(88 days)
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 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.
The provided text describes the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and the Reported Device Performance
The document describes various performance tests conducted, but it does not explicitly list quantitative acceptance criteria for each test in a table format with corresponding reported performance values. Instead, it generally states that the device "met the acceptance criteria" or "demonstrated robust biocompatibility."
However, based on the descriptions, we can infer some general criteria and outcomes:
| Performance Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization | Successful validation per ISO 11135:2014+A1:2019. Bioburden testing per ISO 11737-1. LAL testing per ANSI/AAMI ST72:2019 and FDA Guidance. EO and ECH residuals below limits per EN ISO 10993-7:2008+A1:2022. | Sterilization process developed and validated. Bioburden testing performed. LAL testing performed. EO and ECH residual testing demonstrated results below specified limits. |
| Shelf-Life | Package integrity (label, bubble leak, seal visual, seal strength) maintained after accelerated aging (ASTM F1980-21). Product V&V (safety and performance) confirmed after accelerated aging. | Shelf-life testing performed via accelerated aging. Package integrity testing (label, bubble leak, seal visual, seal strength) performed and confirmed. Product V&V performed and confirmed. (Note: 6-month shelf-life initially, with potential for extension). |
| Biocompatibility | Compliance with ISO 10993-1:2018 for "Externally Communicating Device, Circulating Blood with Limited Exposure" (e.g., passing results for cytotoxicity, hemolysis, complement activation, thrombogenicity, sensitization, irritation, pyrogenicity, acute systemic toxicity). | All tested subject devices met the acceptance criteria for each biological endpoint test and demonstrated robust biocompatibility in accordance with ISO 10993-1. |
| Benchtop Studies | Design outputs met design input acceptance criteria for each specific test (Visual & Dimensional, Buckle Force, Catheter Deflection, Shaft Bending & Kink Resistance, Simulated Use & Compatibility, Freedom from Leakage, Peak Tensile Force & Bond Strength). | Results of benchtop testing demonstrated the design outputs of the subject device met the design input acceptance criteria. |
| Pre-Clinical (GLP Animal Study) | Primary Objective: Overall safety demonstrated. Secondary Objective: Performance and usability assessed with "Acceptable" and "Above Average" ratings. Thrombogenicity assessment completed. | Overall safety demonstrated. Performance and usability evaluation met acceptance criteria with "predominant rating of Acceptable and Above Average." Thrombogenicity assessment completed. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sterilization Testing: Not explicitly stated, but bioburden testing, LAL testing, and EO/ECH residual testing were performed on "the subject device."
- Shelf-Life Testing: Not explicitly stated, but accelerated aging studies and various package integrity tests were performed on "the subject device."
- Biocompatibility Testing: Not explicitly stated, but various in-vitro and in-vivo tests were conducted. The "In-Vivo Thrombogenicity Evaluation [GLP Animal Study]" refers to the animal study below. Materials were from the device itself.
- Benchtop Studies: Not explicitly stated, but various devices would have been tested for each category.
- Pre-Clinical (GLP Animal Study):
- Sample Size: Six (6) healthy canines.
- Data Provenance: Prospective animal study conducted in a GLP (Good Laboratory Practice) environment. The location/country of the GLP lab is not specified but it's an animal model, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Pre-Clinical (GLP Animal Study):
- Number of Experts: Two (2)
- Qualifications: "Board Certified Electrophysiologists specializing in ablation of pulmonary veins in the management of atrial fibrillation."
4. Adjudication Method for the Test Set
- For the Pre-Clinical (GLP Animal Study), the two electrophysiologists "performed the procedures and rated the overall performance and usability of the subject device." The document does not specify a formal adjudication method (e.g., 2+1, 3+1). It states "predominant rating of Acceptable and Above Average," suggesting a consensus or combined assessment was reached, but the process is not detailed.
- For other tests (benchtop, sterilization, biocompatibility), the ground truth is based on standard test methods and established scientific criteria, not expert adjudication in the same sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter introducer kit), not an AI/software device that would typically involve human readers interpreting images with or without AI assistance. The study described is a pre-clinical animal study to assess safety, performance, and usability of the physical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, a standalone algorithm performance study was not done. This is not an AI/software device.
7. The Type of Ground Truth Used
- Sterilization: Regulatory standards (ISO, ANSI/AAMI, EN ISO) for sterilization efficacy, bioburden levels, endotoxin levels, and residual limits.
- Shelf-Life: Regulatory standards (ASTM F1980-21, ASTM F2096-11(2019), ASTM F88/F88M-21) and product V&V testing.
- Biocompatibility: Regulatory standards (ISO 10993-1:2018, ISO 10993-4, -5, -7, -10, -11, -23) and FDA guidance for biological evaluation endpoints.
- Benchtop Studies: Design input acceptance criteria based on engineering specifications and industry standards relevant to catheter function (e.g., buckle force, deflection, kink resistance, leakage, bond strength).
- Pre-Clinical (GLP Animal Study): Direct observation, clinical assessment, and expert rating by Board Certified Electrophysiologists in a canine model for safety, performance, and usability. This includes observations for adverse events, device maneuverability, and overall handling, as well as thrombogenicity assessment.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. The "training set" concept is typically relevant to AI/machine learning models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML model.
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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).
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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
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Enclosure
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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 Corporation1959 Kellogg AvenueCarlsbad, CA 92008, USAOffice Phone: +1-760-608-8388 |
|---|---|
| Contact Person: | Jake HarandiQuality & Regulatory ManagerSynaptic 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 forSubstantial 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 forUse | The NaviGo 12F Steerable IntracardiacCatheter Introducer Kit is intended tointroduce various cardiovascular cathetersinto the heart, including the left side of theheart through the interatrial septum. | The Steerable Intracardiac Catheter IntroducerKit is intended to introduce variouscardiovascular catheters into the heart,including the left side of the heart through theinteratrial septum. | Same Indications for Use as PredicateDevice. |
| Intended Use | The NaviGo 12F Steerable IntracardiacCatheter Introducer Kit is intended tointroduce various cardiovascular cathetersinto the heart, including the left side of theheart through the interatrial septum. | The Steerable Intracardiac Catheter IntroducerKit is intended to introduce variouscardiovascular catheters into the heart,including the left side of the heart through theinteratrial septum. | Same Intended Use as Predicate Device. |
| Sterilization | Ethylene Oxide Sterilized | Ethylene Oxide Sterilized | Same Sterilization Method as PredicateDevice |
| Single Use | Yes | Yes | Same Single Use as Predicate Device. |
| Shelf Life | 6-months | 3-years | The subject device does not exceed the shelflife of the predicate. The 6-month shelf lifeof the subject device is qualified byaccelerated aging shelf-life studies. Theshelf-life of the subject device may beextended at a later time upon completion ofadditional shelf-life studies. |
| Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1 | Same Biocompatibility compliance asPredicate Device - subject device compliesto current revision of the standard. |
| Performance | Per ISO 11070:2014/AMD 1:2018 | Per ISO 11070:1998 | Same Performance standards as PredicateDevice - subject device complies to currentrevision of the standard. |
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
| Feature | Subject Device | Predicate Device (K151936) | Rationale forSubstantial Equivalence |
| Design Features | Steerable Sheath Introducer Tip | Steerable Sheath Introducer Tip | Same as predicate device. Both devices haveradiopaque tip markers and vent holes. |
| Curl at Sheath Introducer Tip | Curl at Sheath Introducer Tip | Same as predicate device. Both devices havethe same asymmetrical bi-directionaldeflection, clockwise ≥ 180° andcounterclockwise ≥ 90° | |
| Radiopaque | Radiopaque | Same as predicate. Both devices met radio-detectability requirements per ISO 11070. | |
| Compatible with Synaptic Medical LimitedTransseptal Needles | Curve at Transseptal Needle Tip | The subject device is not supplied with anaccessory needle; however, the subjectdevice is designed to be compatible withexisting market cleared Synaptic LimitedTransseptal Needle models N18980A andN1890E (K132943). Compatibility has beendemonstrated through V&V testing. | |
| 0.032" J Curved (Radius: 3mm) Guidewire | 0.032" J Curved (Radius: 3mm) Guidewire | The subject device is packaged with theidentical J Shape Guidewire as the predicate(K132943). The guidewire used in both thesubject and predicate devices is alsoseparately 510(k) cleared for use as acardiovascular guidewire by Lake Region(K935170). Compatibility has beendemonstrated through V&V testing. | |
| Materials | Sheath IntroducerVestamid 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 IntroducerHDPE• 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 IntroducerThe subject and predicate devices areconstructed of equivalent materials. Anydifferences have been qualified throughbiological safety and V&V testing.DilatorThe subject and predicate devices areconstructed of equivalent materials. Anydifferences have been qualified throughbiological safety and V&V testing. |
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
| Feature | Subject Device | Predicate Device (K151936) | Rationale forSubstantial Equivalence |
| DilatorLDPE Dilator Tube Barium sulfate and Titanium Dioxide radiopaque additives ABS Dilator Hub Guidewire 304L Stainless Steel PTFE Coating | DilatorHDPE 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.
§ 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).