(89 days)
Not Found
No
The description focuses on the mechanical and material properties of a catheter and does not mention any computational or algorithmic functions.
No
This device is described as a delivery catheter to facilitate the insertion and guidance of other catheters; it does not directly treat a disease or condition.
No
The device is a delivery catheter used to guide other catheters into a blood vessel. It facilitates a medical procedure rather than diagnosing a condition.
No
The device description clearly details a physical catheter with various material and structural components (single-lumen, variable stiffness, tapered tip, radiopaque markers, hydrophilic coating, hypotube, luer hub, fluoro-saver marker). The performance studies also focus on bench testing of physical properties and biocompatibility, not software validation.
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 catheters into blood vessels in the neurovascular system. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical catheter designed for insertion into the body. It mentions features like a flexible tip, radiopaque markers, a hydrophilic coating, and a luer hub for guidewire introduction. These are characteristics of a device used for direct intervention within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens or analysis performed outside the body.
Therefore, the Route 92 Medical Delivery Catheter 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 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 (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Delivery Catheter is a single-lumen, variable stiffness catheter with a flexible, tapered tip delineated by two radiopaque markers. The distal shaft of the Delivery Catheter has a hydrophilic coating. On the proximal end is a hypotube attached to a luer hub for guidewire introduction. This proximal hypotube includes a fluoro-saver marker indicating when the tip of the catheter is about to exit a long femoral sheath/guide. 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 access catheter. The Delivery Catheter and access 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
fluoroscopy
Anatomical Site
neurovascular system
Neurovasculature
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:
- Study Type: Biocompatibility evaluation (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen, Hemocompatibility, Genotoxicity).
- Sample Size: Not specified, but involved in vitro and in vivo (guinea pig, rabbits, rabbits, test animals) tests.
- Key Results:
- Cytotoxicity: Non-cytotoxic.
- Sensitization: Did not elicit a sensitization response.
- Irritation: Met requirements of intracutaneous reactivity test.
- Acute Systemic Toxicity: Met requirements of acute systemic injection test, no clinical signs of toxicity.
- Pyrogen: Non-pyrogenic.
- Hemocompatibility (Complement Activation): Would not be expected to result in adverse effects in vivo.
- Hemocompatibility (Partial Thromboplastin Time): Non-activator of the intrinsic coagulation pathway.
- Hemocompatibility (ASTM Hemolysis): Non-hemolytic.
- Hemocompatibility (Thromboresistance): Similar thromboresistance characteristics as control devices.
- Genotoxicity (Bacterial Mutagenicity Test - Ames Assay): Non-mutagenic.
- Genotoxicity (In Vitro Mouse Lymphoma): Non-mutagenic and non-clastogenic.
- Conclusion: All tests passed.
Performance Testing - Bench:
- Study Type: Bench testing (Dimensional Verification, Luer Integrity, RHV Sealing, Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Air Leakage, Liquid Leakage, Hydrophilic Coating Integrity, Particulate Recovery, Corrosion Resistance, Catheter Burst Pressure (Static & Dynamic), Catheter Flow Rate, Simulated Use Testing, Packaging Integrity, Radiopacity).
- Sample Size: Not specified for each test.
- Key Results: All samples met the pre-determined acceptance criteria for all tests.
- Conclusion: All tests passed, demonstrating suitability for intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Route 92 Medical Access System (K180201)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
December 10, 2018
Route 92 Medical Inc. Kathy Tansey Senior Director of Regulatory Affairs and Quality Assurance 1700 S. El Camino Real, Suite 206 San Mateo, California 94402
Re: K182512
Trade/Device Name: Route 92 Medical Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 10, 2018 Received: September 12, 2018
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
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
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
K182512 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: | November 14, 2018 |
| 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 |
Device Description
The Delivery Catheter is a single-lumen, variable stiffness catheter with a flexible, tapered tip delineated by two radiopaque markers. The distal shaft of the Delivery Catheter has a hydrophilic coating. On the proximal end is a hypotube attached to a luer hub for guidewire introduction. This proximal hypotube includes a fluoro-saver marker indicating when the tip of the catheter is about to exit a long femoral sheath/guide. 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 access catheter. The Delivery Catheter and access 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 Route 92 Medical Delivery Catheter are identical to the Delivery Catheter component of the Route 92 Medical Access System as shown in the following table.
3
| Attribute | Predicate Delivery Catheter Provided
as Part of the Route 92 Medical Access
System (K180201) | Subject Route 92 Medical Delivery
Catheter |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Route 92 Medical 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 systems. | 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. |
| Device
Description | The Delivery Catheter is a sterile, single-
use, single-lumen, hydrophilically
coated, variable stiffness catheter with a
flexible, tapered tip. | Same as predicate device |
| User | Physicians trained in neurovascular
interventional techniques | Same as predicate device |
| Anatomical Sites | Neurovasculature only | Same as predicate device |
| Materials | Biocompatible polymers and metals
commonly used in the manufacture of
medical devices | Same as predicate device |
| | Distal shaft: varying durometers of
Pebax | |
| | Proximal shaft: PTFE coated stainless
steel | |
| | Luer: polycarbonate | |
| Inner Diameter | 0.019'' | Same as predicate device |
| Outer Diameter | Distal: 0.062"
Proximal: 0.028" | Same as predicate device |
| Device Working
Length | 143 cm | Same as predicate device |
| Hydrophilic
Coating | Present on polymer section of the
Delivery Catheter | Same as predicate device |
| Accessories
Included | No accessory included | Same as predicate device |
| Packaging | Nylon/Tyvek pouch inside of an SBS
shelf carton | Same as predicate device |
| Sterilization
Method | Ethylene Oxide | Same as predicate device |
| Shelf Life | 8 months | Same as predicate device |
| Sterility | Validated to achieve Sterility Assurance
Level (SAL) of 10-6 | Same as predicate device |
| Endotoxin Testing | Meets requirement for less or equal to
2.15 endotoxin units per device | Same as predicate device |
| Attribute | Predicate Delivery Catheter Provided
as Part of the Route 92 Medical Access
System (K180201) | Subject Route 92 Medical Delivery
Catheter |
| Principle of
Operation | During use, a standard neurovascular
guidewire may be inserted through the
Delivery Catheter. The Delivery
Catheter is inserted through a compatible
access catheter. The Delivery Catheter
and access catheter are advanced to the
targeted location under fluoroscopy
using standard endovascular techniques. | Same as predicate device |
4
Non-Clinical Testing
Biocompatibility Testing
The Route 92 Medical Delivery Catheter is constructed using materials that are commonly used in the medical device industry. 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. The Route 92 Medical Access System is classified per ISO 10993-1 as externally communicating with limited circulating blood contact (≤ 24 hours). The following biocompatibility testing was performed for the predicate Route 92 Medical Access System (K180201) and leveraged from the predicate device submission to support the biocompatibility profile of the subject device because the subject Route 92 Medical Delivery Catheter contains the same materials of construction, design, and manufacturing processes as the predicate device.
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity - ISO MEM | ||
| Elution | Grade 0 at 24, 48, 72 ± 4 hrs | The test article is non- |
| cytotoxic. | ||
| Sensitization - ISO | ||
| Guinea Pig Maximization | ||
| Sensitization Test | ||
| (Normal Saline and | ||
| Sesame Oil) | Clinical Observations: none of the animals | |
| showed abnormal clinical signs during the | ||
| test period. | ||
| Main Test Results: | ||
| Negative Control, grade =0 | ||
| Normal Saline, grade = 0 | ||
| Sesame Oil, grade = 0 | Test article did not elicit a | |
| sensitization response. | ||
| Irritation - ISO | ||
| Intracutaneous Reactivity | ||
| (Normal Saline and | ||
| Sesame Oil) | Dermal observations: | |
| Comparative Results Mean Test-Mean | ||
| Control (Normal Saline) = 0 | ||
| Mean Test-Mean Control (Sesame Oil) = 0.1 | ||
| Differences between mean test and control | ||
| scores were less than 1.0 | 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) | None of the test article extract treated | |
| animals were observed with clinical signs | ||
| consistent with toxicity. Body weight | ||
| changes were within acceptable parameters. | Requirements of the ISO | |
| acute systemic injection | ||
| test have been met for the | ||
| test article. | ||
| Pyrogen - Material | ||
| Mediated Pyrogen | ||
| (Normal Saline) | During the 3-hr observation period, none of | |
| the rabbits administered with the text article | ||
| extract had a temperature rise ≥ 0.5℃ at | ||
| the required observation time points. The | ||
| response did not exceed the USP limits and | ||
| meets the requirements for this test. | The test article is non- | |
| pyrogenic. | ||
| Test | Results | Conclusions |
| Hemocompatibility - | ||
| Complement | ||
| Activation (C3a & | ||
| SC5b-9) | When compared to a legally US-marketed | |
| device, the minimal increase in complement | ||
| activation noted in the test article would not | ||
| be expected to result in adverse effects in | ||
| vivo. | The test article would not | |
| be expected to result in | ||
| adverse effects in vivo. | ||
| Hemocompatibility - | ||
| Partial Thromboplastin | ||
| Time (PTT) | The PTT of the test article was 100% of the | |
| negative control. | The test article is | |
| considered to be a non- | ||
| activator of the intrinsic | ||
| coagulation pathway and | ||
| passes the test. | ||
| Hemocompatibility - | ||
| ASTM Hemolysis | Blank corrected hemolytic index above the | |
| negative control: | ||
| Direct Method: 0.0% | ||
| Extract Method: 0.3% | The test article is | |
| considered non-hemolytic. | ||
| Hemocompatibility - | ||
| Thromboresistance | All test animals survived the general | |
| anesthesia and study observation interval | ||
| without test article related complications. | ||
| The combined data of blood test reports, pre- | ||
| and post-implant weight differences, and the | ||
| patency and thrombus scores were not | ||
| subjectively different between the test and | ||
| control articles. | The test devices appear to | |
| have similar | ||
| thromboresistance | ||
| characteristics as the | ||
| control devices. | ||
| Genotoxicity - ISO | ||
| Bacterial Mutagenicity | ||
| Test - Ames Assay | ||
| (Normal Saline and | ||
| Polyethylene Glycol) | The test article did not induce substantial | |
| increases in reversion rates of the type that | ||
| are associated with mutagenesis and no | ||
| substantial test article toxicity was noted that | ||
| may have interfered with the ability of the | ||
| test system to detect mutagens. | The test article is | |
| considered non-mutagenic. | ||
| Genotoxicity - ISO In | ||
| Vitro Mouse Lymphoma | ||
| (Normal Saline and | ||
| Polyethylene Glycol) | The test article did not cause notable changes | |
| in the typical growth pattern of the L5178Y | ||
| cells in suspension culture during the growth | ||
| and expression period. The cloning | ||
| efficiencies of these preparations were within | ||
| normal limits. | The test article is | |
| considered to be non- | ||
| mutagenic and non- | ||
| clastogenic. |
5
6
Performance Testing - Bench
The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Delivery Catheter is suitable for its intended use. The following performance (bench) tests, except the dimensional verification, were all leveraged from the predicate Route 92 Medical Access System (K180201) because the subject Route 92 Medical Delivery Catheter is identical in design to the same catheter component in the predicate device.
| 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 | ||
| RHV Sealing | RHV sealing were tested | 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 | ||
| Corrosion | ||
| Resistance | Tested per ISO 10555-1:2013 | |
| Annex A. | 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 | ||
| Test | Test Method | Results |
| Simulated Use | ||
| Testing | Deliverability and | |
| compatibility with accessory | ||
| devices was 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 | ||
| Radiopacity | Radiopacity of the device was | |
| evaluated in an animal model | ||
| under fluoroscopy | PASS | |
| All samples met the pre-determined acceptance | ||
| criteria |
7
Substantial Equivalence
The Route 92 Medical Delivery Catheter has the same intended use, the same technological characteristics and same method of action as the predicate Route 92 Medical Access System. Therefore, based on the identical design and materials of construction between the subject and predicate devices and the completed non-clinical testing, the subject Route 92 Medical Delivery Catheter is substantially equivalent to the predicate Route 92 Medical Access System (K180201).
8
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