Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reprocessed electrophysiology catheter used for recording and stimulation, with no mention of AI or ML in its function or processing.

Therapeutic

No.
The device is used for diagnostic purposes (electrogram recording and cardiac stimulation during diagnostic electrophysiology studies to evaluate cardiac arrhythmias), not for treating or curing a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the catheters are used for "evaluation of a variety of cardiac arrhythmias" and "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies," which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical catheter used for electrophysiological studies, involving hardware components like electrodes and a shaft. The performance studies also focus on physical properties and reprocessing of the hardware.

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 describes the device as being used for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites" and for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies." These activities are performed in vivo (within the living body) to assess the electrical activity of the heart.
Device Description: The description reinforces the in vivo nature of the device, mentioning placement within the heart and coronary sinus for recording and stimulation.
Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the living body) to provide information about a patient's health. This device does not fit that description.

Therefore, the Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters are not IVD devices. They are medical devices used for in vivo diagnostic and therapeutic procedures related to cardiac electrophysiology.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Product codes (comma separated list FDA assigned to the subject device)

NLH

Device Description

Medline ReNewal Reprocessed St. Jude Supreme and Response Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.
The electrophysiology catheters are manufactured in various fixed curves and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

high right atrium, right ventricular apex and His bundle, coronary sinus, endocardial and intravascular sites.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests:
Functional performance studies: simulated use and artificial soiling; bond strength (tensile testing); torsional strength; leakage current; catheter/handle joint flexibility and continuity (flex fatigue); electrode adherence; shaft flexibility; tip buckling; direct current resistance; impedance at 5 kHz; and corrosion resistance.
Cleaning: protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification.
Biocompatibility: cytotoxicity; sensitization; irritation; acute systemic toxicity; pyrogenicity; and hemocompatibility (hemolysis, thrombogenicity; & complement activation).
Packaging and shelf life validation; sterilization validation: bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing.
Product stability

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K002976

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K151617

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of three human profiles facing right, layered on top of each other. The profiles are connected and form a single, flowing shape.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 18, 2017

Medline ReNewal Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K161272

Trade/Device Name: Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 12, 2017 Received: May 16, 2017

Dear Brandi Panteleon:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

1

related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

M.A. Willemsen

for

for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

| Table 1a: K161272 List of Models in Scope

Supreme EP Catheters
Manufacturer Model No.	Electrodes	Spacing	Curve	Size
401430	4	5	JSNa	6 Fr x 120 cm
401433	4	10	CRDb	5 Fr x 120 cm
401434	4	10	CRD	6 Fr x 120 cm
401435	4	10	JSN	5 Fr x 120 cm
401436	4	10	JSN	6 Fr x 120 cm
401438	4	10	DAOc	6 Fr x 120 cm
401441	4	5	CRD	5 Fr x 120 cm
401442	4	5	CRD	6 Fr x 120 cm
401443	4	5	JSN	5 Fr x 120 cm
401444	4	5	DAO	5 Fr x 120 cm
401445	4	5	DAO	6 Fr x 120 cm
401448	4	2-5-2	CRD	5 Fr x 120 cm
401449	4	2-5-2	CRD	6 Fr x 120 cm
401450	4	2-5-2	JSN	5 Fr x 120 cm
401451	4	2-5-2	JSN	6 Fr x 120 cm
401453	4	2-5-2	DAO	6 Fr x 120 cm
401466	4	5	DAO-1d	5 Fr x 120 cm
401468	4	2-5-2	DAO-1	5 Fr x 120 cm
401474	4	5	CRD-1e	6 Fr x 120 cm
401475	4	5	JSN-1f	6 Fr x 120 cm
401859	4	10	CRD-2g	5 Fr x 120 cm
401860	4	5	CRD-2	5 Fr x 120 cm
401863	10	2-8-2	CSLh	5 Fr x 120 cm
401864	10	2-8-2	CSL	5 Fr x 65 cm
401865	10	5-5-5	CSL	5 Fr x 120 cm
401871	4	2	CRD-1	5 Fr x 120 cm
401872	6	2-2-2	CRD-1	5 Fr x 120 cm
401876	6	5-5-5-175-175	CRD-1	6 Fr x 120 cm
401877	6	5-5-5-175-175	JSN	6 Fr x 120 cm
401878	6	5-5-5-175-175	JSN	5 Fr x 120 cm
401950	4	5	CRD	6 Fr x 120 cm
401951	4	5	JSN	6 Fr x 120 cm
401952	4	10	CRD	6 Fr x 120 cm
401956	2	10	CRD	6 Fr x 120 cm
401957	2	10	CRD	5 Fr x 120 cm
402004	4	5	CRD-2	6 Fr x 120 cm
402008	6	2-5-2	CRD-2	5 Fr x 120 cm
402009	6	5-5-5	CRD-2	5 Fr x 120 cm
402010	6	2-5-2	CRD-2	6 Fr x 120 cm
402011	6	5-5-5	CRD-2	6 Fr x 120 cm
Table 1b: K161272 List of Models in Scope
Response EP Catheters
Manufacturer Model No.	Electrodes	Spacing	Curve Size
401150	6	2-1-1-10-1-1-1-1-1-	CRD 6 Fr x 120 cm
401154	4	5	CRD 6 Fr x 120 cm
401155	4	5	JSN 6 Fr x 120 cm
401156	4	5	DAO-1 6 Fr x 120 cm
401158	4	10	CRD 6 Fr x 120 cm
401206	4	10	CRD 5 Fr x 120 cm
401207	4	10	JSN 5 Fr x 120 cm
401210	4	10	CRD 6 Fr x 120 cm
401211	4	10	JSN 6 Fr x 120 cm
401212	4	10	DAO 6 Fr x 120 cm
401222	4	5	CRD 5 Fr x 120 cm
401223	4	5	JSN 5 Fr x 120 cm
401226	4	5	CRD 6 Fr x 120 cm
401227	4	5	JSN 6 Fr x 120 cm
401228	4	5	DAO 6 Fr x 120 cm
401260	4	2-5-2	CRD 6 Fr x 120 cm
401261	4	2-5-2	JSN 6 Fr x 120 cm
401271	6	2-5-2	JSN 6 Fr x 120 cm
401275	6	2-2-2	CRD 6 Fr x 120 cm
401276	6	2-2-2	JSN 6 Fr x 120 cm
401278	6	2-2-2	CRD 6 Fr x 120 cm
401282	6	5-5-5	JSN 6 Fr x 120 cm
401305	10	2-5-2	CRD 6 Fr x 120 cm
401306	10	2-5-2	JSN 6 Fr x 65 cm
401308	10	2-5-2	CRD 6 Fr x 120 cm
401309	10	2-5-2	JSN 6 Fr x 120 cm
401310	10	2-5-2	DAO 6 Fr x 120 cm
401311	10	2-2-2	CRD 6 Fr x 120 cm
401312	10	2-2-2	JSN 6 Fr x 120 cm
401317	2	10	CRD 6 Fr x 120 cm
401318	2	10	JSN 6 Fr x 120 cm
401353	10	2-8-2	CSL 6 Fr x 120 cm
401356	4	5	CRD-1 6 Fr x 120 cm
401357	4	5	JSN-1 6 Fr x 120 cm
401360	6	2-5-2	JSN 5 Fr x 120 cm
401381	10	2-8-2	CSL 6 Fr x 120 cm
401386	6	5-5-5	CSL 6 Fr x 120 cm
401392	10	2-2-2	CSL 6 Fr x 120 cm
401399	10	5-5-5	CSL 6 Fr x 120 cm
401400	10	5-5-5	CSL 6 Fr x 120 cm
401425	6	5-5-5-150-5	CRD 6 Fr x 120 cm

Table 1a: K161272 List of Models in Scope

(List of models continued on next page)

3

Table 1b: K161272 List of Models in Scope

4

Indications for Use

510(k) Number (if known) K161272

Device Name

Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters

Indications for Use (Describe)

The Medline ReNewal Reprocessed Supreme and Response Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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 contains the logos for Medline and Renewal. The Medline logo is on the left and features the company name in a stylized font with a blue star-like symbol. To the right of the Medline logo is a vertical line, followed by the Renewal logo. The Renewal logo has the word "Renewal" in a combination of green and blue, with the words "Full Circle Reprocessing" underneath in a smaller font.

510(k) Summary — K161272

| Submitter/
Owner | Medline ReNewal
2747 SW 6th St.
Redmond, OR 97756 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Brandi Panteleon
Director, Quality Assurance and Regulatory Affairs
P: 541-923-3310
F: 541-923-3375
E: bpanteleon@medline.com |
| Prepared by | Stephanie Boyle Mays
Regulatory Affairs Specialist
P: 541-516-4205
F: 541-923-3375
E: smays@medline.com |
| Date Prepared | May 2, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Supreme and Response
Electrophysiology Catheters
Common Name: Diagnostic Electrophysiology Catheter, Reprocessed |
| Classification | Classification: Class II
Regulation Number: 21 CFR § 870.1220
Product Code: NLH |
| Predicate
Device | K002976 St. Jude Medical Response Electrophysiology Catheter, Supreme
Electrophysiology Catheter |
| Reference
Device | K151617 Medline ReNewal Reprocessed St. Jude Medical Livewire
Electrophysiology Catheters |
| Device
Description/
Intended Use | Medline ReNewal Reprocessed St. Jude Supreme and Response
Electrophysiology Catheters are commonly placed at the high right atrium,
right ventricular apex and His bundle, and in the coronary sinus, and are
used for electrogram recording and cardiac stimulation during diagnostic
electrophysiology studies.
The electrophysiology catheters are manufactured in various fixed curves
and electrode spacings for electrophysiological mapping for the evaluation
of a variety of cardiac arrhythmias from endocardial and intravascular
sites. 1 |
| Indications for
Use | The Medline ReNewal Reprocessed Supreme and Response
Electrophysiology Catheters can be used in the evaluation of a variety of
cardiac arrhythmias from endocardial and intravascular sites. |

l

Device Description and Intended Use were the same category in predicate K002976.

6

Image /page/6/Picture/0 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal Full Circle Reprocessing logo is on the right. The Medline logo is a blue stylized image of a medical symbol. The Renewal logo is in green and blue, and the Full Circle Reprocessing logo is in a smaller font below the Renewal logo.

| Technological
Characteristics | The technological characteristics of the proposed devices and the
fundamental scientific technology of the subject device are identical to the
predicate device. The proposed devices are a reprocessed version of the
predicate devices. Only Medline ReNewal reprocesses the Medline
ReNewal Reprocessed St. Jude Supreme and Response Electrophysiology
Catheters. Catheters are reprocessed a maximum of two times. Catheters
are marked and taken out of service after the maximum number of cycles is
reached. | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|---------|---------------|---------------|
| Performance
Testing | The functional characteristics of the subject device have been evaluated
and found to be substantially equivalent to the predicate device based on
the following tests:
Functional performance studies: simulated use and artificial soiling; bond strength (tensile testing); torsional strength; leakage current; catheter/handle joint flexibility and continuity (flex fatigue); electrode adherence; shaft flexibility; tip buckling; direct current resistance; impedance at 5 kHz; and corrosion resistance. Cleaning: protein, total organic carbon, and endotoxins; visual inspection under magnification; and cleaning performance qualification. Biocompatibility: cytotoxicity; sensitization; irritation; acute systemic toxicity; pyrogenicity; and hemocompatibility (hemolysis, thrombogenicity; & complement activation). Packaging and shelf life validation; sterilization validation: bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing. Product stability | | | | |
| | Model | Electrodes | Spacing | Curve | Size |
| | 401430 | 4 | 5 | JSN | 6 Fr x 120 cm |
| | 401433 | 4 | 10 | CRD | 5 Fr x 120 cm |
| | 401434 | 4 | 10 | CRD | 6 Fr x 120 cm |
| Device Models

Supreme | 401435 | 4 | 10 | JSN | 5 Fr x 120 cm |
| | 401436 | 4 | 10 | JSN | 6 Fr x 120 cm |
| | 401438 | 4 | 10 | DAO | 6 Fr x 120 cm |
| | 401441 | 4 | 5 | CRD | 5 Fr x 120 cm |
| | 401442 | 4 | 5 | CRD | 6 Fr x 120 cm |
| | 401443 | 4 | 5 | JSN | 5 Fr x 120 cm |
| Model | Electrodes | Spacing | Curve | Size | |
| 401444 | 4 | 5 | DAO | 5 Fr x 120 cm | |
| 401445 | 4 | 5 | DAO | 6 Fr x 120 cm | |
| 401448 | 4 | 2-5-2 | CRD | 5 Fr x 120 cm | |
| 401449 | 4 | 2-5-2 | CRD | 6 Fr x 120 cm | |
| 401450 | 4 | 2-5-2 | JSN | 5 Fr x 120 cm | |
| 401451 | 4 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401453 | 4 | 2-5-2 | DAO | 6 Fr x 120 cm | |
| 401466 | 4 | 5 | DAO-1 | 5 Fr x 120 cm | |
| 401468 | 4 | 2-5-2 | DAO-1 | 5 Fr x 120 cm | |
| 401474 | 4 | 5 | CRD-1 | 6 Fr x 120 cm | |
| 401475 | 4 | 5 | JSN-1 | 6 Fr x 120 cm | |
| 401859 | 4 | 10 | CRD-2 | 5 Fr x 120 cm | |
| 401860 | 4 | 5 | CRD-2 | 5 Fr x 120 cm | |
| 401863 | 10 | 2-8-2 | CSL | 5 Fr x 120 cm | |
| 401864 | 10 | 2-8-2 | CSL | 5 Fr x 65 cm | |
| 401865 | 10 | 5-5-5 | CSL | 5 Fr x 120 cm | |
| 401871 | 4 | 2 | CRD-1 | 5 Fr x 120 cm | |
| 401872 | 6 | 2-2-2 | CRD-1 | 5 Fr x 120 cm | |
| 401876 | 6 | 5-5-5-175-175 | CRD-1 | 6 Fr x 120 cm | |
| 401877 | 6 | 5-5-5-175-175 | JSN | 6 Fr x 120 cm | |
| 401878 | 6 | 5-5-5-175-175 | JSN | 5 Fr x 120 cm | |
| 401950 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401951 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401952 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| 401956 | 2 | 10 | CRD | 6 Fr x 120 cm | |
| 401957 | 2 | 10 | CRD | 5 Fr x 120 cm | |
| 402004 | 4 | 5 | CRD-2 | 6 Fr x 120 cm | |
| 402008 | 6 | 2-5-2 | CRD-2 | 5 Fr x 120 cm | |
| 402009 | 6 | 5-5-5 | CRD-2 | 5 Fr x 120 cm | |
| 402010 | 6 | 2-5-2 | CRD-2 | 6 Fr x 120 cm | |
| 402011 | 6 | 5-5-5 | CRD-2 | 6 Fr x 120 cm | |
| 401893 | 10 | 2-8-2 | CSL | 5 Fr x 65 cm | |
| Model | Electrodes | Spacing | Curve | Size | |
| 401150 | 10 | 2-1-1-10-1-1-
1-1-1- | CRD | 6 Fr x 120 cm | |
| 401154 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401155 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401156 | 4 | 5 | DAO-1 | 6 Fr x 120 cm | |
| 401158 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| 401206 | 4 | 10 | CRD | 5 Fr x 120 cm | |
| 401207 | 4 | 10 | JSN | 5 Fr x 120 cm | |
| 401210 | 4 | 10 | CRD | 6 Fr x 120 cm | |
| 401211 | 4 | 10 | JSN | 6 Fr x 120 cm | |
| 401212 | 4 | 10 | DAO | 6 Fr x 120 cm | |
| 401222 | 4 | 5 | CRD | 5 Fr x 120 cm | |
| 401223 | 4 | 5 | JSN | 5 Fr x 120 cm | |
| 401226 | 4 | 5 | CRD | 6 Fr x 120 cm | |
| 401227 | 4 | 5 | JSN | 6 Fr x 120 cm | |
| 401228 | 4 | 5 | DAO | 6 Fr x 120 cm | |
| 401260 | 4 | 2-5-2 | CRD | 6 Fr x 120 cm | |
| 401261 | 4 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401271 | 6 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401275 | 6 | 2-2-2 | CRD | 6 Fr x 120 cm | |
| 401276 | 6 | 2-2-2 | JSN | 6 Fr x 120 cm | |
| 401278 | 6 | 2-2-2 | CRD | 6 Fr x 65 cm | |
| 401282 | 6 | 5-5-5 | JSN | 6 Fr x 120 cm | |
| 401305 | 10 | 2-5-2 | CRD | 6 Fr x 120 cm | |
| 401306 | 10 | 2-5-2 | JSN | 6 Fr x 120 cm | |
| 401308 | 10 | 2-5-2 | CRD | 6 Fr x 65 cm | |
| 401309 | 10 | 2-5-2 | JSN | 6 Fr x 65 cm | |
| 401310 | 10 | 2-5-2 | DAO | 6 Fr x 65 cm | |
| 401311 | 10 | 2-2-2 | CRD | 6 Fr x 120 cm | |
| 401312 | 10 | 2-2-2 | JSN | 6 Fr x 120 cm | |
| 401317 | 2 | 10 | CRD | 6 Fr x 120 cm | |
| 401318 | 2 | 10 | JSN | 6 Fr x 120 cm | |
| 401353 | 10 | 2-8-2 | CSL | 6 Fr x 65 cm | |
| 401356 | 4 | 5 | CRD-1 | 6 Fr x 120 cm | |
| 401357 | 4 | 5 | JSN-1 | 6 Fr x 120 cm | |
| Response
(concluded) | Model | Electrodes | Spacing | Curve | Size |
| | 401360 | 6 | 2-5-2 | JSN | 5 Fr x 120 cm |
| | 401381 | 10 | 2-8-2 | CSL | 6 Fr x 120 cm |
| | 401386 | 6 | 5-5-5 | CSL | 6 Fr x 120 cm |
| | 401392 | 10 | 2-2-2 | CSL | 6 Fr x 120 cm |
| | 401399 | 10 | 5-5-5 | CSL | 6 Fr x 120 cm |
| | 401400 | 10 | 5-5-5 | CSL | 6 Fr x 65cm |
| 401425 | 6 | 5-5-5-150-5 | CRD | 6 Fr x 120 cm | |
| Based on comparisons of the indications for use, intended use,
technological characteristics, and performance data to the predicate
devices, Medline ReNewal Reprocessed St. Jude Medical Supreme and
Response Electrophysiology Catheters are substantially equivalent to the
predicate device. | | | | | |

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Image /page/7/Picture/0 description: The image contains the logos for Medline and Renewal. The Medline logo is on the left and features the company name in blue with a stylized blue symbol below it. 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 size.

Device Models

Supreme
(concluded)

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Image /page/8/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in large font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font. To the left of the word "Renewal" is the word "Medline" in blue with a blue star below it.

vice Models Response

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Image /page/9/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, with the words "Full Circle Reprocessing" in smaller letters below it.