(30 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and safety testing of a microcatheter, with no mention of AI or ML capabilities.
Yes.
The device is intended for drug infusion in intra-arterial therapy and infusion of embolic materials, which are therapeutic interventions.
No
The device is intended for the infusion of contrast media, drugs, and embolic materials, which are interventional or therapeutic uses, not diagnostic.
No
The device description clearly outlines physical components like a luer lock hub, strain relief cover, central shaft, distal tip, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of substances (contrast media, drugs, embolic materials) directly into peripheral blood vessels. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The device is a microcatheter, which is a tool used for accessing and delivering substances within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters. The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer laver. which ensures high lubricity when wet with saline or blood. The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Risk assessment pursuant to ISO 14971 was performed to assess the impact of the change. The following bench tests were performed to evaluate the design elements and performance characteristics of the modified Drakon™ and Sequre® microcatheters and to demonstrate substantial equivalence to the predicate device. The modified Drakon™ and Sequre® microcatheters met the predetermined acceptance criteria.
Biocompatibility testing was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1. Testing included Cytotoxicity (ISO 10993-5:2009), ISO Intracutaneous Study (ISO 10993-10:2010), ISO Guinea Pig Maximization Sensitization Test (ISO 10993-10:2010), ISO Acute Systemic Toxicity Study in Mice (ISO 10993-11:2017), ASTM Hemolysis Study (ASTM F756 and ISO 10993-12:2012), ASTM Partial Thromboplastin Time (ASTM F2382:2018), SC5b-9 Complement Activation Assay (ISO 10993-4:2017), USP Rabbit Pyrogen Study, Material Mediated (USP General Chapter Pyrogen Test: 2019 and ISO 10993-11: 2017), and In Vivo Thromboresistance Study in Dogs - Jugular Vein ISO 10993-4:2009.
Sterilization validation testing was performed in compliance with ISO 11135-1 for a SAL 10^6. Shelf life and packaging testing were also performed.
Bench testing included: Bead Compatibility Bench Test, Vessel Flow Dynamic Indication (Beads Reflux) Bench Test, Tensile Bench Test, Burst Pressure Bench Test, Torque Strength Bench Test, Strain Relief Bench Test, Guidewire & Guide Catheter Compatibility; Dimensional and Visual Inspection, Bend Radius Bench Test, Power Injection Bench Test, Preconditioning and Injected Substances Compatibility Bench Test, Torque Transmission Bench Test, Acute Particulate Matter Evaluation, Air Leakage Bench Test, Liquid Leakage Bench Test, Trackability Bench Test.
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 23, 2020
Accurate Medical Therapeutics Ltd. Osnat Harbater R&D and RA Manager 19 Eli Hurvitz Street Rehovot, 7608802 Israel
Re: K202797
Trade/Device Name: Drakon™ and Sequre® Microcatheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: September 17, 2020 Received: September 23, 2020
Dear Osnat Harbater:
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 medical devices and radiation-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,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202797
Device Name Drakon™ and Sequre® microcatheters
Indications for Use (Describe)
The Drakon™ and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon™ and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials.
The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.
| 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
Image /page/3/Picture/1 description: The image shows the logo for Accurate Medical, a Guerbet company. The logo features a teal circle with a purple arrow pointing upwards and to the right. The text "accuratemedical" is written in purple and gray next to the circle. Below the company name, the text "a Guerbet company" is written in a smaller font.
510(k) Summary Drakon™ and Sequre® microcatheters 510(k) Number K202797
Date Prepared: October 19th, 2020
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
I. SUBMITTER
Company
Accurate Medical Therapeutics Ltd. 19 Eli Hurvitz St Rehovot, Israel 7608802 +972-54-3386871
Contact Person
Osnat Harbater 19 Eli Hurvitz St Rehovot, Israel 7608802 +972-54-3386871 osnat(@accurmed.com
II. DEVICE
Name of Device: Common or Usual Name: Classification Name: Regulation: Regulatory Product Code:
Drakon™ and Sequre® microcatheters Drakon™ and Sequre® microcatheters Catheter, Intravascular, Diagnostic 21 CFR 870.1200 Class: II DQO
III. PREDICATE DEVICE
Accurate Medical Therapeutics Ltd. claims substantial equivalence to the Sequre NF and Sequre® microcatheters, cleared under K173430
IV. DEVICE DESCRIPTION
The Drakon™ and Sequre® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The Sequre®'s distal end has side holes and two radiopaque markers while the Drakon™'s distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters.
4
Image /page/4/Picture/1 description: The image shows the logo for Accurate Medical, a Guerbet company. The logo features a teal circle with a purple arrow pointing upwards and to the right. The text "accurate medical" is written in purple next to the circle, and the text "a Guerbet company" is written in a smaller font below the main text.
The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer laver. which ensures high lubricity when wet with saline or blood.
The Drakon™ and Sequre® microcatheters are sterile single lumen devices and are available in several different diameters (1.7 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
V. INDICATIONS FOR USE
The Drakon™ and Sequre® microcatheters are intended for the infusion of contrast media into all peripheral vessels.
The Drakon™ and Sequre® microcatheters are also intended for drug infusion in intraarterial therapy and infusion of embolic materials.
The Drakon™ and Sequre® microcatheters should not be used in cerebral vessels.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device is substantially equivalent to the predicate device with respect to indications for use, principle of operation, fundamental design principles, performance, sterilization, and packaging. The primary reason for submitting this special 510(k) is the addition of sizes that differ in outer and inner diameter and material changes. Note that the 1.7 Fr, 1.9 Fr, and 3.0 Fr. microcatheters also have a minimal addition to the length (from 150 cm to 155 cm).
These differences do not impact product performance or modify the intended use but are mainly designed to reach smaller or larger target vessels in the same anatomy. The Microcatheter's instructions for use identically indicate the sizes requirements for devices compatible with the Microcatheter outer diameter/inner diameter. Therefore, these differences do not raise any new issues of safety and effectiveness.
Although different materials were used in the additional sized models, the materials are all of the same type (e.g. polymer based hydrophilic coating, PTFE, etc). Thus, these changes also do not raise new questions of safety and effectiveness in comparison to predicate device.
VII. PERFORMANCE DATA
Risk assessment pursuant to ISO 14971 was performed to assess the impact of the change. The following bench tests were performed to evaluate the design elements and performance characteristics of the modified Drakon™ and Sequre® microcatheters and to demonstrate substantial equivalence to the predicate device. The modified Drakon™ and Sequre® microcatheters met the predetermined acceptance criteria.
5
Image /page/5/Picture/1 description: The image shows the logo for Accurate Medical, a Guerbet company. The logo features a teal circle with a purple arrow pointing upwards and to the right. To the right of the circle is the text "accurate medical" in a dark purple sans-serif font, with the words "a Guerbet company" in a smaller, lighter purple font below.
Biocompatibility testing
biocompatibility evaluation for the modified Drakon™ and Sequre® The microcatheters was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process
The following testing was conducted:
- Cytotoxicity (ISO 10993-5:2009) ●
- ISO Intracutaneous Study (ISO 10993-10:2010) .
- ISO Guinea Pig Maximization Sensitization Test (ISO 10993-10:2010)
- ISO Acute Systemic Toxicity Study in Mice (ISO 10993-11:2017)
- ASTM Hemolysis Study (ASTM F756 and ISO 10993-12:2012) ●
- ASTM Partial Thromboplastin Time (ASTM F2382:2018) ●
- SC5b-9 Complement Activation Assay (ISO 10993-4:2017) .
- USP Rabbit Pyrogen Study, Material Mediated (USP General Chapter Pyrogen Test: 2019 and ISO 10993-11: 2017).
- In Vivo Thromboresistance Study in Dogs - Jugular Vein ISO 10993-4:2009
Sterilization, Packaging and Shelf Life Testing
Sterilization validation testing of the Drakon™ and Sequre® microcatheters is performed in compliance with ISO 11135-1 for a SAL 106. In addition, shelf life and packaging testing were performed to support the labeled shelf life.
Bench Testing
The following Bench testing was completed successfully by meeting the predefined acceptance criteria:
- Bead Compatibility Bench Test ●
- Vessel Flow Dynamic Indication (Beads Reflux) Bench Test ●
- Tensile Bench Test ●
- Burst Pressure Bench Test
- Torque Strength Bench Test
- . Strain Relief Bench Test
- Guidewire & Guide Catheter Compatibility; Dimensional and Visual ● Inspection
- Bend Radius Bench Test ●
6
Image /page/6/Picture/1 description: The image shows the logo for Accurate Medical, a Guerbet company. The logo features a teal circle with a purple arrow pointing upwards and to the right. To the right of the logo is the text "accuratemedical" in purple and gray, with the words "a Guerbet company" in smaller gray font below.
- Power Injection Bench Test ●
- . Preconditioning and Injected Substances Compatibility Bench Test
- Torque Transmission Bench Test
- Acute Particulate Matter Evaluation
- Air Leakage Bench Test
- Liquid Leakage Bench Test .
- . Trackability Bench Test
VIII. CONCLUSIONS
The modified Drakon™ and Sequre® microcatheters are substantially equivalent in intended use and indications for use, principles of operation, fundamental design, performance, sterilization, and packaging to the predicate device. Differences between the devices do not raise any new issues of safety or effectiveness. In conclusion, the modified Drakon™ and Sequre® are substantially equivalent to its predicate devices.