 |
|------------------------|---------------------------------------------------------------------------------------------|
| Contact: | Kirsten Valley |
| Date Prepared: | July 20, 2021 |
| Device Name: | Route 92 Medical Full Length 088 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 088 Access System, K201518 |
Device Description
The Route 92 Medical Full Length 088 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 Route 92 Medical Full Length 088 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 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.
Comparison to the Predicate Device
The method of action, design, and materials of the Route 92 Medical Full Length 088 Access System are equivalent to the Predicate Device as shown in the following table.
| Attribute | Predicate Device
Route 92 Medical 088 Access System
(K201518) | Subject Device
Route 92 Medical Full Length 088
Access System (K210635) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Route 92 Medical 088 Access
System, 143 cm, is indicated for use | The Route 92 Medical Full Length
088 Access System is indicated for |
| | Predicate Device
Route 92 Medical 088 Access System
(K201518) | Subject Device
Route 92 Medical Full Length 088
Access System (K210635) |
| Attribute | 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 with proximal
control wire | Sterile, single-use, variable stiffness,
coil-reinforced catheter |
| 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 | Same |
| Support Catheter | | |
| Inner
Diameter | 0.088" | Same |
| Outer
Diameter | Distal: 0.101"
Proximal: 0.105" | 0.101" |
| Length | 143 cm | 132 cm and 125 cm |
| Delivery Catheter | | |
| Inner
Diameter | 0.019" | Same |
| Outer
Diameter | Distal: 0.080"
Proximal: 0.062" | Same |
| Length | 151 cm | Same |
4
Non-Clinical Testing
Biocompatibility Testing
The Route 92 Medical Full Length 088 Access System is constructed using the same materials as the predicate device. All patient contacting components have been evaluated for biocompatibility in
5
accordance with ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. The Route 92 Medical Full Length 088 Access System is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (. Particulates were
characterized for size ranges ≥10
µm, ≥25 µm, ≥50 µm, ≥100 µm,
≥200 µm, ≥500 µm and ≥1000 µm | 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 |
| Packaging
Integrity | ISO 11607-1 Part 1
ISO 11607-2 Part 2 | PASS
All samples met the pre-determined
acceptance criteria |
7
Conclusions
The Route 92 Medical Full Length 088 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 successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical Full Length 088 Access System is substantially equivalent to the predicate device.