(88 days)
No
The device description and performance studies focus on the mechanical and material properties of a steerable catheter introducer kit. There is no mention of AI, ML, or any software-driven analysis or decision-making capabilities.
No
The device is an introducer kit designed to facilitate the insertion of other cardiovascular catheters into the heart. It does not exert its own therapeutic effect but rather serves as an access tool for therapeutic procedures carried out by other devices.
No
This device is an introducer kit designed to facilitate the insertion of other cardiovascular catheters into the heart. It does not perform any diagnostic function itself, such as detecting or measuring physiological parameters or identifying diseases. Its purpose is purely interventional/procedural.
No
The device description explicitly details physical components (Steerable Sheath, Dilator, Guidewire, handle, valves, ports, etc.) and performance studies related to material properties, physical testing, and animal studies, indicating it is a hardware medical device.
Based on the provided information, the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "introduce various cardiovascular catheters into the heart." This is a procedural device used in vivo (within the body) to facilitate other medical procedures.
- Device Description: The description details a physical device (sheath, dilator, guidewire) used for accessing and navigating within the heart. It does not describe a device that analyzes biological samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
- Performance Studies: The performance studies focus on sterilization, shelf-life, biocompatibility, benchtop performance (mechanical properties, leakage), and pre-clinical animal studies assessing safety and usability during a procedure. There are no studies related to the accuracy or performance of a diagnostic test on biological samples.
- Key Metrics: The document does not mention typical IVD metrics like sensitivity, specificity, PPV, or NPV, which are used to evaluate the performance of diagnostic tests.
In summary, the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a medical device used for accessing and navigating within the heart during interventional procedures, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures.
Product codes
DYB
Device Description
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit consists of a 1) Steerable Sheath, 2) Dilator and 3) Guidewire, and is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures.
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a sterile, single use device, with asymmetrical bi-directional steerable introducer with usable length of 65cm. The Steerable Sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the Steerable Sheath tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and a radiopaque tip marker to improve fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization (implied for radiopaque tip marker)
Anatomical Site
Heart, including the left side of the heart through the interatrial septum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Benchtop Studies:
Visual & Dimensional Inspection
Buckle Force Testing
Catheter Deflection in Sheath Testing
Catheter Shaft Bending & Kink Resistance Testing
Simulated Use & Compatibility Testing for Intended Use in Anatomical Model
Freedom from Leakage Testing
Peak Tensile Force & Bond Strength Testing
Key Results: The results of benchtop testing demonstrated the design outputs of the subject device met the design input acceptance criteria required to demonstrate substantial equivalence with the predicate device.
Pre-Clinical Testing Summary - GLP Animal Study:
Study type: Chronic GLP animal study
Sample size: Six (6) healthy canines
Data source: Canine animal model
Annotation protocol: Two (2) Board Certified Electrophysiologists specializing in ablation of pulmonary veins in the management of atrial fibrillation performed the procedures and rated the overall performance and usability of the subject device.
Key Results: The study simulated a clinical pulmonary vein isolation (PVI) procedure. The subject device was used to navigate an ablation catheter and pulmonary vein diagnostic catheter to a minimum of two (2) pulmonary veins (PV) in each canine. Overall, the GLP animal study demonstrated that the subject device can be safely and effectively used for its intended use. Additionally, performance and usability evaluation of the subject device in the canine model met the acceptance criteria with predominant rating of Acceptable and Above Average.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 16, 2024
Synaptic Medical Corporation Jake Harandi Ouality and Regulatory Manager 1959 Kellogg Avenue Carlsbad, California 92008
Re: K233708
Trade/Device Name: NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 20, 2023 Received: November 20, 2023
Dear Jake Harandi:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Katherine N. Trivedi -S
for Rachel Neubrander Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K233708
Device Name
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)
Indications for Use (Describe)
The NaviGo 12F Steerable Intracardiac Catheter Introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for Synaptic Medical. The logo consists of a blue circle with a white "S" shape inside, followed by the word "Synaptic" in blue and the word "MEDICAL" in gray. The logo is simple and modern, and it is likely used to represent the company's brand.
510(k) SUMMARY
This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92:
K233708
I. SUBMITTER
| Manufacturer: | Synaptic Medical Corporation
1959 Kellogg Avenue
Carlsbad, CA 92008, USA
Office Phone: +1-760-608-8388 |
|-----------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jake Harandi
Quality & Regulatory Manager
Synaptic Medical Corporation |
| Email: | jake.harandi@synapticmed.com |
| Direct Phone: | +1-661-345-1199 |
Date Prepared: February 16, 2024
II. DEVICE
| Device Trade Name: | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit |
|---|---|
| Common Name: | Introducer, Catheter |
| Classification Name: | Catheter Introducer |
| Regulation: | 21 CFR 870.1340 |
| Regulatory Class: | Class II |
| Review Panel: | Cardiovascular |
| Product Classification Code: | DYB |
III. PREDICATE DEVICE
| Predicate Manufacturer: | Synaptic Medical Limited |
|---|---|
| Predicate Trade Name: | Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle |
| Predicate 510(k): | K151936 |
IV. DEVICE DESCRIPTION
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit consists of a 1) Steerable Sheath, 2) Dilator and 3) Guidewire, and is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures.
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a sterile, single use device, with asymmetrical bi-directional steerable introducer with usable length of 65cm. The Steerable Sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port
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Image /page/5/Picture/1 description: The image shows the logo for Synaptic Medical. The logo consists of a blue circle with a white "S" shape inside, followed by the word "Synaptic" in dark blue, and the word "MEDICAL" in light gray below it. The logo is simple and modern, and the colors are professional and trustworthy.
with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the Steerable Sheath tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and a radiopaque tip marker to improve fluoroscopic visualization.
V. INDICATIONS FOR USE
The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the interatrial septum.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The subject and predicate devices have the same intended use and indications for use and utilize the same fundamental scientific technology and principles of operation. The purpose of this submission is to introduce a 12F version of the 8.5F predicate device to be compatible with various cardiovascular catheters up to 12F diameter.
Table 1 provides a comparison of the subject and predicate devices technological characteristics.
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Image /page/6/Picture/0 description: The image shows the logo for Synaptic Medical. The logo consists of a blue circle with a white "S" shape inside, followed by the word "Synaptic" in blue and the word "MEDICAL" in gray. The logo is simple and modern, and it is likely used to represent the company's brand.
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
|---|---|---|---|
| Feature | Subject Device | Predicate Device (K151936) | Rationale for |
| Substantial Equivalence | |||
| Product Code | DYB | DYB | Same Product Code as Predicate Device. |
| Regulation | 21 CFR 870.1340 | 21 CFR 870.1340 | Same Regulation Number as Predicate. |
| Indications for | |||
| Use | The NaviGo 12F Steerable Intracardiac | ||
| Catheter Introducer Kit is intended to | |||
| introduce various cardiovascular catheters | |||
| into the heart, including the left side of the | |||
| heart through the interatrial septum. | The Steerable Intracardiac Catheter Introducer | ||
| Kit is intended to introduce various | |||
| cardiovascular catheters into the heart, | |||
| including the left side of the heart through the | |||
| interatrial septum. | Same Indications for Use as Predicate | ||
| Device. | |||
| Intended Use | The NaviGo 12F Steerable Intracardiac | ||
| Catheter Introducer Kit is intended to | |||
| introduce various cardiovascular catheters | |||
| into the heart, including the left side of the | |||
| heart through the interatrial septum. | The Steerable Intracardiac Catheter Introducer | ||
| Kit is intended to introduce various | |||
| cardiovascular catheters into the heart, | |||
| including the left side of the heart through the | |||
| interatrial septum. | Same Intended Use as Predicate Device. | ||
| Sterilization | Ethylene Oxide Sterilized | Ethylene Oxide Sterilized | Same Sterilization Method as Predicate |
| Device | |||
| Single Use | Yes | Yes | Same Single Use as Predicate Device. |
| Shelf Life | 6-months | 3-years | The subject device does not exceed the shelf |
| life of the predicate. The 6-month shelf life | |||
| of the subject device is qualified by | |||
| accelerated aging shelf-life studies. The | |||
| shelf-life of the subject device may be | |||
| extended at a later time upon completion of | |||
| additional shelf-life studies. | |||
| Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1 | Same Biocompatibility compliance as |
| Predicate Device - subject device complies | |||
| to current revision of the standard. | |||
| Performance | Per ISO 11070:2014/AMD 1:2018 | Per ISO 11070:1998 | Same Performance standards as Predicate |
| Device - subject device complies to current | |||
| revision of the standard. | |||
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
| Feature | Subject Device | Predicate Device (K151936) | Rationale for |
| Substantial Equivalence | |||
| Design Features | Steerable Sheath Introducer Tip | Steerable Sheath Introducer Tip | Same as predicate device. Both devices have |
| radiopaque tip markers and vent holes. | |||
| Curl at Sheath Introducer Tip | Curl at Sheath Introducer Tip | Same as predicate device. Both devices have | |
| the same asymmetrical bi-directional | |||
| deflection, clockwise ≥ 180° and | |||
| counterclockwise ≥ 90° | |||
| Radiopaque | Radiopaque | Same as predicate. Both devices met radio- | |
| detectability requirements per ISO 11070. | |||
| Compatible with Synaptic Medical Limited | |||
| Transseptal Needles | Curve at Transseptal Needle Tip | The subject device is not supplied with an | |
| accessory needle; however, the subject | |||
| device is designed to be compatible with | |||
| existing market cleared Synaptic Limited | |||
| Transseptal Needle models N18980A and | |||
| N1890E (K132943). Compatibility has been | |||
| demonstrated through V&V testing. | |||
| 0.032" J Curved (Radius: 3mm) Guidewire | 0.032" J Curved (Radius: 3mm) Guidewire | The subject device is packaged with the | |
| identical J Shape Guidewire as the predicate | |||
| (K132943). The guidewire used in both the | |||
| subject and predicate devices is also | |||
| separately 510(k) cleared for use as a | |||
| cardiovascular guidewire by Lake Region | |||
| (K935170). Compatibility has been | |||
| demonstrated through V&V testing. | |||
| Materials | Sheath Introducer | ||
| Vestamid Care ML21 Polyamide | |||
| • PTFE Liner | |||
| • Pebax 3533/6333/7233 SA01 MED | |||
| • Barium sulfate radiopaque additive | |||
| • 304 L Stainless Steel Marker Band | |||
| • ABS Hemostasis Valve Shelf | |||
| • Silicone Rubber Hemostasis Valve | |||
| • Polycarbonate 3-way stopcock | |||
| • Polyurethane side arm | Sheath Introducer | ||
| HDPE | |||
| • PTFE Liner | |||
| • Pebax 2533/3533/5533/7233 SA01 MED | |||
| • Barium sulfate radiopaque additive | |||
| • 304 L Stainless Steel Marker Band | |||
| • ABS Hemostasis Valve Shelf | |||
| • Silicone Rubber Hemostasis Valve | |||
| • Polycarbonate 3-way stopcock | |||
| • Polyurethane side arm | Sheath Introducer | ||
| The subject and predicate devices are | |||
| constructed of equivalent materials. Any | |||
| differences have been qualified through | |||
| biological safety and V&V testing. | |||
| Dilator | |||
| The subject and predicate devices are | |||
| constructed of equivalent materials. Any | |||
| differences have been qualified through | |||
| biological safety and V&V testing. | |||
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
| Feature | Subject Device | Predicate Device (K151936) | Rationale for |
| Substantial Equivalence | |||
| Dilator | |||
| LDPE Dilator Tube Barium sulfate and Titanium Dioxide radiopaque additives ABS Dilator Hub Guidewire 304L Stainless Steel PTFE Coating | Dilator | ||
| HDPE Dilator Tube Bismuth Subcarbonate radiopaque additive ABS Dilator Hub Guidewire 304L Stainless Steel PTFE Coating | Guidewire The subject device is packaged with the identical J Shape Guidewire as the predicate (K132943). The guidewire used in both the subject and predicate devices is also separately 510(k) cleared for use as a cardiovascular guidewire by Lake Region (K935170). Compatibility has been demonstrated through V&V testing. |
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Image /page/7/Picture/0 description: The image contains the logo for Synaptic Medical. The logo consists of a blue circle with two white, curved lines inside, resembling an "S". To the right of the circle is the word "Synaptic" in a dark blue, sans-serif font. Below "Synaptic" is the word "MEDICAL" in a smaller, gray, sans-serif font.
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit 510(k) Notification
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Image /page/8/Picture/0 description: The image shows the logo for Synaptic Medical. The logo consists of a blue circle with a white, stylized "S" inside, followed by the word "Synaptic" in dark blue, and the word "MEDICAL" in light gray below it. The logo is clean and modern, with a focus on the company's name and field of expertise.
NaviGo 12F Steerable Intracardiac Catheter Introducer Kit 510(k) Notification
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Image /page/9/Picture/0 description: The image shows the logo for Synaptic Medical. The logo consists of a blue circle with a white "S" shape inside, followed by the word "Synaptic" in blue and the word "MEDICAL" in gray. The logo is simple and modern, and it is likely used to represent the company's brand.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization Testing
The subject device and predicate device are both sterilized by Ethylene Oxide (EO).
The sterilization process for the subject device was developed and validated in accordance with ISO 11135:2014+A1:2019 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices).
To determine the natural bioburden of the sterilized product, bioburden testing was performed in accordance with ISO 11737-1for the subject device as part of the sterilization validation.
To demonstrate implemented microbiological controls are effective at preventing bacterial endotoxins on the sterilized product, LAL testing was performed in accordance with ANSI/AAMI ST72:2019 and FDA Guidance for Industry "Pyrogen and Endotoxins Testing: Questions and Answers."
Validation of the Kinetic-Turbidimetric LAL Procedure as an End-Product Endotoxin Test has been performed for the subject device for routine monitoring as part of the sterilization release process.
EO and ECH Residual testing was conducted for the subject device and demonstrated the sterilized product results in residuals below the limits specified in EN ISO 10993-7:2008 + A1:2022.
Shelf-Life Testing
Shelf-life testing was performed for the subject device by conducting accelerated aging studies in accordance with ASTM F1980-21. Package Integrity testing including label inspection, bubble leak testing per ASTM F2096-11(2019), seal visual inspection, and seal strength testing per ASTM F88/F88M-21 were performed after accelerated aging to confirm sterile barrier shelf-life. Product V&V was performed after accelerated aging to confirm product safety and performance through shelf-life.
Biocompatibility Testing
The subject device is manufactured from equivalent materials as the predicate device and complies with the same biocompatibility requirements of ISO 10993-1.
Biological evaluation was performed in accordance with ISO 10993-1:2018 and FDA's September 4. 2020, Guidance Document - Use of ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
When used as intended the subject device will be in contact with circulating blood and/or cardiac tissue for a cumulative exposure of less than 24 hours. Therefore, the device is categorized as Externally Communicating Device, Circulating Blood with Limited Exposure. Biological evaluation included assessment of relevant endpoints for this patient contact categorization including conducting the following tests:
- ISO MEM Elution using L-929 Mouse Fibroblast Cell (ISO 10993-5)
- ASTM Hemolysis - Direct Contact and Extract Method (ISO 10993-4)
- SC5b-9 Complement Activation Assay (ISO 10993-4) ●
- ASTM Partial Thromboplastin Time (PTT (ISO 10993-4) ●
- In-Vivo Thrombogenicity Evaluation [GLP Animal Study] (ISO 10993-4)
- ISO Guinea Pig Maximization Sensitization Test (ISO 10993-10) ●
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Image /page/10/Picture/0 description: The image contains the logo for Synaptic Medical. The logo consists of a blue circle with a white "S" shape inside of it. To the right of the logo is the word "Synaptic" in a dark blue font, with the word "MEDICAL" underneath it in a light gray font.
- ISO Intracutaneous Study in Rabbits (ISO 10993-23)
- ISO Material Mediated Pyrogen Study (GLP) (ISO 10993-11) .
- ISO Acute Systemic Toxicity Study in Mice (ISO 10993-11) ●
All tested subject devices met the acceptance criteria for each biological endpoint test and demonstrated robust biocompatibility in accordance with ISO 10993-1.
Non-Clinical Testing Summary - Benchtop Studies
The following benchtop testing was provided to demonstrate substantial equivalence with the predicate device:
- . Visual & Dimensional Inspection
- Buckle Force Testing ●
- Catheter Deflection in Sheath Testing
- Catheter Shaft Bending & Kink Resistance Testing
- Simulated Use & Compatibility Testing for Intended Use in Anatomical Model ●
- Freedom from Leakage Testing ●
- Peak Tensile Force & Bond Strength Testing .
The results of benchtop testing demonstrated the design outputs of the subject device met the design input acceptance criteria required to demonstrate substantial equivalence with the predicate device.
Pre-Clinical Testing Summary - GLP Animal Study
A chronic GLP animal study was performed to validate the chronic safety, performance, and usability of the subject device when used in a canine animal model.
The primary objective of the GLP animal study was to demonstrate the overall safety of the subject device when used in a pulmonary vein isolation (PVI) procedure in a canine model. The secondary objective was to assess the performance and usability of the subject device in the canine model.
The study simulated a clinical pulmonary vein isolation (PVI) procedure using six (6) healthy canines. The subject device was used to navigate an ablation catheter and pulmonary vein diagnostic catheter to a minimum of two (2) pulmonary veins (PV) in each canine.
Two (2) Board Certified Electrophysiologists specializing in ablation of pulmonary veins in the management of atrial fibrillation performed the procedures and rated the overall performance and usability of the subject device. At the end of the procedure all devices were removed, and a thrombogenicity assessment was completed.
Overall, the GLP animal study demonstrated that the subject device can be safely and effectively used for its intended use.
Additionally, performance and usability evaluation of the subject device in the canine model met the acceptance criteria with predominant rating of Acceptable and Above Average.
VIII. CONCLUSIONS
The data presented in this submission demonstrate that the subject device is substantially equivalent to the predicate device.