The Reprocessed Torqr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Device Description

The Reprocessed Torqr Diagnostic EP Catheter is a flexible, radiopaque catheter constructed of extruded polyurethane over stainless steel braid and platinum electrodes. The catheter is of high torque construction to aid in precise catheter placement.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Torqr Diagnostic EP Catheter, formatted to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly list acceptance criteria in a quantitative, pass/fail manner with specific numerical targets. Instead, it details the types of functional and safety testing performed to demonstrate that the reprocessed catheter is "as safe and effective as the predicate devices." The "reported device performance" is described qualitatively as having successfully undergone these tests.

Acceptance Criteria Category (Implied)	Reported Device Performance
Biocompatibility	Tested and validated (successful)
Cleaning Validation	Tested and validated (successful)
Sterilization Validation	Tested and validated (successful)
Functional Testing:
* Visual Inspection	Tested and validated (successful)
* Dimensional Verification	Tested and validated (successful)
* Electrical Continuity and Resistance	Tested and validated (successful)
* Simulated Use	Tested and validated (successful)
* Mechanical Characteristics	Tested and validated (successful)
Electrical Safety Testing:
* Dielectric and Current Leakage	Tested and validated (successful)
Packaging Validation	Tested and validated (successful)
Reprocessing Cycle Limit	Reprocessed no more than one (1) time; devices rejected after maximum cycles.
Exclusion of previously reprocessed devices	Reprocessing restricted to exclude devices previously reprocessed by other reprocessors.

Study Proving Device Meets Acceptance Criteria:

The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Catheter." This "Functional and Safety Testing" section (on page 6) lists the tests performed, which collectively constitute the study. The conclusion is that these tests showed the reprocessed catheter to be "as safe and effective as the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each of the functional and safety tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective. Given the nature of the device (reprocessed catheter) and the tests listed (bench and laboratory), the data would inherently be prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for this type of medical device (a reprocessed catheter) would primarily be established through objective engineering and scientific measurements and analyses against established performance standards and predicate device specifications rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., imaging) where multiple human readers' opinions need to be reconciled to form a ground truth. For bench and laboratory testing of a physical medical device, the criteria are usually objective (e.g., does it meet a specific resistance value, does it withstand a certain pull force).

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

An MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic tools or systems where human performance is enhanced by AI assistance. The Reprocessed Torqr Diagnostic EP Catheter is a physical medical device, not an AI diagnostic tool.

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

A standalone performance study of an algorithm was not done. Again, this device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the performance of the Reprocessed Torqr Diagnostic EP Catheter is based on a combination of:

Engineering Specifications: Adherence to design requirements, such as dimensional accuracy, electrical properties (continuity, resistance, dielectric, leakage), and mechanical characteristics.
Predicate Device Equivalence: The reprocessed device is deemed safe and effective if its performance during these tests is comparable to the original, legally marketed predicate device (Torqr Series Diagnostic EP Catheters, K923915).
Validation Standards: Compliance with established validation protocols for biocompatibility, cleaning, sterilization, and packaging.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. Training sets are used for machine learning algorithms. The studies performed were bench and laboratory tests on physical units of the reprocessed catheter.

9. How the Ground Truth for the Training Set Was Established

Since there was no training set for a machine learning algorithm, the question of how its ground truth was established is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains 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 18, 2018

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

Re: K181618

Trade/Device Name: Reprocessed Torqr Diagnostic EP Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: September 7, 2018 Received: September 10, 2018

Dear Amanda Babcock:

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.

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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely

Mada Jellman
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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Description	ItemNumber	Length(cm)	Curve	FrenchSize	No. ofElectrodes	Spacing(mm)
TorqrDiagnostic EPCatheter	04122JM	110	Josephson	5F	4	2-5-2
04125JM	110	Josephson	5F	4	5-5-5
04122UM	110	Cournand	5F	4	2-5-2
04125UM	110	Cournand	5F	4	5-5-5
04130DS	110	Damato	5F	4	2-2-2
041002JM	110	Josephson	6F	4	2-5-2
041005JM	110	Josephson	6F	4	5-5-5
041002UM	110	Cournand	6F	4	2-5-2
041005UM	110	Cournand	6F	4	5-5-5
041005DM	110	Damato	6F	4	5-5-5
041565CS	65	CS	5F	10	2-5-2
041865CS	65	CS	5F	10	2-8-2
041590CS	90	CS	5F	10	2-5-2

The item numbers included in the scope of this submission K181618 are as follows:

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Indications for Use

510(k) Number (if known) K181618

Device Name

Reprocessed Torqr Diagnostic Electrophysiology (EP) Catheter

Indications for Use (Describe)

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 Principal Regulatory Affairs Specialist Innovative Health, LLC. (480) 525-5911 (office) (888) 965-7705 (fax) ababcock@innovative-health.com

Date prepared:

June 18, 2018

Device Information:

Trade/Proprietary Name:	Reprocessed Torqr Diagnostic EP Catheter
Common or Usual Name:	Diagnostic Electrophysiology Catheter
Classification Name:	Electrode Recording Catheter or Electrode Recording Probe
Classification:	Class II, 21 CFR 870.1220
Product Code:	NLH

Predicate Device:

510(k) Number	510(k) Title	Manufacturer
K923915	Torqr Series Diagnostic EP Catheters	Medtronic (CardioRhythm)

Device Description:

The item numbers in scope of this submission are as follows:

Description	ItemNumber	Length(cm)	Curve	FrenchSize	No. ofElectrodes	Spacing(mm)
TorqrDiagnostic EPCatheter	04122JM	110	Josephson	5F	4	2-5-2
	04125JM	110	Josephson	5F	4	5-5-5
	04122UM	110	Cournand	5F	4	2-5-2
	04125UM	110	Cournand	5F	4	5-5-5
	04130DS	110	Damato	5F	4	2-2-2

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041002JM	110	Josephson	6F	4	2-5-2
041005JM	110	Josephson	6F	4	5-5-5
041002UM	110	Cournand	6F	4	2-5-2
041005UM	110	Cournand	6F	4	5-5-5
041005DM	110	Damato	6F	4	5-5-5
041565CS	65	CS	5F	10	2-5-2
041865CS	65	CS	5F	10	2-8-2
041590CS	90	CS	5F	10	2-5-2

Table 5.1: Device Scope

Indications for Use:

The Reprocessed Torgr Catheter is intended for use in diagnostic electrophysiologic procedures. The catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed Torqr Catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation. In addition, Innovative Health's reprocessing of the Catheter 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 Reprocessed Catheter. This included the following:

Biocompatibilitv .
Cleaning Validation .
Sterilization Validation 0
Functional testing 0
- . Visual Inspection
- = Dimensional Verification
- . Electrical Continuity and Resistance
- Simulated Use
- . Mechanical Characteristics
Electrical Safety Testing ●
- . Dielectric and Current Leakage
o Packaging Validation

The Reprocessed Torqr Catheter is 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.

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Conclusion:

Innovative Health concludes that the Reprocessed Torqr Catheter is 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).