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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for a reprocessed medical device, the "Reprocessed Orbiter ST Steerable Diagnostic Electrophysiology Catheters". It focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing, rather than an AI-driven diagnostic or prognostic device that would have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested items related to AI system performance, such as sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this type of device submission.

However, I can extract information related to the device's functional and safety testing to present as "acceptance criteria" and "reported device performance" in the spirit of your request.

Here's the closest representation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a reprocessed medical device like this electrophysiology catheter, the "acceptance criteria" are generally based on ensuring that the reprocessed device performs equivalently to a new device and meets established safety and functionality standards. The "reported device performance" reflects the successful demonstration of these criteria through specific validation tests.

Acceptance Criteria Category	Specific Criteria/Test Outcome	Reported Device Performance (as per document)
Biocompatibility	Device materials remain safe for patient contact after reprocessing.	Demonstrated successfully.
Cleaning Validation	Residual soil and contaminants are effectively removed.	Validated successfully.
Sterilization Validation	Device achieves and maintains sterility.	Validated successfully.
Functional Testing
Visual Inspection	Device meets visual quality standards.	Demonstrated successfully.
Dimensional Verification	Device dimensions remain within specifications.	Demonstrated successfully.
Electrical Continuity and Resistance	Electrical properties remain within specifications.	Demonstrated successfully.
Simulated Use	Device performs as intended during simulated clinical use.	Demonstrated successfully.
Mechanical Characteristics	Mechanical properties (e.g., steerability, flexibility) remain within specifications.	Demonstrated successfully.
Electrical Safety Testing
Dielectric and Current Leakage	Electrical safety parameters meet standards.	Demonstrated successfully.
Packaging Validation	Packaging maintains device integrity and sterility.	Validated successfully.
Reprocessing Limits	Not reprocessed more than one (1) time.	Each device marked and tracked to ensure this limit is not exceeded.
Source of Reprocessed Device	Only devices not previously reprocessed by other reprocessors.	Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Equivalence to Predicate	"Safe and effective as the predicate devices."	Innovative Health concludes that the Reprocessed Orbiter ST Steerable Diagnostic EP Catheters are as safe and effective as the predicate devices.

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

The document does not specify the exact sample sizes (number of catheters) used for each of the functional and safety tests. The provenance of the "data" in this context refers to the reprocessed devices themselves. These are original Orbiter ST Steerable Diagnostic EP Catheters that have been used once and then collected for reprocessing. The document does not specify the country of origin for these used devices, nor does it explicitly state whether the testing data itself is retrospective or prospective, though performance validation studies for reprocessing are typically prospective in their design (i.e., new tests are run on a set of reprocessed devices).

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

This section is not applicable. Ground truth, in the context of diagnostic AI, refers to a definitive diagnosis or outcome. For a physical medical device, "ground truth" is established through engineering and laboratory testing protocols, and compliance with established standards. This typically involves engineers, quality control specialists, and potentially clinical experts for simulated use environments, rather than experts establishing a "truth" in a diagnostic sense.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers might disagree on a diagnostic assessment. For device performance testing, the results are typically objectively measured against defined specifications, and any deviations would be investigated by engineering/quality teams.

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

This section is not applicable. This is a submission for a reprocessed electrophysiology catheter, not an AI-assisted diagnostic or imaging system.

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

This section is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For this device, the "ground truth" or reference standard is:

Engineering Specifications: The original design and performance specifications of the new predicate device.
Regulatory Standards: Relevant FDA regulations (e.g., 21 CFR 870.1220 for electrode recording catheters) and consensus standards for biocompatibility, sterility, electrical safety, etc.
Laboratory Performance Measurements: Objective measurements derived from bench and laboratory testing (e.g., resistance values, dimensional accuracy, mechanical force measurements).

8. The sample size for the training set

This section is not applicable. This device does not involve machine learning or a "training set."

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

This section is not applicable as there is no training set for this type of device.

Summary

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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

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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

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Description	ItemNumber	FrenchSize	Number ofElectrodes	Electrode Spacing (mm)	Curve	Usable Length(cm)
Orbiter STSteerableDiagnostic EPCatheter	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)

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 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
K992373	Orbiter ST Diagnostic Electrode Catheterand Orbiter ST Extension Cable	C.R. Bard, Inc.

Device Description:

Description	ItemNumber	FrenchSize	Number ofElectrodes	Electrode Spacing (mm)	Curve	Usable Length(cm)
Orbiter STSteerableDiagnostic EPCatheter	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	2,20,2,2,2,2,2,2,2,2,2,2,2,2,25,2,25,2,25,2	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

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Indications for Use:

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.

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).