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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Reprocessed Inquiry Steerable Diagnostic EP Catheter." The submission aims to increase the allowed reprocessing cycles for the device from one to three.

However, the document does not contain information about a study that compares the performance of the reprocessed device against specific acceptance criteria in terms of diagnostics or clinical outcomes, particularly involving AI/human reader studies, expert consensus, or specific diagnostic performance metrics like sensitivity, specificity, or AUC. The document focuses on showing substantial equivalence to predicate devices through bench and laboratory testing related to the reprocessing process itself, rather than diagnostic accuracy or effectiveness in clinical reading scenarios.

Therefore, many of the requested details about acceptance criteria, test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

The document outlines functional and safety testing performed for the reprocessed device to demonstrate its performance (safety and effectiveness) for three reprocessing cycles. However, it does not provide specific quantitative acceptance criteria or reported values for these tests in a table format. It lists categories of tests.

Acceptance Criteria (Categories):
- 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
Reported Device Performance:
The document states that "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." It concludes: "Innovative Health concludes that the Reprocessed Inquiry Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices described herein." However, no quantifiable results for these tests are presented.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the document. The testing described is bench and laboratory testing on the physical device, not a diagnostic study with a dataset of patient cases.
Data Provenance: Not applicable in the context of diagnostic data. The "data" here refers to results from physical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" here is established by the specifications and performance metrics of the device itself through engineering and laboratory testing, not by expert interpretation of diagnostic images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This applies to expert reading studies, not device functional testing.

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:

No, an MRMC study was NOT done. This document is for a medical device (catheter), not an AI diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was NOT done. This document is for a medical device (catheter), not an AI diagnostic software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Ground Truth Type: For the device's performance, the "ground truth" is defined by established engineering standards, material properties, electrical specifications, and functional benchmarks for the specific medical device (electrophysiology catheter). For example, electrical continuity is measured against a known standard of what constitutes an intact circuit, and sterilization validation against accepted sterility assurance levels.

8. The sample size for the training set:

Not applicable. This document describes a physical medical device, not a machine learning model. There is no "training set" in this context.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set or machine learning model.

In summary: The provided FDA 510(k) clearance letter and summary are for a reprocessed electrophysiology catheter. The "studies" mentioned are bench and laboratory tests to demonstrate the safety and effectiveness of the reprocessed device, particularly regarding the increase in allowed reprocessing cycles. The document does not pertain to an AI diagnostic device and therefore does not include the types of studies, acceptance criteria, or ground truth establishment methods typically associated with such systems (e.g., MRMC studies, expert consensus, AUC, sensitivity/specificity).

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:

ItemNumber	Number ofElectrodes	FrenchSize	ElectrodeSpacing (mm)	Curve	UsableLength (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)

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. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com

Date prepared:

November 4, 2020

Device Information:

Trade/Proprietary Name:	Reprocessed Inquiry Steerable DiagnosticElectrophysiology 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 SteerableDiagnostic EP Catheter	Innovative Health, LLC.
K982232	Modification of the IBI-1100 SteerableElectrophysiology Catheter System	Irvine Biomedical, Inc.
K961924	IBI-1100 Steerable ElectrophysiologyCatheter System	Irvine Biomedical, Inc.

Device Description:

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ItemNumber	Number ofElectrodes	FrenchSize	ElectrodeSpacing (mm)	Curve	UsableLength (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
ltemNumber	Number ofElectrodes	FrenchSize	ElectrodeSpacing (mm)	Curve	UsableLength (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:

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
ReprocessingCycles:	3	1	0	0
ReprocessingMethod:	Change to processingparameters and method.Shelf life change.	Cleared/validatedprocess	N/A	N/A
Sterilization:	Change to releasemethod. No change to thesterilization method orSAL.	Cleared/validatedprocess	N/A	N/A
RoutineMonitoring:	Change to frequency andadjustment 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.

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).