(160 days)
Not Found
No
The 510(k) summary describes a physical catheter with mechanical steering and electrical sensing capabilities. There is no mention of AI, ML, image processing, or any software-based analysis that would typically involve these technologies. The performance studies focus on the physical and electrical properties of the device.
No
The device is described as a "Steerable Diagnostic Electrophysiology Catheter" intended for "sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," which are diagnostic functions, not therapeutic. The performance studies also focus on safety and effectiveness for diagnostic use, such as electrical safety and functional testing.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias," which are diagnostic procedures. Furthermore, the device name itself includes "Diagnostic Electrophysiology Catheter."
No
The device description and performance studies clearly indicate a physical catheter with mechanical and electrical components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias." This describes a device used within the body for diagnostic and therapeutic purposes, not a device used to examine specimens outside the body (which is the definition of an IVD).
- Device Description: The description details a catheter designed to be inserted into the heart.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient's heart.
N/A
Intended Use / Indications for Use
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
Product codes
NLH
Device Description
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is a radiopaque, flexible, insulated catheter with a polymer shaft and a 2mm distal tip. The catheter handle has a slider mechanism which, when moved forward or back from the neutral position, results in curvature of the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Orbiter ST 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2016
Innovative Health, LLC. Rafal Chudzik VP Of Engineering and Operations 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257
Re: K161393
Trade/Device Name: Reprocessed Orbiter ST Steerable Diagnostic EP Catheters (see Enclosed Model List) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: September 21, 2016 Received: September 23, 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 yours.
Minde Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Description | Item
Number | French
Size | Number of
Electrodes | Electrode Spacing (mm) | Curve | Usable Length
(cm) |
|------------------------------------------------------|----------------|----------------|-------------------------|------------------------------------------------|--------|-----------------------|
| Orbiter ST
Steerable
Diagnostic EP
Catheter | 320003 | 7 | 10 | 2,5,2 | D Type | 95 |
| | 320001 | 7 | 20 | 2,14,2 | Large | 95 |
| | 320002 | 7 | 20 | 2, 10, 2 | Small | 95 |
| | 320004 | 7 | 20 | 2,2,2 | Small | 95 |
| | 320005 | 7 | 20 | 5,5,5 | Small | 95 |
| | 320006 | 7 | 20 | 2,7,2 | Small | 95 |
| | 320007 | 7 | 20 | 2,5,2 | Small | 95 |
| | 320008 | 7 | 20 | 2,20,2,2,2,2,2,2,2,2,2,2,2,2,
5,2,25,2,25,2 | Small | 95 |
| | 320009 | 7 | 20 | 1,3,1 | D Type | 95 |
| | 320010 | 7 | 20 | 2,8,2,8,2,8,2,8,2,60,
2,8,2,8,2,8,2,8,2 | Small | 95 |
Table 1: K161393 List of Models in Scope
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Indications for Use
510(k) Number (if known) K161393
Device Name
Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheters
Indications for Use (Describe)
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is 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)
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:
Rafal Chudzik VP, R&D and Operations (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com
Date prepared:
May18, 2016
Device Information:
| Trade/Proprietary Name: | Reprocessed Orbiter ST 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 |
|---|---|---|
| K992373 | Orbiter ST Diagnostic Electrode Catheter | |
| and Orbiter ST Extension Cable | C.R. Bard, Inc. |
Device Description:
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is a radiopaque, flexible, insulated catheter with a polymer shaft and a 2mm distal tip. The catheter handle has a slider mechanism which, when moved forward or back from the neutral position, results in curvature of the distal tip.
| Description | Item
Number | French
Size | Number of
Electrodes | Electrode Spacing (mm) | Curve | Usable Length
(cm) |
|------------------------------------------------------|----------------|----------------|-------------------------|-------------------------------------------------|--------|-----------------------|
| Orbiter ST
Steerable
Diagnostic EP
Catheter | 320003 | 7 | 10 | 2,5,2 | D Type | 95 |
| | 320001 | 7 | 20 | 2,14,2 | Large | 95 |
| | 320002 | 7 | 20 | 2, 10, 2 | Small | 95 |
| | 320004 | 7 | 20 | 2,2,2 | Small | 95 |
| | 320005 | 7 | 20 | 5,5,5 | Small | 95 |
| | 320006 | 7 | 20 | 2,7,2 | Small | 95 |
| | 320007 | 7 | 20 | 2,5,2 | Small | 95 |
| | 320008 | 7 | 20 | 2,20,2,2,2,2,2,2,2,2,2,2,2,2,2
5,2,25,2,25,2 | Small | 95 |
| | 320009 | 7 | 20 | 1,3,1 | D Type | 95 |
| | 320010 | 7 | 20 | 2,8,2,8,2,8,2,60,
2,8,2,8,2,8,2,8,2 | Small | 95 |
The item numbers included in the scope of this submission are as follows:
Table 5.1: Device Scope
5
Indications for Use:
The Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheter is 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 Orbiter ST 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 Orbiter ST 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 Orbiter ST 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 Orbiter ST Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.