(108 days)
Not Found
No
The document describes a physical medical device (microcatheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The "Intended Use" explicitly states that the microcatheter is used in "therapeutic procedures" for the selective placement of devices and/or fluids.
No
The device is a microcatheter used for selective placement of devices and/or fluids. While it can be used during diagnostic procedures, its function is not to diagnose. It facilitates diagnostic procedures by delivering substances like contrast media, but it does not perform the diagnostic assessment itself.
No
The device description clearly describes a physical catheter with a braided shaft, radiopaque markers, a luer hub, and a hydrophilic coating. This indicates a hardware device, not software only.
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 "selective placement of devices and/or fluids... into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedures, not a device used to test samples outside the body.
- Device Description: The description details a physical catheter with a lumen, braided shaft, radiopaque markers, and a luer hub. This is consistent with a medical device used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This microcatheter does not fit that description.
N/A
Intended Use / Indications for Use
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
DQO, DQY
Device Description
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Data – Bench Testing
The results of design verification and design validation testing conducted on the Trevo Trak 21 Microcatheter demonstrates that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Predicate device. The design verification and design validation bench testing are summarized in Table 2. Each test met acceptance criteria.
Performance Data - Animal Study, Clinical Study
No animal study or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
Shelf Life Testing
The labeled shelf life for the Trevo Trak 21 Microcatheter is two years. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing were performed on the Subject device, and the results met established criteria.
Sterilization
The Trevo Trak 21 Microcatheter and accessory (RHV) are sterilized with 100% Ethylene Oxide. The Trevo Trak 21 Microcatheter and accessory are provided sterility assurance level (SAL) of 10 6 has been demonstrated. The Trevo Trak 21 Microcatheter and accessory meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The Trevo Trak 21 Microcatheter and accessory are for single use only.
Biocompatibility
The Trevo Trak 21 Microcatheter was assessed for biocompatibility in accordance with EN ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process". The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The Trevo Trak 21 Microcatheter passed all recommended biocompatibility testing. (Table 3 provides an overview of biocompatibility studies and their results).
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.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(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: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
November 22, 2019
Stryker Neurovascular Rhoda Santos Senior Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K192122
Trade/Device Name: Trevo Trak™ 21 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, DQY Dated: November 7, 2019 Received: November 8, 2019
Dear Rhoda Santos:
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,
Xiaolin Zheng, Ph.D., M.S. 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) K192122
Device Name Trevo Trak 21 Microcatheter
Indications for Use (Describe)
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
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 K192122
| Trade/Proprietary Name: | Trevo Trak™ 21 Microcatheter |
|---|---|
| Common Name: | Catheter, intravascular, diagnostic |
| Regulation Name: | Catheter, intravascular, diagnostic, 21 CFR 870.1200 – Class II |
| Product Code: | DQO |
| Trade/Proprietary Name: | Trevo Trak™ 21 Microcatheter |
| Common Name: | Percutaneous Catheter |
| Regulation Name: | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Product Code: | DQY |
| Submitter: | Stryker Neurovascular |
| 47900 Bayside Parkway | |
| Fremont, CA 94538-6515 | |
| (FDA Registration Number: 3008853977) | |
| Contact: | Rhoda M. Santos |
| Senior Principal Regulatory Affairs Specialist | |
| Phone: 510-413-2269 | |
| Fax: 510-413-2724 | |
| Email: rhoda.santos@stryker.com | |
| Date Prepared: | November 20, 2019 |
Legally Marketed Predicate Devices
| Name of Predicate Device | Name of
Manufacturer | 510(k)
Number |
|--------------------------------|--------------------------|------------------|
| Trevo® Pro 18
Microcatheter | Stryker
Neurovascular | K113260 |
Device Description
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization.
4
Indications for Use
The Microcatheter is indicated for use in the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular has demonstrated the Trevo Trak™ 21 Microcatheter is substantially equivalent to the Predicate device, Trevo Pro18 Microcatheter (K113260) based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject device with the Predicate device is summarized in
Table 1 below.
| Detail | Subject Device (K192122) | Predicate Device (K113260) |
|---|---|---|
| Manufacturer | Stryker Neurovascular | Stryker Neurovascular |
| 510(k) Number | K192122 | K113260 |
| Device Trade Name | Trevo TrakTM 21 | |
| Microcatheter | Trevo® Pro 18 Microcatheter | |
| Regulation Number | 21 CFR 870.1250 | Same |
| Regulation Name | Percutaneous Catheter | Same |
| Classification | II | Same |
| Product Code | DQY | Same |
| Intended | ||
| Use/Indication for | ||
| Use | The Microcatheter is indicated | |
| for use in the selective placement | ||
| of devices and/or fluids, such as | ||
| contrast media, into the | ||
| peripheral, coronary, and neuro | ||
| vasculature during diagnostic | ||
| and/or therapeutic procedures. | The Microcatheter is indicated | |
| for use in the selective placement | ||
| of fluids and/or other devices or | ||
| agents into the peripheral, | ||
| coronary, and neuro vasculature | ||
| during diagnostic and/or | ||
| therapeutic procedures. | ||
| Device Description | The Microcatheter is a single- | |
| lumen, braided shaft, variable | ||
| stiffness catheter with radiopaque | ||
| marker(s) on the distal end and a | ||
| luer hub on the proximal end. | ||
| The catheter shaft has a | ||
| hydrophilic coating to reduce | ||
| friction during use. The | The Microcatheter is a single- | |
| lumen, braided shaft, variable | ||
| stiffness catheter with radiopaque | ||
| marker(s) on the distal end and a | ||
| luer hub on the proximal end. | ||
| The catheter shaft has a | ||
| hydrophilic coating on the distal 100cm to reduce friction during | ||
| Detail | Subject Device (K192122) | Predicate Device (K113260) |
| radiopaque shaft and distal | ||
| marker(s) facilitate fluoroscopic | ||
| visualization. | ||
| Device dimensions and | ||
| configuration are shown on the | ||
| product label. A rotating | ||
| hemostasis valve with side-arm | ||
| adapter is provided with each | ||
| microcatheter. | use. The radiopaque shaft and | |
| distal marker(s) facilitate | ||
| fluoroscopic visualization. | ||
| Device dimensions and | ||
| configuration are shown on the | ||
| product | ||
| label. A rotating hemostasis | ||
| valve with side-arm adapter is | ||
| provided with each | ||
| microcatheter. | ||
| Accessory Devices | ||
| Provided (not in | ||
| direct contact with | ||
| patient) | Rotating Hemostasis Valve | |
| (RHV) packaged within device | Same | |
| Outer Jacket | Polymeric microcatheter | Same |
| Shaft Braid | Stainless Steel | Same |
| Strain Relief | Polyolefin | Same |
| Inner Layer | PTFE | Same |
| Catheter Hub | Polyurethane | Same |
| Marker Band | Platinum/Iridium | Same |
| Adhesive | Acrylic (Acrylated Urethane) | Same |
| Outer Jacket Coating | Hydrophilic Coating | Same |
| Labeled Shaft Outer | ||
| Diameter | 2.4F/2.0F | Same |
| Labeled Shaft Inner | ||
| Diameter | .021" | Same |
| Effective Length | 162 cm | 150 cm |
| Packaging Materials | ||
| and Configuration | HDPE Packaging Hoop, | |
| Tyvek/Film Pouch, SBS Carton | HDPE Packaging Hoop, HDPE | |
| mounting card, Tyvek/Film | ||
| Pouch, HDPE Tubing Clips, SBS | ||
| Carton | ||
| Sterilization Method | EO Sterilization | Same |
| How Supplied | Single Use/Sterile | Same |
| Detail | Subject Device (K192122) | Predicate Device (K113260) |
| Principles of | ||
| Operation | The device is advanced into the | |
| vasculature over an appropriately | ||
| sized guide wire. Once the | ||
| microcatheter is inserted, the | ||
| catheter can be advanced through | ||
| the vasculature to the desired | ||
| location. | Same |
Table 1. Product Feature Comparison of Subject Device to Predicate Device
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Testing Summary
Performance Data – Bench Testing
The results of design verification and design validation testing conducted on the Trevo Trak 21 Microcatheter demonstrates that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Predicate device. The design verification and design validation bench testing are summarized in Table 2 below.
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Dimensional | ||
| Verification | Purpose: To describe the procedure and technique | |
| of making dimensional measurements using | ||
| various measurement equipment. |
Method: Verify dimensions using specified
measurement tool. Record measurements. | Dimensional
verification met
acceptance criteria. |
| Tensile Strength | Purpose: To determine tensile strength of
catheters based on EN ISO 10555-1.
Method: Identify catheter joints, including
catheter to hub junction, and prepare sample for
test. Use tensile tester to apply tensile load to
sample and identify peak tensile force. Record
results. | Tensile strength
met acceptance
criteria. |
| Air Leak Resistance | Purpose: To determine whether the device meets
the freedom from leakage-air aspiration
requirement of 4.7.2 of EN ISO 10555-1 and
4.2.2 of EN 1707.
Method: Connect test hub sample to a partially
filled syringe. With the nozzle of the syringe
pointing down towards the ground, withdraw the
plunger to the 10cc mark. Hold for 15 seconds | Air leak resistance
of catheter met
acceptance criteria. |
| Test | Test Method Summary | Conclusions |
| | and examine the water in the syringe for the
formation of air bubbles. Record results. | |
| Liquid Leak
Resistance | Purpose: To determine whether the device meets
the freedom from leakage-liquid leak requirement
4.7.1 of EN ISO 10555-1 and 4.2.1 of EN 1707. | Liquid leak
resistance of
catheter met |
| | Method: Connect test hub sample to fixture and
flush with water to expel air. Occlude distal tip.
Apply pressure of 300 kPa to 320 kPa and
maintain pressure for 30s. Visually inspect
catheter/hub joint and catheter shaft for leaks.
Record results. | acceptance criteria. |
| Burst pressure | Purpose: To determine if the catheter can resist its
rated burst pressure without causing leakage or
damage to the catheter. This test is performed in
accordance with EN ISO 10555-1:2013, Annex F. | Burst pressure met
acceptance criteria. |
| | Method: Prepare test sample. Apply specified
burst pressure (greater than the rated burst
pressure) to test sample and maintain pressure for
at least 2 seconds. Observe sample for any
leakage or damage. Record results. | |
| Particulate
characterization | Purpose: To characterize acute phase particulate
generated as a result of product specific simulated
use steps. | Particulate
generation was
acceptable. |
| | Method: Measure the total number of particulates
generated during simulated use. Report in each of
four size ranges ≥10μm, ≥25μm, ≥50μm, and
≥100μm. | |
| | If >100μm are observed, complete particle count
analysis of bin sizes ≥200μm, ≥500μm and
≥1000μm. Record results. | |
| Coating Integrity | Purpose: Coated surface shall be visually
characterized before and after simulated use with
sufficient magnification to identify any defects
which could be associated with loss of coating
under anticipated clinical use conditions. | Coating integrity
was acceptable. |
| | Method: Remove test sample from packaging and
inspect for damage. Visually inspect external
surface of test sample using minimum 10x
magnification for surface defects. Record results. | |
| Test | Test Method Summary | Conclusions |
| Torsion Bond
Strength | Purpose: To measure the strength of a catheter
shaft when torque is applied.
Method: Prepare test sample and insert into
torsional bond strength test fixture with tortuous
path model. Apply torque to proximal end of
catheter while distal end is fixed. Record
maximum observed number of 360-degree
rotations. | Torsional Bond
Strength met
acceptance criteria. |
| Kink Resistance | Purpose: To measure the kink radius of a catheter
shafts.
Method: Prepare test sample. Position test sample
in a loop and place within a vice ensuring loop
apex is within the vice. Slowly close the vice until
the test sample kinks. Measure distance between
vice grips and record result. | Kink resistance met
acceptance criteria. |
| Chemical
Compatibility | Purpose: To determine visual and dimensional
integrity of catheter following exposure to saline
and non-ionic contrast liquids.
Method: Prepare sample for test. Flush sample
with water for 1 minute and then measure OD and
ID of test sample. Insert mandrel and take images
of test sample for initial characterization. Dip test
sample and mandrel into specified chemicals and
hold for 1 minute. Remove test sample, measure
OD, ID and cross-sectional area. Take images of
test sample for post-exposure characterization.
Record results. | Chemical
compatibility met
acceptance criteria. |
| Tip Flexibility | Purpose: To measure the maximum force required
to deflect test sample by 45°.
Method: Prepare sample for test. Use Instron and
appropriate fixtures to deflect test sample while
measuring force. Record maximum force
achieved. | Tip Flexibility met
acceptance criteria. |
| Distal Tip Shape | Purpose: To verify that the catheter tip is smooth,
rounded, tapered or similarly finished in order to
minimize trauma to vessels during use per EN
ISO 10555-1.
Method: Visually inspect distal tip to verify distal
tip end is smooth, rounded, tapered or similarly
finished. Record results. | Distal Tip Shape
met acceptance
criteria. |
| Test | Test Method Summary | Conclusions |
| Surface Condition | Purpose: To verify the external surface of the
catheter is free from extraneous matter, process or
surface defects along the shaft.
Method: Visually inspect external surface of test
sample using minimum 2.5x magnification for
surface defects. Record results. | Surface condition
met acceptance
criteria. |
| Distal Shaft
Trackability | Purpose: To evaluate the force required to track
the catheter through a tortuous model as well as
evaluate the lubricity and durability of the
catheter.
Method: Prepare sample for test. Use track tester
to measure the track force of the test sample
through a tortuous model using a tri-axial
approach. Record the peak force during advance
tracking at 6th cycle. | Distal shaft
trackability met
acceptance criteria. |
| Luer Testing per EN
1707 | Purpose: To determine if microcatheter hub and
accessory meet requirements 4.1 through 4.7 of
EN 1707.
Method: Test methods conforms with section 5 of
EN 1707. | Luer testing meets
acceptance criteria. |
| In-vitro Simulated
Use Study | Purpose: To evaluate interventional device
delivery, durability and integrity of the Subject
device as a general access and delivery catheter in
a tortuous anatomical model with multiple
physician users.
Method: Perform a simulated interventional
procedure by tracking the device to the target site
for interventional device delivery using a
neurovascular model that replicates the tortuosity,
diameter and location of the arteries in the
neurovasculature. Devices were visually
inspected post testing. | All test samples met
acceptance criteria. |
| Compatibility with
Retrieval devices | Purpose: To ensure the microcatheter shall be
able to resheath a retriever in good condition
without a captured thrombus after deployment of
the entire shaped section into the vessel at least 2
times without functional impact and integrity to
the tip. | Compatibility with
Retrieval devices
met acceptance
criteria. |
| Test | Test Method Summary | Conclusions |
| | Method: Entire shaped section is deployed into
the vessel at least 2 times and inspected for
functional impact and integrity of the tip.
Integrity is defined as no missing material or tears
at the tip. Functional impact is defined as inability
to resheath the shaped section. A deployment is
defined as the entire shaped section of the
retriever is deployed into the vessel. | |
| Product Integrity Post
Removal | Purpose: To determine damage to product
following removal of the catheter and its
accessories from its packaging.
Method: Prepare product and remove from
packaging per DFU, followed by
-inspecting for kinks, stretches or crushing of the
catheter shaft.
Self-evident inspection:
-No damage on RHV. | Product integrity
post removal met
acceptance criteria. |
Table 2. Performance Data - Bench Testing
7
8
9
10
Performance Data - Animal Study, Clinical Study
No animal study or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
Shelf Life Testing
The labeled shelf life for the Trevo Trak 21 Microcatheter is two years. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing were performed on the Subject device, and the results met established criteria.
Sterilization
The Trevo Trak 21 Microcatheter and accessory (RHV) are sterilized with 100% Ethylene Oxide. The Trevo Trak 21 Microcatheter and accessory are provided sterility assurance level (SAL) of 10 6 has been demonstrated. The Trevo Trak 21 Microcatheter and accessory meet EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The Trevo Trak 21 Microcatheter and accessory are for single use only.
11
Biocompatibility
The Trevo Trak 21 Microcatheter was assessed for biocompatibility in accordance with EN ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process". The Subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The Trevo Trak 21 Microcatheter passed all recommended biocompatibility testing. An overview of the biocompatibility testing is summarized below.
| Test | Acceptance Criteria | Conclusion | ||
|---|---|---|---|---|
| ISO | ||||
| 10993-4 | Hemolysis | Direct Contact | Hemolysis is $\le$ 5%. | Pass |
| Extraction | Non-hemolytic | |||
| (0.0%) | Pass | |||
| Thrombosis | Thromboresistance | Thrombosis is acceptable for clinical | ||
| application. | Pass | |||
| Complement | ||||
| Activation | Potential activator | |||
| ( $p$ ) | Non-volatile Residue $\le$ 15 mg | |||
| Residue on Ignition $\le$ 5 mg | ||||
| Heavy Metals $\le$ 1 ppm | ||||
| Buffering Capacity $\le$ 10.0 mL | Pass | |||
| FTIR | No unexpected readings. | Pass | ||
| Latex | ||||
| (LEAP - ASTM D6499) | No detectable latex. | Pass |
| Table 3. Overview of Biocompatibility Studies Performed on the Subject Device |
|---|
| ------------------------------------------------------------------------------- |
Conclusion
Stryker Neurovascular has demonstrated the Trevo Trak 21 Microcatheter is substantially equivalent to the Predicate device (K113260) based on same intended use / indications for use, same or similar materials, same fundamental design, and the same operating principles. The conclusions drawn from risk assessment and the bench testing results summarized above demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Directions for Use. Stryker Neurovascular has demonstrated that the Trevo Trak 21 Microcatheter is substantially equivalent to the legally marketed Predicate device.