RithmID-SD Steerable Diagnostic Electrophysiology Catheter

K203793 · Synaptic Medical Corporation · DRF · Feb 14, 2022 · Cardiovascular

Device Facts

• Record ID: K203793
• Device Name: RithmID-SD Steerable Diagnostic Electrophysiology Catheter
• Applicant: Synaptic Medical Corporation
• Product Code: DRF · Cardiovascular
• Decision Date: Feb 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Device Story

The RithmID-SD is a steerable diagnostic electrophysiology catheter used by clinicians to map cardiac electrical activity. It consists of a handle, a high-torque shaft, and a steerable distal tip equipped with platinum-iridium electrodes. The device is inserted through a sheath into the femoral vein and navigated to the heart or coronary sinus. It records electrical signals from endocardial and intravascular sites, which are then displayed for the clinician to evaluate cardiac arrhythmias. The catheter is biocompatible, radiopaque, and available in various curve shapes. It is a single-use, sterile device.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and animal testing. Bench testing included corrosion resistance, signal acquisition, usability, electrical safety, mechanical fatigue (tip, shaft, flexural), torque strength, and packaging integrity (ASTM D4169-16, F1886/F1886M-16, F2096-11, F88/F88M-15). Biocompatibility testing followed ISO 10993 standards, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, and hemocompatibility (thrombogenicity, hemolysis, complement activation).

Technological Characteristics

Catheter shaft made of PEBAX (7033, 5533, 6333, or 4033). Electrodes are platinum-iridium alloy. Adhesive: Loctite 4311. Features steerable tip, 6F diameter, and 4-10 electrodes. Sterilization via 100% Ethylene Oxide (EO) gas to SAL 10^-6. Complies with ISO 10993-7 for EO/ECH residuals. No software or electronic algorithm components.

Indications for Use

Indicated for the evaluation of cardiac arrhythmias from endocardial and intravascular sites in patients requiring electrophysiological mapping.

Regulatory Classification

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.

Predicate Devices

• Map-It™ Diagnostic Mapping Catheters (K160390)

Reference Devices

• Inquiry™ Steerable Diagnostic Catheter (K961924)

Submission Summary (Full Text)

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February 14, 2022

Synaptic Medical Corporation Charles Yang Vice President of Quality and Regulatory Affairs 1817 Aston Ave, Suite 101 Carlsbad, California 92008

Re: K203793

Trade/Device Name: RithmID-SD Steerable Diagnostic Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: December 21, 2020 Received: December 28, 2020

Dear Charles Yang:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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## Indications for Use

510(k) Number (if known) K203793

#### Device Name

RithmID-SD Steerable Diagnostic Electrophysiology Catheter

Indications for Use (Describe)

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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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## RithmID-SD Steerable Diagnostic Electrophysiology Catheter 510(k) Summary

This 510(k) Summary for the RithmID-SD Electrophysiology Catheter is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.

## SUBMITTER [807.92(a)(1)]

Synaptic Medical Corporation 1817 Aston Ave Suite 101 Carlsbad CA 92008

| Contact Person: | Charles Yang |
|-----------------|------------------------------|
| Telephone: | 760-608-8388 |
| E-mail: | [e-mail] |
| Date prepared: | January 2, 2022 |

#### DEVICE [807.92(a)(2)]

| Trade/Device Name: | RithmID-SD Steerable Diagnostic Electrophysiology Catheter |
|---------------------------|-------------------------------------------------------------------------|
| Common/Generic Name: | Diagnostic Electrophysiology Catheter |
| Regulation Name: | Electrode Recording Catheter |
| Product Code: | DRF |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 21 C.F.R. 870.1220 |
| Reviewing Product Branch: | Division of Cardiovascular Devices<br>Office of Device Evaluation, CDRH |

## PREDICATE DEVICE [807.92(a)(3)]

Map-ItTM Diagnostic Mapping Catheters (K160390)

#### REFERENCE DEVICE

InquiryTM Steerable Diagnostic Catheter (K961924)

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#### DEVICE DESCRIPTION [807.92(a)(4)]

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are intended to be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.

## INDICATIONS FOR USE [807.92(a)(5)]

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]

The technological characteristics of the RithmID-SD Steerable Diagnostic Electrophysiology Catheter is highly analogous to the technological characteristics of the Map-It™ Diagnostic Mapping Catheters (Predicate Device, K160390) and Inquiry™ Steerable Diagnostic Catheter (Reference Device, K961924). Substantial equivalence is determined based on the following similarities:

- . Same intended use/indications for use
- Same principle of operation ●
- Same fundamental scientific technology .
- Incorporate similar catheter construction material ●
- Incorporate similar basic catheter design .

Table 1 comprises the comparison among RithmID-SD Steerable Diagnostic Electrophysiology Catheter (Subject Device), Map-It™ Diagnostic Mapping Catheters (Predicate Device, K160390), and Inquiry™ Steerable Diagnostic Catheter (Reference Device, K961924)

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# Table 1: Predicate Device, Reference Device vs. Subject Device Comparison

| Feature | [Predicate Device]<br>Map-It™ Diagnostic Mapping<br>Catheters<br>K160390 | [Reference Device]<br>Inquiry™ Steerable Diagnostic<br>Catheter<br>K961924 | [Subject Device]<br>RithmID-SD Steerable Diagnostic<br>Electrophysiology Catheter |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DRF | DRF | Same as Predicate Device and Reference<br>Device |
| Regulatory Class | II | II | Same as Predicate Device and Reference<br>Device |
| Regulation<br>Number | 21 CFR 870.1220 | 21 CFR 870.1220 | Same as Predicate Device and Reference<br>Device |
| Regulation Name | Electrode Recording Catheter | Electrode Recording Catheter | Same as Predicate Device and Reference<br>Device |
| Generic Name | Diagnostic Electrophysiology Catheter | Diagnostic Electrophysiology Catheter | Same as Predicate Device and Reference<br>Device |
| Indications for Use<br>Statement | The APT Map-It™ diagnostic Mapping<br>Catheters can be used in the evaluation<br>of a variety of cardiac arrhythmias<br>from endocardial and intravascular<br>sites. | The Inquiry fixed curve and steerable<br>electrophysiology catheters are used for<br>electrogram recording and cardiac<br>stimulation during diagnostic<br>electrophysiology studies. The catheters<br>are commonly placed at the high right<br>atrium, right ventricular apex, and HIS<br>bundle. | The RithmID-SD Steerable Diagnostic<br>Electrophysiology Catheter can be used in<br>the evaluation of a variety of cardiac<br>arrhythmias from endocardial and<br>intravascular sites. |
| Intended Use | Intended to facilitate the<br>electrophysiological mapping of the<br>heart. | Intended to facilitate the<br>electrophysiological mapping of the<br>heart. | Same as Predicate Device and Reference<br>Device |
| Feature | [Predicate Device]<br>Map-It™ Diagnostic Mapping<br>Catheters<br>K160390 | [Reference Device]<br>Inquiry™ Steerable Diagnostic<br>Catheter<br>K961924 | [Subject Device]<br>RithmID-SD Steerable Diagnostic<br>Electrophysiology Catheter |
| Component | Handle Shaft Steerable diagnostic tip | Not Listed | Handle Shaft Steerable diagnostic tip |
| Effective Length | 1100 mm | Not Listed | 1050 mm |
| Number of<br>Electrodes | 4/5/10/20 | Not Listed | 4/6/10 |
| French Size | 4F/5F/6F/7F | Between 5F and 8F | 6F |
| Outer Diameter | 4F, 5F, 6F, 7F<br>Fixed Catheters: 4/3.3F, 4F, 5F, and<br>6F sizes with a 0.026" guidewire tip<br>configuration | Not Listed | 6F |
| Tip Form | Electrode tip on all models except the<br>guidewire tip and PV loop<br>configuration | Not Listed | Electrode Tip |
| Ring Electrode<br>Width | 0.6mm/1mm/2mm | Not Listed | 1.25 mm |
| Feature | [Predicate Device]<br>Map-It™ Diagnostic Mapping<br>Catheters<br>K160390 | [Reference Device]<br>Inquiry™ Steerable Diagnostic<br>Catheter<br>K961924 | [Subject Device]<br>RithmID-SD Steerable Diagnostic<br>Electrophysiology Catheter |
| Configuration | Cable connector and handle Pt-Ir Electrodes (4-20), various widths Shaft 4F to 7F Thermoplastic elastomer Strain reinforcement shrink tubing Various Curves | Not Listed | Cable connector and handle Pt-Ir Electrodes (4 to 10) Shaft 6F Thermoplastic elastomer Strain reinforcement shrink tubing Various Curves |
| Material | PEBAX catheter shaft,<br>Platinum-iridium electrodes and<br>electrical connectors | Not Listed | Shaft (main tube): PEBAX 7033 Tip Tubing: PEBAX 5533, PEBAX<br>6333, or PEBAX 4033 Electrodes (Ring & Tip): Pt/Ir alloy Adhesive: Loctite 4311 |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as Predicate Device and Reference<br>Device |
| Method of Supply | Sterile and Single Use | Sterile and Single Use | Same as Predicate Device and Reference<br>Device |

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## PERFORMANCE DATA [807.92(b)]

Performance Bench Testing and Animal Testing: Results of the performance bench testing (Table 2) indicate that RithmID-SD Steerable Diagnostic Electrophysiology Catheter meets established performance requirements and is substantially equivalent for its intended use.

| Performance Bench Testing | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tests | Results |
| Corrosion<br>Resistance | All test samples met the acceptance criteria. |
| Particulate<br>Matter<br>Evaluation | All test samples met the acceptance criteria<br>and is equivalent to the Reference Device. |
| Radiopacity<br>Detectability | All test samples met the acceptance criteria. |
| Signal<br>Acquisition | All test samples met the acceptance criteria. |
| Usability | All test samples met the acceptance criteria.<br>The performance of the Subject Device is<br>better or equivalent to the Reference Device. |
| Electrical Safety | All test samples met the acceptance criteria. |
| Visual Inspection | All test samples met the acceptance criteria. |
| Dimensional<br>Verification | All test samples met the acceptance criteria. |
| Simulated Use | All test samples met the acceptance criteria. |
| Connection Plug<br>Force | All test samples met the acceptance criteria. |
| Tip Fatigue<br>Tolerance | All test samples met the acceptance criteria. |
| Shaft Fatigue<br>Tolerance | All test samples met the acceptance criteria. |
| Flexural Fatigue<br>Tolerance | All test samples met the acceptance criteria. |
| Torsional Force | All test samples met the acceptance criteria. |
| Electrode<br>Conductor<br>Resistance | All test samples met the acceptance criteria. |
| Buckling Force | All test samples met the acceptance criteria.<br>The buckling force of the Subject Device is<br>less than or equal to the Reference Device. |
| Peak Tensile<br>Force | All test samples met the acceptance criteria.<br>The peak tensile force of the Subject Device<br>was compared to the Reference Device. |
| Torque Strength | The average number of 360° rotations when<br>permanent mechanical deformation occurs<br>was recorded for the Subject Device and<br>Reference Device.<br>The torque strength of the Subject device is<br>compared to the Reference Device for<br>reference only. |
| Packaging Integrity | |
| Distribution<br>Simulation | All test samples met the acceptance criteria<br>per ASTM D4169-16. |
| Visual Inspection | All test samples met the acceptance criteria<br>per ASTM F1886/F1886M-16 |
| Bubble Leak Test | All test samples met the acceptance criteria<br>per ASTM F2096-11. |
| Tray Seal<br>Strength | All test samples met the acceptance criteria<br>per F88/F88M-15. |

#### Table 2: Performance Bench Testing Summary

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Biocompatibility: Results of the biocompatibility testing (Table 3) indicate that RithmID-SD Steerable Diagnostic Electrophysiology Catheter is biocompatible and is substantially equivalent for its intended use.

| Test | Conclusion |
|------------------------------------------------------------------------------------------------------------|----------------|
| Cytotoxicity – MEM Elution<br>Assay<br><br>ISO 10993-5 | Non-cytotoxic |
| Sensitization - ISO Guinea Pig<br>Maximization (2 Extracts)<br><br>ISO 10993-10 | Non-sensitizer |
| Intracutaneous Reactivity – ISO<br>Intracutaneous Study in Rabbits<br>(2 Extracts)<br><br>ISO 10993-10 | Non-irritant |
| Acute Systemic Toxicity – ISO<br>Acute Systemic Toxicity Study in<br>Mice (2 Extracts)<br><br>ISO 10993-11 | Non-Toxic |
| Systemic Toxicity – ISO Materials<br>Mediated Pyrogenicity in Rabbits<br><br>ISO 10993-11 | Non-Pyrogenic |
| Hemocompatibility – Hemolysis<br>Assay (Direct and Indirect)<br><br>ISO 10993-4 | Non-Hemolytic |
| Hemocompatibility – ISO<br>Thrombogenicity in Canine<br>(GLP) | Passed |
| ISO 10993-4 | |
| Hemocompatibility –<br>Complement Activation SC5b-9<br>Assay<br>ISO 10993-4 | Non-Activator |
| Hemocompatibility – ISO Partial<br>Thromboplastin Time (PTT)<br>Assay<br>ISO 10993-4 | Passed |

## Table 3: Biocompatibility Test Summary

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Shelf life: The accelerated shelf-life testing for RithmID-SD Steerable Diagnostic Electrophysiology Catheter has been conducted (t=1 year accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness were raised. Based on the results, we can conclude that RithmID-SD Steerable Diagnostic Electrophysiology Catheter will perform as intended to the Design Specification. RithmID-SD Steerable Diagnostic Electrophysiology Catheter is labeled for 1-year shelf life.

Packaging: The packaging validation, t=1 year accelerated aging was performed on the RithmID-SD Steerable Diagnostic Electrophysiology Catheter. The results from packaging testing conducted on RithmID-SD Steerable Diagnostic Electrophysiology Catheter showed that the acceptance criteria were met. Therefore, we can conclude the RithmID-SD Steerable Diagnostic Electrophysiology Catheter packaging will provide the adequate and effective protection and sterile barrier requirements.

Sterilization: RithmID-SD Steerable Diagnostic Electrophysiology Catheter is sterilized using 100% Ethylene Oxide (EO) gas in the same manner as FDA cleared Predicate Device, Map-It™ Diagnostic Mapping Catheters (K160390) and Reference Device, Inquiry™ Steerable Diagnostic Catheter (K961924). RithmID-SD Steerable Diagnostic Electrophysiology Catheter is sold sterile, for single use, and single patient only. The sterilization results showed that the stylization dose and routine sterilization process was validated to achieve a SAL of 106 for the RithmID-SD Steerable Diagnostic Electrophysiology Catheter.

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| Test Description | Results |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Original Sterilization<br>Validation and Adoption | The validation study demonstrated that the sterilization<br>process and equipment are capable of reliably and<br>consistently sterilizing the device to a minimum SAL of 10-6. |
| | The sterilization adoption study demonstrated the<br>appropriateness of the ethylene oxide sterilization process for<br>the subject device family. The subject device family was<br>adopted to the original validated sterilization cycle<br>parameters and chambers. |
| EO and ECH Residuals | The residual traces of EO and ECH for the subject device are<br>below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels | <20.0 EU/Device |

## CONCLUSIONS

RithmID-SD Steerable Diagnostic Electrophysiology Catheter met all specified criteria. We conclude that the Subject Device, RithmID-SD Steerable Diagnostic Electrophysiology Catheter, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the Predicate Device, Map-It™ Diagnostic Mapping Catheters (K160390) and the Reference Device, Inquiry™ Steerable Diagnostic Catheter (K961924).