SeQure® NF and SeQure® Microcatheters

K173430 · Accurate Medical Therapeutics, Ltd. · DQO · Jan 26, 2018 · Cardiovascular

Device Facts

• Record ID: K173430
• Device Name: SeQure® NF and SeQure® Microcatheters
• Applicant: Accurate Medical Therapeutics, Ltd.
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SeQure® NF and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The SeQure® NF and the SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The SeQure® NF and the SeQure® microcatheters should not be used in cerebral vessels.

Device Story

Single-use, sterile, single-lumen microcatheters; used for infusion of contrast media, drugs, and embolic materials into peripheral vasculature. Device components: luer lock hub, strain relief, central shaft, distal tip with radiopaque markers (1 or 2 depending on model). Inner lumen PTFE-lined; distal shaft hydrophilic-coated for lubricity. Operated by physicians in hospital settings; delivered over-the-wire. Fluoroscopic visualization via radiopaque markers. Enables targeted delivery of therapeutic/diagnostic agents; facilitates intra-arterial therapy and embolization procedures.

Clinical Evidence

Bench testing and GLP animal study. Bench testing included biocompatibility (ISO 10993), sterilization (ISO 11135-1), and mechanical performance (tensile, torque, burst pressure, trackability, leakage). GLP animal study conducted in a canine model compared subject device to predicate; results showed no adverse events, successful performance of required tasks, and satisfactory histopathology/gross pathology outcomes.

Technological Characteristics

Single-lumen microcatheter; PTFE inner lumen; multi-polymer outer shaft; hydrophilic coating on distal section; tungsten braid reinforcement; radiopaque marker bands; female luer lock hub. Sterilized via EtO. Dimensions: 2.4-3.0 Fr outer diameter; 0.022-0.027" inner diameter. Compatible with 0.038" guide catheters and 0.018-0.021" guidewires.

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

• Terumo Medical Corporation PROGREAT (K033583)

Submission Summary (Full Text)

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January 26, 2018

Accurate Medical Therapeutics Ltd. % Ms. Orly Maor Company Consultant 25A Sirkin Street Kfar Saba, Israel, 4442156

Re: K173430

Trade/Device Name: SeQure® NF and SeQure® Microcatheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: January 7, 2018 Received: January 10, 2018

Dear Ms. Maor:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173430

Device Name

SeQure® NF and SeQure® microcatheters

Indications for Use (Describe)

The SeQure® NF and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels.

The SeQure® NF and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials.

The SeQure® NF and the SeQure® microcatheters should not be used in cerebral vessels.

Type of Use (Select one or both, as applicable)

| <div style="display:flex; align-items:center;"> <input checked="true" type="checkbox"/> <span>Research involving NIH-defined Clinical Research</span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <input type="checkbox"/> <span>Other Clinical research involving NIH-defined Clinical Research</span> </div> |

|× | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# Traditional Premarket Notification Submission - 510(k) SeQure® NF and SeQure® microcatheters 510(k) Number K173430

Date Prepared: October 30, 2017

### I. SUBMITTER

Accurate Medical Therapeutics Ltd. 21 Habarzel Street Tel-Aviv 6971029 Israel Tel: [phone]

### Contact Person

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: [phone] Fax: [phone] oram.ma(a)gmail.com

## II. DEVICE

Name of Device: SeQure® NF and SeQure® microcatheters Common or Usual Name: SeQure® NF and SeQure® microcatheters Classification Name: Catheter, Intravascular, Diagnostic (21 CFR 870.1200) Regulatory Class: II Product Code: DQO

## III. PREDICATE DEVICE

Accurate Medical Therapeutics Ltd. believes that the SeQure® NF and the SeQure® microcatheters are substantially equivalent to the following predicate device:

- Terumo Medical Corporation PROGREAT cleared under K033583 (product ● code DQO Regulation No. 870.1200)

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Image /page/4/Picture/0 description: The image shows the logo for Accurate Medical. The logo consists of a blue and green circle with a purple arrow pointing downwards and to the right. To the right of the circle is the text "accuratemedical" in a purple sans-serif font.

### IV. DEVICE DESCRIPTION

The SeQure® NF 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 SeQure® NF'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 SeQure® NF and the SeQure® microcatheters are sterile single lumen devices and are available in several different diameters and lengths.

#### V. INDICATIONS FOR USE

The SeQure® NF and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels.

The SeQure® NF and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials.

The SeQure® NF and the SeQure® microcatheters should not be used in cerebral vessels.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The SeQure® NF and the SeQure® microcatheters have the same intended use as the predicate device. Their indications for use are similar to that of the Progreat predicate device. The dimensions of the SeQure® NF and the SeQure® microcatheters, are comparable to the predicate's. Similar tests and tests methods performed in accordance with the same standards were used in both SeQure® NF and the SeQure® microcatheters and the predicate device to validate the design. The testing results showed that the minor differences in device characteristics between the subject devices and predicate devices do not raise any new questions of safety or effectiveness.

The SeQure® NF and the SeQure® microcatheters have the same technological characteristics as the predicate device as demonstrated in the SE table below:

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| | SeQure® NF / SeQure®<br>Microcatheter | Progreat | SE JUSTIFICATION |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K033913 | — |
| Manufacturer | Accurate Medical Therapeutics<br>Ltd. | Terumo Medical<br>Corporation | — |
| Product Code | DQO | DQO | Same |
| CFR | 870.1200 | 870.1200 | Same |
| Intended Use | The SeQure® NF and<br>SeQure® microcatheters<br>are intended for the<br>infusion of contrast media<br>into all peripheral vessels.<br>The SeQure® NF and the<br>SeQure® microcatheters<br>are also intended for drug<br>infusion in intra-arterial<br>therapy and infusion of<br>embolic materials.<br>The SeQure® NF and the<br>SeQure® microcatheters<br>should not be used in<br>cerebral vessels. | The Progreat is intended<br>for the infusion of contrast<br>media into all peripheral<br>vessels up to and including<br>the cervical vessels, all<br>vessels in the lower and<br>upper extremities, visceral<br>vessels, and all coronary<br>vessels. The Progreat is<br>also intended for drug<br>infusion in intra-arterial<br>therapy and infusion of<br>embolic materials for<br>hemostasis in procedures<br>including but not limited to<br>Uterine Fibroid<br>Embolization. The Progreat<br>should not be used in<br>cerebral vessels. | Substantially<br>Equivalent<br>The SeQure®<br>NF/ SeQure®<br>microcatheter<br>indications for<br>use is within the<br>Progreat<br>indications for<br>use |
| | SeQure® NF / SeQure®<br>Microcatheter | Progreat | SE JUSTIFICATION |
| Outer Diameter<br>Proximal/Distal | 2.9/2.4 Fr<br>2.9/2.7 Fr<br>3.0/2.8 Fr | 2.9/2.4 Fr<br>2.9/2.7 Fr<br>3.0/2.8 Fr | Same |
| Inner Diameter | 0.022"<br>0.025"<br>0.027" | 0.022"<br>0.025"<br>0.027" | Same |
| Guide Catheter<br>Compatibility | Min. 0.038"<br>(0.97 mm)<br>guidewire compatible | Min. 0.038"<br>(0.97 mm)<br>guidewire compatible | Same |
| Working Length | 105-150 | 100-150 | Substantially<br>Equivalent,<br>included in the<br>same range |
| Guide Wire<br>Compatibility | 0.018" (for 2.4 Fr models)<br>0.021" (for 2.7/ 2.8 models) | 0.018" (for 2.4 Fr model)<br>0.021" (for 2.7/ 2.8 models) | Same for each<br>size |
| Inner Lumen<br>Material | PTFE | PTFE | Same |
| Metal<br>Reinforcement | Tungsten Braid | Tungsten Coil | Substantially<br>Equivalent<br>(same material) |
| Outer Shaft<br>Material | Multi-polymer tubing | Multilayer polymer tubing | Same |
| Radiopaque<br>Markers | 1 or 2 marker bands | 1 or 2 marker bands | Same |
| Strain Relief | Yes (polymeric) | Yes (polymeric) | Same |
| Hub connector | Female Luer connector | Female Luer connector | Same |
| Delivery to Site | Over the wire | Over the wire | Same |
| Coating | Hydrophilic coating on the distal<br>section of the outer shaft | Hydrophilic coating on the<br>distal section of the outer shaft | Same |
| Maximum<br>Pressure | 2.4 Fr, 2.7 Fr ,2.8 Fr - 900 PSI | 2.4 Fr, 2.7 Fr - 750 PSI<br>2.8 Fr - 900 PSI | Substantially<br>Equivalent |
| Anatomical Site<br>used | Peripheral | Peripheral, coronary | Substantially<br>Equivalent |
| Packaging | Hoop and pouch | Hoop and pouch | Same |
| Environments of<br>Use | Hospitals | Hospitals | Same |
| Sterilization | Sterile for single use (EtO) | Sterile for single use (EtO) | Same |
| Prescription Use | The catheter should be used by a<br>physician who is familiar to the<br>intended procedures. | The catheter should be used by<br>a physician who is familiar to<br>the intended procedures. | Same |

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Based on the above analysis, Accurate Medical Therapeutics Ltd. believes that the SeQure® NF and the SeQure® microcatheters are substantially equivalent to the legally marketed predicate device.

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

- Risk analysis per ISO 14971:2012 -
- Biocompatibility testing -

An evaluation of biocompatibility was performed in compliance with ISO 10993-1. Biocompatibility evaluation included:

| # | Test | Standard |
|---|-------------------------------------------------------|--------------------|
| 1 | Cytotoxicity Study Using the ISO Elution<br>Method | ISO 10993-5: 2009 |
| 2 | Irritation - ISO Intracutaneous Study –<br>Extract | ISO 10993-10:2010 |
| 3 | ISO Systemic Toxicity Study – Extract | ISO 10993-11: 2010 |
| 4 | SC5b-9 Complement Activation Assay | ISO 10993-4:2009 |
| 5 | ASTM Hemolysis | ISO 10993-4:2009 |
| 6 | Pyrogen Study - Material Mediated | ISO 10993-11:2010 |
| 7 | ASTM Partial Thromboplastin Time | ISO 10993-4:2009 |
| 8 | In-Vivo Thrombogenicity, Canine Jugular<br>NAVI (ISO) | ISO 10993-4:2009 |
| 9 | ISO Maximization Sensitization Test | ISO 10993-10: 2010 |

All tests were completed with passing results.

#### Sterilization, Packaging and Shelf Life Testing -

Sterilization validation testing of the SeQure® NF and the SeQure® microcatheters was performed to demonstrate compliance with ISO 11135-1. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.

#### Bench Testing -

Bench testing included the following:

| Tests | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| • Bead Compatibility Bench Test | • Power Injection Bench Test |
| • Vessel Flow Dynamic Indication<br>(Beads Reflux) Bench Test | • Tensile Bench Test |
| • Embolization Coil Compatibility<br>Bench Test | • Torque Strength Bench Test |
| • Strain Relief Bench Test | • Guidewire & Guide Catheter<br>Compatibility; Dimensional and<br>Visual Inspection Bench Test |
| • Bend Radius Bench Test | • Corrosion Bench Test |

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Image /page/8/Picture/0 description: The image shows the logo for Accurate Medical. The logo consists of a teal circle with a purple arrow pointing downwards and to the right. The text "accuratemedical" is written in gray, sans-serif font to the right of the circle.

| Tests | |
|----------------------------------|--------------------------------------------------------------------------|
| • Torque Transmission Bench Test | • Preconditioning and Injected<br>Substances Compatibility Bench<br>Test |
| • Air Leakage Bench Test | • Usability Bench Test |
| • Liquid Leakage Bench Test | • Acute Particulate Matter Evaluation |
| • Burst Pressure Bench Test | • Trackability Bench Test |

All tests met the predefined acceptance criteria.

### GLP Animal Study

GLP Animal Study was performed at the Asaf Harophe GLP facility in Israel by different users in comparison to the predicate device.

The purpose of the study was to assess the safety and usability of the SeQure® microcatheters.

No adverse events occurred, devices performed well without malfunction to users' satisfaction. Users were able to perform the required tasks. Gross pathology and histopathology evaluation was also conducted. The test met the predefined acceptance criteria.

### VIII. CONCLUSIONS

The SeQure® NF and the SeQure® microcatheters have the same intended use as the predicate device. The principal features of the device that were described, as well as the testing provided, show that the minor differences in device characteristics between the subject device and predicate devices do not raise any new questions of safety or effectiveness.

Performance data and GLP animal study have been provided, establishing that the SeQure® NF and the SeQure® microcatheters perform as intended and in a manner that is substantially equivalent to the predicate.

Therefore, the devices may be found substantially equivalent.