(283 days)
The Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.
Khelix Diagnostic Electrophysiology Catheters are a range of electrophysiology diagnostic cardiac catheters designed to facilitate electrophysiological mapping of the heart. The devices are intended for the electrical recording and/or stimulation of endocardial structures. The device consists of a catheter handle and catheter shaft containing an array of platinum-iridium electrodes for stimulation and recording. The subject device comes in a variety of models based on the distal catheter configuration including Steerable and Loop models. The device interfaces with standard electrophysiological recording equipment, such as ECG monitoring equipment, impedance based navigational equipment and cardiac stimulation equipment, via the Khelix Diagnostic Extension Cable (supplied separately). The device is available in different device models with several variants according to electrode configurations, curve types and loop diameters, as applicable. The subject catheters use 4 to 20 electrodes with variable spacing to provide for variation in physician preference. The catheter is intended to be used with the Khelix Diagnostic Extension Cable. The extension cable connects distally to the catheter (sterile field) and proximally to standard electrophysiology (EP) laboratory equipment such as heart signal monitors/records and stimulators (non-sterile field) via shielded tip pins. The Khelix Diagnostic Electrophysiology Catheter range is supplied sterile. The devices are sterilized using an ethylene oxide (EtO) sterilization process.
This K211327 510(k) summary is for a diagnostic electrophysiology catheter. As such, the acceptance criteria and study that proves the device meets the criteria are typically bench and laboratory tests rather than clinical studies requiring human-in-the-loop performance, expert consensus, or complex ground truth establishment like pathology or outcomes data. The document confirms this expectation.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document doesn't detail specific quantitative acceptance criteria values beyond "Pass" for each test. It lists the tests performed and their methodologies.
| Test | Test Methodology | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Sterilization Validation | ISO 11135 | Achieves Sterility Assurance Level (SAL) of 10^-6 | Pass |
| SAL = 10^-6 | ISO 11135 | Achieves Sterility Assurance Level (SAL) of 10^-6 | Pass |
| EO Residuals | ISO 10993-7 | Ethylene Oxide residuals within acceptable limits | Pass |
| Biocompatibility | ISO 10993, ASTM 756 | Biocompatible for intended use | Pass |
| Packaging Validation | ASTM 4332, ASTM 4169 | Packaging integrity maintained for shelf life | Pass |
| Shelf Life | ASTM F1980, ISO 11607 | Device maintains performance and safety over shelf life | Pass |
| Sterile Barrier Integrity | ASTM F1886/F1886M-16, ASTM F2096-11 (2019), ASTM F88/F88M-15 | Sterile barrier maintained (no leaks, secure seals) | Pass |
| Electrical Safety Testing | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27 | Meets electrical safety standards | Pass |
| Functional Performance Testing | ISO 10555-1 | Catheter performs as intended functionally | Pass |
| Attribute Inspection | Visual inspection to workmanship standards | Meets workmanship standards | Pass |
| Mechanical Characterization | N/A | Mechanical properties as designed | Pass |
| Functional Performance | N/A | Performs intended function | Pass |
| Simulated Use | N/A | Performs effectively in simulated use environment | Pass |
| Joint Strength (Integrity) | ISO 10555-1 | Joints maintain structural integrity | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each of the bench and laboratory tests. It states that "Bench and laboratory testing was conducted." The data provenance is derived from the manufacturer's own internal testing. The manufacturer is CathRx Ltd, located in Rydalmere NSW 2116, Australia, implying the testing was conducted in Australia. The testing is retrospective as it was done to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of testing (bench and laboratory) does not typically involve human experts establishing ground truth in the same way clinical studies do. The "ground truth" for these tests is established by adherence to recognized international and industry standards (e.g., ISO, ASTM, IEC). The expertise lies in the engineers, technicians, and quality professionals who conduct these tests and interpret the results against the defined standards. The document does not specify the number or qualifications of these individuals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or data by multiple readers. Since this device's performance was evaluated through bench and laboratory testing against established engineering and safety standards, no such adjudication method was employed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was conducted. This device is an electrophysiology catheter, not an AI-assisted diagnostic tool for image interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable to the scope of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an algorithm without human intervention, usually in the context of AI/ML devices. Since the Khelix Diagnostic Electrophysiology Catheters are physical medical devices for electrical recording and stimulation, and not a software algorithm, this concept is not applicable. The device's "standalone" performance is assessed through its physical, electrical, and functional characteristics validated by the bench and laboratory tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for these bench and laboratory tests is based on engineering specifications and established international/industry standards. For example:
- Sterilization: Defined by ISO 11135 (SAL of 10^-6).
- Biocompatibility: Defined by ISO 10993 and ASTM 756.
- Electrical Safety: Defined by IEC 60601 series.
- Functional Performance: Defined by ISO 10555-1 and internal workmanship standards.
There is no "expert consensus" on individual cases, pathology, or outcomes data used as ground truth for this type of device submission.
8. The sample size for the training set
This device does not involve a "training set" as it is not an AI/ML device that requires machine learning model training. Its design and manufacturing are based on established engineering principles.
9. How the ground truth for the training set was established
As there is no training set for this device, the concept of establishing ground truth for it is not applicable.
{0}------------------------------------------------
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" in a stacked format.
February 10, 2022
CathRx Ltd % Amy Oakes Quality & Regulatory Consultant Acorn N Oakes LLC 333 N. Dobson Rd. Suite 5 Chandler, Arizona 85224
Re: K211327
Trade/Device Name: Khelix Diagnostic Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: April 6, 2021 Received: May 3, 2021
Dear Amy Oakes:
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
{1}------------------------------------------------
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 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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K211327
Device Name
Khelix Diagnostic Electrophysiology Catheters
Indications for Use (Describe)
The Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
SECTION 5: 510(K) SUMMARY
Submitter's Name and Address:
CathRx Ltd Unit 8, 2-8 South St Rydalmere NSW 2116, Australia
Owner Name and Information
lan Fong CathRx Ltd Chief Executive Officer +61 411 421 354 lan.fong@cathrx.com
US Agent and Official Correspondent
Contact Name and Information: Amy Oakes Acorn N Oakes, LLC Quality & Regulatory Consultant 333 N. Dobson Rd Suite 5 Chandler AZ 85224 USA (480) 304-2165 acornnoakes@cox.net
Date Prepared:
March 24, 2021
Device Information:
| Trade/Proprietary Name: | Khelix Diagnostic Electrophysiology Catheters |
|---|---|
| Common Name: | Diagnostic Electrophysiology Catheters |
| Classification Name: | Electrode Recording Catheter or electrode recording probe |
| Classification Number: | 21 CFR 870.1220 |
| Product Code: | DRF |
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer | |
|---|---|---|---|
| K113213 | Lasso NAV 2515 Variable | Biosense Webster | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Table 5.1: Predicate Device
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for CathRx. The logo features a stylized heart shape on the left, followed by the text "CATH" in bold, sans-serif font. To the right of "CATH" is "RX" enclosed in a rounded rectangle.
Manufacturer:
CathRx Ltd Unit 8, 2-8 South St Rydalmere NSW 2116, Australia
Manufacturing Facilities:
Manufacturing CathRx Ltd Unit 8, 2-8 South St Rydalmere NSW 2116, Australia
Sterilization 5 and 7 Widemere Rd, Wetherill Park NSW 2164, Australia
Device Description:
Khelix Diagnostic Electrophysiology Catheters are a range of electrophysiology diagnostic cardiac catheters designed to facilitate electrophysiological mapping of the heart. The devices are intended for the electrical recording and/or stimulation of endocardial structures.
The Khelix Diagnostic Electrophysiology Catheter range is used by cardiologists in electrophysiology (EP) studies to determine the cause of an abnormal heart rhythm, to locate the site of origin of an abnormal heart rhythm, to decide the best treatment for an abnormal heart rhythm, and/or to check the effectiveness of ablation therapy. An EP study is sometimes conducted before placement of an implantable cardioverter/defibrillator (ICD) to determine the best type of device, and to monitor treatment effectiveness.
The device consists of a catheter handle and catheter shaft containing an array of platinum-iridium electrodes for stimulation and recording. The subject device comes in a variety of models based on the distal catheter configuration including Steerable and Loop models. The device interfaces with standard electrophysiological recording equipment, such as ECG monitoring equipment, impedance based navigational equipment and cardiac stimulation equipment, via the Khelix Diagnostic Extension Cable (supplied separately). The device is available in different device models with several variants according to electrode configurations, curve types and loop diameters, as applicable. A full list of model variants is detailed at the end of this summary.
The subject catheters use 4 to 20 electrodes with variable spacing to provide for variation in physician preference.
The catheter is intended to be used with the Khelix Diagnostic Extension Cable. The extension cable connects distally to the catheter (sterile field) and proximally to standard electrophysiology (EP) laboratory equipment such as heart signal monitors/records and stimulators (non-sterile field) via shielded tip pins.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for CathRx. The logo features a stylized heart shape on the left, followed by the text "CATH" in bold, sans-serif font. To the right of "CATH", the letters "RX" are enclosed in a black box with rounded corners.
The Khelix Diagnostic Electrophysiology Catheter range is supplied sterile. The devices are sterilized using an ethylene oxide (EtO) sterilization process.
Indications for Use:
The Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording or stimulation of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.
Technological Characteristics:
A high-level comparison of the proposed and predicate devices is in Table 5.2 below:
| Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Product Code | DRF | DRF | Identical |
| Operating Principles / Mechanism of Action | Electrical Stimulation & Recording | Electrical Stimulation & Recording | Identical |
| Materials | PEBAX insulation with platinum electrodes | PEBAX insulation with platinum electrodes | Identical |
| Key technological characteristics | Equivalent | ||
| Fr Size | 7 Fr | 6Fr, 7Fr | Equivalent |
| Working Length | 115 cm | 115 cm | Identical |
| Deflection Plane | In Plane | In Plane | Identical |
| Deflection Type | Unidirectional | Unidirectional | Identical |
| # of Electrodes | 10-20 | 4-20 | Equivalent |
| Electrode Spacing | 2-6-2mm (20 pole)8-8-8mm (10 pole)In Lasso Nav fixed loop catheters:5-5-5mm (15mm)6-6-6mm (20mm)8-8-8mm (25mm) | 2-5-2mm2-2-2mm5-5-5mm2-8-2mm2-10-2mm2-12-2mm | Equivalent |
| Tip Electrode | Passive | Passive | Identical |
| Loop Diameter | 25-15 mm | 25-15 mm | Identical |
| Curve Shape | D Curve (6.4 cm) | D-curve (40.7mm)Other curve sizes available:F-curve (48.3mm)G- curve (56.6mm)J-curve (64.9mm)P-curve (80.8mm)Q-curve (96.7mm)R-curve (113.3mm) | Equivalent |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for CathRx. The logo consists of a heart shape with a line going through it, followed by the text "CATH" in bold, sans-serif font. To the right of "CATH" is the text "RX" in a similar font, enclosed in a black box with rounded corners. The logo appears to be for a medical or pharmaceutical company, given the "RX" abbreviation often used for prescriptions.
| Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Accessory Devices | Extension Cable | Extension Cable | Identical |
| Environment of use | Cath Lab | Cath Lab | Identical |
| Sterility & Reusability | Single Use | Single Use | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
Table 5.2: Comparison Table
The purpose, design, materials, function, and intended use of the Khelix Diagnostic Electrophysiology Catheters are substantially equivalent to the predicate devices.
Function and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Khelix Diagnostic Electrophysiology Catheters.
Testing includes the following:
| Test | Test Methodology | Result |
|---|---|---|
| Sterilization Validation | ISO 11135 | Pass |
| SAL = 10-6 | ISO 11135 | Pass |
| EO Residuals | ISO 10993-7 | Pass |
| Biocompatibility | ISO 10993ASTM 756 | Pass |
| Packaging Validation | ASTM 4332ASTM 4169 | Pass |
| Shelf Life | ASTM F1980ISO 11607 | Pass |
| Sterile Barrier Integrity | ASTM F1886/F1886M-16ASTM F2096-11 (2019)ASTM F88/F88M-15 | Pass |
| Electrical Safety Testing | IEC 60601-1IEC 60601-1-2IEC 60601-2-27 | Pass |
| Functional Performance Testing | ISO 10555-1 | Pass |
| Attribute Inspection | Visual inspection toworkmanship standards | Pass |
| Mechanical Characterization | N/A | Pass |
| Functional Performance | N/A | Pass |
| Simulated Use | N/A | Pass |
| Joint Strength (Integrity) | ISO 10555-1 | Pass |
Conclusion:
CathRx concludes that the Khelix Diagnostic Electrophysiology Catheters are substantially equivalent to the predicate device described herein.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image contains the logo for "CATHRX". The logo features a heart shape with a line running through it on the left side. The text "CATH" is in bold, black letters, and "RX" is in a black box with white letters on the right side.
Khelix Diagnostic Electrophysiology Catheters
Steerable Models
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-DOU-04P6222 | 6.4 | In Plane | Unidirectional | 4 | Passive | 2-2-2 | |
| SS1-DOU-04P6252 | 4 | 2-5-2 | |||||
| SS1-DOU-04P6555 | 4 | 5-5-5 | |||||
| SS1-DOU-04P6282 | 4 | 2-8-2 | |||||
| SS1-DOU-04P62102 | 4 | 2-10-2 | |||||
| SS1-DOU-06P6222 | 6.4 | In Plane | Unidirectional | 6 | 2-2-2 | ||
| SS1-DOU-06P6252 | 6 | 2-5-2 | |||||
| SS1-DOU-06P6555 | 6 | 5-5-5 | |||||
| SS1-DOU-06P6282 | 6 | 2-8-2 | |||||
| SS1-DOU-06P62102 | 6 | 2-10-2 | |||||
| SS1-DOU-08P6222 | 6.4 | In Plane | Unidirectional | 8 | 2-2-2 | ||
| SS1-DOU-08P6252 | 8 | 2-5-2 | |||||
| SS1-DOU-08P6555 | 8 | 5-5-5 | |||||
| SS1-DOU-08P6282 | 8 | 2-8-2 | |||||
| SS1-DOU-08P62102 | 8 | 2-10-2 | |||||
| SS1-DOU-10P6222 | 6.4 | In Plane | Unidirectional | 10 | Passive | 2-2-2 | |
| SS1-DOU-10P6252 | 10 | 2-5-2 | |||||
| SS1-DOU-10P6555 | 10 | 5-5-5 | |||||
| SS1-DOU-10P6282 | 10 | 2-8-2 | |||||
| SS1-DOU-10P62102 | 10 | 2-10-2 |
CathRx Khelix Diagnostic Electrophysiology Catheters
Traditional 510(k)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for CathRx. The logo features a heart shape with a line running through it on the left side. To the right of the heart is the text "CATH" in bold, sans-serif font, followed by "RX" in a rounded rectangle.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-FOU-04P6222 | Unidirectional | 4 | Passive | 2-2-2 | |||
| SS1-FOU-04P6252 | 2-5-2 | ||||||
| SS1-FOU-04P6555 | 5-5-5 | ||||||
| SS1-FOU-04P6282 | 2-8-2 | ||||||
| SS1-FOU-04P62102 | 2-10-2 | ||||||
| SS1-FOU-06P6222 | 6 | 2-2-2 | |||||
| SS1-FOU-06P6252 | 2-5-2 | ||||||
| SS1-FOU-06P6555 | 5-5-5 | ||||||
| SS1-FOU-06P6282 | 2-8-2 | ||||||
| SS1-FOU-06P62102 | 2-10-2 | ||||||
| SS1-FOU-08P6222 | 7.6 | In Plane | 8 | 2-2-2 | |||
| SS1-FOU-08P6252 | 2-5-2 | ||||||
| SS1-FOU-08P6555 | 5-5-5 | ||||||
| SS1-FOU-08P6282 | |||||||
| SS1-FOU-08P62102 | |||||||
| SS1-FOU-10P6222 | 10 | 2-2-2 | |||||
| SS1-FOU-10P6252 | 2-5-2 | ||||||
| SS1-FOU-10P6555 | 5-5-5 | ||||||
| SS1-FOU-10P6282 | 2-8-2 | ||||||
| SS1-FOU-10P62102 | 2-10-2 |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains the logo for CATHRX. The logo features a stylized heart shape with a line extending from the bottom, resembling a medical symbol. The text "CATH" is written in bold, sans-serif font, followed by "RX" enclosed in a rounded rectangle.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-GOU-04P6222 | 4 | Passive | 2-2-2 | ||||
| SS1-GOU-04P6252 | 2-5-2 | ||||||
| SS1-GOU-04P6555 | 5-5-5 | ||||||
| SS1-GOU-04P6282 | 2-8-2 | ||||||
| SS1-GOU-04P62102 | 2-10-2 | ||||||
| SS1-GOU-06P6222 | 6 | 2-2-2 | |||||
| SS1-GOU-06P6252 | 2-5-2 | ||||||
| SS1-GOU-06P6555 | 5-5-5 | ||||||
| SS1-GOU-06P6282 | 2-8-2 | ||||||
| SS1-GOU-06P62102 | 2-10-2 | ||||||
| SS1-GOU-08P6222 | 8.9 | In Plane | Unidirectional | 8 | 2-2-2 | ||
| SS1-GOU-08P6252 | 2-5-2 | ||||||
| SS1-GOU-08P6555 | 5-5-5 | ||||||
| SS1-GOU-08P6282 | 2-8-2 | ||||||
| SS1-GOU-08P62102 | 2-10-2 | ||||||
| SS1-GOU-10P6222 | 10 | 2-2-2 | |||||
| SS1-GOU-10P6252 | 2-5-2 | ||||||
| SS1-GOU-10P6555 | 5-5-5 | ||||||
| SS1-GOU-10P6282 | 2-8-2 | ||||||
| SS1-GOU-10P62102 | 2-10-2 |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for CathRx. The logo consists of a heart shape with a line running through it on the left side, followed by the text "CATH" in bold, sans-serif font. To the right of "CATH" is "RX" in a similar font, enclosed in a rounded rectangle.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-JOU-04P6222 | 4 | Passive | 2-2-2 | ||||
| SS1-JOU-04P6252 | 2-5-2 | ||||||
| SS1-JOU-04P6555 | 5-5-5 | ||||||
| SS1-JOU-04P6282 | 2-8-2 | ||||||
| SS1-JOU-04P62102 | 2-10-2 | ||||||
| SS1-JOU-06P6222 | 10.2 | In Plane | Unidirectional | ||||
| SS1-JOU-06P6252 | |||||||
| SS1-JOU-06P6555 | |||||||
| SS1-JOU-06P6282 | |||||||
| SS1-JOU-06P62102 | |||||||
| SS1-JOU-08P6222 | 8 | 2-2-2 | |||||
| SS1-JOU-08P6252 | 2-5-2 | ||||||
| SS1-JOU-08P6555 | 5-5-5 | ||||||
| SS1-JOU-08P6282 | 2-8-2 | ||||||
| SS1-JOU-08P62102 | 2-10-2 | ||||||
| SS1-JOU-10P6222 | 10 | 2-2-2 | |||||
| SS1-JOU-10P6252 | 2-5-2 | ||||||
| SS1-JOU-10P6555 | 5-5-5 | ||||||
| SS1-JOU-10P6282 | 2-8-2 | ||||||
| SS1-JOU-10P62102 | 2-10-2 |
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for CathRx. The logo consists of a heart shape with a line running through it on the left side, followed by the text "CATH" in bold, sans-serif font. To the right of "CATH" is "RX" in a similar font, enclosed in a rounded rectangle.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-POU-04P6222 | 12.7 | In Plane | Unidirectional | 4 | Passive | 2-2-2 | |
| SS1-POU-04P6252 | 12.7 | In Plane | Unidirectional | 2-5-2 | |||
| SS1-POU-04P6555 | 12.7 | In Plane | Unidirectional | 5-5-5 | |||
| SS1-POU-04P6282 | 12.7 | In Plane | Unidirectional | 2-8-2 | |||
| SS1-POU-04P62102 | 12.7 | In Plane | Unidirectional | 2-10-2 | |||
| SS1-POU-04P6101010 | 12.7 | In Plane | Unidirectional | 10-10-10 | |||
| SS1-POU-06P6222 | 12.7 | In Plane | Unidirectional | 6 | 2-2-2 | ||
| SS1-POU-06P6252 | 12.7 | In Plane | Unidirectional | 2-5-2 | |||
| SS1-POU-06P6555 | 12.7 | In Plane | Unidirectional | 5-5-5 | |||
| SS1-POU-06P6282 | 12.7 | In Plane | Unidirectional | 2-8-2 | |||
| SS1-POU-06P62102 | 12.7 | In Plane | Unidirectional | 2-10-2 | |||
| SS1-POU-06P6101010 | 12.7 | In Plane | Unidirectional | 10-10-10 | |||
| SS1-POU-08P6222 | 12.7 | In Plane | Unidirectional | 8 | 2-2-2 | ||
| SS1-POU-08P6252 | 12.7 | In Plane | Unidirectional | 2-5-2 | |||
| SS1-POU-08P6555 | 12.7 | In Plane | Unidirectional | 5-5-5 | |||
| SS1-POU-08P6282 | 12.7 | In Plane | Unidirectional | 2-8-2 | |||
| SS1-POU-08P62102 | 12.7 | In Plane | Unidirectional | 2-10-2 | |||
| SS1-POU-08P6101010 | 12.7 | In Plane | Unidirectional | 10-10-10 | |||
| SS1-POU-10P6222 | 12.7 | In Plane | Unidirectional | 10 | 2-2-2 | ||
| SS1-POU-10P6252 | 12.7 | In Plane | Unidirectional | 2-5-2 | |||
| SS1-POU-10P6555 | 12.7 | In Plane | Unidirectional | 5-5-5 | |||
| SS1-POU-10P6282 | 12.7 | In Plane | Unidirectional | 2-8-2 | |||
| SS1-POU-10P62102 | 12.7 | In Plane | Unidirectional | 2-10-2 | |||
| SS1-POU-10P6101010 | 12.7 | In Plane | Unidirectional | 10-10-10 |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image contains the logo for "CATHRx". The logo features a heart shape with a line extending from the bottom, resembling a heartbeat. The text "CATH" is written in bold, sans-serif font, followed by "Rx" enclosed in a rounded rectangle.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-Q0U-04P6222 | 15.2 | In Plane | Unidirectional | 4 | Passive | 2-2-2 | |
| SS1-Q0U-04P6252 | 2-5-2 | ||||||
| SS1-Q0U-04P6555 | 5-5-5 | ||||||
| SS1-Q0U-04P6282 | 2-8-2 | ||||||
| SS1-Q0U-04P62102 | 2-10-2 | ||||||
| SS1-Q0U-04P6101010 | 10-10-10 | ||||||
| SS1-Q0U-06P6222 | 6 | 2-2-2 | |||||
| SS1-Q0U-06P6252 | 2-5-2 | ||||||
| SS1-Q0U-06P6555 | 5-5-5 | ||||||
| SS1-Q0U-06P6282 | 2-8-2 | ||||||
| SS1-Q0U-06P62102 | 2-10-2 | ||||||
| SS1-Q0U-06P6101010 | 10-10-10 | ||||||
| SS1-Q0U-08P6222 | 8 | 2-2-2 | |||||
| SS1-Q0U-08P6252 | 2-5-2 | ||||||
| SS1-Q0U-08P6555 | 5-5-5 | ||||||
| SS1-Q0U-08P6282 | 2-8-2 | ||||||
| SS1-Q0U-08P62102 | 2-10-2 | ||||||
| SS1-Q0U-08P6101010 | 10 | 10-10-10 | |||||
| SS1-Q0U-10P6222 | 2-2-2 | ||||||
| SS1-Q0U-10P6252 | 2-5-2 | ||||||
| SS1-Q0U-10P6555 | 5-5-5 | ||||||
| SS1-Q0U-10P6282 | 2-8-2 | ||||||
| SS1-Q0U-10P62102 | 2-10-2 | ||||||
| SS1-Q0U-10P6101010 | 10-10-10 |
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for "CATHRx". The logo features a heart shape with a line running through it on the left side. The text "CATH" is in bold, sans-serif font, and the "Rx" is in a rounded rectangle on the right side.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-ROU-04P6222 | 17.8 | In Plane | Unidirectional | 4 | Passive | 2-2-2 | |
| SS1-ROU-04P6252 | 2-5-2 | ||||||
| SS1-ROU-04P6555 | 5-5-5 | ||||||
| SS1-ROU-04P6282 | 2-8-2 | ||||||
| SS1-ROU-04P62102 | 2-10-2 | ||||||
| SS1-ROU-04P6101010 | 10-10-10 | ||||||
| SS1-ROU-06P6222 | 6 | 2-2-2 | |||||
| SS1-ROU-06P6252 | 2-5-2 | ||||||
| SS1-ROU-06P6555 | 5-5-5 | ||||||
| SS1-ROU-06P6282 | 2-8-2 | ||||||
| SS1-ROU-06P62102 | 2-10-2 | ||||||
| SS1-ROU-06P6101010 | 10-10-10 | ||||||
| SS1-ROU-08P6222 | 8 | 2-2-2 | |||||
| SS1-ROU-08P6252 | 2-5-2 | ||||||
| SS1-ROU-08P6555 | 5-5-5 | ||||||
| SS1-ROU-08P6282 | 2-8-2 | ||||||
| SS1-ROU-08P62102 | 2-10-2 | ||||||
| SS1-ROU-08P6101010 | 10-10-10 | ||||||
| SS1-ROU-10P6222 | 10 | 2-2-2 | |||||
| SS1-ROU-10P6252 | 2-5-2 | ||||||
| SS1-ROU-10P6555 | 5-5-5 | ||||||
| SS1-ROU-10P6282 | 2-8-2 | ||||||
| SS1-ROU-10P62102 | 2-10-2 | ||||||
| SS1-ROU-10P6101010 | 10-10-10 |
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the logo for CATH RX. The logo features a heart shape with a line running through it on the left side. The text "CATH" is in bold, sans-serif font, and "RX" is in a rounded rectangle on the right side.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS1-YOU-04P6222 | 6.4 HIS | In Plane | Unidirectional | 4 | Passive | 2-2-2 | |
| SS1-YOU-04P6252 | 2-5-2 | ||||||
| SS1-YOU-04P6555 | 5-5-5 | ||||||
| SS1-YOU-04P6282 | 2-8-2 | ||||||
| SS1-YOU-04P62102 | 2-10-2 | ||||||
| SS1-YOU-04P6101010 | 10-10-10 | ||||||
| SS1-YOU-06P6222 | 6 | 2-2-2 | |||||
| SS1-YOU-06P6252 | 2-5-2 | ||||||
| SS1-YOU-06P6555 | 5-5-5 | ||||||
| SS1-YOU-06P6282 | 2-8-2 | ||||||
| SS1-YOU-06P62102 | 2-10-2 | ||||||
| SS1-YOU-06P6101010 | 10-10-10 | ||||||
| SS1-YOU-08P6222 | 8 | 2-2-2 | |||||
| SS1-YOU-08P6252 | 2-5-2 | ||||||
| SS1-YOU-08P6555 | 5-5-5 | ||||||
| SS1-YOU-08P6282 | 2-8-2 | ||||||
| SS1-YOU-08P62102 | 2-10-2 | ||||||
| SS1-YOU-08P6101010 | 10-10-10 | ||||||
| SS1-YOU-10P6222 | 10 | 2-2-2 | |||||
| SS1-YOU-10P6252 | 2-5-2 | ||||||
| SS1-YOU-10P6555 | 5-5-5 | ||||||
| SS1-YOU-10P6282 | 2-8-2 | ||||||
| SS1-YOU-10P62102 | 2-10-2 | ||||||
| SS1-YOU-10P6101010 | 10-10-10 |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image contains the logo for "CATH RX". The logo features a stylized heart shape on the left, followed by the word "CATH" in bold, sans-serif font. To the right of "CATH" is "RX" enclosed in a rounded rectangle.
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS2-POU-20P6242 | 2-4-2 | ||||||
| SS2-POU-20P6282 | CCD0104 | 2-8-2 | |||||
| SS2-POU-20P62102 | Passive | 2-10-2 | |||||
| SS2-POU-20P62122 | CCD0042 | 2-12-2 | |||||
| SS2-POU-20P62132 | 2-13-2 | ||||||
| SS2-POU-20P620282 | 20-2-8-2 | ||||||
| SS2-Q0U-20P6242 | 2-4-2 | ||||||
| SS2-Q0U-20P6282 | 2-8-2 | ||||||
| SS2-Q0U-20P62102 | Passive | 2-10-2 | |||||
| SS2-Q0U-20P62122 | CCD0089 | 2-12-2 | |||||
| SS2-Q0U-20P62132 | 2-13-2 | ||||||
| SS2-Q0U-20P620282 | 20-2-8-2 | ||||||
| SS2-ROU-20P6242 | 2-4-2 | ||||||
| SS2-ROU-20P6282 | 2-8-2 | ||||||
| SS2-ROU-20P62102 | Passive | 2-10-2 | |||||
| SS2-ROU-20P62122 | CCD0090 | 2-12-2 | |||||
| SS2-ROU-20P62132 | 2-13-2 | ||||||
| SS2-ROU-20P620282 | 20-2-8-2 |
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | DeflectionPlane | Deflection Type | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SS2-YOU-20P6242 | 2-4-2 | ||||||
| SS2-YOU-20P6282 | 2-8-2 | ||||||
| SS2-YOU-20P62102 | 2-10-2 | ||||||
| SS2-YOU-20P62122 | Passive | 2-12-2 | |||||
| SS2-YOU-20P62132 | 2-13-2 | ||||||
| SS2-YOU-20P620282 | 20-2-8-2 |
Loop Fixed Models
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image contains the logo for "CATHRx". The logo features a stylized heart shape with a line extending from it on the left side. To the right of the heart is the text "CATH" in bold, followed by "Rx" in a black box.
| Product ReferenceNumber | Allocated ItemNumber | Curve | Loop Type | Loop Size (mm) | # ofElectrodes | Tip Electrode | Spacing (mm) |
|---|---|---|---|---|---|---|---|
| SCF-S15-10P7555 | Straight | Fixed | 15 | 10 | Passive | 5-5-5 | |
| SCF-S20-10P7666 | 20 | 6-6-6 | |||||
| SCF-S25-10P7888 | 25 | 8-8-8 | |||||
| SCF-S30-10P7999 | 30 | 9-9-9 |
Fixed Loop Steerable Models
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | Deflection Type | Loop Type | Loop Size(mm) | # ofElectrodes | Tip Electrode | Spacing(mm) |
|---|---|---|---|---|---|---|---|---|
| SC1-B15U-10P7555 | CCD0051 | Unidirectional | Fixed | 15 | 10 | Passive | 5-5-5 | |
| SC1-B20U-10P7666 | CCD0052 | 5.1 | 20 | 6-6-6 | ||||
| SC1-B25U-10P7888 | CCD0053 | 25 | 8-8-8 | |||||
| SC1-D15U-10P7555 | 15 | 5-5-5 | ||||||
| SC1-D20U-10P7666 | 6.4 | 20 | 6-6-6 | |||||
| SC1-D25U-10P7888 | 25 | 8-8-8 |
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | Deflection Type | Loop Type | Loop Size(mm) | # ofElectrodes | Tip Electrode | Spacing(mm) |
|---|---|---|---|---|---|---|---|---|
| SC2-B15U-14P7333 | 5.1 | Unidirectional | Fixed | 15 | 14 | Passive | 3-3-3 | |
| SC2-B20U-14P7444 | 20 | 4-4-4 | ||||||
| SC2-B30U-14P7777 | 30 | 7-7-7 | ||||||
| SC2-B15U-20P7232 | 15 | 20 | 2-3-2 | |||||
| SC2-B20U-20P7242 | 20 | 2-4-2 | ||||||
| SC2-B25U-20P7262 | 25 | 2-6-2 | ||||||
| SC2-B30U-20P7272 | 30 | 2-7-2 | ||||||
| SC2-D15U-14P7333 | 6.4 | 15 | 14 | 3-3-3 | ||||
| SC2-D20U-14P7444 | 20 | 4-4-4 | ||||||
| SC2-D30U-14P7777 | 30 | 7-7-7 | ||||||
| SC2-D15U-20P7232 | 15 | 20 | 2-3-2 | |||||
| SC2-D20U-20P7242 | 20 | 2-4-2 | ||||||
| SC2-D25U-20P7262 | 25 | 2-6-2 | ||||||
| SC2-D30U-20P7272 | 30 | 2-7-2 |
CathRx Traditional 510(k) Khelix Diagnostic Electrophysiology Catheters
Page 14/15 K211327
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image contains the logo for "CATHRX". The logo features a stylized heart shape on the left, followed by the text "CATH" in bold, sans-serif font. To the right of "CATH", the letters "RX" are enclosed in a rounded rectangle.
Variable Loop Steerable Models
| Product ReferenceNumber | Allocated ItemNumber | Curve Length(cm) | Deflection Type | Loop Type | Loop Size(mm) | # ofElectrodes | Tip Electrode | Spacing(mm) |
|---|---|---|---|---|---|---|---|---|
| SC2-B2515U-10P7888 | CCD0069 | 5.1 | Unidirectional | Variable | 25-15 | 10 | Passive | 8-8-8 |
| SC2-B2515U-20P7262 | CCD0040 | 5.1 | Unidirectional | Variable | 25-15 | 20 | Passive | 2-6-2 |
§ 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).