(58 days)
No
The device description and performance studies focus on the physical and mechanical properties of a microcatheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to introduce embolic coils and diagnostic agents, but it does not directly treat a disease or condition itself.
No
The device description indicates that the Plato 17 Microcatheter is intended for "introduction of embolic coils and infusion of diagnostic agents, such as contrast media," not directly for diagnosis. The contrast media itself aids in diagnosis, but the catheter is a delivery tool, not a diagnostic device.
No
The device description clearly details a physical catheter with various material components, a lumen, radiopaque markers, and accessories. It is a hardware medical device.
Based on the provided information, the Plato 17 Microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the introduction of embolic coils and infusion of diagnostic agents to the peripheral and neuro vasculature systems. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a catheter designed for insertion into blood vessels, which is consistent with an in vivo procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples of human origin (like blood, urine, tissue) in vitro to provide diagnostic information.
Therefore, the Plato 17 Microcatheter is a medical device used for therapeutic and diagnostic procedures within the body, not an IVD.
N/A
Intended Use / Indications for Use
The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, QJP
Device Description
Scientia Vascular's Plato® 17 Microcatheter is a single lumen, open-ended catheter designed to be flexible and axially stable, to aid the physician in the accessing of distal vasculature. The Plato 17 Microcatheter is supplied sterile and is for single use only. The Plato 17 Microcatheter is packaged with various tip configurations, including straight and pre-shaped (45° and 90°). The microcatheter shaft design includes nitinol, polymers of varying durometer and an internal liner providing lubricity for intraluminal delivered embolic coils and contrast media: the distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The working length of the catheter is 160 cm. The microcatheter includes two radiopague tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief. The Plato 17 Microcatheter is compatible with 0.014 inch guidewires or embolic coils.
The microcatheter is provided with a steam shaping mandrel, peel-away introducer and a ruler. The shaping mandrel, peel-away introducer and ruler are accessories included to facilitate use of the microcatheter and are not intended to contact the patient's body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature systems.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Non-Clinical Performance Tests:
Results of bench tests performed on the new Plato® 17 Microcatheter demonstrates it met the testing acceptance criteria, performs as well as the predicate device, and/or meets requirements of relevant standards. Further, any differences in technological characteristics of the Plato 17 Microcatheters when compared with predicate device characteristics do not raise new questions of safety and effectiveness.
Biocompatibility:
The biocompatibility evaluation for the subject device, Plato 17 Microcatheter was performed in accordance with ISO 10993-1: 2018.
- Cytotoxicity (MEM Elution): Cell culture was observed for cytotoxic reactivity. Conclusion: Non-cytotoxic.
- Sensitization: Study animals with subject device were observed for dermal sensitization. Conclusion: No sensitization reaction.
- Intracutaneous Reactivity- by extract: Study animals with subject device were observed for dermal reaction. Conclusion: No significant dermal reactions at the injected site.
- Acute Systemic Toxicity - by extract: Study animals with the subject device were observed for abnormal clinical signs indicative of toxicity during the 72-hour test period. Conclusion: No signs of toxicity.
- Material-Mediated Pyrogenicity: Study animals were observed for individual temperature rise. Conclusion: Non-pyrogenic.
- Direct Contact and Extract method Hemolysis Test: The difference between the hemolytic indexes of the subject device and the negative control was evaluated. Conclusion: Non-hemolytic.
- Partial Thromboplastin Time (PTT) Test: The clotting time was observed for both the subject device and the predicate. Conclusion: The difference in average clot time between the subject device and predicate was 7 seconds. The two samples are considered similar.
- Complement activation of SC5b-9: Comparison of the subject device SC5b-9 value to the predicate device for all exposure times was performed. Conclusion: The subject device had similar or lower potential to activate the complement system when compared to the predicate.
- Hemocompatibility In-vitro Blood Loop: The catheters are placed in an in-vitro blood loop for three runs. The thrombus score for the subject device and predicate device is observed. Conclusion: The lab testing concluded that the subject device showed minimal thrombus formation and is considered thromboresistant.
Functional Testing:
Functional testing was performed in accordance with ISO 80369-7:2016, ISO 80369-20:2015, ISO 10555-1:2013 (corrected 2014), and FDA Guidance Documents: Premarket Notifications [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters (March 1995), Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems (April 2010). All tests passed.
- Visual and Dimensional Inspection: Visual inspection of the catheter effective length was free from surface defects, surface extraneous matter, and coating droplets. Catheter met dimensional specifications. Results: PASS
- Tensile Strength: The minimum tensile force for all microcatheters met the tensile requirements of ISO 10555-1. Results: PASS
- Tip Flexibility: Comparable to the tip flexibility of the predicate catheter. Results: PASS
- Flexural Fatigue: Catheter withstood cyclic fatigue without catheter damage. Results: PASS
- Flow Characterization and Power Injection: Characterized fluid (saline and contrast media) flow rate through the catheter. No leak or break in the catheter when subject to power injection. Results: PASS
- Catheter Liquid Leak Under Pressure: No liquid leakage on the hub or catheter body. Results: PASS
- Catheter Static Burst: Maximum catheter burst pressure > 300psi. Results: PASS
- Torque Turns to Failure: Maintained catheter integrity after applied hub rotations with the distal end held stationary. Results: PASS
- Particulate Generation During Simulated Use: The amount of particulate matter that came off the hydrophilic coated shaft during simulated use testing was determined and compared to competitive products. Results: PASS
- Coating Lubricity, Durability and Integrity: After 15 cycles the coating maintained a minimum lubricity and maintained a minimum surface coating coverage. Results: PASS
- Negative Collapse Pressure and Air Ingress: No air ingress while under vacuum with a syringe held for 10 seconds. No catheter lumen collapse after applied vacuum with a syringe. Results: PASS
- Kink Radius: The catheter maintained lumen integrity while wrapped around an anatomically relevant bend radius. Results: PASS
- Tip Shape and Shape Retention: Catheter tip met defined tip dimensional tolerances and maintained tip shape. Results: PASS
- Catheter Elongation: Catheter shaft elongation at breakage was comparable to the predicate. Results: PASS
- Catheter Hub Luer Validation: Plato 17 Microcatheter hub was compliant to requirements found in ISO 80369-7. Results: PASS
- Simulated Use Model and Product Compatibility Evaluation: Simulated use testing of the microcatheter was performed with accessory devices in a neurovascular model. The microcatheter and interfacing devices were delivered through the model and evaluated for effectiveness of delivery and functionality. Results: PASS
- Accessory Verification: The Peel-Away Introducer facilitated introduction of catheter into a guide catheter. The tip shaping mandrel facilitated steam shaping of the catheter tip and showed no signs of corrosion. The ruler on the accessories card met design specifications. Results: PASS
- Radiopacity: Catheter tip markers were visible under X-Ray fluoroscopy within the neuro vasculature. Results: PASS
- Catheter Usability Study: Physician evaluation of the microcatheter in a cadaver study demonstrated acceptable use when compared to current marketed devices. The microcatheter and interfacing devices were delivered through a representative procedure and evaluated for effectiveness of delivery and functionality. Results: PASS
- Corrosion Resistance: No corrosion was visible on the catheter samples in compliance with ISO 10555-1. Results: PASS
Additionally, the Plato 17 Microcatheter and packaging were evaluated for Shelf-life testing (subject device), packaging integrity, and sterilization including EO, ECH residuals and bacterial endotoxin levels.
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.
Excelsior™ SL-10 Pre-Shaped Microcatheter (K042568, cleared 10/15/2004)
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.
Excelsior XT-17 Microcatheter (K142565, cleared 11/14/2014)
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 28, 2021
Scientia Vascular, LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite #510k Saint Paul, Minnesota 55114
Re: K210601
Trade/Device Name: Plato 17 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: April 20, 2021 Received: April 21, 2021
Dear Prithul Bom:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K210601
Device Name Plato® 17 Microcatheter
Indications for Use (Describe)
The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.
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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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3
Image /page/3/Picture/3 description: The image shows the logo for Scientia. The logo features a stylized, abstract symbol above the word "SCIENTIA" in a sans-serif font. The symbol consists of two curved, parallel lines that resemble a stylized "S" or a chain link. The color of the symbol and the text is a shade of blue.
510(K) SUMMARY (Per 21 CFR 807.92)
SCIENTIA VASCULAR, LLC Plato® 17 Microcatheter
Submitter Name and Address: Scientia Vascular, LLC 3487 West 2100 South Suite 100 West Valley City, UT 84119
Contact Person:
Amy McManus
Regulatory Affairs Manager Phone: 1 (888) 385-9016 Email: amcmanus@scientiavascular.com
Date Prepared: March 2021
| Trade Name: | Plato® 17 Microcatheter |
|---|---|
| Common Name: | Microcatheter |
| Classification Name: | Catheter, Percutaneous |
| Primary Product Code: | DQY |
| Secondary Product Code: | QJP |
| Review Panel: | Cardiovascular |
| Device Class: | Class II device per 21 CFR 870.1250 |
| Predicate Device: | Excelsior™ SL-10 Pre-Shaped Microcatheter (K042568, cleared 10/15/2004) |
| Reference Device | Excelsior XT-17 Microcatheter (K142565, cleared 11/14/2014) |
4
DEVICE DESCRIPTION
Scientia Vascular's Plato® 17 Microcatheter is a single lumen, open-ended catheter designed to be flexible and axially stable, to aid the physician in the accessing of distal vasculature. The Plato 17 Microcatheter is supplied sterile and is for single use only. The Plato 17 Microcatheter is packaged with various tip configurations, including straight and pre-shaped (45° and 90°). The microcatheter shaft design includes nitinol, polymers of varying durometer and an internal liner providing lubricity for intraluminal delivered embolic coils and contrast media: the distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The working length of the catheter is 160 cm. The microcatheter includes two radiopague tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief. The Plato 17 Microcatheter is compatible with 0.014 inch guidewires or embolic coils.
The microcatheter is provided with a steam shaping mandrel, peel-away introducer and a ruler. The shaping mandrel, peel-away introducer and ruler are accessories included to facilitate use of the microcatheter and are not intended to contact the patient's body.
The Plato 17 Microcatheter is substantially equivalent with respect to technological characteristics, design, and materials to the currently marketed Excelsior™ SL-10 Pre-Shaped Microcatheter cleared under K042568, by Boston Scientific.
INDICATIONS FOR USE / INTENDED USE
The Plato 17 Microcatheter is intended for the introduction of embolic coils and infusion of diagnostic agents, such as contrast media, to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.
5
TECHNOLOGICAL CHARACTERISTICS
The Plato® 17 Microcatheter is equivalent to the predicate device in the following ways:
- . Functionality
- Intended use ●
- Indication for use .
- . Biological safety
Shown in the table below is the comparison of technological characteristics for the Plato 17 Microcatheter to those of the predicate device, the Excelsior SL-10 Pre-Shaped Microcatheter (K042568) and reference device Excelsior XT-17 Microcatheter (K142565).
| Table 1: Comparison between Subject, Predicate & Reference Device Technological Characteristics: | ||||
|---|---|---|---|---|
| Characteristic | Subject Device | |||
| Plato® 17 Microcatheter | Predicate Device | |||
| Excelsior™ SL-10 Pre- | ||||
| Shaped Microcatheter | ||||
| (K042568) | Reference Device | |||
| Excelsior XT-17 | ||||
| Microcatheter (K142565) | Comparison | |||
| Analysis | ||||
| Anatomical | ||||
| Location | Neuro and peripheral | |||
| vasculature | Neuro, coronary, and | |||
| peripheral vasculature | Neuro, coronary, and | |||
| peripheral vasculature | Similar | |||
| Indications for Use | The Plato 17 | |||
| Microcatheter is intended | ||||
| for the introduction of | ||||
| embolic coils and | ||||
| infusion of diagnostic | ||||
| agents, such as contrast | ||||
| media, to the peripheral | ||||
| and neuro vasculature | ||||
| systems. The Plato 17 | ||||
| Microcatheter is not | ||||
| intended for use in the | ||||
| coronary vasculature. | "Boston Scientific's | |||
| Excelsior™ SL-10 Pre- | ||||
| Shaped Microcatheter and | ||||
| Excelsior™ 1018™ Pre- | ||||
| Shaped Microcatheter are | ||||
| intended to assist in the | ||||
| delivery of diagnostic | ||||
| agents, such as contrast | ||||
| media, and therapeutic | ||||
| agents, such as occlusion | ||||
| coils to the peripheral, | ||||
| coronary, and neuro | ||||
| vasculature." | "Stryker | |||
| Neurovascular's | ||||
| Excelsior XT-17 | ||||
| Microcatheters are | ||||
| intended to assist in the | ||||
| delivery of diagnostic | ||||
| agents, such as contrast | ||||
| media, and therapeutic | ||||
| agents, such as occlusion | ||||
| coils, into the peripheral, | ||||
| coronary and neuro | ||||
| vasculature." | Similar | |||
| Materials | Hub: | |||
| Clear polymer | Hub: | |||
| Clear polymer | Hub: | |||
| Clear polymer | Same | |||
| Strain Relief: | ||||
| Thermoplastic Elastomer | Strain Relief: | |||
| Thermoplastic Elastomer | Strain Relief: | |||
| Thermoplastic Elastomer | Same | |||
| Catheter Shaft: | ||||
| Polyamide over Nitinol, | ||||
| Stainless Steel, and | ||||
| PTFE | Catheter Shaft: | |||
| Polyamide, Stainless | ||||
| Steel and rubber | Catheter Shaft: | |||
| Polyamide, Stainless | ||||
| Steel and rubber | Different | |||
| Radiopaque Marker | ||||
| Bands: Platinum Iridium | Radiopaque Marker | |||
| Bands: Platinum Iridium | Radiopaque Marker | |||
| Bands: Platinum Iridium | Same | |||
| Proximal ID | 0.17" (0.43mm) | 0.165" (0.42mm) | 0.17" (0.43mm) | Same |
| Table 1: Comparison between Subject, Predicate & Reference Device Technological Characteristics: | ||||
| Characteristic | Subject Device | |||
| Plato® 17 Microcatheter | Predicate Device | |||
| Excelsior™ SL-10 Pre-Shaped Microcatheter (K042568) | Reference Device | |||
| Excelsior XT-17 Microcatheter (K142565) | Comparison Analysis | |||
| Proximal OD | 2.1F (0.70mm) | 2.4F (0.80mm) | 2.4F (0.80mm) | Different |
| Distal ID | 0.17" (0.43mm) | 0.165" (0.42mm) | 0.17" (0.43mm) | Similar |
| Distal OD | 1.7F (0.60mm) | 1.7F (0.60mm) | 1.7F (0.60mm) | Same |
| Effective Length | 160cm | 150cm | 150cm | Different |
| Tip Design | Straight and pre-shaped tips | Straight and pre-shaped tips | Straight and pre-shaped tips | Same |
| Steam-Shapeable tip | Yes | Yes | Yes | Same |
| Distal Coating | Hydrophilic coating | Hydrophilic coating | Hydrophilic coating | Same |
| Coating Length | 90cm | 100cm | 100cm | Different |
| Radiopaque Markers | 2 radiopaque markers located at distal tip of the microcatheter | 1 or 2 radiopaque markers located at distal tip of the microcatheter | 2 radiopaque markers located at distal tip of the microcatheter | Same |
| Sterilization Method | 100% Ethylene Oxide (EO) | 100% Ethylene Oxide (EO) | 100% Ethylene Oxide (EO) | Same |
| Guidewire Compatibility | 0.014" | 0.014" | 0.014" | Same |
| Accessories: Introducer | Included | Included | Included | Same |
| Accessories: Tip Shaping Mandrel | 0.015" diameter stainless steel tip shaping mandrel included | 0.013" diameter stainless steel tip shaping mandrel included | 0.016" diameter stainless steel tip shaping mandrel included | Different |
| Accessories: Ruler | Included | Included | Included | Same |
6
The subject device and predicate device indications for use statements are similar but not the same. The differences in the indications for use statements are device name, anatomical location for use and the example of therapeutic device. These differences do not raise new questions of safety and effectiveness or alter the intended use of the subject device. The subject device is not indicated for use in the coronary vasculature, but only in the peripheral and neuro vasculature systems; this is a subset of the predicate
7
device and this subset does not raise any additional safety and effectiveness concerns for the subject device. The predicate device indicates an occlusion coil as an example of a therapeutic device and the subject device lists only embolic coils. The subject device was tested for compatibility with embolic coils only; this does not represent additional risk or impact to safety and effectiveness of the device when compared to the predicate.
The subject device, Plato® 17 Microcatheter, has two technological characteristic differences compared to the predicate device: catheter shaft materials and dimensions (effective length, proximal OD and coating length); these differences do not raise new questions of safety and effectiveness for the subject device. The subject device design completed and passed functional testing. The differences in materials were evaluated through functional and biological testing. The evaluation of the risks for the subject device in the form of failure modes and effects analysis (FMEA) was conducted along with testing of the subject device to demonstrate the substantial equivalence of the device.
NON-CLINICAL PERFORMANCE TESTS
Results of bench tests performed on the new Plato® 17 Microcatheter demonstrates it met the testing acceptance criteria, performs as well as the predicate device, and/or meets requirements of relevant standards. Further, any differences in technological characteristics of the Plato 17 Microcatheters when compared with predicate device characteristics do not raise new questions of safety and effectiveness.
Biocompatibility
The biocompatibility evaluation for the subject device, Plato 17 Microcatheter was performed in accordance with ISO 10993-1: 2018. The testing is summarized in Table 2.
| Table 2: Summary of Subject Device Biocompatibility Testing Performed. | ||
|---|---|---|
| Name of Test | Test Summary | Conclusion of Testing |
| Cytotoxicity: MEM | ||
| Elution | Cell culture was observed for | |
| cytotoxic reactivity. | Non-cytotoxic. | |
| Sensitization | Study animals with subject device | |
| were observed for dermal | ||
| sensitization. | No sensitization reaction. | |
| Intracutaneous | ||
| Reactivity- by extract | Study animals with subject device | |
| were observed for dermal | ||
| reaction. | No significant dermal | |
| reactions at the injected | ||
| site. | ||
| Acute Systemic | ||
| Toxicity - by extract | Study animals with the subject | |
| device were observed for abnormal | ||
| clinical signs indicative of toxicity | ||
| during the 72-hour test period. | No signs of toxicity. | |
| Material-Mediated | ||
| Pyrogenicity | Study animals were observed for | |
| individual temperature rise. | Non-pyrogenic. |
8
| Table 2: Summary of Subject Device Biocompatibility Testing Performed. | ||
|---|---|---|
| Name of Test | Test Summary | Conclusion of Testing |
| Direct Contact and | ||
| Extract method | ||
| Hemolysis Test | The difference between the | |
| hemolytic indexes of the subject | ||
| device and the negative control | ||
| was evaluated. | Non-hemolytic. | |
| Partial Thromboplastin | ||
| Time (PTT) Test | The clotting time was observed for | |
| both the subject device and the | ||
| predicate. | The difference in average clot | |
| time between the subject | ||
| device and predicate was 7 | ||
| seconds. The two samples are | ||
| considered similar. | ||
| Complement | ||
| activation of SC5b-9 | Comparison of the subject device | |
| SC5b-9 value to the predicate | ||
| device for all exposure times was | ||
| performed. | The subject device had | |
| similar or lower potential to | ||
| activate the complement | ||
| system when compared to | ||
| the predicate. | ||
| Hemocompatibility In- | ||
| vitro Blood Loop | The catheters are placed in an in- | |
| vitro blood loop for three runs. | ||
| The thrombus score for the subject | ||
| device and predicate device is | ||
| observed. | The lab testing concluded that | |
| the subject device showed | ||
| minimal thrombus formation | ||
| and is considered | ||
| thromboresistant. |
Functional Testing
Functional testing was performed in accordance with the following standards:
- . ISO 80369-7:2016 - Small bore connectors for liquids and gases in healthcare applications -Connectors for intravascular or hypodermic applications,
- . ISO 80369-20:2015 - Small bore connectors for liquids and gases in healthcare applications -Common test methods,
- ISO 10555-1:2013 (corrected 2014) Intravascular catheters Sterile and single-use catheters -. Part 1: General requirements,
as well as the FDA Guidance Documents:
- Premarket Notifications [510(k)] Submissions for Short-Term and Long-Term . Intravascular Catheters (March 1995),
- . Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems (April 2010).
Table 3 Summarizes the functional verification testing performed.
| Table 3: Summary of Subject Device Functional Testing. | ||
|---|---|---|
| Test | Attribute and Acceptance Criteria | Results |
| Visual and Dimensional | ||
| Inspection | Visual inspection of the catheter effective length to be free | |
| from surface defects, surface extraneous matter, and coating | ||
| droplets. Catheter to meet the dimensional specifications per | ||
| the design specifications. | PASS | |
| Tensile Strength | The minimum tensile force for all microcatheters must | |
| meet the tensile requirements of ISO 10555-1. | PASS | |
| Tip Flexibility | Comparable to the tip flexibility of the predicate catheter. | PASS |
| Flexural Fatigue | Catheter shall withstand cyclic fatigue without catheter | |
| damage. | PASS | |
| Table 3: Summary of Subject Device Functional Testing. | ||
| Test | Attribute and Acceptance Criteria | Results |
| Flow Characterization | ||
| and Power Injection | Characterize fluid (saline and contrast media) flow rate | |
| through the catheter. | ||
| No leak or break in the catheter when subject to power | PASS | |
| Catheter Liquid Leak | ||
| Under Pressure | injection. | |
| No liquid leakage on the hub or catheter body. | PASS | |
| Catheter Static Burst | Maximum catheter burst pressure > 300psi. | PASS |
| Torque Turns to | ||
| Failure | Maintain catheter integrity after applied hub rotations with | |
| the distal end held stationary. | PASS | |
| Particulate Generation | ||
| During Simulated Use | The amount of particulate matter that comes off the | |
| hydrophilic coated shaft during simulated use testing shall be | ||
| determined and compared to the competitive products. | PASS | |
| Coating Lubricity, | ||
| Durability and | ||
| Integrity | After 15 cycles the coating must maintain a minimum | |
| lubricity and maintain a minimum surface coating coverage. | PASS | |
| Negative Collapse | ||
| Pressure and Air | ||
| Ingress | No air ingress while under vacuum with a syringe held for 10 | |
| seconds. | ||
| No catheter lumen collapse after applied vacuum with a | ||
| syringe. | PASS | |
| Kink Radius | The catheter must maintain lumen integrity while wrapped | |
| around an anatomically relevant bend radius. | PASS | |
| Tip Shape and Shape | ||
| Retention | Catheter tip meets defined tip dimensional tolerances and | |
| must maintain tip shape. | PASS | |
| Catheter Elongation | Catheter shaft elongation at breakage should be comparable to | |
| the predicate. | PASS | |
| Catheter Hub Luer | ||
| Validation | Plato 17 Microcatheter hub will be compliant to requirements | |
| found in ISO 80369-7. | PASS | |
| Simulated Use Model | ||
| and Product | ||
| Compatibility | ||
| Evaluation | Simulated use testing of the microcatheter was performed | |
| with accessory devices in a neurovascular model. The | ||
| microcatheter and interfacing devices were delivered through | ||
| the model and evaluated for effectiveness of delivery and | ||
| functionality. | PASS | |
| Accessory | ||
| Verification | The Peel-Away Introducer must facilitate introduction of | |
| catheter into a guide catheter. | ||
| The tip shaping mandrel must facilitate steam shaping of the | ||
| catheter tip and show no signs of corrosion. | ||
| The ruler on the accessories card must meet design | ||
| specifications. | PASS | |
| Radiopacity | Catheter tip markers to be visible under X-Ray fluoroscopy | |
| within the neuro vasculature. | PASS | |
| Catheter Usability | ||
| Study | Physician evaluation of the microcatheter in a cadaver study | |
| demonstrates acceptable use when compared to current | ||
| marketed devices. The microcatheter and interfacing devices | ||
| were delivered through a representative procedure and | ||
| evaluated for effectiveness of delivery and functionality. | PASS | |
| Corrosion Resistance | No corrosion is visible on the catheter samples in | |
| compliance with ISO 10555-1. | PASS |
9
Additionally, the Plato 17 Microcatheter and packaging were evaluated for Shelf-life testing (subject device), packaging integrity, and sterilization including EO, ECH residuals and bacterial endotoxin levels.
10
CONCLUSION:
The Plato® 17 Microcatheter has a similar intended use and indications for use statement as the predicate device. The identified technological differences do not raise new questions of safety or effectiveness regarding the use of the subject device. Risk evaluation along with testing, functional and biological, was completed for the subject device. The testing and risk evaluation demonstrate that the subject device is substantially equivalent to the predicate. The subject device and the predicate device share the same intended use, basic technological characteristics, and similar functional performance, as demonstrated through testing.