(133 days)
The Reprocessed Viking Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
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.
This document is a 510(k) premarket notification for Reprocessed Viking Diagnostic Electrophysiology Catheters (K162251) by Innovative Health, LLC. It focuses on demonstrating substantial equivalence to a predicate device, not on the performance of a novel AI/ML algorithm. Therefore, many of the requested details related to AI/ML device studies are not applicable to this submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this reprocessed device are based on demonstrating that it performs as safely and effectively as the original, legally marketed predicate device. The study performed is a series of bench and laboratory tests to ensure the reprocessed device meets the original design specifications and safety standards.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | (Not explicitly detailed in this summary) | Meets established biocompatibility standards. |
| Cleaning Validation | (Not explicitly detailed in this summary) | Demonstrates effective removal of visible soil and decontamination. |
| Sterilization Validation | (Not explicitly detailed in this summary) | Demonstrates effective sterilization. |
| Functional Testing | - Visual Inspection - Dimensional Verification - Electrical Continuity and Resistance - Simulated Use - Mechanical Characteristics | Meets original device specifications and performance. |
| Electrical Safety Testing | - Dielectric and Current Leakage | Meets electrical safety standards. |
| Packaging Validation | (Not explicitly detailed in this summary) | Demonstrates maintenance of sterility and integrity until use. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample size for each test conducted. It states that "Bench and laboratory testing was conducted."
- Data Provenance: The tests were conducted internally by Innovative Health, LLC, as part of their reprocessing validation. This is a prospective testing environment to validate their reprocessing procedures. There is no indication of country of origin for data; it's assumed to be within the US where Innovative Health operates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the submission is for a reprocessed medical device, not an AI/ML device requiring expert ground truth for image interpretation or similar tasks. The "ground truth" for this device lies in its physical, electrical, and functional properties meeting specifications.
4. Adjudication method for the test set
Not applicable. The testing described involves objective measurements and validation against established standards for medical devices, rather than subjective expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's safety and effectiveness is based on:
- Established medical device standards (e.g., for biocompatibility, sterility, electrical safety).
- The original design specifications and performance characteristics of the predicate device (C.R. Bard, Inc. Viking Diagnostic Electrode Catheter K971265).
- Objective measurements obtained from functional, dimensional, and electrical testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore no "training set" in the context of machine learning was used.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm in this submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a sense of community and care.
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
{1}------------------------------------------------
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 | ItemNumber | Number ofElectrodes | ElectrodeSpacing (mm) | CurveType | FrenchSize | UsableLength(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 | ItemNumber | Number ofElectrodes | ElectrodeSpacing (mm) | CurveType | FrenchSize | UsableLength(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) |
|---|
| Research and/or Testing (R&D) Vehicle being driven |
| Other: Transportation of materials |
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 | ItemNumber | Number ofElectrodes | ElectrodeSpacing (mm) | CurveType | FrenchSize | UsableLength(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 | ItemNumber | Number ofElectrodes | ElectrodeSpacing (mm) | CurveType | FrenchSize | UsableLength(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
§ 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).