Reprocessed Inquiry Steerable Diagnostic EP Catheter

• K Number: K203261
• Device Name: Reprocessed Inquiry Steerable Diagnostic EP Catheter
• Manufacturer: Innovative Health, LLC.
• Date Cleared: 2021-03-05 ( 120 days)
• Product Code: DRF
• Regulation Number: 870.1220

Intended 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 atrium, right ventricular apex, and HIS bundle.

Device Description

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology 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 of the proximal end of the catheter.

Predicate Devices

K171277, K982232, K961924

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reprocessed physical catheter used for electrogram recording and cardiac stimulation, with no mention of AI or ML in its function or description.

Therapeutic

No
The device is described as "Diagnostic Electrophysiology Catheters" used for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies," indicating its purpose is for diagnosis rather than treatment.

Diagnostic

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," directly indicating a diagnostic purpose. The device name itself also contains "Diagnostic."

SaMD (Software as a Medical Device)

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.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "electrogram recording and cardiac stimulation during diagnostic electrophysiology studies." This involves directly interacting with the patient's body (in vivo) to measure electrical activity and stimulate the heart.
• Device Description: The description details a physical catheter designed to be inserted into the body.
• Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.

The device is a medical device used for diagnostic procedures performed within the patient's body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 atrium, right ventricular apex, and HIS bundle.

Product codes

DRF, NHL

Device Description

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology 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 of 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 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 for three (3) reprocessing cycles. 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.

K171277, K982232, K961924

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

Regulation Number and Section

§ 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).

Summary

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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 5, 2021

Innovative Health, LLC. Amanda Babcock Regulatory Affairs Manager 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257

Re: K203261

Trade/Device Name: Reprocessed Inquiry Steerable Diagnostic EP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF. NHL Dated: February 5, 2021 Received: February 8, 2021

Dear Amanda Babcock:

(NOTE: Reprocessed SUD device types require a separate attachment of the list of all models cleared in the submission. A corrected SE letter will be required if the attachment is omitted.)

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.

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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 and Part 809); 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Paulsen Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality 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) K203261

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 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)

| 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:

Amanda Babcock Regulatory Affairs Manager Innovative Health, LLC. [phone] (office) [phone] (fax) [e-mail]

Date prepared:

November 4, 2020

Device Information:

| Trade/Proprietary Name: | Reprocessed Inquiry 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
K171277	Reprocessed Inquiry Steerable
Diagnostic EP Catheter	Innovative Health, LLC.
K982232	Modification of the IBI-1100 Steerable
Electrophysiology Catheter System	Irvine Biomedical, Inc.
K961924	IBI-1100 Steerable Electrophysiology
Catheter System	Irvine Biomedical, Inc.

Device Description:

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology 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 of the proximal end of the catheter.

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| 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 |
| ltem
Number | Number of
Electrodes | French
Size | Electrode
Spacing (mm) | Curve | Usable
Length (cm) |
| 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:

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Table 1: Item Numbers in Scope

This 510(k) increases the Reprocessing Cycles for the devices cleared under K171277 from one (1) to three (3).

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 for three (3) reprocessing cycles. 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 three (3) times. 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.

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Predicate Comparison:

A comparison of the device and reprocessing methods with the predicates are provided in the table below:

	K203261	K171277	K982232	K961924
Device:	Identical	Identical	Identical	Identical
Reprocessing
Cycles:	3	1	0	0
Reprocessing
Method:	Change to processing
parameters and method.
Shelf life change.	Cleared/validated
process	N/A	N/A
Sterilization:	Change to release
method. No change to the
sterilization method or
SAL.	Cleared/validated
process	N/A	N/A
Routine
Monitoring:	Change to frequency and
adjustment of limits.	Cleared process	N/A	N/A

Conclusion:

Innovative Health concludes that the Reprocessed Inquiry Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein.