Reprocessed Viking Diagnostic Electrophysiology Catheters
Device Facts
| Record ID | K162251 |
|---|---|
| Device Name | Reprocessed Viking Diagnostic Electrophysiology Catheters |
| Applicant | Innovative Health, LLC |
| Product Code | NLH · Cardiovascular |
| Decision Date | Dec 21, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1220 |
| Device Class | Class 2 |
Intended Use
The Reprocessed Viking Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Device Story
Reprocessed diagnostic electrophysiology (EP) catheters; used for temporary intracardiac sensing, recording, stimulation, and pacing during arrhythmia evaluation. Device consists of insulated polymer shaft with distal platinum electrodes; available in various fixed curves and electrode spacings. Operated by physicians in clinical settings. Reprocessing involves cleaning, decontamination, inspection, and functional testing; limited to one reprocessing cycle. Output provides electrical signals for cardiac mapping/evaluation; aids clinical decision-making regarding arrhythmia diagnosis and management. Benefits include clinical utility of diagnostic EP catheters while reducing medical waste through reprocessing.
Clinical Evidence
Bench testing only. Testing included biocompatibility, cleaning validation, sterilization validation, and functional testing (visual inspection, dimensional verification, electrical continuity/resistance, simulated use, mechanical characteristics, electrical safety/dielectric/leakage, and packaging validation).
Technological Characteristics
Insulated polymer shaft with platinum electrodes. Fixed curve designs. Reprocessed device; limited to one cycle. Sterilization validation performed. Electrical sensing/stimulation principle. No software or active electronic components.
Indications for Use
Indicated for patients undergoing evaluation of cardiac arrhythmias requiring temporary intracardiac sensing, recording, stimulation, and pacing.
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
- Viking Diagnostic Electrode Catheter (K971265)
Related Devices
- K161769 — Reprocessed Supreme Diagnostic Electrophysiology Catheters · Innovative Health, LLC · Dec 6, 2016
- K182488 — Reprocessed Response Diagnostic Electrophysiology Catheter · Innovative Health, LLC · Feb 22, 2019
- K161827 — Reprocessed Response Diagnostic Electrophysiology Catheters · Innovative Health, LLC · Dec 8, 2016
- K112232 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS · Stryker Sustainability Solutions · Sep 26, 2011
- K030279 — REPROCESSED ELECTROPHYSIOLOGY CATHETER · Alliance Medical Corp. · Oct 3, 2003
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Innovative Health, LLC. Rafal Chudzik VP, R&D and Operations 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257
Re: K162251
Trade/Device Name: Reprocessed Viking Diagnostic Electrophysiology Catheters (see list of models enclosed) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter, or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: November 16, 2016 Received: November 17, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 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.
Mark Jellison
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Page 3 - Rafal Chudzik
The item numbers included in the scope of this submission (K162251) are as follows:
| Description | Item<br>Number | Number of<br>Electrodes | Electrode<br>Spacing (mm) | Curve<br>Type | French<br>Size | Usable<br>Length<br>(cm) |
|-------------------------------|----------------|-------------------------|---------------------------|---------------|----------------|--------------------------|
| Viking Diagnostic EP Catheter | 400039 | 2 | 10 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400040 | 2 | 10 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400037 | 2 | 10 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400038 | 2 | 10 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400041 | 4 | 2 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400042 | 4 | 2 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400044 | 4 | 5 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400045 | 4 | 5 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400050 | 4 | 10 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400051 | 4 | 10 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400047 | 4 | 2,5,2 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400048 | 4 | 2,5,2 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400001 | 4 | 2 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400002 | 4 | 2 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400004 | 4 | 5 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400005 | 4 | 5 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400007 | 4 | 2,5,2 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400008 | 4 | 2,5,2 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400010 | 4 | 10 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400011 | 4 | 10 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400056 | 6 | 5 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400057 | 6 | 5 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400053 | 6 | 2 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400054 | 6 | 2 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400059 | 6 | 2,5,2 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400060 | 6 | 2,5,2 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400062 | 6 | 10 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400013 | 6 | 2 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400014 | 6 | 2 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400016 | 6 | 5 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400017 | 6 | 5 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400019 | 6 | 2,5,2 | Josephson | 6 | 115 |
| Viking Diagnostic EP Catheter | 400020 | 6 | 2,5,2 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400022 | 6 | 10 | Cournand | 6 | 115 |
| Viking Diagnostic EP Catheter | 400063 | 8 | 2 | Josephson | 5 | 115 |
| Viking Diagnostic EP Catheter | 400064 | 8 | 2 | Cournand | 5 | 115 |
| Viking Diagnostic EP Catheter | 400066 | 8 | 5 | Cournand | 5 | 115 |
| Description | Item<br>Number | Number of<br>Electrodes | Electrode<br>Spacing (mm) | Curve<br>Type | French<br>Size | Usable<br>Length<br>(cm) |
| | 400067 | 8 | 2,5,2 | Josephson | 5 | 115 |
| | 400068 | 8 | 2,5,2 | Cournand | 5 | 115 |
| | 400023 | 8 | 2 | Josephson | 6 | 115 |
| | 400024 | 8 | 2 | Cournand | 6 | 115 |
| | 400026 | 8 | 5 | Cournand | 6 | 115 |
| | 400027 | 8 | 2,5,2 | Josephson | 6 | 115 |
| | 400028 | 8 | 2,5,2 | Cournand | 6 | 115 |
| | 400070 | 10 | 2 | Josephson | 5 | 115 |
| | 400071 | 10 | 2 | Cournand | 5 | 115 |
| | 400072 | 10 | 5 | Cournand | 5 | 115 |
| | 400073 | 10 | 5 | Josephson | 5 | 115 |
| | 400074 | 10 | 2,5,2 | Josephson | 5 | 115 |
| | 400075 | 10 | 2,5,2 | Cournand | 5 | 115 |
| | 400104 | 10 | 5,5,5,20,5,5,5,5,5 | Josephson | 5 | 115 |
| | 400030 | 10 | 2 | Josephson | 6 | 115 |
| | 400031 | 10 | 2 | Cournand | 6 | 115 |
| | 400033 | 10 | 5 | Cournand | 6 | 115 |
| | 400034 | 10 | 2,5,2 | Josephson | 6 | 115 |
| | 400035 | 10 | 2,5,2 | Cournand | 6 | 115 |
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The item numbers included in the scope of this submission (K162251) are as follows:
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# Indications for Use
510(k) Number (if known) K162251
#### Device Name
Reprocessed Viking Diagnostic Electrophysiology Catheter
Indications for Use (Describe)
The Reprocessed Viking Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Research and/or Testing (R&D) Vehicle being driven</label> |
| <label><input type="checkbox"/> Other: Transportation of materials</label> |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 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:
Sharon Higgins Sr. Quality Engineer Innovative Health, LLC. (480) 525-5970 (office) (844) 965-9359 (fax) snhigqins@innovative-health.com
## Date prepared:
August 9, 2016
## Device Information:
Trade/Proprietary Name: Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Viking Diagnostic Electrophysiology Catheters Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II. 21 CFR 870.1220 NLH
## Predicate Device:
| 510(k) Number | Device | Manufacturer |
|---------------|--------------------------------------|-----------------|
| K971265 | Viking Diagnostic Electrode Catheter | C.R. Bard, Inc. |
## Device Description:
The Reprocessed Viking Diagnostic Electrophysiology Catheters are manufactured in various fixed curves and electrode spacing. The catheter has an insulated polymer shaft with platinum electrodes located along the distal section of the shaft.
#### Indications for Use:
The Reprocessed Viking Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
## Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Viking 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
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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 Viking Diagnostic EP Catheter. This included the following:
- Biocompatibility ●
- Cleaning Validation ●
- Sterilization Validation
- Functional Testing ●
- Visual Inspection ●
- Dimensional Verification ●
- Electrical Continuity and Resistance ●
- Simulated Use
- o Mechanical Characteristics
- Electrical Safety Testing
- . Dielectric and Current Leakage
- o Packaqing Validation
The Reprocessed Viking 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 Viking Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.
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| Description | Item<br>Number | Number of<br>Electrodes | Electrode<br>Spacing (mm) | Curve<br>Type | French<br>Size | Usable<br>Length<br>(cm) |
|-------------------------------|----------------|-------------------------|---------------------------|---------------|----------------|--------------------------|
| Viking Diagnostic EP Catheter | 400039 | 2 | 10 | Josephson | 5 | 115 |
| | 400040 | 2 | 10 | Cournand | 5 | 115 |
| | 400037 | 2 | 10 | Josephson | 6 | 115 |
| | 400038 | 2 | 10 | Cournand | 6 | 115 |
| | 400041 | 4 | 2 | Josephson | 5 | 115 |
| | 400042 | 4 | 2 | Cournand | 5 | 115 |
| | 400044 | 4 | 5 | Josephson | 5 | 115 |
| | 400045 | 4 | 5 | Cournand | 5 | 115 |
| | 400050 | 4 | 10 | Josephson | 5 | 115 |
| | 400051 | 4 | 10 | Cournand | 5 | 115 |
| | 400047 | 4 | 2,5,2 | Josephson | 5 | 115 |
| | 400048 | 4 | 2,5,2 | Cournand | 5 | 115 |
| | 400001 | 4 | 2 | Josephson | 6 | 115 |
| | 400002 | 4 | 2 | Cournand | 6 | 115 |
| | 400004 | 4 | 5 | Josephson | 6 | 115 |
| | 400005 | 4 | 5 | Cournand | 6 | 115 |
| | 400007 | 4 | 2,5,2 | Josephson | 6 | 115 |
| | 400008 | 4 | 2,5,2 | Cournand | 6 | 115 |
| | 400010 | 4 | 10 | Josephson | 6 | 115 |
| | 400011 | 4 | 10 | Cournand | 6 | 115 |
| | 400056 | 6 | 5 | Josephson | 5 | 115 |
| | 400057 | 6 | 5 | Cournand | 5 | 115 |
| | 400053 | 6 | 2 | Josephson | 5 | 115 |
| | 400054 | 6 | 2 | Cournand | 5 | 115 |
| | 400059 | 6 | 2,5,2 | Josephson | 5 | 115 |
| | 400060 | 6 | 2,5,2 | Cournand | 5 | 115 |
| | 400062 | 6 | 10 | Cournand | 5 | 115 |
| | 400013 | 6 | 2 | Josephson | 6 | 115 |
| | 400014 | 6 | 2 | Cournand | 6 | 115 |
| | 400016 | 6 | 5 | Josephson | 6 | 115 |
| | 400017 | 6 | 5 | Cournand | 6 | 115 |
| | 400019 | 6 | 2,5,2 | Josephson | 6 | 115 |
| | 400020 | 6 | 2,5,2 | Cournand | 6 | 115 |
| | 400022 | 6 | 10 | Cournand | 6 | 115 |
| | 400063 | 8 | 2 | Josephson | 5 | 115 |
| | 400064 | 8 | 2 | Cournand | 5 | 115 |
| | 400066 | 8 | 5 | Cournand | 5 | 115 |
| | 400067 | 8 | 2,5,2 | Josephson | 5 | 115 |
| Description | Item<br>Number | Number of<br>Electrodes | Electrode<br>Spacing (mm) | Curve<br>Type | French<br>Size | Usable<br>Length<br>(cm) |
| | 400068 | 8 | 2,5,2 | Cournand | 5 | 115 |
| | 400023 | 8 | 2 | Josephson | 6 | 115 |
| | 400024 | 8 | 2 | Cournand | 6 | 115 |
| | 400026 | 8 | 5 | Cournand | 6 | 115 |
| | 400027 | 8 | 2,5,2 | Josephson | 6 | 115 |
| | 400028 | 8 | 2,5,2 | Cournand | 6 | 115 |
| | 400070 | 10 | 2 | Josephson | 5 | 115 |
| | 400071 | 10 | 2 | Cournand | 5 | 115 |
| | 400072 | 10 | 5 | Cournand | 5 | 115 |
| | 400073 | 10 | 5 | Josephson | 5 | 115 |
| | 400074 | 10 | 2,5,2 | Josephson | 5 | 115 |
| | 400075 | 10 | 2,5,2 | Cournand | 5 | 115 |
| | 400104 | 10 | 5,5,5,20,5,5,5,5,5 | Josephson | 5 | 115 |
| | 400030 | 10 | 2 | Josephson | 6 | 115 |
| | 400031 | 10 | 2 | Cournand | 6 | 115 |
| | 400033 | 10 | 5 | Cournand | 6 | 115 |
| | 400034 | 10 | 2,5,2 | Josephson | 6 | 115 |
| | 400035 | 10 | 2,5,2 | Cournand | 6 | 115 |
The item numbers included in the scope of this submission are as follows:
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Table 5.1: Item Numbers
