Drakon and Sequre Microcatheters

K203487 · Accurate Medical Therapeutics, Ltd. · DQO · Dec 11, 2020 · Cardiovascular

Device Facts

• Record ID: K203487
• Device Name: Drakon and Sequre Microcatheters
• Applicant: Accurate Medical Therapeutics, Ltd.
• Product Code: DQO · Cardiovascular
• Decision Date: Dec 11, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Single-use, single-lumen microcatheters; used for infusion of contrast media, drugs, and embolic materials into peripheral vasculature. Device components include luer lock hub, strain relief, central shaft, and distal tip with radiopaque markers for fluoroscopic visualization. Sequre® model features side holes; Drakon™ model has no side holes. Inner lumen composed of PTFE for smooth passage of fluids/devices; distal shaft features hydrophilic coating for lubricity. Operated by clinicians in interventional procedures. Provides pathway for delivery of therapeutic/diagnostic agents; enables targeted peripheral vessel therapy. Benefits include precise delivery of embolic materials and contrast agents.

Clinical Evidence

Bench testing only. No clinical data provided. Bench tests included bead compatibility, vessel flow dynamics, tensile strength, burst pressure, torque strength, guidewire/catheter compatibility, bend radius, power injection, preconditioning, embolization coil compatibility, particulate matter evaluation, and trackability. All tests met predefined acceptance criteria.

Technological Characteristics

Single-lumen microcatheter; PTFE inner lumen; hydrophilic polymer coating on distal shaft. Radiopaque markers for fluoroscopic visualization. Diameters: 1.7 Fr. to 3.0 Fr.; lengths: 105 cm to 155 cm. Sterile (ISO 11135-1, SAL 10^-6). Mechanical device; no software or electronic components.

Indications for Use

Indicated for infusion of contrast media, drugs, and embolic materials into peripheral vessels. Contraindicated for use in cerebral vessels.

Regulatory Classification

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.

Predicate Devices

• Drakon™ and Sequre® microcatheters (K173430)
• Drakon™ and Sequre® microcatheters (K202797)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------|
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| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> 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 [phone]

### Contact Person

Osnat Harbater 19 Eli Hurvitz St Rehovot, Israel 7608802 [phone] 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.