Who is the manufacturer of REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?

Stryker Sustainability Solutions filed the 510(k) submission for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER (K112292).

What is the FDA product code for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?

NLH. It is classified under 21 CFR 870.1220 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?

Lasso™ 2515 NAV Variable Catheter, D-1290-01 & D-1290-02 (K081258); Reprocessed Electrophysiology Catheters (K082023); Lasso™ 2515 Variable Circular Mapping Catheter (K031161).

Who can help prepare an FDA 510(k) submission like REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER

K112292 · Stryker Sustainability Solutions · NLH · Oct 21, 2011 · Cardiovascular

Device Facts

Record ID	K112292
Device Name	REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
Applicant	Stryker Sustainability Solutions
Product Code	NLH · Cardiovascular
Decision Date	Oct 21, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1220
Device Class	Class 2

Intended Use

The Reprocessed 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV Variable EP Catheter provides location information when used with compatible CARTO® EP Navigation Systems version 1.0 or higher.

Device Story

Device is a reprocessed electrophysiology (EP) catheter featuring platinum electrodes on a distal Nitinol loop; loop expands/contracts to fit veins (15-25mm diameter). Used for atrial mapping, stimulation, and recording. Operates in conjunction with CARTO® 3 EP Navigation System (v1.0+) to provide location information. Used by physicians in clinical settings. Reprocessing involves cleaning, decontamination, and functional testing to ensure performance equivalent to original device. Output consists of electrograms and location data used by clinicians to guide cardiac mapping and clinical decision-making.

Clinical Evidence

No clinical data. Bench and laboratory testing performed, including biocompatibility validation, sterilization validation, and functional testing. Performance testing demonstrated that the reprocessed catheter performs as originally intended.

Technological Characteristics

Platinum electrodes; Nitinol loop design; dimensions accommodate 15-25mm veins. Connectivity via CARTO® EP Navigation System. Reprocessing includes cleaning, decontamination, and functional testing. No changes to original materials or mechanical design.

Indications for Use

Indicated for patients requiring electrophysiology mapping of cardiac structures, specifically for recording or stimulation in the atrial regions of the heart.

Regulatory Classification

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.

Predicate Devices

Lasso™ 2515 NAV Variable Catheter, D-1290-01 & D-1290-02 (K081258)
Reprocessed Electrophysiology Catheters (K082023)
Lasso™ 2515 Variable Circular Mapping Catheter (K031161)

Related Devices

K153153 — Reprocessed Electrophysiology Catheter · Innovative Health, LLC · Mar 14, 2016
K191170 — Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter · Innovative Health, LLC · Oct 30, 2019
K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter · Sterilmed, Inc. · Jun 23, 2016
K171503 — Reprocessed CristaCath Diagnostic Electrophysiology Catheter · Innovative Health, LLC · Oct 5, 2017
K211662 — Reprocessed IntellaMap Orion High Resolution Mapping Catheter · Innovative Health, LLC · Nov 18, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ K//2292 OCT 2 1 2011 ## SECTION 5: 510(k) SUMMARY | Submitter: | Stryker Sustainability Solutions 10232 South 51st Street Phoenix, Arizona 85044 | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Contact: | Ramona Kulik Regulatory Affairs Engineer (480) 763-5300 (o) (480) 763-2952 (f) Ramona.kulik@stryker.com | | | Date of preparation: | August 9, 2011 | | | Name of device: | Trade/Proprietary Name: Reprocessed 2515 NAV Variable Electrophysiology Catheter Classification Name: Electrode recording catheter or electrode recording probe | | | Predicate Device K081258 | 510(k) Title Lasso™ 2515 NAV Variable Catheter, D-1290-01 & D-1290-02 | Manufacturer Biosense Webster, Inc. | | K082023 | Reprocessed Electrophysiology Catheters | Ascent Healthcare Solutions | | K031161 | Lasso™ 2515 Variable Circular Mapping Catheter | Biosense Webster, Inc. | | Device description: | The Reprocessed 2515 NAV Variable Electrophysiology (EP) Catheter is specially designed for electrophysiological mapping of the atria of the heart when used with the CARTO® 3 EP Navigation System and a reference device. The 2515 NAV Variable EP Catheter has platinum electrodes positioned on the distal end that can be used for stimulation and recording. The Nitinol loop design allows for the expansion and contraction of the loop to fit veins ranging from 25mm to 15mm diameter (±15%). | | | Indications for Use: | The Reprocessed 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV Variable EP Catheter provides location information when used with compatible CARTO® EP Navigation Systems version 1.0 or higher. | | | Technological characteristics: | The design, materials, and intended use of Reprocessed 2515 NAV Variable EP Catheter is identical to the predicate devices. The mechanism of action of Reprocessed 2515 NAV Variable EP Catheter is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of 2515 NAV Variable EP Catheter includes removal of adherent visible soil and decontamination. Each individual 2515 NAV Variable EP Catheter is tested for appropriate function of its components prior to packaging and labeling operations. | | | Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 2515 NAV Variable EP Catheter. This included the following tests: Biocompatibility Validation of reprocessing Sterilization Validation Function test(s) Packaging Validation Performance testing demonstrates that Reprocessed 2515 NAV Variable Electrophysiology Catheter perform as originally. intended. | | | Conclusion: | Stryker Sustainability Solutions concludes that the modified devices (Reprocessed 2515 NAV Variable Electrophysiology Catheter) are safe, effective, and substantially equivalent to the | | Stryker Sustainability Solutions Reprocessed 2515 NAV Variable EP Catheter Traditional 510(k) {1}------------------------------------------------ predicate devices as described herein. Stryker Sustainability Solutions Reprocessed 2515 NAV Variable EP Catheter Traditional 510(k) {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 2 1 2011 Stryker Sustainability Solutions c/o Ms. Ramona Kulik Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix. AZ 85044 Re: K112292 > Trade/Device Name: Reprocessed 2515 NAV Variable Electrophysiology Catheter (See Enclosed List of Models) Regulatory Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: 74 NLH Dated: August 3, 2011 Received: August 4, 2011 Dear Ms. Kulik: 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. 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. {3}------------------------------------------------ Page 2 - Ms. Ramona Kulik 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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours 2. Brian D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## SECTION 4: INDICATIONS FOR USE STATEMENT 510(k) Number (if known): //2292 Device Name: Reprocessed 2515 NAV Variable Electrophysiology Catheter Indications For Use: The Reprocessed 2515 NAV Variable EP Catheter are indicated for multiple electrode electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Reprocessed 2515 NAV Variable EP Catheter are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV Variable EP Catheter provides location information when used with compatible CARTO® EP Navigation Systems version 1.0 or higher. Prescription Use AND/OR × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Division Sign-Off) Division of Cigh Oil) Division of Cardiovascular Devices 510(k) Number K112292 Stryker Sustainability Solutions Reprocessed 2515 NAV Variable EP Catheter Traditional 510(k) Press 49