(175 days)
No
The summary describes a physical medical device (catheter) used for electrogram recording and stimulation, with no mention of AI or ML in its function, description, or performance studies.
No.
The device is described as diagnostic, used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheters are used for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies." The name "Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters" also includes the word "Diagnostic."
No
The device description clearly states it is a physical catheter constructed of thermoplastic elastomer material and noble metal electrodes, with a control mechanism in the handle. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used within the body for electrogram recording and cardiac stimulation. They are invasive devices used for direct physiological measurement and intervention, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies," which are procedures performed directly on the patient.
Therefore, this device falls under the category of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the hight right atrium, right ventricular apex, and HIS bundle.
Product codes (comma separated list FDA assigned to the subject device)
NLH
Device Description
The Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle 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
hight right atrium, right ventricular apex, and HIS bundle.
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 Inquiry 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/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 23, 2017
Innovative Health, LLC. Amy Stoklas-Oakes Director, Quality and Regulatory Affairs 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257
Re: K171277
Trade/Device Name: Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheter (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, 2017 Received: September 22, 2017
Dear Amy Stoklas-Oakes:
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 device-related 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
M.A. Wilhelm
for __________________________________________________________________________________________________________________________________________________________________________ Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| The following device models are included in the scope of this 510(k) submission: | ||
|---|---|---|
| ---------------------------------------------------------------------------------- | -- | -- |
| Item
Number | Number of
Electrodes | French
Size | Electrode
Spacing (mm) | Curve | Usable
Length (cm) |
|----------------|-------------------------|----------------|---------------------------|---------------|-----------------------|
| 81530 | 10 | 4F | 2 | Medium | 110 |
| 81531 | 10 | 4F | 2.5-2 | Medium | 110 |
| 81532 | 10 | 4F | 2.5-2 | Large | 110 |
| 81534 | 10 | 4F | 5 | Large | 110 |
| 81537 | 10 | 4F | 25 | M(SC)(60) | 60 |
| 81871 | 8 | 5F | 2 | Medium | 110 |
| 81872 | 8 | 5F | 2.5-2 | Medium | 110 |
| 81540 | 4 | 4F | 2.5-2 | Medium | 110 |
| 81542 | 4 | 4F | 5 | Medium | 110 |
| 81543 | 4 | 4F | 2.5-2 | Large | 110 |
| 81472 | 4 | 5F | 2.5-2 | Medium | 110 |
| 81473 | 4 | 5F | 5 | Medium | 110 |
| 81474 | 4 | 5F | 2.5-2 | Large | 110 |
| 81483 | 4 | 5F | 5 | E(HIS) | 110 |
| 81402 | 4 | 6F | 2.5-2 | Medium | 110 |
| 81403 | 4 | 6F | 5 | Medium | 110 |
| 81404 | 4 | 6F | 2.5-2 | Large | 110 |
| 81405 | 4 | 6F | 5 | Large | 110 |
| 81417 | 4 | 6F | 5 | X-Large | 110 |
| 81418 | 4 | 6F | 2.5-2 | X-Large | 110 |
| 81102 | 10 | 6F | 2.5-2 | Medium | 110 |
| 81104 | 10 | 6F | 2.5-2 | Large | 110 |
| 81105 | 10 | 6F | 2.5-2 | X-Large | 110 |
| 81107 | 10 | 6F | 5 | Large | 110 |
| 81520 | 10 | 6F | 2 | X-Large | 110 |
| 81524 | 10 | 6F | 2 | Large | 110 |
| 81945 | 10 | 6F | 2.5-2 | Large | 110 |
| 81947 | 10 | 6F | 5 | Medium/ Large | 110 |
| 81504 | 10 | 6F | 5 | Medium | 110 |
| 81801 | 8 | 6F | 2 | Medium | 110 |
| 81802 | 8 | 6F | 2.5-2 | Medium | 110 |
| 81807 | 8 | 6F | 2 | Large | 110 |
| 81809 | 8 | 6F | 2.5-2 | Large | 110 |
| 81516 | 8 | 6F | 2.5-2 | L1 | 110 |
| 81171 | 10 | 5F | 2 | Medium | 110 |
| 81172 | 10 | 5F | 2.5-2 | Medium | 110 |
| 81174 | 10 | 5F | 2.5-2 | Large | 110 |
| 81223 | 10 | 5F | 2.50-3 | X-Large | 110 |
| 81224 | 10 | 5F | 2.30-3 | Medium | 110 |
| 81202 | 20 | 7F | 2.10-2 | XX-Large | 110 |
| 81207 | 20 | 7F | 5 | Super Large | 110 |
| 81209 | 20 | 7F | 2.5-2 | Super Large | 110 |
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Indications for Use
510(k) Number (if known) K171277
Device Name
Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheter
Indications for Use (Describe)
The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the hight right atrium, right ventricular apex, and HIS bundle.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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:
Amy Stoklas-Oakes Innovative Health, LLC. Sr. Quality and Regulatory Manager (480) 525-5972 (office) (888) 965-7705 (fax) astoklas-oakes@innovative-health.com
Date prepared:
April 28, 2017
Device Information:
Trade/Proprietary Name:
Common Name: Classification Name: Classification Number: Product Code:
Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheter Diagnostic Electrophysiology Catheter Catheter, Recording, Electrode, Reprocessed Class II, 21 CFR 870.1220 NEH
Predicate Device:
| 510(k) Number | 510(k) Title | Manufacturer |
|---|---|---|
| K982232 | Modification of the IBI-1100 Steerable | |
| Electrophysiology Catheter System | Irvine Biomedical, Inc. | |
| K961924 | IBI-1100 Steerable Electrophysiology | |
| Catheter System | Irvine Biomedical, Inc. |
Reference Device:
| 510(k) Number | 510(k) Title | Reprocessor |
|---|---|---|
| K160496 | Inquiry H-Curve Steerable Diagnostic EP | |
| Catheter | Innovative Health, LLC. |
Device Description:
The Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.
5
| Description | Item
Number | Number of
Electrodes | French
Size | Electrode
Spacing
(mm) | Curve | Usable
Length
(cm) |
|---------------------------------------------------|----------------|-------------------------|----------------|------------------------------|---------------|--------------------------|
| Inquiry
Steerable
Diagnostic EP
Catheter | 81530 | 10 | 4F | 2 | Medium | 110 |
| | 81531 | 10 | 4F | 2-5-2 | Medium | 110 |
| | 81532 | 10 | 4F | 2-5-2 | Large | 110 |
| | 81534 | 10 | 4F | 5 | Large | 110 |
| | 81537 | 10 | 4F | 25 | M(SC)(60) | 60 |
| | 81871 | 8 | 5F | 2 | Medium | 110 |
| | 81872 | 8 | 5F | 2-5-2 | Medium | 110 |
| | 81540 | 4 | 4F | 2-5-2 | Medium | 110 |
| | 81542 | 4 | 4F | 5 | Medium | 110 |
| | 81543 | 4 | 4F | 2-5-2 | Large | 110 |
| | 81472 | 4 | 5F | 2-5-2 | Medium | 110 |
| | 81473 | 4 | 5F | 5 | Medium | 110 |
| | 81474 | 4 | 5F | 2-5-2 | Large | 110 |
| | 81483 | 4 | 5F | 5 | E(HIS) | 110 |
| | 81402 | 4 | 6F | 2-5-2 | Medium | 110 |
| | 81403 | 4 | 6F | 5 | Medium | 110 |
| | 81404 | 4 | 6F | 2-5-2 | Large | 110 |
| | 81405 | 4 | 6F | 5 | Large | 110 |
| | 81417 | 4 | 6F | 5 | X-Large | 110 |
| | 81418 | 4 | 6F | 2-5-2 | X-Large | 110 |
| | 81102 | 10 | 6F | 2-5-2 | Medium | 110 |
| | 81104 | 10 | 6F | 2-5-2 | Large | 110 |
| | 81105 | 10 | 6F | 2-5-2 | X-Large | 110 |
| | 81107 | 10 | 6F | 5 | Large | 110 |
| | 81520 | 10 | 6F | 2 | X-Large | 110 |
| | 81524 | 10 | 6F | 2 | Large | 110 |
| | 81945 | 10 | 6F | 2-5-2 | Large | 110 |
| | 81947 | 10 | 6F | 5 | Medium/ Large | 110 |
| | 81504 | 10 | 6F | 5 | Medium | 110 |
| | 81801 | 8 | 6F | 2 | Medium | 110 |
| | 81802 | 8 | 6F | 2-5-2 | Medium | 110 |
| | 81807 | 8 | 6F | 2 | Large | 110 |
| | 81809 | 8 | 6F | 2-5-2 | Large | 110 |
| | 81516 | 8 | 6F | 2-5-2 | L1 | 110 |
| | 81171 | 10 | 5F | 2 | Medium | 110 |
| | 81172 | 10 | 5F | 2-5-2 | Medium | 110 |
| | 81174 | 10 | 5F | 2-5-2 | Large | 110 |
| | 81223 | 10 | 5F | 2-50-3 | X-Large | 110 |
| | 81224 | 10 | 5F | 2-30-3 | Medium | 110 |
| | 81202 | 20 | 7F | 2-10-2 | XX-Large | 110 |
| | 81207 | 20 | 7F | 5 | Super Large | 110 |
| | 81209 | 20 | 7F | 2-5-2 | Super Large | 110 |
The item numbers included in the scope of this submission are as follows:
Table 5.1: Item Numbers in Scope
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Indications for Use:
The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.
Technological Characteristics:
The purpose, design, materials, function, and intended use of the Reprocessed Inquiry 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 Inquiry 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 Inquiry 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 Inquiry Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.