(47 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended to assist in the delivery of diagnostic and/or therapeutic agents, but it is not itself a therapeutic device. It is a delivery tool.
No
Explanation: The "Intended Use" states that the device is intended to assist in the delivery of diagnostic and/or therapeutic agents, but it is not a diagnostic device itself. It is a microcatheter used for delivery.
No
The device description clearly details a physical catheter with a metal hypotube, hydrophilic coating, and radiopaque marker, along with an accessory mandrel. This indicates a hardware medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for assisting in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems. This means it's used within the body (in vivo) to deliver substances, not to test samples outside the body (in vitro).
- Device Description: The description details a catheter designed for accessing the vasculature, which is an in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for delivering substances within the body, which falls under the category of a medical device used for treatment or diagnosis in vivo.
N/A
Intended Use / Indications for Use
The Scientia Vascular LLC Plato MICROCATH 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.
Product codes
DOO
Device Description
The Plato MICROCATH® 27 Microcatheters are single lumen catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neurovascular 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)
Non-clinical testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1 with Amendments 1 and 2, and in the FDA guidance for Short-Term and Long-Term Intravascular Catheters, dated March 16, 1995. Testing performed on the proposed device included:
- Visual/Dimensional Inspection
- Air Ingress/Negative Collapse
- Kink Resistance
- Tensile Strength/Elongation
- Liquid Leakage under Pressure/Leakage at Hub
- Tip Stiffness
- Pressure vs. Flow Characterization
- Static and Dynamic Burst Pressure
- Flex Fatigue
- Shape Retention
- Coating Lubricity and Durability
- Coating Integrity
- Particulates
- Chemical compatibility
- Latex
- Corrosion Resistance
Additionally, simulated use testing included navigating the device through an anatomical model to test the guidewire tracking and movement within the catheter. In a human cadaver model, the device was comparable to the predicate for advancement to the intended vascular site.
Conclusions: The non-clinical bench testing, simulated-use testing and human cadaver test results demonstrate that the Plato MICROCATH 27 Microcatheter functions as intended, meets the requirements of ISO 10555-1, and performs equivalent or better than the predicate devices in small tortuous vessels. The testing supports a determination of substantial equivalence to products previously cleared by FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ev3 Rebar-027, K993672
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K|21734
Image /page/0/Picture/1 description: The image shows the logo for Scientia. The logo consists of a stylized letter 'S' above the word 'SCIENTIA' in a futuristic-looking font. The 'S' is made up of thick, rounded lines, giving it a bold and modern appearance.
JUL 30 2012
510(K) SUMMARY (21 CFR 807.92)
SCIENTIA VASCULAR LLC PLATO MICROCATH® 27 MICROCATHETER
510(k) Owner:
Scientia Vascular LLC 2700 South 900 West Suite D Salt Lake City, UT 84119 Tel: (775) 657-6330 Fax: (888) 503-6529
Contact Person:
Sharon Rockwell Tel: (714) 695-9269 Fax: (714) 779-0406 E-mail: srockwell(@writeme.com
May, 2012 Date Prepared:
Plato MICROCATH® 27 Microcatheter Trade Name:
Common Name: Microcatheter
Classification Name: Percutaneous catheter per 21 CFR 870.1200, DOO
Predicate Device: ev3 Rebar-027, K993672
The Plato MICROCATH® 27 Microcatheters are single lumen Device Description: catheters designed to be used with a guiding catheter and a steerable guidewire for accessing the vasculature. The microcatheter contains a metal hypotube reinforced shaft with a maximum diameter of 3.7F, tapering to a distal end of 3.3F, which can be inserted into a 6F guide catheter. The inner diameter is constant throughout the shaft length and accommodates up to a 0.025" guidewire. The catheter is 150 cm in length with two tip configurations; straight and 45°. All have steam shapeable tips, hydrophilic coating and a radiopaque marker at the distal tip. The devices are marketed with an accessory mandrel which allows the catheter tips to be steam-shaped to the doctor's preferred shape when desired.
1
Indications for Use: LLC Plato MICROCATH The Scientia Vascular 27 Microcatheters are intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.
The indications are substantively identical to those of the ev3 Rebar-027 microcatheter.
Technological Characteristics:
The Plato MICROCATH 27 Microcatheter is designed with a low profile distal shaft with enhanced skeletal support, and a proximal hypotube to increase the ability to advance the catheter in peripheral and neuro vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The device is compatible with 6 Fr or larger guiding catheters and can be advanced over guidewires up to 0.025". The distal shaft has a hydrophilic coating for lubricity.
The technological characteristics are comparable to the predicate device, the ev3 Rebar-027 Microcatheter. The Rebar-027 is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft. The outer surface of the catheter is coated to increase lubricity.
The technological differences between the Plato MICROCATH 27 Microcatheter and the predicate device reside in the design of the The predicate catheter has embedded catheter reinforcement. wires which are shaped to impart additional strength and stiffness. to the proximal and distal ends. The Plato MICROCATH 27 Microcatheter uses a proximal stainless steel hypotube to improve the control the physician has over the distal end and then uses a polymeric skeletal support in the distal end to support the lumen and prevent collapse in tortuous vessels. The technological differences do not raise new questions of safety or efficacy.
Non-Clinical Performance Data:
Non-clinical testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1 with Amendments 1 and 2, and in the FDA guidance for Short-Term and Long-Term Intravascular Catheters, dated March 16, 1995. Testing performed on the proposed device included:
- Visual/Dimensional Inspection .
2
- Air Ingress/Negative Collapse
- Kink Resistance �
- Tensile Strength/Elongation .
- Liquid Leakage under Pressure/Leakage at Hub .
- . Tip Stiffness
- Pressure vs. Flow Characterization .
- Static and Dynamic Burst Pressure .
- Flex Fatigue .
- . Shape Retention
- . Coating Lubricity and Durability
- Coating Integrity .
- Particulates .
- Chemical compatibility �
- . Latex
- Corrosion Resistance .
Additionally, simulated use testing included navigating the device through an anatomical model to test the guidewire tracking and movement within the catheter. In a human cadaver model, the device was comparable to the predicate for advancement to the intended vascular site.
Conclusions:
The non-clinical bench testing, simulated-use testing and human cadaver test results demonstrate that the Plato MICROCATH 27 Microcatheter functions as intended, meets the requirements of ISO 10555-1, and performs equivalent or better than the predicate devices in small tortuous vessels. The testing supports a determination of substantial equivalence to products previously cleared by FDA.
3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 30 2012
Scientia Vascular LLC c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K121734
Trade/Device Name: Plato MICROCATH 27 Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (Two) Product Code: DQO Dated: June 12, 2012 Received: June 13, 2012
Dear Mr. Job:
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. 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.
4
Page 2 - Mr. Mark Job
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
M.S. Hillel
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 121734
Device Name: Plato MICROCATH® 27 Microcatheter
Indications for Use: The Plato MICROCATH® 27 Microcatheter is intended to assist in the delivery of diagnostic and/or therapeutic agents to the peripheral and neurovascular systems.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.A. Hilleben
(Division Sign-Off) Division of Cardiovascular Devices
¥121734 510(k) Number
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