(27 days)
Not Found
No
The summary describes a physical medical device (catheter) and its mechanical properties and performance. There is no mention of software, algorithms, image processing, AI, or ML.
No
The device is described as a delivery catheter used to facilitate the insertion and guidance of other catheters; it does not directly treat a disease or condition, which is a characteristic of a therapeutic device.
No
Explanation: The device is described as a delivery catheter used for guiding other catheters into blood vessels, not for diagnosing medical conditions. Its function is to facilitate the insertion and guidance of other tools, which is an interventional or therapeutic function rather than a diagnostic one.
No
The device description clearly describes a physical catheter with hardware components (lumen, tip, hub, radiopaque markers) and mentions bench testing related to physical properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system." This describes a surgical or interventional procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are used to perform tests on these types of samples.
- Anatomical Site: The device is used within the "Neurovascular system," which is an anatomical location within the living patient.
IVDs are typically used in laboratories or point-of-care settings to analyze biological samples for diagnostic purposes. This device is an interventional medical device used during a procedure on a patient.
N/A
Intended Use / Indications for Use
The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
Product codes
DOY
Device Description
The modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coated catheter with a flexible tapered tip. The tapered tip is delineated by two radiopaque markers. On the proximal end is a luer hub for guidewire introduction and fluid or contrast injection. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible catheter. The Delivery Catheter and compatible catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.
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)
Performance Testing – Bench:
- Test: Package Integrity after Aging and Distribution; Test Method: The test specimens were subjected to EO sterilization and environmental conditioning, mechanical transit challenges, visual inspection and bubble leak test and peel test per ASTM F2096 and ASTM F88.; Results: PASS All samples met the pre-determined acceptance criteria
- Test: Label Integrity after Aging and Distribution; Test Method: The test specimens were subjected to EO sterilization and climatic conditioning per ASTM D4169.; 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: 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: Particulate Recovery; Test Method: After multiple insertion and withdrawal cycles, the effluent water rinsed and flushed from the devices and model was tested per USP .; Results: PASS All samples met the pre-determined acceptance criteria
- Test: Catheter Burst Pressure (Static & Dynamic); Test Method: Tested per ISO 10555-1:2013 Annex F.; Results: PASS All samples met the pre-determined acceptance criteria
- Test: Catheter Flow Rate; Test Method: Tested per ISO 10555-1:2013 Annex E.; Results: PASS All samples met the pre-determined acceptance criteria
- Test: Simulated Use Testing; Test Method: Deliverability and compatibility with accessory devices was evaluated in a neurovascular model; Results: PASS All samples met the pre-determined acceptance criteria
- Test: Packaging Integrity; Test Method: ISO 11607-1 Part 1; Results: PASS All samples met the pre-determined acceptance criteria
- Test: Packaging Integrity; Test Method: 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 Delivery Catheter (K182512)
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 21, 2019
Route 92 Medical Inc. Kathy Tansev Senior Director of Regulatory Affairs and Quality Assurance 1700 South El Camino Real, Suite 206 San Mateo, California 94402
Re: K190431
Trade/Device Name: Route 92 Medical Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 20, 2019 Received: February 22, 2019
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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by
Xiaolin Zheng -S
Lin Zheng Date: 2019.03.21
14:57:10-04'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190431
Device Name Route 92 Medical Delivery Catheter
Indications for Use (Describe)
The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K190431 510(k) Summary
| 510(k) Summary | |
|---|---|
| Sponsor: | Route 92 Medical |
| 1700 S. El Camino Real, Suite 206 | |
| San Mateo, CA 94022 | |
| Phone: 408-391-6536 | |
| Fax: 650-343-5827 | |
| Contact: | Kathy Tansey |
| Date Prepared: | March 18, 2019 |
| Device Name: | Route 92 Medical Delivery Catheter |
| Common Name: | Percutaneous Catheter |
| Classification Name: | Percutaneous Catheter (Product Code DQY, 21 CFR |
| 870.1250) | |
| Legally Marketed Predicate Device: | Route 92 Medical Delivery Catheter (K182512) |
Device Description
The modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coated catheter with a flexible tapered tip. The tapered tip is delineated by two radiopaque markers. On the proximal end is a luer hub for guidewire introduction and fluid or contrast injection. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible catheter. The Delivery Catheter and compatible catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.
Indications for Use
The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.
Comparison to Predicate Device
The method of action, design, and materials of the modified Route 92 Medical Delivery Catheter are equivalent to the cleared Route 92 Medical Delivery Catheter as shown in the following table.
| Attribute | Cleared Route 92 Medical Delivery
Catheter (K182512) | Modified Route 92 Medical
Delivery Catheter |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Route 92 Medical Delivery Catheter
is indicated for use with compatible
catheters in facilitating the insertion and | Same as cleared device |
| Attribute | Cleared Route 92 Medical Delivery
Catheter (K182512) | Modified Route 92 Medical
Delivery Catheter |
| Device
Description | The Delivery Catheter is a sterile, single-
use, single-lumen, hydrophilically
coated, variable stiffness catheter with a
flexible, tapered tip. | Same as cleared device |
| User | Physicians trained in neurovascular
interventional techniques | Same as cleared device |
| Anatomical Sites | Neurovasculature only | Same as cleared device |
| Materials | Biocompatible polymers and metals
commonly used in the manufacture of
medical devices
Catheter Shaft: stainless steel and
varying durometers of Pebax
Luer: polycarbonate
Marker bands: Tungsten/Pebax | Same as cleared device |
| Coating | Hydrophilic coating | Same as cleared device |
| Inner Diameter | 0.019" | Same as cleared device |
| Outer Diameter | 0.062" | Same as cleared device |
| Working Length | 143 cm | 151 cm |
| Length of Polymer
Section (non-
hypotube section) | 38 cm | 71 cm |
| Hydrophilic
Coating Length | 48.5 cm | 90 cm |
| Steam Shapeable
Tip | Not discussed in labeling | Steam shaping added to labeling |
| Packaging | The shelf carton contains two (2) sterile
pouches, each containing a Delivery
Catheter and one (1) Directions for Use
(DFU). | The shelf carton contains one (1)
sterile pouch containing a Delivery
Catheter and one (1) Directions for
Use (DFU). |
| Sterilization | Ethylene Oxide | Same as cleared device |
4
Performance Testing – Bench
The successful completion of the performance testing listed in the following table demonstrates that the modified Route 92 Medical Delivery Catheter is suitable for its intended use.
5
| Test | Test Method | Results |
|---|---|---|
| Package Integrity | ||
| after Aging and | ||
| Distribution | The test specimens were subjected to | |
| EO sterilization and environmental | ||
| conditioning, mechanical transit | ||
| challenges, visual inspection and | ||
| bubble leak test and peel test per | ||
| ASTM F2096 and ASTM F88. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Label Integrity | ||
| after Aging and | ||
| Distribution | The test specimens were subjected to | |
| EO sterilization and climatic | ||
| conditioning per ASTM D4169. | 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 | ||
| 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 | ||
| Particulate | ||
| Recovery | After multiple insertion and | |
| withdrawal cycles, the effluent water | ||
| rinsed and flushed from the devices | ||
| and model was tested per USP . | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Catheter Burst | ||
| Pressure (Static | ||
| & Dynamic) | Tested per ISO 10555-1:2013 Annex | |
| F. | PASS | |
| All samples met the pre-determined | ||
| acceptance criteria | ||
| Catheter Flow | ||
| Rate | Tested per ISO 10555-1:2013 Annex | |
| E. | 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 |
| Packaging | ||
| Integrity | ISO 11607-1 Part 1 | PASS |
| ISO 11607-2 Part 2 | All samples met the pre-determined | |
| acceptance criteria |
6
Biocompatibility
Biocompatibility evaluations were not conducted using the modified Route 92 Medical Delivery Catheter because the materials of construction and manufacturing processes have not changed from the predicate device. Therefore, the biocompatibility evaluations performed using the predicate Route 92 Medical Delivery Catheter (K182512) can also support the biocompatibility profile of the subject device.
Substantial Equivalence
The modified Route 92 Medical Delivery Catheter has the same intended use, similar technological characteristics and same method of action as the predicate Route 92 Medical Delivery Catheter (K182512). The successful completion of performance testing demonstrates that the modified Route 92 Medical Delivery Catheter is substantially equivalent to the predicate Route 92 Medical Delivery Catheter.