(207 days)
Not Found
No
The summary describes a physical catheter and its reprocessing, with no mention of software, algorithms, or AI/ML terms. The performance studies focus on physical and electrical properties, not algorithmic performance.
No
The device is used for diagnostic purposes (evaluating cardiac arrhythmias), not for treating or curing a condition.
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 indicates a diagnostic purpose. Additionally, the device name itself includes "Diagnostic Electrophysiology Catheter."
No
The device description clearly states it is a physical catheter constructed of polyurethane and incorporating platinum electrodes, which are hardware components. The performance studies also focus on physical and electrical characteristics of the hardware.
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 a condition.
- Device Description: The description details a catheter with electrodes designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a diagnostic tool used directly within the patient's cardiovascular system.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 23, 2019
Innovative Health, LLC. Amanda Babcock Principal Regulatory Affairs Specialist 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K190127
Trade/Device Name: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: July 23, 2019 Received: July 24, 2019
Dear Amanda Babcock:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
The following device models are included in the scope of this 510(k) submission: | |||
---|---|---|---|
| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French
Size | Usable
Length
(cm) |
|-------------|----------------------------------------------|------------|---------------------------------------------------|------------------------|----------------|--------------------------|
| 401582 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 7F | 115 |
| 401932 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-8-2-(60)-2-8-2 | Super Lrg Curl | 7F | 95 |
| 401918 | Livewire Steerable
Diagnostic EP 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
Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep | 7F | 115 |
| 401581 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-5-2 | Med Sweep | 7F | 115 |
| 401938 | Livewire Steerable
Diagnostic EP Catheter | 10 | 5-5-5 | Med Sweep | 5F | 115 |
| 401939 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-2-2 | Med Sweep | 5F | 115 |
| 401940 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 5F | 115 |
| 401941 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Curl | 5F | 115 |
| 401990 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 5F | 115 |
| 401991 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 5F | 115 |
| 401575 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 6F | 115 |
| 401915 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 6F | 115 |
| 401923 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 6F | 115 |
| 401926 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Sweep
CSL | 6F | 115 |
| 401904 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-10-2 | Super Lrg Curl | 7F | 95 |
| 401905 | Livewire Steerable
Diagnostic EP Catheter | 20 | 5-5-5 | Super Lrg Curl | 7F | 95 |
| 401914 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-5-2 | Super Lrg Curl | 7F | 95 |
| 401908 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-2-2 | Med Curl | 7F | 115 |
| 401917 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep | 6F | 115 |
| 401949 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-2-2 | Lrg Sweep | 6F | 115 |
| 401600 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401603 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 6F | 115 |
| 401572 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401606 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 6F | 115 |
| 401933 | Livewire Steerable
Diagnostic EP Catheter | 4 | 5-5-5 | Med Sweep | 6F | 115 |
| | | | | | | |
| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French
Size | Usable
Length
(cm) |
| 401934 | Livewire Steerable
Diagnostic EP Catheter | 4 | 5-5-5 | Lrg Sweep | 6F | 115 |
| 401576 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Sml Sweep | 7F | 115 |
| 401577 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 7F | 115 |
| 401578 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 7F | 115 |
| 401586 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Sml Curl | 7F | 115 |
| 401587 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 7F | 115 |
| 401588 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Curl | 7F | 115 |
| 401652 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep
CRD-2 | 5F | 115 |
| 401653 | Livewire Steerable
Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep
CRD2 | 5F | 115 |
| 401654 | Livewire Steerable
Diagnostic EP Catheter | 6 | 5 | Med Sweep
CRD-2 | 5F | 115 |
(Continued on the following page)
3
The following device models are included in the scope of this 510(k) submission (continued):
4
Indications for Use
510(k) Number (if known) K190127
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5
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:
Amanda Babcock Requlatory Affairs Manager Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com
Date prepared:
January 25, 2019
Device Information:
Trade/Proprietary Name:
Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NLH
Predicate Device:
510(k) Number | 510(k) Device | Manufacturer |
---|---|---|
K160242 | Reprocessed Livewire Steerable | |
Diagnostic EP Catheter | Innovative Health, LLC. | |
K151622 | Livewire Electrophysiology Catheter | St. Jude Medical |
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.
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.
6
| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French
Size | Usable
Length
(cm) |
|-------------|----------------------------------------------|------------|-------------------------------------------------|------------------------|----------------|--------------------------|
| 401582 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 7F | 115 |
| 401932 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-8-2-(60)-2-8-2 | Super Lrg Curl | 7F | 95 |
| 401918 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-20-2-2-2-2-2-
2-2-2-2-2-25-
2-25-2-25-2 | Super Lrg Curl | 7F | 95 |
| 401580 | Livewire Steerable
Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep | 7F | 115 |
| 401581 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-5-2 | Med Sweep | 7F | 115 |
| 401938 | Livewire Steerable
Diagnostic EP Catheter | 10 | 5-5-5 | Med Sweep | 5F | 115 |
| 401939 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-2-2 | Med Sweep | 5F | 115 |
| 401940 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 5F | 115 |
| 401941 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Curl | 5F | 115 |
| 401990 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 5F | 115 |
| 401991 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 5F | 115 |
| 401575 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Med Sweep | 6F | 115 |
| 401915 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-5-2 | Extra Lrg Curl | 6F | 115 |
| 401923 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-2-2 | Extra Lrg Curl | 6F | 115 |
| 401926 | Livewire Steerable
Diagnostic EP Catheter | 10 | 2-8-2 | Extra Lrg Sweep
CSL | 6F | 115 |
| 401904 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-10-2 | Super Lrg Curl | 7F | 95 |
| 401905 | Livewire Steerable
Diagnostic EP Catheter | 20 | 5-5-5 | Super Lrg Curl | 7F | 95 |
| 401914 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-5-2 | Super Lrg Curl | 7F | 95 |
| 401908 | Livewire Steerable
Diagnostic EP Catheter | 20 | 2-2-2 | Med Curl | 7F | 115 |
| 401917 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep | 6F | 115 |
| 401949 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-2-2 | Lrg Sweep | 6F | 115 |
| 401600 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401603 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 6F | 115 |
| 401572 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 6F | 115 |
| 401606 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 6F | 115 |
| 401933 | Livewire Steerable
Diagnostic EP Catheter | 4 | 5-5-5 | Med Sweep | 6F | 115 |
| Item Number | Device Description | Electrodes | Spacing (mm) | Curve Type | French
Size | Usable
Length
(cm) |
| 401934 | Livewire Steerable
Diagnostic EP Catheter | 4 | 5-5-5 | Lrg Sweep | 6F | 115 |
| 401576 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Sml Sweep | 7F | 115 |
| 401577 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Sweep | 7F | 115 |
| 401578 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Sweep | 7F | 115 |
| 401586 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Sml Curl | 7F | 115 |
| 401587 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Med Curl | 7F | 115 |
| 401588 | Livewire Steerable
Diagnostic EP Catheter | 4 | 2-5-2 | Lrg Curl | 7F | 115 |
| 401652 | Livewire Steerable
Diagnostic EP Catheter | 8 | 2-2-2 | Med Sweep
CRD-2 | 5F | 115 |
| 401653 | Livewire Steerable
Diagnostic EP Catheter | 6 | 2-5-2 | Med Sweep
CRD2 | 5F | 115 |
| 401654 | Livewire Steerable
Diagnostic EP Catheter | 6 | 5 | Med Sweep
CRD-2 | 5F | 115 |
The item numbers in scope of this submission are as follows:
7
Table 5.1: Device Scope
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
8
The Reprocessed Livewire Steerable Diagnostic EP Catheters are reprocessed no more than three (3) times. Each device is marked, serialized 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.