(270 days)
No
The summary describes a diagnostic catheter for recording and stimulating cardiac signals. There is no mention of AI, ML, or any computational analysis of the recorded data that would suggest the use of these technologies. The performance studies focus on physical, electrical, and biological safety and performance, not algorithmic performance.
No.
The device is a diagnostic catheter used for electrophysiological mapping (recording and stimulation only) and does not directly treat a condition. Its function is to obtain electrograms, which falls under diagnostic rather than therapeutic use.
Yes.
The device is explicitly described as a "diagnostic catheter designed to map cardiac signals". Its intended use involves "electrophysiological mapping of cardiac structures" to "obtain electrograms" and "recording, pacing, and interrogation of electrical conduction", all of which are diagnostic functions.
No
The device description clearly states it is a physical catheter with electrodes and an electrical connection, designed to be deployed in the vasculature. The performance studies also include extensive testing of physical and electrical properties, biocompatibility, and animal studies, which are not applicable to a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrophysiological mapping of cardiac structures (i.e., recording and stimulation only)." This involves measuring electrical signals within the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a catheter designed to be inserted into the body to contact the endocardial surface and record electrical signals. This is an in-vivo procedure, not an in-vitro one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in-vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly within the body to record electrical activity.
N/A
Intended Use / Indications for Use
The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures; atrial regions of the heart
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization Testing: The sterilization process for the subject device was developed and validated in accordance with ISO 11135:2014+A1:2019. The results demonstrate the sterilization process is capable of achieving a sterility assurance level (SAL) of 10-6 or better and physically conforming to the required specifications throughout the load for the duration of the sterilization process. Bioburden was assessed in accordance with ISO 11737-1 and met the acceptance criteria. LAL testing was conducted in accordance with ANSI/AAMI ST72:2009 and FDA Guidance for Industry "Pyrogen and Endotoxin Testing: Questions and Answers." All samples met requirements of less than 0.5 EU/mL or 20.0 EU/device. EO and ECH Residual testing was conducted 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 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: Biological evaluation was performed in accordance with ISO 10993-1:2018 and FDA's September 4, 2020, Guidance Document - Use of ISO 10993-1. The device is categorized as Externally Communicating Device, Circulating Blood with Limited Exposure (cumulative exposure of less than 24 hours). Tests conducted included: 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); 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.
Non-Clinical Testing Summary - Benchtop Studies: The following benchtop testing was provided: 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; Connector Axial Strength; Continuity and Electrical Short Testing; Peak Tensile Force & Bond Strength Testing. The results demonstrated the design outputs of the subject device met the design input acceptance criteria required to demonstrate substantial equivalence with the predicate device.
Software Verification and Validation Testing: Not applicable as the subject and predicate devices do not contain any software components or utilize software for their intended use.
Electrical safety and electromagnetic compatibility (EMC): The Nordica PV Cryo Mapping Catheter complies with: IEC 60601-1-2 Ed. 4.1 (2020-09) for Class A for Emissions; IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601- 1:2005/AMD2:2020; IEC 60601-1-6:2010, AMD1:2013, AMD2:2020 for use in conjunction with IEC 62366-1:2015, AMD1:2020, and IEC 60601-1:2005, AMD1:2012, AMD2:2020.
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 results demonstrated the subject device can safely perform its intended use required to demonstrate substantial equivalence.
Human Clinical Performance Testing: Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
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.
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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
September 6, 2024
Synaptic Medical Corporation Jake Harandi Quality and Regulatory Manager 1959 Kellogg Avenue Carlsbad, California 92008
Re: K233900
Trade/Device Name: Nordica PV Cryo Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: August 6, 2024 Received: August 7, 2024
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"
1
(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 mediation-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).
2
Sincerely,
for
MARCO CANNELLA -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233900
Device Name Nordica PV Cryo Mapping Catheter
Indications for Use (Describe)
The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
|× | 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/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 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) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92:
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: | September 4, 2024 |
II. DEVICE
| Device Trade Name: | Nordica PV Cryo Mapping Catheter |
|---|---|
| Common Name: | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Classification Name: | Electrode Recording Catheter |
| Regulation: | 21 CFR 870.1220 |
| Regulatory Class: | Class II |
| Review Panel: | Cardiovascular |
| Product Classification Code: | DRF |
III. PREDICATE DEVICE
| Predicate Manufacturer: | Medtronic, Inc. |
|---|---|
| Predicate Trade Name: | Achieve Advance Mapping Cathete |
| Predicate 510(k): | K162892 |
DEVICE DESCRIPTION IV.
The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.
5
Image /page/5/Picture/0 description: The image contains the logo for Synaptic Medical. The logo consists of a blue circle with a white "S" shape inside, followed by the text "Synaptic" in a larger, bolder blue font. Below "Synaptic" is the word "MEDICAL" in a smaller, gray font.
INDICATIONS FOR USE V.
The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.
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.
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 contains the logo for Synaptic Medical. The logo consists of a blue circle with a white stylized "S" inside it. To the right of the circle is the word "Synaptic" in a larger, bolder, blue font. Below "Synaptic" is the word "MEDICAL" in a smaller, lighter gray font.
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
|---|---|---|---|
| Feature | Subject Device: | ||
| Synaptic Medical Corporation, | |||
| Nordica PV Cryo Mapping Catheter | Predicate Device: Medtronic, Inc., | ||
| Achieve Advance Mapping Catheter | |||
| (K162892) | Rationale for | ||
| Substantial Equivalence | |||
| Product Code | DRF | DRF | Same Product Code as Predicate Device. |
| Regulation | 21 CFR 870.1220 | 21 CFR 870.1220 | Same Regulation Number as Predicate. |
| Indications for Use | The Nordica PV Cryo Mapping Catheter is | ||
| indicated for multiple electrode | |||
| electrophysiological mapping of cardiac | |||
| structures (i.e., recording and stimulation only). | |||
| The Nordica PV Cryo Mapping Catheter is | |||
| designed to obtain electrograms in the atrial | |||
| regions of the heart. | The Achieve Advance mapping catheter is | ||
| indicated for multiple electrode | |||
| electrophysiological mapping of the cardiac | |||
| structures of the heart, i.e. recording or | |||
| stimulation only. The Achieve Advance | |||
| mapping catheter is designed to obtain | |||
| electrograms in the atrial regions of the | |||
| heart. | Same Indications for Use as Predicate | ||
| Device. | |||
| Intended Use | The intended use of the Nordica PV Cryo | ||
| Mapping Catheter is to map intracardiac | |||
| structures of the heart. | The intended use of the Achieve Advance | ||
| Mapping Catheter is to map intracardiac | |||
| structures of the heart. | 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. |
| Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1 | |
| as specified in predicate K153139 | Same Biocompatibility compliance as | ||
| Predicate Device - subject device complies | |||
| to current revision of the standard. | |||
| Performance | Per ISO 10555-1:2013/AMD 1:2017 | Per ISO 10555-1 | 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: | ||
| Synaptic Medical Corporation, | |||
| Nordica PV Cryo Mapping Catheter | Predicate Device: Medtronic, Inc., | ||
| Achieve Advance Mapping Catheter | |||
| (K162892) | Rationale for | ||
| Substantial Equivalence | |||
| Design Features | Outer Diameter: | ||
| 3F (1mm) | Outer Diameter: | ||
| 3F (1mm) | Same Outer Diameter size as predicate | ||
| device. | |||
| Effective Length: | |||
| 149 cm | Effective Length: | ||
| 146 cm | The subject device has equivalent effective | ||
| length compared to predicate device. The | |||
| effective length of the subject device has | |||
| demonstrated compatibility with Synaptic | |||
| catheters and safe and effective use through | |||
| V&V studies. | |||
| Distal End Shape: | |||
| Circular Loop | Distal End Shape: | ||
| Circular Loop | Same Distal End Shape as predicate device. | ||
| Loop Diameter: | |||
| 15mm & 20mm | Loop Diameter: | ||
| 15mm & 20mm (K162892) | |||
| 25 mm (K153139) | Same Loop Diameters as predicate device. | ||
| Number of Electrodes: | |||
| 8 (15mm loop) | |||
| 10 (20mm loop) | Number of Electrodes: | ||
| 8 (15mm loop) | |||
| 10 (25mm loop) | Same number of electrodes as predicate | ||
| device. | |||
| Electrode Spacing: | |||
| Paired Electrodes, Spacing Between Pairs | |||
| 7.3 mm (15mm loop/8 electrodes) | |||
| 7.3mm (20mm loop/10 electrodes) | |||
| Paired Electrodes, Spacing Between Electrodes | |||
| 2 mm (15mm and 20mm loops) | Electrode Spacing: | ||
| Unpaired, Spacing Between Electrodes | |||
| 4.1mm (15mm loop) | |||
| 5.8mm (20mm loop) | |||
| 5.8mm (25mm loop) | Similar electrode spacing to predicate | ||
| device. Differences in spacing are due to the | |||
| paired electrodes implemented for the | |||
| subject device. The paired electrodes have | |||
| demonstrated safety and performance | |||
| through V&V testing. | |||
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
| Feature | Subject Device: | ||
| Synaptic Medical Corporation, | |||
| Nordica PV Cryo Mapping Catheter | Predicate Device: Medtronic, Inc., | ||
| Achieve Advance Mapping Catheter | |||
| (K162892) | Rationale for | ||
| Substantial Equivalence | |||
| Delivered Through a Delivery Catheter: | |||
| Yes | Delivered Through a Delivery Catheter: | ||
| Yes | Same delivery method as predicate device. | ||
| Materials | Catheter Body Tubing: | ||
| Nitinol / Pebax (Distal Body) | |||
| Stainless Steel (Proximal) | Catheter Body Tubing: | ||
| Nitinol / Pebax (Distal Body) | |||
| Stainless Steel / Polyimide (Proximal) | The subject and predicate devices are | ||
| constructed of equivalent materials. Any | |||
| differences have been qualified through | |||
| biological safety and V&V testing. | |||
| Loop Material: | |||
| Nitinol covered with Pebax | |||
| Electrode Material: | |||
| 90% Platinum / 10% Iridium | Loop Material: | ||
| Nitinol insulated with PET | |||
| (Pebax Covered) | |||
| Electrode Material: | |||
| Not Specified | |||
| Tip: | |||
| Loctite 4311 Medical Grade Adhesive | Tip: | ||
| Not Specified | |||
| Performance | |||
| Testing | Thermal Conditioning & Packaging Distribution | ||
| per ASTM D4332-22 and ASTM D4169-22 | Thermal Conditioning & Packaging | ||
| Distribution TT0224 (per ASTM 4332 and | |||
| D4169) | Same as predicate device - testing for | ||
| subject device performed in accordance | |||
| with latest versions of standards. | |||
| Performance Testing per ISO 10555-1: | |||
| ● Dimensional | |||
| ● Atraumatic Tip & Surface | |||
| ● Joint Strength / Peak Tensile Force | |||
| ● Corrosion Resistance | |||
| ● Radiopacity (verified in GLP animal study) | Performance Testing per ISO 10555-1: | ||
| ● Joint Strength | |||
| ● Corrosion Resistance (K153139) | |||
| ● Radiopacity | Same as predicate device - testing for | ||
| subject device performed in accordance | |||
| with latest versions of standards. | |||
| Requirements established for these tests | |||
| were validated for their intended use | |||
| through V&V testing. | |||
| Device Specific Performance Testing: | |||
| ● Radial Loop Compliance | |||
| ● Distal Stiffness | |||
| ● Axial Load | |||
| ● Torque Response | |||
| ● Electrical Continuity | |||
| ● Turns to Failure | Device Specific Performance Testing: | ||
| ● Radial Loop Compliance | |||
| ● Distal Stiffness | |||
| ● Axial Load | |||
| ● Torque Response | |||
| ● Electrical Continuity | |||
| ● Turns to Failure | Same as predicate device. | ||
| Requirements established for these tests | |||
| were validated for their intended use | |||
| through V&V testing. | |||
| TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
| Feature | Subject Device: | ||
| Synaptic Medical Corporation, | |||
| Nordica PV Cryo Mapping Catheter | Predicate Device: Medtronic, Inc., | ||
| Achieve Advance Mapping Catheter | |||
| (K162892) | Rationale for | ||
| Substantial Equivalence | |||
| Device Functionality Kink Resistance Stiffness Life Testing | Device Functionality Kink Resistance Stiffness Life 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 a white, stylized "S" inside of it. To the right of the circle is the word "Synaptic" in a larger, blue font. Below "Synaptic" is the word "MEDICAL" in a smaller, gray font.
Nordica PV Cryo Mapping Catheter 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 "S" shape inside, followed by the word "Synaptic" in a dark blue font. Below "Synaptic" is the word "MEDICAL" in a light gray font.
Nordica PV Cryo Mapping Catheter 510(k) Notification
9
Image /page/9/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 a dark blue sans-serif font. Below "Synaptic" is the word "MEDICAL" in a light gray sans-serif font.
Nordica PV Cryo Mapping Catheter 510(k) Notification
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Image /page/10/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 a larger, dark blue font. Below "Synaptic" is the word "MEDICAL" in a smaller, light gray font. The logo is clean and modern, with a focus on the company name and a simple, recognizable symbol.
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).
The results of the validation provided in this submission demonstrate the sterilization process is capable of:
- Achieving a sterility assurance level (SAL) of 10-6 or better ●
- . Physically conforming to the required specifications throughout the load for the duration of the sterilization process
Additionally, bioburden was assessed in accordance with ISO 11737-1 and met the acceptance criteria. LAL testing was conducted in accordance with ANSI/AAMI ST72:2009 and FDA Guidance for Industry "Pyrogen and Endotoxin Testing: Questions and Answers." All samples met requirements of less than 0.5 EU/mL or 20.0 EU/device.
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) ●
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Image /page/11/Picture/0 description: The image shows 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 circle is the word "Synaptic" in a dark blue font, with the word "MEDICAL" underneath it in a light gray font.
- . In-Vivo Thrombogenicity Evaluation [GLP Animal Study] (ISO 10993-4)
- ISO Guinea Pig Maximization Sensitization Test (ISO 10993-10) ●
- 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
- . Connector Axial Strength
- Continuity and Electrical Short 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.
Software Verification and Validation Testing
This section is not applicable as the subject and predicate devices do not contain any software components or utilize software for their intended use.
Electrical safety and electromagnetic compatibility (EMC)
The Nordica PV Cryo Mapping Catheter complies with the following:
- . All applicable EMC requirements of: IEC 60601-1-2 Ed. 4.1 (2020-09) for Class A for Emissions (Professional Healthcare Facility Environment).
- . All applicable basic safety and essential performance requirements of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601- 1:2005/AMD2:2020.
- . All applicable usability requirements of IEC 60601-1-6:2010, AMD1:2013, AMD2:2020 for use in conjunction with IEC 62366-1:2015, AMD1:2020, and IEC 60601-1:2005, AMD1:2012, AMD2:2020.
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 according to its intended use of subject device is identical to the predicate device). The results of the GLP canine study demonstrated the subject device can safely perform its intended use required to demonstrate substantial equivalence.
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Image /page/12/Picture/0 description: The image is a logo for Synaptic Medical. The logo consists of a blue circle with a white, stylized "S" inside of it. 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, light gray, sans-serif font.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
VIII. CONCLUSIONS
Extensive non-clinical and pre-clinical testing has been performed on the Nordica PV Cryo Mapping Catheter to evaluate the substantial equivalence of the subject device. The data presented in this submission demonstrates that the subject device is substantially equivalent to the predicate device in regards to device design, materials, and intended use.