(413 days)
InquiryTM Steerable Diagnostic Catheter (K961924)
No
The summary describes a physical catheter for recording electrical signals and does not mention any software or algorithms that would utilize AI/ML.
No.
The device's intended use is for diagnostic evaluation of cardiac arrhythmias and electrophysiological mapping of the heart, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites," and the "Device Description" section notes that it "can be used for recording electrical signals" and is "designed to facilitate the electrophysiological mapping of the heart." These phrases clearly indicate its role in diagnosing conditions through physiological measurements.
No
The device description explicitly details a physical catheter with a handle, shaft, and steerable tip, made of biocompatible, flexible, radiopaque materials with platinum iridium alloy electrodes. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing happens outside the body (in vitro).
- Device Function: The RithmID-SD Steerable Diagnostic Electrophysiology Catheter is used inside the body (in vivo) to record electrical signals directly from the heart. It is a diagnostic tool, but it operates by being inserted into the patient's body, not by analyzing samples taken from the body.
The description clearly states the catheter is introduced into the body and used for "electrophysiological mapping of the heart" and "recording electrical signals" from "endocardial and intravascular sites." This is an in vivo diagnostic procedure, not an in vitro one.
N/A
Intended Use / Indications for 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.
Product codes
DRF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac arrhythmias from endocardial and intravascular sites
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
Performance Bench 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. Tests included: Corrosion Resistance, Particulate Matter Evaluation, Radiopacity Detectability, Signal Acquisition, Usability, Electrical Safety, Visual Inspection, Dimensional Verification, Simulated Use, Connection Plug Force, Tip Fatigue Tolerance, Shaft Fatigue Tolerance, Flexural Fatigue Tolerance, Torsional Force, Electrode Conductor Resistance, Buckling Force, Peak Tensile Force, Torque Strength, Packaging Integrity, Distribution Simulation, Visual Inspection, Bubble Leak Test, Tray Seal Strength. All test samples met the acceptance criteria for the respective tests, with some showing equivalence or superiority to the Reference Device.
Biocompatibility Testing: 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. Tests included: Cytotoxicity – MEM Elution Assay (ISO 10993-5), Sensitization - ISO Guinea Pig Maximization (2 Extracts) (ISO 10993-10), Intracutaneous Reactivity – ISO Intracutaneous Study in Rabbits (2 Extracts) (ISO 10993-10), Acute Systemic Toxicity – ISO Acute Systemic Toxicity Study in Mice (2 Extracts) (ISO 10993-11), Systemic Toxicity – ISO Materials Mediated Pyrogenicity in Rabbits (ISO 10993-11), Hemocompatibility – Hemolysis Assay (Direct and Indirect) (ISO 10993-4), Hemocompatibility – ISO Thrombogenicity in Canine (GLP) (ISO 10993-4), Hemocompatibility – Complement Activation SC5b-9 Assay (ISO 10993-4), Hemocompatibility – ISO Partial Thromboplastin Time (PTT) Assay (ISO 10993-4). All tests concluded non-cytotoxic, non-sensitizer, non-irritant, non-toxic, non-pyrogenic, non-hemolytic, passed for thrombogenicity and PTT, and non-activator for complement activation.
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. The device is labeled for 1-year shelf life.
Packaging: The packaging validation, t=1 year accelerated aging, was performed. The results showed that the acceptance criteria were met, ensuring adequate and effective protection and sterile barrier requirements.
Sterilization: The device is sterilized using 100% Ethylene Oxide (EO) gas. The sterilization validation study demonstrated that the process and equipment are capable of reliably and consistently sterilizing the device to a minimum SAL of 10-6. The residual traces of EO and ECH are below the limits specified in ISO 10993-7. Bacterial Endotoxin Levels are
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
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
1
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
2
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 Devices |
| 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]
Map-It™ Diagnostic Mapping
Catheters
K160390 | [Reference Device]
Inquiry™ Steerable Diagnostic
Catheter
K961924 | [Subject Device]
RithmID-SD Steerable Diagnostic
Electrophysiology Catheter |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DRF | DRF | Same as Predicate Device and Reference
Device |
| Regulatory Class | II | II | Same as Predicate Device and Reference
Device |
| Regulation
Number | 21 CFR 870.1220 | 21 CFR 870.1220 | Same as Predicate Device and Reference
Device |
| Regulation Name | Electrode Recording Catheter | Electrode Recording Catheter | Same as Predicate Device and Reference
Device |
| Generic Name | Diagnostic Electrophysiology Catheter | Diagnostic Electrophysiology Catheter | Same as Predicate Device and Reference
Device |
| Indications for Use
Statement | The APT Map-It™ diagnostic Mapping
Catheters can be used in the evaluation
of a variety of cardiac arrhythmias
from endocardial and intravascular
sites. | The Inquiry fixed curve and steerable
electrophysiology catheters are used for
electrogram recording and cardiac
stimulation during diagnostic
electrophysiology studies. The catheters
are commonly placed at the high right
atrium, right ventricular apex, and HIS
bundle. | The RithmID-SD Steerable Diagnostic
Electrophysiology Catheter can be used in
the evaluation of a variety of cardiac
arrhythmias from endocardial and
intravascular sites. |
| Intended Use | Intended to facilitate the
electrophysiological mapping of the
heart. | Intended to facilitate the
electrophysiological mapping of the
heart. | Same as Predicate Device and Reference
Device |
| Feature | [Predicate Device]
Map-It™ Diagnostic Mapping
Catheters
K160390 | [Reference Device]
Inquiry™ Steerable Diagnostic
Catheter
K961924 | [Subject Device]
RithmID-SD Steerable Diagnostic
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
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
Fixed Catheters: 4/3.3F, 4F, 5F, and
6F sizes with a 0.026" guidewire tip
configuration | Not Listed | 6F |
| Tip Form | Electrode tip on all models except the
guidewire tip and PV loop
configuration | Not Listed | Electrode Tip |
| Ring Electrode
Width | 0.6mm/1mm/2mm | Not Listed | 1.25 mm |
| Feature | [Predicate Device]
Map-It™ Diagnostic Mapping
Catheters
K160390 | [Reference Device]
Inquiry™ Steerable Diagnostic
Catheter
K961924 | [Subject Device]
RithmID-SD Steerable Diagnostic
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,
Platinum-iridium electrodes and
electrical connectors | Not Listed | Shaft (main tube): PEBAX 7033 Tip Tubing: PEBAX 5533, PEBAX
6333, or PEBAX 4033 Electrodes (Ring & Tip): Pt/Ir alloy Adhesive: Loctite 4311 |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same as Predicate Device and Reference
Device |
| Method of Supply | Sterile and Single Use | Sterile and Single Use | Same as Predicate Device and Reference
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 | |
| Resistance | All test samples met the acceptance criteria. |
| Particulate | |
| Matter | |
| Evaluation | All test samples met the acceptance criteria |
| and is equivalent to the Reference Device. | |
| Radiopacity | |
| Detectability | All test samples met the acceptance criteria. |
| Signal | |
| Acquisition | All test samples met the acceptance criteria. |
| Usability | All test samples met the acceptance criteria. |
| The performance of the Subject Device is | |
| 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 | |
| Verification | All test samples met the acceptance criteria. |
| Simulated Use | All test samples met the acceptance criteria. |
| Connection Plug | |
| Force | All test samples met the acceptance criteria. |
| Tip Fatigue | |
| Tolerance | All test samples met the acceptance criteria. |
| Shaft Fatigue | |
| Tolerance | All test samples met the acceptance criteria. |
| Flexural Fatigue | |
| Tolerance | All test samples met the acceptance criteria. |
| Torsional Force | All test samples met the acceptance criteria. |
| Electrode | |
| Conductor | |
| Resistance | All test samples met the acceptance criteria. |
| Buckling Force | 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 | All test samples met the acceptance criteria. |
| The peak tensile force of the Subject Device | |
| was compared to the Reference Device. | |
| Torque Strength | 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 | |
| Simulation | All test samples met the acceptance criteria |
| per ASTM D4169-16. | |
| Visual Inspection | All test samples met the acceptance criteria |
| per ASTM F1886/F1886M-16 | |
| Bubble Leak Test | All test samples met the acceptance criteria |
| per ASTM F2096-11. | |
| Tray Seal | |
| Strength | All test samples met the acceptance criteria |
| per F88/F88M-15. |
Table 2: Performance Bench Testing Summary
9
10
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 | |
| Assay |
ISO 10993-5 | Non-cytotoxic |
| Sensitization - ISO Guinea Pig
Maximization (2 Extracts)
ISO 10993-10 | Non-sensitizer |
| Intracutaneous Reactivity – ISO
Intracutaneous Study in Rabbits
(2 Extracts)
ISO 10993-10 | Non-irritant |
| Acute Systemic Toxicity – ISO
Acute Systemic Toxicity Study in
Mice (2 Extracts)
ISO 10993-11 | Non-Toxic |
| Systemic Toxicity – ISO Materials
Mediated Pyrogenicity in Rabbits
ISO 10993-11 | Non-Pyrogenic |
| Hemocompatibility – Hemolysis
Assay (Direct and Indirect)
ISO 10993-4 | Non-Hemolytic |
| Hemocompatibility – ISO
Thrombogenicity in Canine
(GLP) | Passed |
| ISO 10993-4 | |
| Hemocompatibility –
Complement Activation SC5b-9
Assay
ISO 10993-4 | Non-Activator |
| Hemocompatibility – ISO Partial
Thromboplastin Time (PTT)
Assay
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 | |
| Validation and Adoption | The validation study demonstrated that the sterilization |
| process and equipment are capable of reliably and | |
| consistently sterilizing the device to a minimum SAL of 10-6. | |
| The sterilization adoption study demonstrated the | |
| appropriateness of the ethylene oxide sterilization process for | |
| the subject device family. The subject device family was | |
| adopted to the original validated sterilization cycle | |
| parameters and chambers. | |
| EO and ECH Residuals | The residual traces of EO and ECH for the subject device are |
| below the limits specified in ISO 10993-7. | |
| Bacterial Endotoxin Levels |