(14 days)
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.
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 layer, 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., 1.9 Fr., 2.4 Fr, 2.7 Fr., 2.8Fr, and 3.0 Fr.) and lengths (105 cm, 130 cm, or 150 or 155 cm).
The provided FDA 510(k) Pre-Market Notification does not contain information about a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, nor does it detail a study involving human reader performance, ground truth establishment, or training/test set data for such a device.
The document pertains to the Drakon™ and Sequre® microcatheters, which are physical medical devices (intravascular catheters) used for infusing contrast media, drugs, or embolic materials. The "performance data" section (Section VII) outlines bench testing and biocompatibility testing conducted to demonstrate that the modified microcatheters are substantially equivalent to their predicate devices, and that these physical devices meet predefined acceptance criteria for metrics such as bead compatibility, tensile strength, burst pressure, torque strength, etc.
Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, and the provided text is for a physical medical catheter, I cannot extract the requested information as it does not exist in this document.
Therefore, I must state that the provided text does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD, human reader performance, training/test set details, or ground truth establishment relevant to an AI model. The document explicitly focuses on the substantial equivalence of a physical microcatheter based on bench testing.
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December 11, 2020
Accurate Medical Therapeutics Ltd Osnat Harbater R&D RA Manager 19 Eli Hurvitz Street Rehovot, 7608802 Israel
Re: K203487
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: November 22, 2020 Received: November 27, 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
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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,
For
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) K203487
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 intraatterial therapy and infusion of embolic materials.
The Drakon™ and 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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510(k) Summary Drakon™ and Sequre® microcatheters 510(k) Number K203487
Date Prepared: November 22nd, 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 Drakon™ and Sequre® microcatheters, cleared under K173430 (primary predicate) and K202797.
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.
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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., 1.9 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 the Sequre® 2.7 Fr. XSB.
The Sequre® 2.7 Fr. XSB model differs from the cleared Sequre® 2.7 Fr. primarily in its microsphere bead compatibility range and includes minor material changes.
These differences do not impact product performance or modify the intended use but are mainly designed to enable the Sequre® microcatheter family to be compatible with the same range of microsphere sizes that are compatible with the cleared Drakon™ microcatheters. The Microcatheter's instructions for use identically indicate the size requirements for devices compatible with the Sequre® 2.7 Fr. XSB. In summary, these differences do not raise any new issues of safety and effectiveness.
Although different materials were used in Sequre® 2.7 Fr. XSB, the materials are all either the same as in the cleared models or of the same type. 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 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.
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Biocompatibility testing
Biocompatibility was leveraged from previous testing and demonstrated that the biocompatibility evaluation for the modified Drakon™ and Sequre® microcatheters is in compliance 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.
Sterilization and Shelf Life Testing
The Drakon™ and Sequre® microcatheters are provided sterile in compliance with ISO 11135-1 for a SAL 10-6. Shelf life testing to support the labeled shelf life was performed.
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
- 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
- Embolization Coil Compatibility
- Acute Particulate Matter Evaluation
- Trackability Bench Test ●
VII. 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.
§ 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).