Drakon™ and Sequre® Microcatheters

K231293 · Accurate Medical Therapeutics · DQO · Jun 1, 2023 · Cardiovascular

Device Facts

• Record ID: K231293
• Device Name: Drakon™ and Sequre® Microcatheters
• Applicant: Accurate Medical Therapeutics
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 1, 2023
• 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 intra-arterial therapy and infusion of embolic materials. The Drakon™ and the SeQure® microcatheters should not be used in cerebral vessels.

Device Story

Drakon™ and SeQure® are single-use, single-lumen microcatheters for peripheral vascular access. Input: manual infusion of contrast media, therapeutic drugs, or embolic materials. Operation: physician-guided navigation through peripheral vasculature using fluoroscopic visualization of radiopaque markers; hydrophilic coating ensures lubricity. Output: delivery of fluids/agents to target peripheral vessel sites. Used in clinical settings (e.g., interventional radiology) by physicians. Benefits: enables targeted intra-arterial therapy and diagnostic imaging in peripheral anatomy. Differences from previous versions include expanded length options (up to 180 cm) and additional tip shapes to accommodate varied patient anatomies.

Clinical Evidence

Bench testing only. Tests included cytotoxicity (ISO 10993-5), guidewire/guide catheter compatibility, dimensional/visual inspection, bead compatibility, vessel flow dynamics, trackability, tensile strength, torque transmission, air/liquid leakage, burst pressure, power injection, and acute particulate matter evaluation. All tests met predetermined acceptance criteria.

Technological Characteristics

Single-lumen microcatheter; PTFE inner lumen; hydrophilic polymer coating on distal shaft; luer lock hub; radiopaque markers. Available in lengths 105-180 cm, diameters 1.7-3.0 Fr, and straight/SP1/SP2 tip shapes. Sterilized per ISO 11135-1 (SAL 10^-6).

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)
• Drakon™ and Sequre® microcatheters (K203487)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

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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 [phone]

#### Contact Person

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

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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

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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.