(413 days)
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can 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.
The provided text is a 510(k) summary for a medical device called the "RithmID-SD Steerable Diagnostic Electrophysiology Catheter". This document focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility testing, and comparisons of technical characteristics.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria for each test in a separate column. Instead, for most tests, it states "All test samples met the acceptance criteria," indicating that the criteria were satisfied. The performance results are qualitative; for a few tests, comparative statements are made relative to the reference device.
Here's a compilation of the tests and their reported performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Corrosion Resistance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Particulate Matter Evaluation | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria and is equivalent to the Reference Device. |
| Radiopacity Detectability | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Signal Acquisition | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Usability | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. The performance of the Subject Device is better or equivalent to the Reference Device. |
| Electrical Safety | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Visual Inspection (Bench Testing) | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Dimensional Verification | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Simulated Use | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Connection Plug Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Tip Fatigue Tolerance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Shaft Fatigue Tolerance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Flexural Fatigue Tolerance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Torsional Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Electrode Conductor Resistance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Buckling Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. The buckling force of the Subject Device is less than or equal to the Reference Device. |
| Peak Tensile Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. The peak tensile force of the Subject Device was compared to the Reference Device. |
| Torque Strength | Data comparison, not a pass/fail criterion | The average number of 360° rotations when permanent mechanical deformation occurs was recorded for the Subject Device and Reference Device. The torque strength of the Subject device is compared to the Reference Device for reference only. |
| Packaging Integrity (Distribution Sim.) | ASTM D4169-16 | All test samples met the acceptance criteria per ASTM D4169-16. |
| Packaging Integrity (Visual Insp.) | ASTM F1886/F1886M-16 | All test samples met the acceptance criteria per ASTM F1886/F1886M-16. |
| Packaging Integrity (Bubble Leak) | ASTM F2096-11 | All test samples met the acceptance criteria per ASTM F2096-11. |
| Packaging Integrity (Tray Seal Strength) | F88/F88M-15 | All test samples met the acceptance criteria per F88/F88M-15. |
| Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic |
| Sensitization | Non-sensitizer (ISO 10993-10) | Non-sensitizer |
| Intracutaneous Reactivity | Non-irritant (ISO 10993-10) | Non-irritant |
| Acute Systemic Toxicity | Non-Toxic (ISO 10993-11) | Non-Toxic |
| Systemic Toxicity (Pyrogenicity) | Non-Pyrogenic (ISO 10993-11) | Non-Pyrogenic |
| Hemocompatibility (Hemolysis) | Non-Hemolytic (ISO 10993-4) | Non-Hemolytic |
| Hemocompatibility (Thrombogenicity) | Passed (ISO 10993-4) | Passed |
| Hemocompatibility (Complement Act.) | Non-Activator (ISO 10993-4) | Non-Activator |
| Hemocompatibility (PTT) | Passed (ISO 10993-4) | Passed |
| Shelf Life (Accelerated Aging) | Meets design specification at 1 year | All acceptance criteria met; device performs as intended to Design Specification. |
| Sterilization (SAL) | SAL of 10^-6 | Achieved a SAL of 10^-6. |
| EO and ECH Residuals | Below limits specified in ISO 10993-7 | Below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels | <20.0 EU/Device | <20.0 EU/Device |
2. Sample Size Used for the Test Set and Data Provenance
The document consistently states "All test samples met the acceptance criteria" for various bench tests and indicates "All test samples" for packaging and sterilization validations. However, it does not specify the exact numerical sample size (e.g., "n=5" or "n=10") for any of these tests.
Regarding data provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: The studies are described as "Performance Bench Testing and Animal Testing," "Biocompatibility Testing," "Accelerated Shelf-Life Testing," "Packaging validation," and "Sterilization validation." These are all standard types of prospective pre-market validation studies conducted specifically for regulatory submission, rather than retrospective data analysis.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable for this device. This document describes the 510(k) submission for an electrophysiology catheter, not an AI/ML-driven diagnostic device. The performance data presented are primarily from physical, chemical, and biological bench tests and animal studies, not clinical studies involving human observers or interpretative tasks where "ground truth" would be established by experts like radiologists.
4. Adjudication Method for the Test Set
- Not applicable. As stated above, this is not a study involving human interpretation or subjective assessments that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not done. MRMC studies are typically conducted for imaging devices or AI algorithms where human readers' performance (with or without AI assistance) is evaluated. The RithmID-SD is a physical diagnostic catheter. The "Usability" test mentioned is likely a bench test or simulated use to assess the device's functional handling, not a human reader study.
6. Standalone (Algorithm Only) Performance
- Not applicable. This device is a physical catheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Engineering specifications and standards: For most bench tests (e.g., dimensional verification, electrical safety, fatigue tolerance, tensile force, buckling force), the "acceptance criteria" are derived from the device's design specifications and often relevant international standards for medical devices (though the specific standards beyond ISO 10993 for biocompatibility and ASTM for packaging aren't explicitly listed for every bench test).
- Biocompatibility standards: ISO 10993 series for the biocompatibility tests.
- Sterilization standards: For bacterial endotoxin levels and residuals (ISO 10993-7).
- Animal testing: The document mentions "Animal Testing" and specifically for hemocompatibility, "Thrombogenicity in Canine (GLP)" was performed. This forms part of the "ground truth" for biocompatibility.
- Physical measurements and objective criteria: For tests like torque strength, specific physical properties are measured.
8. Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: | Charles.yang@synapticmed.com |
| 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 DevicesOffice 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]Map-It™ Diagnostic MappingCathetersK160390 | [Reference Device]Inquiry™ Steerable DiagnosticCatheterK961924 | [Subject Device]RithmID-SD Steerable DiagnosticElectrophysiology Catheter |
|---|---|---|---|
| Product Code | DRF | DRF | Same as Predicate Device and ReferenceDevice |
| Regulatory Class | II | II | Same as Predicate Device and ReferenceDevice |
| RegulationNumber | 21 CFR 870.1220 | 21 CFR 870.1220 | Same as Predicate Device and ReferenceDevice |
| Regulation Name | Electrode Recording Catheter | Electrode Recording Catheter | Same as Predicate Device and ReferenceDevice |
| Generic Name | Diagnostic Electrophysiology Catheter | Diagnostic Electrophysiology Catheter | Same as Predicate Device and ReferenceDevice |
| Indications for UseStatement | The APT Map-It™ diagnostic MappingCatheters can be used in the evaluationof a variety of cardiac arrhythmiasfrom endocardial and intravascularsites. | The Inquiry fixed curve and steerableelectrophysiology catheters are used forelectrogram recording and cardiacstimulation during diagnosticelectrophysiology studies. The cathetersare commonly placed at the high rightatrium, right ventricular apex, and HISbundle. | The RithmID-SD Steerable DiagnosticElectrophysiology Catheter can be used inthe evaluation of a variety of cardiacarrhythmias from endocardial andintravascular sites. |
| Intended Use | Intended to facilitate theelectrophysiological mapping of theheart. | Intended to facilitate theelectrophysiological mapping of theheart. | Same as Predicate Device and ReferenceDevice |
| Feature | [Predicate Device]Map-It™ Diagnostic MappingCathetersK160390 | [Reference Device]Inquiry™ Steerable DiagnosticCatheterK961924 | [Subject Device]RithmID-SD Steerable DiagnosticElectrophysiology Catheter |
| Component | Handle Shaft Steerable diagnostic tip | Not Listed | Handle Shaft Steerable diagnostic tip |
| Effective Length | 1100 mm | Not Listed | 1050 mm |
| Number ofElectrodes | 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, 7FFixed Catheters: 4/3.3F, 4F, 5F, and6F sizes with a 0.026" guidewire tipconfiguration | Not Listed | 6F |
| Tip Form | Electrode tip on all models except theguidewire tip and PV loopconfiguration | Not Listed | Electrode Tip |
| Ring ElectrodeWidth | 0.6mm/1mm/2mm | Not Listed | 1.25 mm |
| Feature | [Predicate Device]Map-It™ Diagnostic MappingCathetersK160390 | [Reference Device]Inquiry™ Steerable DiagnosticCatheterK961924 | [Subject Device]RithmID-SD Steerable DiagnosticElectrophysiology 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,Platinum-iridium electrodes andelectrical connectors | Not Listed | Shaft (main tube): PEBAX 7033 Tip Tubing: PEBAX 5533, PEBAX6333, or PEBAX 4033 Electrodes (Ring & Tip): Pt/Ir alloy Adhesive: Loctite 4311 |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as Predicate Device and ReferenceDevice |
| Method of Supply | Sterile and Single Use | Sterile and Single Use | Same as Predicate Device and ReferenceDevice |
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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 |
| CorrosionResistance | All test samples met the acceptance criteria. |
| ParticulateMatterEvaluation | All test samples met the acceptance criteriaand is equivalent to the Reference Device. |
| RadiopacityDetectability | All test samples met the acceptance criteria. |
| SignalAcquisition | All test samples met the acceptance criteria. |
| Usability | All test samples met the acceptance criteria.The performance of the Subject Device isbetter or equivalent to the Reference Device. |
| Electrical Safety | All test samples met the acceptance criteria. |
| Visual Inspection | All test samples met the acceptance criteria. |
| DimensionalVerification | All test samples met the acceptance criteria. |
| Simulated Use | All test samples met the acceptance criteria. |
| Connection PlugForce | All test samples met the acceptance criteria. |
| Tip FatigueTolerance | All test samples met the acceptance criteria. |
| Shaft FatigueTolerance | All test samples met the acceptance criteria. |
| Flexural FatigueTolerance | All test samples met the acceptance criteria. |
| Torsional Force | All test samples met the acceptance criteria. |
| ElectrodeConductorResistance | All test samples met the acceptance criteria. |
| Buckling Force | All test samples met the acceptance criteria.The buckling force of the Subject Device isless than or equal to the Reference Device. |
| Peak TensileForce | All test samples met the acceptance criteria.The peak tensile force of the Subject Devicewas compared to the Reference Device. |
| Torque Strength | The average number of 360° rotations whenpermanent mechanical deformation occurswas recorded for the Subject Device andReference Device.The torque strength of the Subject device iscompared to the Reference Device forreference only. |
| Packaging Integrity | |
| DistributionSimulation | All test samples met the acceptance criteriaper ASTM D4169-16. |
| Visual Inspection | All test samples met the acceptance criteriaper ASTM F1886/F1886M-16 |
| Bubble Leak Test | All test samples met the acceptance criteriaper ASTM F2096-11. |
| Tray SealStrength | All test samples met the acceptance criteriaper 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 ElutionAssayISO 10993-5 | Non-cytotoxic |
| Sensitization - ISO Guinea PigMaximization (2 Extracts)ISO 10993-10 | Non-sensitizer |
| Intracutaneous Reactivity – ISOIntracutaneous Study in Rabbits(2 Extracts)ISO 10993-10 | Non-irritant |
| Acute Systemic Toxicity – ISOAcute Systemic Toxicity Study inMice (2 Extracts)ISO 10993-11 | Non-Toxic |
| Systemic Toxicity – ISO MaterialsMediated Pyrogenicity in RabbitsISO 10993-11 | Non-Pyrogenic |
| Hemocompatibility – HemolysisAssay (Direct and Indirect)ISO 10993-4 | Non-Hemolytic |
| Hemocompatibility – ISOThrombogenicity in Canine(GLP) | Passed |
| ISO 10993-4 | |
| Hemocompatibility –Complement Activation SC5b-9AssayISO 10993-4 | Non-Activator |
| Hemocompatibility – ISO PartialThromboplastin Time (PTT)AssayISO 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 SterilizationValidation and Adoption | The validation study demonstrated that the sterilizationprocess and equipment are capable of reliably andconsistently sterilizing the device to a minimum SAL of 10-6. |
| The sterilization adoption study demonstrated theappropriateness of the ethylene oxide sterilization process forthe subject device family. The subject device family wasadopted to the original validated sterilization cycleparameters and chambers. | |
| EO and ECH Residuals | The residual traces of EO and ECH for the subject device arebelow 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).
§ 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).