(266 days)
Not Found
No
The description focuses on the physical design and materials of a microcatheter and its accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are non-clinical and focus on biocompatibility and functional testing of the physical device.
No.
The document states that the Plato 17 Microcatheter is "intended for the introduction of therapeutic devices," indicating it is a delivery system for therapeutic devices, not a therapeutic device itself.
No.
The device injects diagnostic agents but is not itself a diagnostic device.
No
The device description clearly details a physical catheter with various material components, a lumen, tip markers, and accessories. It is a hardware device, not software.
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 that the device is for the introduction of therapeutic devices, infusion of diagnostic agents (like contrast media), and delivery of embolization materials to the peripheral and neuro vasculature systems. This involves direct interaction with the patient's body for therapeutic and diagnostic delivery within the body.
- Device Description: The description details a catheter designed for insertion into blood vessels.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The Plato 17 Microcatheter is an invasive medical device used for procedures performed within the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.
Product codes
QJP, DQY
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 the distal neuro and peripheral vasculature. The Plato® 17 Microcatheter is supplied sterile and is for single use only. The Plato® 17 Microcatheter is supplied in 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 therapeutic device, diagnostic agent, and embolization material delivery. The distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The microcatheter includes two radiopaque tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief.
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
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)
Biocompatibility:
- Cytotoxicity: MEM Elution - Cell culture was observed for cytotoxic reactivity. Conclusion: Non-cytotoxic.
- 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: Non-activator.
- Platelet Leukocyte Counts - The concentration of platelets and leukocytes were determined on an automated hematology analyzer. Conclusion: Non-activator.
Functional Testing:
- Accessory Verification - The Peel-Away Introducer must facilitate introduction of catheter into a guide catheter. Results: PASS.
- Therapeutic Device Compatibility and Simulated Use - The Plato® 17 Microcatheter can successfully deliver representative therapeutic devices, including stent, in a tortuous neurovascular model. The Plato® 17 Microcatheter was evaluated for delivery to target location and functionality post therapeutic device delivery. Results: PASS.
- Embolization Material Compatibility - Visual inspection, lumen check, liquid leakage, static burst, tensile and force to withdraw testing was conducted for the Plato® 17 Microcatheter using representative embolization materials in a tortuous neurovascular model. Results: PASS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
August 21, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Scientia Vascular, Inc. Max Alfonso Regulatory Affairs Specialist 3487 West 2100 South Suite 100 West Valley City, Utah 84119
Re: K223560
Trade/Device Name: Plato 17 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: July 20, 2023 Received: July 21, 2023
Dear Max Alfonso:
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 -S
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
510(k) Number (if known) K223560
Device Name Plato® 17 Microcatheter
Indications for Use (Describe)
The Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials 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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3
Scientia Vascular, Inc. Traditional 510(k) Plato® 17 Microcatheter
Image /page/3/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized, teal-colored symbol resembling an abstract letter 'S' or a curved, interconnected chain. Below the symbol, the word "SCIENTIA" is written in a modern, sans-serif font with a gray color scheme. The font appears to be slightly stylized, with rounded edges and a futuristic aesthetic.
510(K) SUMMARY K223560
(Per 21 CFR 807.92)
SCIENTIA VASCULAR, INC. Plato® 17 Microcatheter
Submitter Name and Address: Scientia Vascular, Inc. 3487 West 2100 South Suite 100 West Valley City, UT 84119
| Contact Person: | Max Alfonso |
|---|---|
| Regulatory Affairs Specialist | |
| Phone: 1 (888) 385-9016 | |
| Email: regulatory@scientiavascular.com |
Date Prepared: 18 August 2023
| Trade Name: | Plato® 17 Microcatheter |
|---|---|
| Common Name: | Microcatheter |
| Classification Name: | Catheter, Percutaneous |
| Primary Product Code: | QJP |
| Secondary Product Code: | DQY |
| Review Panel: | Neurology |
| Device Class: | Class II device per 21 CFR 870.1250 |
| Predicate Device: | Plato® 17 Microcatheter (K210601, cleared 04/28/2021) |
4
Scientia Vascular, Inc. Traditional 510(k) Plato® 17 Microcatheter
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 the distal neuro and peripheral vasculature. The Plato® 17 Microcatheter is supplied sterile and is for single use only. The Plato® 17 Microcatheter is supplied in 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 therapeutic device, diagnostic agent, and embolization material delivery. The distal exterior section of the catheter shaft is hydrophilic coated to reduce friction during manipulation in vessels. The microcatheter includes two radiopaque tip markers to facilitate fluoroscopic visualization and a clear hub with luer lock and a strain relief.
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 intended use, technological characteristics, design, and materials to Scientia Vascular's currently marketed Plato® 17 Microcatheter cleared under K210601.
INTENDED USE
To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
INDICATIONS FOR USE
The Plato 17 Microcatheter is intended for the introduction of therapeutic devices, infusion of diagnostic agents, such as contrast media, and delivery of embolization materials to the peripheral and neuro vasculature systems. The Plato 17 Microcatheter is not intended for use in the coronary vasculature.
TECHNOLOGICAL CHARACTERISTICS
The Plato® 17 Microcatheter is equivalent or similar to the predicate device in the following ways:
- Functionality ●
- Intended use ●
- Materials ●
- Design ●
- . 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 Plato® 17 Microcatheter (K210601).
5
| Table 1: Comparison between Subject & Predicate Device Technological Characteristics: | |
|---|---|
| --------------------------------------------------------------------------------------- | -- |
| Note: Differences are bolded . | |||
|---|---|---|---|
| Characteristic | Subject Device | ||
| Plato® 17 Microcatheter (K223560) | Predicate Device | ||
| Plato® 17 Microcatheter (K210601) | Comparison | ||
| Analysis | |||
| Anatomical | |||
| Location | Neuro and peripheral vasculature | Neuro and peripheral vasculature | Same |
| Indications for Use | The Plato 17 Microcatheter is | ||
| intended for the introduction of | |||
| therapeutic devices , infusion of | |||
| diagnostic agents, such as contrast | |||
| media, and delivery of | |||
| embolization materials to the | |||
| peripheral and neuro vasculature | |||
| systems. The Plato 17 Microcatheter | |||
| is not intended for use in the | |||
| coronary vasculature. | 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. | Similar | ||
| Materials | Hub: | ||
| Clear polymer | Hub: | ||
| Clear polymer | Same | ||
| Strain Relief: | |||
| Thermoplastic Elastomer | Strain Relief: | ||
| Thermoplastic Elastomer | Same | ||
| Catheter Shaft: | |||
| Polyamide, Nitinol, Stainless Steel, | |||
| and PTFE | Catheter Shaft: | ||
| Polyamide, Nitinol, Stainless Steel, | |||
| and PTFE | Same | ||
| Radiopaque Marker Bands: | |||
| Platinum Iridium | Radiopaque Marker Bands: | ||
| Platinum Iridium | Same | ||
| Proximal ID | 0.017" (0.43mm) | 0.017" (0.43mm) | Same |
| Proximal OD | 2.1F (0.70mm) | 2.1F (0.70mm) | Same |
| Distal ID | 0.017" (0.43mm) | 0.017" (0.43mm) | Same |
| Distal OD | 1.7F (0.60mm) | 1.7F (0.60mm) | Same |
| Effective Length | 160cm | 160cm | Same |
| Tip Design | Straight and pre-shaped tips | Straight and pre-shaped tips | Same |
| Steam-Shapeable | |||
| tip | Yes | Yes | Same |
6
| Table 1: Comparison between Subject & Predicate Device Technological Characteristics: | |||||
|---|---|---|---|---|---|
| Note: Differences are bolded. | |||||
| Characteristic | Subject Device | ||||
| Plato® 17 Microcatheter (K223560) | Predicate Device | ||||
| Plato® 17 Microcatheter (K210601) | Comparison | ||||
| Analysis | |||||
| Distal Coating | Hydrophilic coating | Hydrophilic coating | Same | ||
| Coated Length | 90cm | 90cm | Same | ||
| Radiopaque | |||||
| Markers | 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) | Same | ||
| Guidewire | |||||
| Compatibility | 0.014" | 0.014" | Same | ||
| Accessories: | |||||
| Introducer | Included (ID: 0.060") | Included (ID: 0.045") | Different | ||
| Accessories: | |||||
| Tip Shaping | |||||
| Mandrel | 0.015" diameter stainless steel tip | ||||
| shaping mandrel included | 0.015" diameter stainless steel tip | ||||
| shaping mandrel included | Same | ||||
| Accessories: | |||||
| Ruler | Included | Included | Same |
|Table 1: Comparison between Subject & Predicate Device Technological Characteristics:
The subject device, Plato® 17 Microcatheter, has similar intended use and the same fundamental technological characteristics (design, materials, and device features) when compared to the predicate device. The subject device completed and passed required nonclinical testing to support the expanded indications for use. The difference in technological characteristics and intended use do not raise new or different questions of safety and effectiveness for the subject device.
NON-CLINICAL PERFORMANCE TESTS
Results of tests performed on the subject Plato® 17 Microcatheter demonstrates it met the testing acceptance criteria, performs as well as the predicate device, and/or meets requirements of relevant standards and FDA guidance documents.
Biocompatibility
The biocompatibility evaluation for the subject device, Plato® 17 Microcatheter, was performed in accordance with ISO 10993-1: 2018. The previously conducted testing from the predicate device submission, K210601, was used to support the biocompatibility of the subject device and the following
7
Scientia Vascular, Inc. Traditional 510(k) Plato® 17 Microcatheter
additional testing was also conducted:
| 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. | |
| 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. | Non-activator. | |
| Platelet Leukocyte Counts | The concentration of platelets and | |
| leukocytes were determined on an | ||
| automated hematology analyzer. | Non-activator. |
Functional Testing
Functional testing was performed in accordance with the following standards:
- ISO 80369-7:2021 - 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),
- Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (October 2019),
- Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings Labeling . Considerations (October 2019).
The design of the subject device is unchanged when compared to the predicate device, K210601. Therefore, the functional testing from K210601 for the predicate device is utilized and adopted for the subject device. Table 3 Summarizes the additional functional verification testing performed as part of this submission.
8
| Test | Attribute and Acceptance Criteria | Results |
|---|---|---|
| Accessory | ||
| Verification | The Peel-Away Introducer must facilitate introduction of | |
| catheter into a guide catheter. | PASS | |
| Therapeutic Device | ||
| Compatibility and | ||
| Simulated Use | The Plato® 17 Microcatheter can successfully deliver | |
| representative therapeutic devices, including stent, in a | ||
| tortuous neurovascular model. | ||
| The Plato® 17 Microcatheter was evaluated for delivery to | ||
| target location and functionality post therapeutic device | ||
| delivery. | PASS | |
| Embolization | ||
| Material | ||
| Compatibility | Visual inspection, lumen check, liquid leakage, static burst, | |
| tensile and force to withdraw testing was conducted for the | ||
| Plato® 17 Microcatheter using representative embolization | ||
| materials in a tortuous neurovascular model. | PASS |
Table 3: Summary of Subject Device Functional Testing.
Additionally, the sterilization process of the subject device is identical to the predicate device K210601. The shelf-life testing, packaging integrity, and sterilization including EO, ECH residuals and bacterial endotoxin levels for the subject device are supported by the testing conducted for the predicate device.
CONCLUSION
The Plato® 17 Microcatheter has similar intended use and technological characteristics when compared to the predicate device. The identified differences in the indications for use statement and accessory introducer diameter do not raise new questions of safety or effectiveness. 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 have similar intended use, the same fundamental technological characteristics, and similar functional performance, as demonstrated through testing.