Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and electrical properties of a reprocessed mapping catheter and does not mention any AI or ML capabilities.

Therapeutic

No
The device is indicated for electrophysiological mapping, stimulation, and recording only, which are diagnostic functions, not therapeutic.

Diagnostic

Yes

The "Device Description" explicitly states, "The reprocessed catheters are diagnostic bi-directional 7F deflectable mapping electrophysiology EP catheters." Additionally, the "Intended Use / Indications for Use" mentions "electrophysiological mapping of cardiac structures." These phrases directly indicate its function is for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with electrodes, a deflectable tip, and a shaft, indicating it is a hardware device. While it contains an EEPROM for identification, this is a component of the physical device, not a standalone software product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "electrophysiological mapping of cardiac structures, i.e., stimulation and recording only." This describes a procedure performed within the body to measure electrical activity, not a test performed on a sample taken from the body.
Device Description: The description details a catheter designed to be inserted into the coronary sinus for mapping electrical activity. This is an invasive procedure, not an in vitro test.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used in vivo (within the living body) for diagnostic mapping.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NLH

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cardiac structures, coronary sinus

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

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; 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. The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the non-clinical testing data presented in this 510(k) submission.

Key Metrics

Not Found

Predicate Device(s)

K101345, K231312

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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: 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.

1

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

2

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

3

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

4

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)

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.

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."

5

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 Mays
Senior Regulatory Affairs Specialist, Quality Assurance/Regulatory Affairs
P: 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 Webster
Webster CS Catheter with EZ Steer Technology and
Medline ReNewal Reprocessed Biosense Webster
Webster CS Catheter with EZ Steer Technology and
Auto ID |
| | Common or Usual Name | Catheter, recording, electrode, reprocessed |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording
probe/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 the
predicate only that have been reprocessed |
| | 510(k) Number | K101345 |
| Predicate Device 1 | Proprietary or Trade Name | Biosense Webster Webster CS Catheter With EZ
Steer Technology, Webster CS Catheter With EZ
Steer Technology and Auto ID |
| | Common or Usual Name | Catheter, recording, or probe electrode recording |
| | Regulatory Name/Reference | Electrode recording catheter or electrode recording
probe/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 Mapping
Catheter, DECANAV Mapping Catheter, Webster CS
Catheter with Auto ID, Webster CS Catheter with EZ
Steer Technology, Webster CS Catheter with EZ
Steer Technology with Auto ID |
| | Common or Usual Name | Catheter, recording, or probe electrode recording |
| | Regulatory
Name/Reference | Electrode recording catheter or electrode recording
probe/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 |
| Device
Description/
Intended Use | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter
with EZ Steer Technology and Medline ReNewal Reprocessed Biosense
Webster Webster CS Catheter with EZ Steer Technology and Auto ID. 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. | |
| Indications for
Use | The Medline ReNewal Reprocessed Biosense Webster 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. | |
| Technological
Characteristics | The technological characteristics, materials, and the fundamental scientific
technology of the subject device is equivalent to the primary predicate
devices. The proposed devices are reprocessed versions of the Webster
CS predicate devices. K101345 was used as the predicate to support
intended use, technological characteristics, and functional performance
specifications. Each device is marked, tracked and taken out of service
once the maximum number of cycles has been reached. | |
| Non-clinical
Testing
Summary | 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 evaluated
and found to be substantially equivalent to the predicate device based on |

6

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

7

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 Webster
Webster CS Catheter
With EZ Steer
Technology, Webster
CS Catheter With EZ
Steer Technology and
Auto ID	Webster CS Catheter
with EZ Steer
Technology, Webster
CS Catheter with EZ
Steer Technology and
Auto ID	Medline ReNewal
Reprocessed Medline
ReNewal Reprocessed
Biosense Webster
Webster CS Catheter
with EZ Steer
Technology and
Medline ReNewal
Reprocessed Biosense
Webster Webster CS
Catheter with EZ Steer
Technology and Auto ID	Comparison
510(k) number
K101345	K231312	K241224	N/A
Model numbers
Bi-directional catheters:
BD710DF282RTS and
BD710FJ282RTS
Bi-directional catheters
with Auto ID:
BD710DF282CT and
BD710FJ282CTa	Bi-directional catheters:
D-1263-04-S & D-1263-
05-S
Bi-directional catheters
with Auto ID: D-1263-06-
S & D1263-07-S	Bi-directional catheters:
BD710DF282RTS and
BD710FJ282RTS
Bi-directional catheters
with Auto ID:
BD710DF282CT and
BD710FJ282CT	Same -
Proposed and
Predicate 1
Classification Name
Catheter, electrode
recording, or electrode
recording probe	Catheter, Intracardiac
Mapping, High-Density
Array	Catheter, recording,
electrode recording,
reprocessed	Same -
Proposed and
Predicate 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 Webster
Webster CS Catheter
With EZ Steer
Technology, Webster
CS Catheter With EZ
Steer Technology and
Auto ID	Webster CS Catheter
with EZ Steer
Technology, Webster
CS Catheter with EZ
Steer Technology and
Auto ID	Medline ReNewal
Reprocessed Medline
ReNewal Reprocessed
Biosense Webster
Webster CS Catheter
with EZ Steer
Technology and
Medline ReNewal
Reprocessed Biosense
Webster Webster CS
Catheter with EZ Steer
Technology and Auto ID	Comparison
DRF	MTD, DRF	NLH	As stated
	Technological Characteristics
The Webster CS
Catheters have a 2 mm
tip electrode, 10 total
electrodes, 2-8-2 mm
electrode spacing and
have bi-directional
deflection and a usable
length of 115 cm. Auto ID
models are equipped with
an Electronically
Erasable Programmable
Read Only Memory
(EEPROM) that is used
to store unique catheter
identification information
Catheters interface with a
Carto EP Navigation
Systems via an interface
cable with the
appropriate connectors.	The Webster CS is
identical in design and all
technological
characteristics to the
Webster CS catheter
cleared in K101345. The
main difference between
the predicate device and
the modified device is a
change to the instructions
for use to allow for the
use of direct imaging
guidance, such as
fluoroscopy or
ultrasound, during
catheter manipulation.	The Webster CS
Catheters have a 2 mm
tip electrode, 10 total
electrodes, 2-8-2 mm
electrode spacing and
have bi-directional
deflection and a usable
length of 115 cm. Auto ID
models are equipped with
an Electronically
Erasable Programmable
Read Only Memory
(EEPROM) that is used
to store unique catheter
identification information
Catheters interface with a
Carto EP Navigation
Systems via an interface
cable with the
appropriate connectors.	Same
	Indications for Use
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.	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.	Medline ReNewal
Reprocessed Biosense
Webster 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.	Same
Reprocessing
PREDICATE 1	PREDICATE 2	PROPOSED
Biosense Webster
Webster CS Catheter
With EZ Steer
Technology, Webster
CS Catheter With EZ
Steer Technology and
Auto ID	Webster CS Catheter
with EZ Steer
Technology, Webster
CS Catheter with EZ
Steer Technology and
Auto ID	Medline ReNewal
Reprocessed Medline
ReNewal Reprocessed
Biosense Webster
Webster CS Catheter
with EZ Steer
Technology and
Medline ReNewal
Reprocessed Biosense
Webster Webster CS
Catheter with EZ Steer
Technology and Auto ID	Comparison
Each cable is reprocessed no more than two times. Medline ReNewal does not reprocess the
Webster CS Catheters of other reprocessors.
Conclusion
The predicate and proposed devices in this application have the same indications for use and
technological characteristics. Based on this and the non-clinical testing data presented in this
510(k) submission, the Medline ReNewal Reprocessed Biosense Webster CS Catheter
with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster CS
Catheter with EZ Steer Technology and Auto ID are substantially equivalent to the predicate
device.
Original equipment manufacturer models were associated with the K101345 predicate by
a
consulting the GUDID database.

8

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

9

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