(99 days)
No
The summary describes a physical catheter used for diagnosis and does not mention any software or analytical components that would typically incorporate AI/ML.
No.
The device is described as a "diagnostic electrophysiology catheter" used for "evaluation of a variety of cardiac arrhythmias", indicating it is for diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used in the evaluation of a variety of cardiac arrhythmias." This phrasing indicates a diagnostic purpose.
No
The device description clearly states it is a physical catheter constructed of polyurethane and incorporating platinum electrodes, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." This describes a procedure performed within the body (in vivo) to diagnose conditions based on electrical signals, not on samples taken from the body (in vitro).
- Device Description: The description details a catheter with electrodes designed to be inserted into the body. This is consistent with an in vivo diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter 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
The Reprocessed Livewire Steerable Diagnostic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endocardial and intravascular sites (cardiac)
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Livewire Steerable Diagnostic EP Catheter. This included the following:
- Biocompatibility
- Cleaning Validation
- Sterilization Validation
- Functional Testing
- Visual Inspection
- Dimensional Verification
- Electrical Continuity and Resistance
- Simulated Use
- Mechanical Characteristics
- Electrical Safety Testing
- Dielectric and Current Leakage
- Packaging Validation
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 10, 2016
Innovative Health, LLC Rafal Chudzik Director of Engineering 1435 North Hayden Road. Suite 100 Scottsdale, Arizona 85257
Re: K160242
Trade/Device Name: Reprocessed Livewire Steerable Diagnostic EP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: April 5, 2016 Received: April 6, 2016
Dear Rafal Chudzik:
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 of medical devicerelated 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.
1
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,
FDA
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K160242
ITEM NUMBERS IN SCOPE
| Item
Number | Device | Electrodes | Spacing (mm) | Curve Type | French
Size | Usable
Length (cm) |
|----------------|-----------------------------|------------|---------------------------------------------------|------------------------|----------------|-----------------------|
| 401582 | Livewire Steerable Catheter | 10 | 2-5-2 | Med Sweep | 7F | 115 |
| 401932 | Livewire Steerable Catheter | 20 | 2-8-2-(60)-2-8-2 | Super Lrg Curl | 7F | 95 |
| 401918 | Livewire Steerable Catheter | 20 | 2-20-2-2-2-2-2-2-
2-2-2-2-2-25-2-25-
2-25-2 | Super Lrg Curl | 7F | 95 |
| 401580 | Livewire Steerable Catheter | 6 | 2-5-2 | Med Sweep | 7F | 115 |
| 401581 | Livewire Steerable Catheter | 8 | 2-5-2 | Med Sweep | 7F | 115 |
| 401938 | Livewire Steerable Catheter | 10 | 5-5-5 | Med Sweep | 5F | 115 |
| 401939 | Livewire Steerable Catheter | 10 | 2-2-2 | Med Sweep | 5F | 115 |
| 401940 | Livewire Steerable Catheter | 10 | 2-5-2 | Med Sweep | 5F | 115 |
| 401941 | Livewire Steerable Catheter | 10 | 2-8-2 | Extra Lrg Curl | 5F | 115 |
| 401990 | Livewire Steerable Catheter | 10 | 2-2-2 | Extra Lrg Curl | 5F | 115 |
| 401991 | Livewire Steerable Catheter | 10 | 2-5-2 | Extra Lrg Curl | 5F | 115 |
| 401575 | Livewire Steerable Catheter | 10 | 2-5-2 | Med Sweep | 6F | 115 |
| 401915 | Livewire Steerable Catheter | 10 | 2-5-2 | Extra Lrg Curl | 6F | 115 |
| 401923 | Livewire Steerable Catheter | 10 | 2-2-2 | Extra Lrg Curl | 6F | 115 |
| 401926 | Livewire Steerable Catheter | 10 | 2-8-2 | Extra Lrg
Sweep CSL | 6F | 115 |
| 401904 | Livewire Steerable Catheter | 20 | 2-10-2 | Super Lrg Curl | 7F | 95 |
| 401905 | Livewire Steerable Catheter | 20 | 5-5-5 | Super Lrg Curl | 7F | 95 |
| 401914 | Livewire Steerable Catheter | 20 | 2-5-2 | Super Lrg Curl | 7F | 95 |
| 401908 | Livewire Steerable Catheter | 20 | 2-2-2 | Med Curl | 7F | 115 |
| 401917 | Livewire Steerable Catheter | 8 | 2-2-2 | Med Sweep | 6F | 115 |
| 401949 | Livewire Steerable Catheter | 8 | 2-2-2 | Lrg Sweep | 6F | 115 |
| 401600 | Livewire Steerable Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401603 | Livewire Steerable Catheter | 4 | 2-5-2 | Med Curl | 6F | 115 |
| 401572 | Livewire Steerable Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401606 | Livewire Steerable Catheter | 4 | 2-5-2 | Lrg Sweep | 6F | 115 |
| 401933 | Livewire Steerable Catheter | 4 | 5-5-5 | Med Sweep | 6F | 115 |
| 401934 | Livewire Steerable Catheter | 4 | 5-5-5 | Lrg Sweep | 6F | 115 |
| 401576 | Livewire Steerable Catheter | 4 | 2-5-2 | Sml Sweep | 7F | 115 |
| 401577 | Livewire Steerable Catheter | 4 | 2-5-2 | Med Sweep | 7F | 115 |
| 401578 | Livewire Steerable Catheter | 4 | 2-5-2 | Lrg Sweep | 7F | 115 |
| 401586 | Livewire Steerable Catheter | 4 | 2-5-2 | Sml Curl | 7F | 115 |
| 401587 | Livewire Steerable Catheter | 4 | 2-5-2 | Med Curl | 7F | 115 |
| 401588 | Livewire Steerable Catheter | 4 | 2-5-2 | Lrg Curl | 7F | 115 |
3
Indications for Use
510(k) Number (if known) K160242
Device Name
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter
Indications for Use (Describe)
The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
| 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)
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4
SECTION 5: 510(k) SUMMARY
As required by 21 CFR 807.92(c)
Submitter's Name and Address:
Innovative Health, LLC. 1435 N. Hayden Road, Suite 100 Scottsdale, AZ 85257
Contact Name and Information:
Rafal Chudzik Director of Engineering (602) 326-7716 (cell) (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com
Date prepared:
January 28, 2016
Device Information:
| Trade/Proprietary Name: | Reprocessed Livewire Steerable Diagnostic
Electrophysiology Catheters |
|-------------------------|--------------------------------------------------------------------------|
| Common Name: | Diagnostic Electrophysiology Catheter |
| Classification Name: | Catheter, Recording, Electrode, Reprocessed |
| Classification Number: | Class II, 21 CFR 870.1220 |
| Product Code: | NLH |
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K102721 | Livewire Electrophysiology Catheter | St. Jude Medical |
| K022380 | Livewire Electrophysiology Catheter | St. Jude Medical |
Reference Device:
| 510(k) Number | 510(k) Title | Reprocessor |
|---|---|---|
| K052603 | Reprocessed Daig Livewire | |
| Electrophysiology Catheters | Alliance Medical Corp. |
Device Description:
The Reprocessed Livewire Steerable Diagnostic 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.
5
Indications for Use:
The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Livewire Steerable Diagnostic Electrophysiology (EP) Catheters are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of these devices includes removal of visible soil and decontamination. Each device is inspected and function tested prior to packaging and labeling.
Functional and Safety Testing:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Livewire Steerable Diagnostic EP Catheter. This included the following:
- Biocompatibility ●
- Cleaning Validation .
- Sterilization Validation ●
- Functional Testing ●
- . Visual Inspection
- Dimensional Verification .
- Electrical Continuity and Resistance .
- Simulated Use .
- Mechanical Characteristics
- Electrical Safety Testing
- . Dielectric and Current Leakage
- Packaging Validation ●
The Reprocessed Livewire Steerable Diagnostic EP Catheters are reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health. Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Conclusion:
Innovative Health concludes that the Reprocessed Livewire Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.