(27 days)
The St. Jude Medical (SJM) Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The SJM Livewire™ Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by remote means located at the proximal end of the catheter.
This device is a Livewire™ Electrophysiology Catheter. The submission indicates that there were "design modifications" to the predicate device, also a Livewire™ Electrophysiology Catheter (K022380 and K913940). The review focuses on these modifications.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product specification | Modified Livewire™ Electrophysiology Catheters design meets the product specification |
| Intended use | Modified Livewire™ Electrophysiology Catheters design meets the intended use |
| Safety | Design modifications do not adversely affect safety |
| Effectiveness | Design modifications do not adversely affect effectiveness |
2. Sample size used for the test set and the data provenance
The document explicitly states "Bench testing of the modified Livewire™ Electrophysiology Catheters was performed to verify the device modifications." It does not provide specific details on the sample size (e.g., number of catheters tested) or the provenance (e.g., country of origin, retrospective or prospective) of any data beyond the general mention of "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission describes physical bench testing of an electrophysiology catheter, not a study involving human data or expert review for ground truth establishment.
4. Adjudication method for the test set
Not applicable. The testing described is bench testing, not an assessment requiring adjudication by multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the substantial equivalence of device modifications through bench testing, not on comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrophysiology catheter, a physical medical device, not an algorithm or AI system. Therefore, a standalone performance study in the context of AI without human-in-the-loop performance is not relevant.
7. The type of ground truth used
For this device, the "ground truth" for the bench testing would be predefined engineering specifications, performance standards, and established safety/effectiveness parameters for electrophysiology catheters. The device's performance was compared against these established technical and regulatory standards.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device that would require a training set. The "training" in this context would refer to internal design and development processes rather than data used to train a model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of an AI/algorithm. The "ground truth" for the device's design and manufacturing would be based on established engineering principles, material science, regulatory standards (e.g., ISO, ASTM), and historical performance data of similar devices.
{0}------------------------------------------------
510(k) Summary As required by 21 CFR 807.92(c)
2019
510(k) Number: K(0 272)
Date Prepared:
September 20, 2010
Submitter Information:
Submitter's Name/ Address:
St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345-2126 Establishment Registration Number: 3005188751
Contact Person:
Nicole Bowden Sr. Regulatory Affairs Specialist Tel: 651-756-5162 Fax: 952-930-9481 nbowden(@sjm.com
Device Information:
Trade Name: Common Name: Classification Name: Class:
Livewire™ Electrophysiology Catheter Electrode Recording Catheter Electrode Recording Catheter Class II, 21 CFR 870.1220, Product Code DRF
Predicate Device:
Livewire™ Electrophysiology Catheter (K022380 and K913940)
Device Description:
The SJM Livewire™ Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by remote means located at the proximal end of the catheter.
Indications for Use:
The St. Jude Medical (SJM) Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Comparison to Predicate Devices:
The modified Livewire™ Electrophysiology Catheters have the same intended use and fundamental scientific technology as the predicate devices. All technological characteristics of the modified Livewire™ Electrophysiology Catheters are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Through performance
{1}------------------------------------------------
testing it was demonstrated that the design modifications do not adversely affect the safety and effectiveness.
Summary of Non-Clinical Testing:
Bench testing of the modified Livewire™ Electrophysiology Catheters was performed to verify the device modifications. Results of the testing demonstrate that the modified Livewire™ Electrophysiology Catheters design meets the product specification and intended use.
Statement of Equivalence:
The modified St. Jude Medical Livewire™ Electrophysiology Catheters have the same indications for use and technological characteristics as the predicate devices. Based on this and the data provided in the pre-market notification, St. Jude Medical's modified Livewire™ Electrophysiology Catheters have been shown to be substantially equivalent.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and uses a black and white color scheme.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 8 2010
St. Jude Medical c/o Nicole Bowden Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345
Re: K102721
Trade/Device Name: Livewire Electrophysiology Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe. Regulatory Class: Class II (two) Product Code: DRF Dated: September 20, 2010 Received: September 21, 2010
Dear Ms. Bowden:
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. Nicole Bowden
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/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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE
OCT 1 8 2010
14102724 510(K) Number (if known):
Device Name: Livewire™ Electrophysiology Catheter
Indications for Use:
The St. Jude Medical (SJM) Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number. K102721
Page 13 of 29
§ 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).