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.

AI/ML Overview

This document describes the regulatory submission for the SeQure® NF and SeQure® microcatheters, demonstrating their substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed here refer to the performance standards and testing outcomes that were required for FDA clearance, rather than acceptance criteria for a diagnostic AI algorithm. Similarly, the "study that proves the device meets the acceptance criteria" refers to the engineering bench tests, biocompatibility tests, and animal studies conducted to demonstrate the safety and performance of the catheters according to established medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device (catheters) are implicitly defined by the successful completion of various performance tests, demonstrating that the device is safe and performs as intended, comparable to the predicate device. The document states that "All tests met the predefined acceptance criteria."

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Biocompatibility	Cytotoxicity, Irritation, Systemic Toxicity, SC5b-9 Complement Activation Assay, ASTM Hemolysis, Pyrogen Study, ASTM Partial Thromboplastin Time, In-Vivo Thrombogenicity, ISO Maximization Sensitization Test. Conformance to ISO 10993 series.	All tests completed with passing results.
Sterilization & Packaging	Sterilization validation (ISO 11135-1), Shelf life testing, Packaging testing.	All tests successfully completed.
Bench Testing	Bead Compatibility, Vessel Flow Dynamic Indication (Beads Reflux), Embolization Coil Compatibility, Strain Relief, Bend Radius, Torque Transmission, Air Leakage, Liquid Leakage, Burst Pressure, Power Injection, Tensile, Torque Strength, Guidewire & Guide Catheter Compatibility; Dimensional and Visual Inspection, Corrosion, Preconditioning and Injected Substances Compatibility, Usability, Acute Particulate Matter Evaluation, Trackability.	All tests met the predefined acceptance criteria.
GLP Animal Study	Assessment of safety and usability (observing adverse events, malfunction, and ability of users to perform required tasks), Gross pathology and histopathology evaluation.	No adverse events occurred; devices performed well without malfunction to users' satisfaction; users were able to perform required tasks; gross pathology and histopathology evaluation was also conducted. The test met the predefined acceptance criteria.

2. Sample size used for the test set and the data provenance

Test Set (Applicable to Animal Study): The document does not explicitly state the number of animals used in the GLP Animal Study. It refers to the study as "GLP Animal Study" implying a sufficient sample size for regulatory purposes, but the specific number is not provided.
Data Provenance: The GLP Animal Study was performed at the Asaf Harophe GLP facility in Israel. The document does not specify if it was retrospective or prospective, but GLP (Good Laboratory Practice) studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable in the context of this device submission. The device is a physical catheter, not an AI diagnostic algorithm requiring expert annotation for ground truth. The "ground truth" for proving safety and performance comes from objective physical and chemical tests, and pre-clinical animal studies, not human expert consensus on interpreted data.

4. Adjudication method for the test set

Not applicable as this is not an AI diagnostic algorithm study. The animal study involved "different users" for comparison to the predicate device, and the evaluation included gross pathology and histopathology which would be interpreted by qualified personnel, but a specific adjudication method isn't detailed as it would be for reader-based image interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a submission for a physical medical device (catheter), not an AI algorithm, so no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance and safety was established through:

Objective Test Results: Passing results from various bench tests (e.g., burst pressure, trackability, tensile strength) and biocompatibility tests (e.g., cytotoxicity, hemolysis) against predefined, quantitative acceptance criteria.
Animal Study Observations and Pathology: Direct observation of device performance, absence of adverse events, and histology/pathology findings from the animal study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used for this type of device submission.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Research involving NIH-defined Clinical Research
Other Clinical research involving NIH-defined Clinical Research

|× | 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: +972-54-3386871

Contact Person

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 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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IV. DEVICE DESCRIPTION

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®Microcatheter	Progreat	SE JUSTIFICATION
510(k) Number	TBD	K033913	—
Manufacturer	Accurate Medical TherapeuticsLtd.	Terumo MedicalCorporation	—
Product Code	DQO	DQO	Same
CFR	870.1200	870.1200	Same
Intended Use	The SeQure® NF andSeQure® microcathetersare intended for theinfusion of contrast mediainto all peripheral vessels.The SeQure® NF and theSeQure® microcathetersare also intended for druginfusion in intra-arterialtherapy and infusion ofembolic materials.The SeQure® NF and theSeQure® microcathetersshould not be used incerebral vessels.	The Progreat is intendedfor the infusion of contrastmedia into all peripheralvessels up to and includingthe cervical vessels, allvessels in the lower andupper extremities, visceralvessels, and all coronaryvessels. The Progreat isalso intended for druginfusion in intra-arterialtherapy and infusion ofembolic materials forhemostasis in proceduresincluding but not limited toUterine FibroidEmbolization. The Progreatshould not be used incerebral vessels.	SubstantiallyEquivalentThe SeQure®NF/ SeQure®microcatheterindications foruse is within theProgreatindications foruse
	SeQure® NF / SeQure®Microcatheter	Progreat	SE JUSTIFICATION
Outer DiameterProximal/Distal	2.9/2.4 Fr2.9/2.7 Fr3.0/2.8 Fr	2.9/2.4 Fr2.9/2.7 Fr3.0/2.8 Fr	Same
Inner Diameter	0.022"0.025"0.027"	0.022"0.025"0.027"	Same
Guide CatheterCompatibility	Min. 0.038"(0.97 mm)guidewire compatible	Min. 0.038"(0.97 mm)guidewire compatible	Same
Working Length	105-150	100-150	SubstantiallyEquivalent,included in thesame range
Guide WireCompatibility	0.018" (for 2.4 Fr models)0.021" (for 2.7/ 2.8 models)	0.018" (for 2.4 Fr model)0.021" (for 2.7/ 2.8 models)	Same for eachsize
Inner LumenMaterial	PTFE	PTFE	Same
MetalReinforcement	Tungsten Braid	Tungsten Coil	SubstantiallyEquivalent(same material)
Outer ShaftMaterial	Multi-polymer tubing	Multilayer polymer tubing	Same
RadiopaqueMarkers	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 distalsection of the outer shaft	Hydrophilic coating on thedistal section of the outer shaft	Same
MaximumPressure	2.4 Fr, 2.7 Fr ,2.8 Fr - 900 PSI	2.4 Fr, 2.7 Fr - 750 PSI2.8 Fr - 900 PSI	SubstantiallyEquivalent
Anatomical Siteused	Peripheral	Peripheral, coronary	SubstantiallyEquivalent
Packaging	Hoop and pouch	Hoop and pouch	Same
Environments ofUse	Hospitals	Hospitals	Same
Sterilization	Sterile for single use (EtO)	Sterile for single use (EtO)	Same
Prescription Use	The catheter should be used by aphysician who is familiar to theintended procedures.	The catheter should be used bya physician who is familiar tothe 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 ElutionMethod	ISO 10993-5: 2009
2	Irritation - ISO Intracutaneous Study –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 JugularNAVI (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(Beads Reflux) Bench Test	• Tensile Bench Test
• Embolization Coil CompatibilityBench Test	• Torque Strength Bench Test
• Strain Relief Bench Test	• Guidewire & Guide CatheterCompatibility; Dimensional andVisual Inspection Bench Test
• Bend Radius Bench Test	• Corrosion Bench Test

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Tests
• Torque Transmission Bench Test	• Preconditioning and InjectedSubstances Compatibility BenchTest
• 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.

Regulation Number and Section

§ 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).