(72 days)
Not Found
No
The summary describes a reprocessed electrophysiology catheter used for mapping the heart's electrical activity and providing location information when used with a navigation system. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical characteristics and function of the catheter itself.
No.
The device is indicated for electrophysiology mapping (recording or stimulation only) of the heart's cardiac structures, which is a diagnostic function, not a therapeutic one.
Yes
The device is indicated for "multiple electrode electrophysiology mapping of the cardiac structures of the heart" and recording electrograms, which are diagnostic activities.
No
The device description clearly describes a physical catheter with electrodes and a Nitinol loop design, indicating it is a hardware device. While it interacts with a software system (CARTO® EP Navigation Systems), the device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "electrophysiology mapping of the cardiac structures of the heart, i.e. recording or stimulation only." This is a procedure performed within the body (in vivo) to assess electrical activity.
- Device Description: The description details a catheter with electrodes designed to be inserted into the heart. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), such as blood, urine, or tissue. The device's function is directly related to interacting with the patient's internal anatomy.
Therefore, the Reprocessed 2515 NAV Variable EP Catheter is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
74 NLH
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%).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atria of the heart, cardiac structures of the heart, atrial regions of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
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.
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.
Not Found
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
§ 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).
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
- 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