(85 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML.
Yes
The device is intended for drug infusion in intra-arterial therapy and infusion of embolic materials, which are therapeutic interventions.
No
The device is intended for the infusion of contrast media, drugs, or embolic materials, which are interventional or therapeutic actions, not diagnostic. While it aids in visualization through radiopaque markers, this is for guiding the intervention, not for making a diagnosis itself.
No
The device description clearly outlines physical components (luer lock hub, strain relief cover and tube, central shaft, distal tip, radiopaque markers, inner lumen, hydrophilic polymer coating) and performance studies related to hardware characteristics (biocompatibility, sterilization, packaging, bench testing, animal study). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the infusion of contrast media, drugs, and embolic materials into peripheral vessels. This is a therapeutic and diagnostic procedure performed directly on the patient's body, not on samples taken from the body.
- Device Description: The device is a microcatheter, which is an instrument used to access and deliver substances within the vascular system. This is an invasive medical device used for direct patient intervention.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes or markers. IVDs are designed to provide information about a patient's health status based on the analysis of such samples.
In summary, the SeQure® NF and SeQure® microcatheters are medical devices used for interventional procedures within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DQO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals
The catheter should be used by a physician who is familiar to the intended procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Cytotoxicity Study Using the ISO Elution Method
- Irritation - ISO Intracutaneous Study – Extract
- ISO Systemic Toxicity Study – Extract
- SC5b-9 Complement Activation Assay
- ASTM Hemolysis
- Pyrogen Study - Material Mediated
- ASTM Partial Thromboplastin Time
- In-Vivo Thrombogenicity, Canine Jugular NAVI (ISO)
- ISO Maximization Sensitization Test
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:
- Bead Compatibility Bench Test
- Power Injection Bench Test
- Vessel Flow Dynamic Indication (Beads Reflux) Bench Test
- Tensile Bench Test
- Embolization Coil Compatibility Bench Test
- Torque Strength Bench Test
- Strain Relief Bench Test
- Guidewire & Guide Catheter Compatibility; Dimensional and Visual Inspection Bench Test
- Bend Radius Bench Test
- Corrosion Bench Test
- Torque Transmission Bench Test
- Preconditioning and Injected Substances Compatibility Bench 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image contains the logo for Accurate Medical. The logo consists of a teal-colored circle with a purple arrow pointing downwards and to the right. To the right of the circle is the text "accuratemedical" in a dark gray sans-serif font.
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)
4
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:
5
Image /page/5/Picture/0 description: The image contains the logo for Accurate Medical. The logo features a teal-colored circle with a purple arrow pointing upwards and to the right. The text "accuratemedical" is written in a purple sans-serif font to the right of the circle.
| | SeQure® NF / SeQure®
Microcatheter | Progreat | SE JUSTIFICATION |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K033913 | — |
| Manufacturer | Accurate Medical Therapeutics
Ltd. | Terumo Medical
Corporation | — |
| Product Code | DQO | DQO | Same |
| CFR | 870.1200 | 870.1200 | Same |
| 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. | The Progreat is intended
for the infusion of contrast
media into all peripheral
vessels up to and including
the cervical vessels, all
vessels in the lower and
upper extremities, visceral
vessels, and all coronary
vessels. The Progreat is
also intended for drug
infusion in intra-arterial
therapy and infusion of
embolic materials for
hemostasis in procedures
including but not limited to
Uterine Fibroid
Embolization. The Progreat
should not be used in
cerebral vessels. | Substantially
Equivalent
The SeQure®
NF/ SeQure®
microcatheter
indications for
use is within the
Progreat
indications for
use |
| | SeQure® NF / SeQure®
Microcatheter | Progreat | SE JUSTIFICATION |
| Outer Diameter
Proximal/Distal | 2.9/2.4 Fr
2.9/2.7 Fr
3.0/2.8 Fr | 2.9/2.4 Fr
2.9/2.7 Fr
3.0/2.8 Fr | Same |
| Inner Diameter | 0.022"
0.025"
0.027" | 0.022"
0.025"
0.027" | Same |
| Guide Catheter
Compatibility | Min. 0.038"
(0.97 mm)
guidewire compatible | Min. 0.038"
(0.97 mm)
guidewire compatible | Same |
| Working Length | 105-150 | 100-150 | Substantially
Equivalent,
included in the
same range |
| Guide Wire
Compatibility | 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 each
size |
| Inner Lumen
Material | PTFE | PTFE | Same |
| Metal
Reinforcement | Tungsten Braid | Tungsten Coil | Substantially
Equivalent
(same material) |
| Outer Shaft
Material | Multi-polymer tubing | Multilayer polymer tubing | Same |
| Radiopaque
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
section of the outer shaft | Hydrophilic coating on the
distal section of the outer shaft | Same |
| Maximum
Pressure | 2.4 Fr, 2.7 Fr ,2.8 Fr - 900 PSI | 2.4 Fr, 2.7 Fr - 750 PSI
2.8 Fr - 900 PSI | Substantially
Equivalent |
| Anatomical Site
used | Peripheral | Peripheral, coronary | Substantially
Equivalent |
| Packaging | Hoop and pouch | Hoop and pouch | Same |
| Environments of
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
physician who is familiar to the
intended procedures. | The catheter should be used by
a physician who is familiar to
the intended procedures. | Same |
6
Image /page/6/Picture/0 description: The image contains the logo for Accurate Medical. The logo features a teal circle with a purple arrow pointing upwards and to the right. To the right of the logo is the text "accuratemedical" in a sans-serif font, with the first word in teal and the second word in purple.
7
Image /page/7/Picture/0 description: The image contains the logo for Accurate Medical. The logo features a teal circle with a purple arrow pointing downwards and to the right. To the right of the circle is the text "accuratemedical" in a gray sans-serif font.
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 | |
| Method | 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 Jugular | |
| 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 | |
| (Beads Reflux) Bench Test | • Tensile Bench Test |
| • Embolization Coil Compatibility | |
| Bench Test | • Torque Strength Bench Test |
| • Strain Relief Bench Test | • Guidewire & Guide Catheter |
| Compatibility; Dimensional and | |
| Visual Inspection Bench Test | |
| • Bend Radius Bench Test | • Corrosion Bench Test |
8
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 |
| Substances Compatibility Bench | |
| 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.