(28 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No
The device is a microcatheter used for infusing contrast media, drugs, or embolic materials, which are procedures rather than a therapeutic treatment by the device itself.
No
Explanation: The device is intended for the infusion of contrast media, drugs, and embolic materials, which are therapeutic or interventional actions, not diagnostic. While fluoroscopic visualization is mentioned, it's for guiding the device during these procedures, not for the device itself to perform a diagnosis.
No
The device description clearly outlines physical components such as a luer lock hub, strain relief cover and tube, central shaft, distal tip, radiopaque markers, and an inner lumen made of PTFE. The performance studies also focus on bench tests evaluating physical characteristics and compatibility.
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 procedure, meaning it is performed within the living body.
- Device Description: The device is a microcatheter, which is a tool used for delivering substances or devices within the body's vascular system.
- Lack of In Vitro Testing: The performance studies described are bench tests evaluating the physical and mechanical properties of the microcatheter and its compatibility with other devices and substances. There is no mention of testing biological samples (blood, tissue, etc.) outside of the body to diagnose a condition or monitor a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
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
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 varying configurations of length (105 cm, 130 cm, 150 or 155 cm, 180 cm), diameters (1.7 Fr., 1.9 Fr., 2.4 Fr. 2.7 Fr., 2.8Fr. and 3.0 Fr.) and tip shape (straight, SP1, SP2).
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
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
Risk assessment pursuant to ISO 14971 was performed to assess the impact of the changes. 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:
- Cytotoxicity (ISO 10993-5:2009)
- Guidewire & Guide Catheter Compatibility; Dimensional and Visual Inspection including Tip Shape Dimension
- Bead Compatibility Bench Test
- Vessel Flow Dynamic Indication (Beads Reflux) Bench Test
- Trackability Bench Test
- Tensile Bench Test
- Torque Transmission
- Air Leakage Bench Test
- Liquid Leakage Bench Test
- Burst Pressure Bench Test
- Power Injection Bench Test
- Acute Particulate Matter Evaluation
- Usability
- Sterilization validation is performed in compliance with ISO 11135-1 for a SAL 10-6.
- Shelf life and packaging testing were performed to support the labeled shelf life.
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
June 1, 2023
Accurate Medical Therapeutics Osnat Harbater R&D and RA Manager 19 Eli Hurvitz Street Rehovot, 7608802 Israel
Re: K231293
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: May 1, 2023 Received: May 4, 2023
Dear Osnat Harbater:
We have reviewed vour 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
1
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 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, Digitally signed by Eleni Eleni Whatley -S For Whatley -S Date: 2023.06.01
For 20:34:10 -04:00: 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
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Indications for Use
510(k) Number (if known) K231293
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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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. To the right of the circle is the word "accuratemedical" in purple and gray, with "a Guerbet company" in smaller letters below.
510(k) Summary Drakon™ and Sequre® microcatheters 510(k) Number K231293
Date Prepared: May 1st, 2023
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 +972-54-4557493 osnat(@accurmed.com
II. DEVICE
Trade/Device Name: Common or Usual Name: Classification Name: Regulation: Regulatory Product Code:
Drakon™ and Sequre® microcatheters Diagnostic Intravascular Catheter Catheter, Intravascular, Diagnostic 21 CFR 870.1200 Class: II DQO
III. PREDICATE DEVICE
Accurate Medical Therapeutics Ltd. claims substantial equivalence to previous submissions of Drakon™ and Sequre® microcatheters, cleared under K173430, K202797, K203487.
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, followed by the word "accurate" in purple lowercase letters and "medical" in gray lowercase letters. Below the word "accuratemedical" is the phrase "a Guerbet company" in a smaller, lighter purple font.
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 varying configurations of length (105 cm, 130 cm, 150 or 155 cm, 180 cm), diameters (1.7 Fr., 1.9 Fr., 2.4 Fr. 2.7 Fr., 2.8Fr. and 3.0 Fr.) and tip shape (straight, SP1, SP2).
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. The primary reason for submitting this special 510(k) is the addition of sizes (length of up to 180 cm) and availability of different tip shapes for select models (including a packaging change).
These differences do not impact product performance or modify the intended use but are mainly designed to enable additional microcatheter model options to the user in terms of meeting patient anatomies. Therefore, these differences do not raise any new issues of safety and effectiveness.
In summary, the proposed changes 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 changes. 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:
- Cytotoxicity (ISO 10993-5:2009) ●
- Guidewire & Guide Catheter Compatibility; Dimensional and Visual ● Inspection including Tip Shape Dimension
- Bead Compatibility Bench Test
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 word "accurate" in purple and "medical" in gray. Below the word "accurate medical" is the phrase "a Guerbet company" in a smaller font.
- Vessel Flow Dynamic Indication (Beads Reflux) Bench Test .
- Trackability Bench Test
- . Tensile Bench Test
- Torque Transmission
- Air Leakage Bench Test
- . Liquid Leakage Bench Test
- Burst Pressure Bench Test
- . Power Injection Bench Test
- Acute Particulate Matter Evaluation
- Usability ●
- Sterilization validation is performed in compliance with ISO 11135-1 for a . SAL 10-6.
- . Shelf life and packaging testing were performed to support the labeled shelf life.
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.