(67 days)
Not Found
No
The summary describes a mechanical catheter system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used to facilitate the insertion and guidance of microcatheters, not to directly treat a condition.
No
Explanation: The device is an access system for facilitating the insertion and guidance of microcatheters, not for diagnosing a medical condition. Its function is to assist in interventional procedures.
No
The device description explicitly states it is comprised of physical components (Support Catheter and Delivery Catheter) and details performance testing related to these physical components (e.g., Tensile Strength, Kink Resistance, Radiopacity).
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 surgical/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. IVD devices typically involve reagents, analyzers, or other components used to analyze biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the physical and mechanical properties of the device, as well as its biocompatibility and performance in an animal model. These are typical tests for medical devices used in interventional procedures, not for IVD devices which would focus on analytical performance (sensitivity, specificity, etc.).
- Lack of IVD-specific information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
In summary, the Route 92 Medical 088 Access System is a medical device used for interventional procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Route 92 Medical 088 Access System, 143 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, 143 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, 143 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)
Performance Testing:
- Dimensional Verification: Device dimensions were measured to confirm conformance to the specifications. Results: All samples met the pre-determined acceptance criteria.
- Luer Integrity: Tested per ISO 80369-7:2016. Results: All samples met the pre-determined acceptance criteria.
- RHV Sealing: RHV sealing around the catheter shafts was tested. Results: All samples met the pre-determined acceptance criteria.
- Tensile Strength: The tensile strength of the catheter sections and bonds was tested. Results: All samples met the pre-determined acceptance criteria.
- Kink Resistance: Test specimen segments were formed into a defined bend diameter to evaluate kink resistance. Results: All samples met the pre-determined acceptance criteria.
- Torsion Resistance: The test specimens were rotated to evaluate integrity after rotation. Results: All samples met the pre-determined acceptance criteria.
- Tip Flexibility: Test specimens were tested for tip flexibility. Results: All samples met the pre-determined acceptance criteria.
- Air Leakage: Tested per ISO 10555-1:2013 Annex D. Results: All samples met the pre-determined acceptance criteria.
- Liquid Leakage / Static Burst: Tested per ISO 10555-1:2013 Annex C. Results: All samples met the pre-determined acceptance criteria.
- Dynamic Burst: Mechanical integrity was maintained up to the specified pressures. Results: 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. Results: All samples met the pre-determined acceptance criteria.
- Particulate Recovery: After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP . Particulates were characterized for size ranges ≥10 µm, ≥25 µm, ≥50 µm, ≥100 µm, ≥200 µm, ≥500 µm and ≥1000 µm. Results: All samples met the pre-determined acceptance criteria.
- Simulated Use Testing: Deliverability and compatibility with accessory devices was evaluated in a neurovascular model. Results: All samples met the pre-determined acceptance criteria.
- Radiopacity: Radiopacity of the device was evaluated in an animal model under fluoroscopy. Results: All samples met the pre-determined acceptance criteria.
- Contrast Delivery: Contrast delivery using the device was evaluated in an animal model under fluoroscopy. Results: All samples met the pre-determined acceptance criteria.
- Animal Study: Safety and device performance were both evaluated under clinical conditions using an acute swine model with angiographic and histological assessements. The subject device was compared to a predicate control device to demonstrate substantial equivalence. Results: All samples met the pre-determined acceptance criteria.
- Packaging Integrity: ISO 11607-1 Part 1, ISO 11607-2 Part 2. Results: 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, 110 cm, K200121
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" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Route 92 Medical Kathy Tansey Senior Director of Regulatory Affairs and Quality Assurance 155 Bovet Road, Suite 100 San Mateo, California 94402
August 14, 2020
Re: K201518
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: June 5, 2020 Received: June 8, 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 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, Ph.D. Assistant Director (Acting) 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) K201518
Device Name Route 92 Medical 088 Access System
Indications for Use (Describe)
The Route 92 Medical 088 Access System, 143 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
155 Bovet Road, Suite 100
San Mateo, CA 94402
Phone: 650-581-1179 |
|----------------------|---------------------------------------------------------------------------------------------|
| Contact: | Kathy Tansey |
| Date Prepared: | June 05, 2020 |
| Device Name: | Route 92 Medical 088 Access System |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code QJP, 21 CFR
870.1250) |
| Predicate Device: | Route 92 Medical 088 Access System, 110 cm, K200121 |
Device Description
The Route 92 Medical 088 Access System, 143 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, 143 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, 143 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, 143 cm, are equivalent to the Predicate Device as shown in the following table.
4
| Attribute | Predicate Device
Route 92 Medical 088 Access
System, 110 cm (K200121) | Subject Device
Route 92 Medical 088 Access
System, 143 cm |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Route 92 Medical 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. | The Route 92 Medical 088 Access
System, 143 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 | 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 |
| Support Catheter | | |
| Inner
Diameter | 0.088" | Same |
| Outer
Diameter | Distal: 0.101"
Proximal: 0.105" | Same |
| Length | 110 cm | 143 cm |
| Delivery Catheter | | |
| Inner
Diameter | 0.019" | Same |
| Outer
Diameter | Distal: 0.080"
Proximal: 0.062" | Same |
| Length | 151 cm | Same |
Non-Clinical Testing
Biocompatibility Testing
The Route 92 Medical 088 Access System, 143 cm, is constructed using the same materials as the predicate device. 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.
5
The Route 92 Medical 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 was
evaluated in a neurovascular model | 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 |
| Contrast Delivery | Contrast delivery using the device
was evaluated in an animal model
under fluoroscopy | PASS
All samples met the pre-determined
acceptance criteria |
| Animal Study | Safety and device performance
were both evaluated under clinical
conditions using an acute swine
model with angiographic and
histological assessements. The
subject device was compared to a
predicate control device to
demonstrate substantial
equivalence. | 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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7
Substantial Equivalence
The Route 92 Medical 088 Access System, 143 cm, has the same intended use, the same technological characteristics and same method of action as the predicate device. The successful completion of biocompatibility testing and performance testing demonstrates that the Route 92 Medical 088 Access System, 143 cm, is substantially equivalent to the predicate device.