The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

Device Description

The reprocessed catheters are diagnostic bi-directional 7F deflectable mapping electrophysiology EP catheters. The devices have the ability to map electrical activity within the Coronary Sinus (CS) through electrodes along the catheters' pre-shaped tip. The catheters have a braided bi-directional tip section that provides the user with two 180° opposed single plane curves (available curves are DF and FJ). The tip is deflected with a Rocker Lever, and the high torque shaft permits the tip's plane to rotate to ease accurate positioning of the catheter tip at the desired site. The Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID are equipped with an Electronically Erasable Programmable Read Only Memory (EEPROM) that is used to store unique catheter identification information.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a reprocessed medical device: "Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID".

This document is not about an AI/ML medical device. It's about a reprocessed catheter and demonstrates substantial equivalence to existing predicate devices based on non-clinical performance data. Therefore, the specific questions related to AI/ML device acceptance criteria, study methodologies (like MRMC, standalone performance, training sets, expert consensus for ground truth), and effect sizes of AI assistance are not applicable to this document.

The document discusses "non-clinical testing" and "functional performance studies" for the reprocessed catheters to demonstrate their equivalence to new, original equipment manufacturer (OEM) catheters.

Here's an attempt to extract the relevant information from the provided text, while noting the limitations regarding the AI/ML specific questions:

Acceptance Criteria and Device Performance (based on non-clinical testing for a reprocessed device):

The document does not provide a table of precise quantitative acceptance criteria with corresponding performance metrics for the reprocessed catheter in the way one would expect for an AI/ML device's diagnostic performance. Instead, it states that the functional characteristics of the subject device (reprocessed catheter) have been evaluated and found to be substantially equivalent to the predicate device. This substantial equivalence is based on various non-clinical tests.

The types of non-clinical tests performed and implicitly, the areas where acceptance criteria would have been applied (though not explicitly listed with values), include:

Test Category	Specific Tests Mentioned	Reported Performance (Qualitative, as quantitative data is not provided)
Functional Performance	Simulated use and artificial soiling	Found to be substantially equivalent to the predicate device.
Mechanical	Continuity, isolation, resistance; corrosion resistance	Found to be substantially equivalent to the predicate device.
Cleaning	Protein, total organic carbon, visual inspection under magnification; cleaning qualification	Found to be substantially equivalent to the predicate device.
Biocompatibility	Cytotoxicity; irritation; acute systemic toxicity; materials-mediated pyrogen; complement activation; hemolysis; coagulation	Found to be substantially equivalent to the predicate device.
Sterilization	Bioburden; ethylene oxide/ethylene chlorohydrin residuals; bacteriostasis/fungistasis; endotoxin	Found to be substantially equivalent to the predicate device.
Other	Packaging and shelf life validation; Product stability	Found to be substantially equivalent to the predicate device.

The evidence for "proof" that the device meets "acceptance criteria" is the FDA's determination of substantial equivalence (SE) to legally marketed predicate devices. This SE determination is based on the provided non-clinical testing data which, by inference, met the internal acceptance criteria set by Medline ReNewal and deemed sufficient by the FDA for establishing SE.

Regarding the AI/ML specific questions:

A table of acceptance criteria and the reported device performance: As explained above, for this reprocessed medical device, specific quantitative metrics are not provided in the summary. The acceptance is based on demonstrating substantial equivalence through various functional, mechanical, cleaning, biocompatibility, and sterilization tests.
Sample sizes used for the test set and the data provenance: The document mentions "non-clinical testing data" and "functional performance studies" but does not specify the sample sizes (e.g., number of catheters tested) or the provenance (country of origin, retrospective/prospective) of this data. It is inherently laboratory/bench testing data, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For a reprocessed physical device, "ground truth" would be established through laboratory methods and validated testing protocols against known engineering and biological standards, not through human expert consensus in the medical imaging sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no expert adjudication of diagnostic outputs occurred.
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: Not applicable. This is a reprocessed physical catheter, not an AI/ML diagnostic algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an AI algorithm. Its "standalone" performance would refer to its physical properties and functionality outside of human use, as evaluated through the non-clinical tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth" for AI. For this device, "ground truth" refers to the established performance and safety specifications of the original predicate device, against which the reprocessed device's performance is compared through physical and chemical testing.
The sample size for the training set: Not applicable. This is a reprocessed physical medical device, not an AI/ML algorithm that undergoes "training."
How the ground truth for the training set was established: Not applicable. No training set or ground truth in the AI/ML context exists for this device.

Summary

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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: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.

November 15, 2024

Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Stephanie Boyle Mays Senior Regulatory Affairs Specialist, QA/RA 1500 NE Hemlock Ave. Redmond, Oregon 97756

Re: K241224

Trade/Device Name: Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: October 17, 2024 Received: October 17, 2024

Dear Stephanie Boyle Mays:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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-regulatory

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assistance/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 S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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OEM Model No.	Description	Electrodes		Curve	Size
		Qty.	Spacing		(cm)
BD710DF282CT	7F Webster CS AID 2-8-2DF curve with Auto ID,115 cm	10	2-8-2	DF(64/76 mm)	7F x 115
BD710DF282RTS	7F Webster CS 2-8-2 DFcurve, 115 cm	10	2-8-2	DF(64/76 mm)	7F x 115
BD710FJ282CT	7F Webster CS AID 2-8-2FJ curve with Auto ID,115 cm	10	2-8-2	FJ(76/102 mm)	7F x 115
BD710FJ282RTS	7F Webster CS 2-8-2 FJcurve, 115 cm	10	2-8-2	FJ(76/102 mm)	7F x 115

The following devices are included in the scope of this 510(k) premarket notification:

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Indications for Use

510(k) Number (if known) K241224

Device Name

Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID

Indications for Use (Describe)

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)

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Image /page/5/Picture/0 description: The image shows the logo for "ReNewal Full Circle Reprocessing". The word "Re" is in green, and the word "Newal" is in blue. To the left of the word "ReNewal" is the Medline logo, which is a blue square with a white star and the word "MEDLINE" in white letters.

Traditional 510(k) Notification Medline ReNewal Reprocessed Biosense Webster Webster CS ÉP Catheters

510(k) 241224 Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.

Submitter/ Owner	Surgical Instrument Service and Savings Inc. (dba Medline ReNewal)1500 NE Hemlock Ave., Redmond, OR 97756
Contact/ Prepared by	Stephanie Boyle MaysSenior Regulatory Affairs Specialist, Quality Assurance/Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • smays@medline.com
Date Prepared	May 1, 2024
Device Name and Classification	Proprietary/Trade Name:	Medline ReNewal Reprocessed Biosense WebsterWebster CS Catheter with EZ Steer Technology andMedline ReNewal Reprocessed Biosense WebsterWebster CS Catheter with EZ Steer Technology andAuto ID
	Common or Usual Name	Catheter, recording, electrode, reprocessed
	Regulatory Name/Reference	Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220
	Regulatory Class	2
	Product Code	NLH
	Panel	Cardiovascular
	Predicate selection rationale	The models in this submission are the same as in thepredicate only that have been reprocessed
	510(k) Number	K101345
Predicate Device 1	Proprietary or Trade Name	Biosense Webster Webster CS Catheter With EZSteer Technology, Webster CS Catheter With EZSteer Technology and Auto ID
	Common or Usual Name	Catheter, recording, or probe electrode recording
	Regulatory Name/Reference	Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220
	Regulatory Class	2
	Product Code	DRF
	Panel	Cardiovascular
	510(k) applicant	Biosense Webster,333 Diamond Canyon Rd. Diamond Bar, CA 91765
Predicate Device 2	510(k) Number	K231312
	Proprietary or Trade Name	PENTARAY NAV ECO High Density MappingCatheter, DECANAV Mapping Catheter, Webster CSCatheter with Auto ID, Webster CS Catheter with EZSteer Technology, Webster CS Catheter with EZSteer Technology with Auto ID
	Common or Usual Name	Catheter, recording, or probe electrode recording
	RegulatoryName/Reference	Electrode recording catheter or electrode recordingprobe/21 CFR § 870.1220
	Regulatory Class	2
Predicate 2(concluded)	Product Code	MTD, DRF
	Panel	Cardiovascular
	510(k) applicant	Biosense Webster,333 Diamond Canyon Rd. Diamond Bar, CA 91765
DeviceDescription/Intended Use	Medline ReNewal Reprocessed Biosense Webster Webster CS Catheterwith EZ Steer Technology and Medline ReNewal Reprocessed BiosenseWebster Webster CS Catheter with EZ Steer Technology and Auto ID. Thereprocessed catheters are diagnostic bi-directional 7F deflectable mappingelectrophysiology EP catheters. The devices have the ability to mapelectrical activity within the Coronary Sinus (CS) through electrodes alongthe catheters' pre-shaped tip. The catheters have a braided bi-directional tipsection that provides the user with two 180° opposed single plane curves(available curves are DF and FJ). The tip is deflected with a Rocker Lever,and the high torque shaft permits the tip's plane to rotate to ease accuratepositioning of the catheter tip at the desired site. The Medline ReNewalReprocessed Biosense Webster Webster CS Catheter with EZ SteerTechnology and Auto ID are equipped with an Electronically ErasableProgrammable Read Only Memory (EEPROM) that is used to store uniquecatheter identification information.
Indications forUse	The Medline ReNewal Reprocessed Biosense Webster Webster CSCatheter is indicated for electrophysiological mapping of cardiac structures,i.e., stimulation and recording only. The catheter is designed for use in thecoronary sinus.
TechnologicalCharacteristics	The technological characteristics, materials, and the fundamental scientifictechnology of the subject device is equivalent to the primary predicatedevices. The proposed devices are reprocessed versions of the WebsterCS predicate devices. K101345 was used as the predicate to supportintended use, technological characteristics, and functional performancespecifications. Each device is marked, tracked and taken out of serviceonce the maximum number of cycles has been reached.
Non-clinicalTestingSummary	Functional performance studies:simulated use and artificial soiling; Mechanical characteristics continuity, isolation, resistance; corrosion resistance. Cleaning: protein, total organic carbon visual inspection under magnification; and cleaning qualification. Biocompatibility: cytotoxicity;	The functional characteristics of the subject device have been evaluatedand found to be substantially equivalent to the predicate device based on

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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and consists of a blue square with a white cross inside. The word "MEDLINE" is written in white letters inside the blue square. To the right of the Medline logo is the word "Renewal" in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in black letters.

Traditional 510(k) Notification Medline ReNewal Reprocessed Biosense Webster Webster CS ÉP Catheters

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Image /page/7/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of a blue square with a white star and the word "MEDLINE" in white letters. The Renewal logo is on the right and consists of the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in smaller blue letters below it. There is a trademark symbol next to the word Renewal.

Traditional 510(k) Notification

Medline ReNewal Reprocessed Biosense Webster Webster CS EP Catheters

irritation; ●
acute systemic toxicity; ●
materials-mediated pyrogen; ●
complement activation;
hemolysis; and
coagulation; .
Packaging and shelf life validation ●
Sterilization validation: ●
- bioburden;
- ethylene oxide/ ethylene chlorohydrin residuals; ●
- bacteriostasis/fungistasis; and
- . endotoxin
- Product stability

Table 1: Comparison of Predicates and Subject devices.

PREDICATE 1	PREDICATE 2	PROPOSED
Biosense WebsterWebster CS CatheterWith EZ SteerTechnology, WebsterCS Catheter With EZSteer Technology andAuto ID	Webster CS Catheterwith EZ SteerTechnology, WebsterCS Catheter with EZSteer Technology andAuto ID	Medline ReNewalReprocessed MedlineReNewal ReprocessedBiosense WebsterWebster CS Catheterwith EZ SteerTechnology andMedline ReNewalReprocessed BiosenseWebster Webster CSCatheter with EZ SteerTechnology and Auto ID	Comparison
510(k) number
K101345	K231312	K241224	N/A
Model numbers
Bi-directional catheters:BD710DF282RTS andBD710FJ282RTSBi-directional catheterswith Auto ID:BD710DF282CT andBD710FJ282CTa	Bi-directional catheters:D-1263-04-S & D-1263-05-SBi-directional catheterswith Auto ID: D-1263-06-S & D1263-07-S	Bi-directional catheters:BD710DF282RTS andBD710FJ282RTSBi-directional catheterswith Auto ID:BD710DF282CT andBD710FJ282CT	Same -Proposed andPredicate 1
Classification Name
Catheter, electroderecording, or electroderecording probe	Catheter, IntracardiacMapping, High-DensityArray	Catheter, recording,electrode recording,reprocessed	Same -Proposed andPredicate 1
Regulation No.
21 CFR § 870.1220	21 CFR § 870.1220	21 CFR § 870.1220	Same
Regulatory Class
2	2	2	Same
Product Code
PREDICATE 1	PREDICATE 2	PROPOSED
Biosense WebsterWebster CS CatheterWith EZ SteerTechnology, WebsterCS Catheter With EZSteer Technology andAuto ID	Webster CS Catheterwith EZ SteerTechnology, WebsterCS Catheter with EZSteer Technology andAuto ID	Medline ReNewalReprocessed MedlineReNewal ReprocessedBiosense WebsterWebster CS Catheterwith EZ SteerTechnology andMedline ReNewalReprocessed BiosenseWebster Webster CSCatheter with EZ SteerTechnology and Auto ID	Comparison
DRF	MTD, DRF	NLH	As stated
	Technological Characteristics
The Webster CSCatheters have a 2 mmtip electrode, 10 totalelectrodes, 2-8-2 mmelectrode spacing andhave bi-directionaldeflection and a usablelength of 115 cm. Auto IDmodels are equipped withan ElectronicallyErasable ProgrammableRead Only Memory(EEPROM) that is usedto store unique catheteridentification informationCatheters interface with aCarto EP NavigationSystems via an interfacecable with theappropriate connectors.	The Webster CS isidentical in design and alltechnologicalcharacteristics to theWebster CS cathetercleared in K101345. Themain difference betweenthe predicate device andthe modified device is achange to the instructionsfor use to allow for theuse of direct imagingguidance, such asfluoroscopy orultrasound, duringcatheter manipulation.	The Webster CSCatheters have a 2 mmtip electrode, 10 totalelectrodes, 2-8-2 mmelectrode spacing andhave bi-directionaldeflection and a usablelength of 115 cm. Auto IDmodels are equipped withan ElectronicallyErasable ProgrammableRead Only Memory(EEPROM) that is usedto store unique catheteridentification informationCatheters interface with aCarto EP NavigationSystems via an interfacecable with theappropriate connectors.	Same
	Indications for Use
Webster CS Catheter isindicated forelectrophysiologicalmapping of cardiacstructures, i.e.,stimulation and recordingonly. The catheter isdesigned for use in thecoronary sinus.	Webster CS Catheter isindicated forelectrophysiologicalmapping of cardiacstructures, i.e.,stimulation and recordingonly. The catheter isdesigned for use in thecoronary sinus.	Medline ReNewalReprocessed BiosenseWebster Webster CSCatheter is indicated forelectrophysiologicalmapping of cardiacstructures, i.e.,stimulation and recordingonly. The catheter isdesigned for use in thecoronary sinus.	Same
Reprocessing
PREDICATE 1	PREDICATE 2	PROPOSED
Biosense WebsterWebster CS CatheterWith EZ SteerTechnology, WebsterCS Catheter With EZSteer Technology andAuto ID	Webster CS Catheterwith EZ SteerTechnology, WebsterCS Catheter with EZSteer Technology andAuto ID	Medline ReNewalReprocessed MedlineReNewal ReprocessedBiosense WebsterWebster CS Catheterwith EZ SteerTechnology andMedline ReNewalReprocessed BiosenseWebster Webster CSCatheter with EZ SteerTechnology and Auto ID	Comparison
Each cable is reprocessed no more than two times. Medline ReNewal does not reprocess theWebster CS Catheters of other reprocessors.
Conclusion
The predicate and proposed devices in this application have the same indications for use andtechnological characteristics. Based on this and the non-clinical testing data presented in this510(k) submission, the Medline ReNewal Reprocessed Biosense Webster CS Catheterwith EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster CSCatheter with EZ Steer Technology and Auto ID are substantially equivalent to the predicatedevice.
Original equipment manufacturer models were associated with the K101345 predicate byaconsulting the GUDID database.

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Image /page/8/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of a blue square with the word "MEDLINE" in white letters and a white cross-like symbol. To the right of the Medline logo is the Renewal logo, with "Re" in green and "Newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font.

Medline ReNewal Reprocessed Biosense Webster Webster CS ÉP Catheters

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Image /page/9/Picture/0 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of a blue square with the word "MEDLINE" in white text and a white cross-like symbol. To the right of the Medline logo is the Renewal logo, with "Re" in green and "Newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font.

Traditional 510(k) Notification Medline ReNewal Reprocessed Biosense Webster Webster CS ÉP Catheters

Regulation Number and Section

§ 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).