The Reprocessed Cristacath Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed to facilitate electrograms in the atrial regions of the heart.

Device Description

The Reprocessed CristaCath Diagnostic Electrophysiology (EP) Catheters have been designed for electrophysiological mapping of cardiac structures. The catheters have a high-torque shaft with a tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The Deflectable Tip CristaCath catheters facilitate simultaneous local electrograms due to the greater number of electrodes and their deflection capabilities.

The deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed CristaCath Diagnostic Electrophysiology (EP) Catheter. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of a novel AI-powered device. Therefore, a significant portion of the requested information, such as sample sizes for training/test sets, expert qualifications related to AI ground truth, MRMC studies, or standalone AI performance, is not applicable to this submission.

However, I can extract information related to the acceptance criteria and the type of studies conducted to support the safety and effectiveness of the reprocessed catheter.

Acceptance Criteria and Device Performance (Reprocessed CristaCath Diagnostic EP Catheter)

Since this is a reprocessed device submission aiming for substantial equivalence, the "acceptance criteria" are typically defined by demonstrating that the reprocessed device performs comparably to a new, legally marketed predicate device and maintains its safety and effectiveness after reprocessing. The studies conducted are focused on ensuring that the reprocessing does not compromise the original device's performance characteristics.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria (Implied from "as safe and effective as the predicate" and test types)	Reported Device Performance (Summary from text)
Biocompatibility	Compatibility with biological systems	Reaching acceptable biocompatibility levels post-reprocessing, comparable to original device.	"Biocompatibility" testing was conducted. (Implies satisfactory results to meet equivalence).
Cleaning Validation	Effectiveness of cleaning process to remove contaminants	Demonstrated effective removal of contaminants to prevent patient harm and ensure sterility.	"Cleaning Validation" was conducted. (Implies successful validation of the cleaning process).
Sterilization Validation	Effectiveness of sterilization process	Demonstrated sterility of the reprocessed device to prevent infection.	"Sterilization Validation" was conducted. (Implies successful validation of the sterilization process).
Functional Testing	Visual Inspection (integrity, damage, foreign matter)	No unacceptable visual defects, damage, or foreign matter post-reprocessing.	"Visual Inspection" was conducted. Each device is inspected. Innovative Health's reprocessing includes removal of visible soil and decontamination. (Implies devices meet visual standards).
	Dimensional Verification (physical dimensions)	Dimensions remain within specified tolerances, comparable to the original device.	"Dimensional Verification" was conducted. (Implies dimensions are maintained).
	Electrical Continuity and Resistance (electrode function)	Electrical performance (continuity, resistance) remains within specifications for accurate electrophysiological mapping, comparable to the original device.	"Electrical Continuity and Resistance" testing was conducted. (Implies electrical function is preserved).
	Simulated Use (performance under intended conditions)	Performance during simulated use demonstrates effective electrophysiological mapping capabilities.	"Simulated Use" testing was conducted. (Implies the device functions as intended during simulated procedures).
	Mechanical Characteristics (flexibility, deflection, durability)	Mechanical properties (e.g., deflection, torque, shaft integrity) are maintained after reprocessing to allow for proper manipulation and positioning.	"Mechanical Characteristics" testing was conducted. The device description highlights deflection control and high-torque shaft for accurate positioning, implying these characteristics are maintained. (Implies mechanical integrity and functionality are preserved).
Electrical Safety Testing	Dielectric and Current Leakage (electrical insulation)	Electrical insulation integrity and leakage current are within safe limits to prevent electrical hazards to patients and users.	"Dielectric and Current Leakage" testing was conducted as part of Electrical Safety Testing. (Implies electrical safety standards are met).
Packaging Validation	Integrity of sterile barrier and shelf-life	Packaging maintains sterility and device integrity until point of use, and shelf-life is established.	"Packaging Validation" was conducted. (Implies packaging is adequate to maintain sterility).
Reprocessing Limits	Number of reprocessing cycles	Device remains safe and effective for one reprocessing cycle.	The Reprocessed CristaCath Diagnostic Electrophysiology (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, excluding devices previously reprocessed by others. (Indicates controlled reprocessing limits and processes are in place).
Overall Equivalence	Safety and Effectiveness	The reprocessed device is as safe and effective as the predicate device, with similar purpose, design, materials, function, and intended use, and no changes to claims, clinical applications, or performance.	Innovative Health concludes that the Reprocessed CristaCath Diagnostic EP Catheters are as safe and effective as the predicate devices described herein. The purpose, design, materials, function, and intended use are identical to the predicate. There are no changes to claims, clinical applications, patient population, performance specifications, or method of operation.

Study Details and Data Provenance

Sample sizes used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for each of the "bench and laboratory testing" categories (Biocompatibility, Cleaning Validation, Sterilization Validation, Functional Testing, Electrical Safety Testing, Packaging Validation).
- The data provenance is from bench and laboratory testing, which is typically performed internally by the manufacturer (Innovative Health, LLC.) in the USA (Scottsdale, Arizona, as per the address). This type of testing is generally prospective for the specific reprocessed units being evaluated, though the methodologies are often established based on existing standards and predicate device data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. "Ground truth" in the context of AI/machine learning typically refers to expert-labeled data used to train and validate algorithms. This submission is for a reprocessed physical medical device, not an AI or diagnostic algorithm. The "truth" for the tests performed (e.g., sterility, electrical continuity) is established by validated assays and measurement techniques, not by expert interpretation of data for ground truth labeling.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable for the same reasons as above. Adjudication methods are used in cases where multiple experts interpret complex data (e.g., medical images) and their decisions need to be reconciled to establish a "ground truth" for algorithmic validation. The tests described here are objective physical, chemical, or electrical measurements.
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 is not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers (e.g., radiologists) with and without AI assistance is evaluated across multiple cases. This submission is for a reprocessed diagnostic catheter, which is an invasive tool for electrophysiological mapping, not an imaging or interpretive diagnostic AI system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the submission is for a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- As noted, the concept of "ground truth" in the AI/machine learning sense is not applicable here. For the bench and laboratory tests, the "truth" is established by:
  - Validated measurement standards/protocols: For dimensional verification, electrical properties, mechanical characteristics.
  - Chemical/biological assays: For biocompatibility, cleaning validation (e.g., residual protein, endotoxin), sterility testing.
  - Functional performance specifications: For simulated use testing.
The sample size for the training set:
- This is not applicable as there is no AI algorithm being developed or "trained."
How the ground truth for the training set was established:
- This is not applicable as there is no AI algorithm or training set.

Summary

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October 5, 2017

Innovative Health, LLC. Amy Stoklas-Oakes Director, Quality and Regulatory Affairs 1435 North Hayden Road Suite 100 Scottsdale, Arizona 85257

Re: K171503

Trade/Device Name: Reprocessed CristaCath 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: August 28, 2017 Received: August 29, 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);

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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 (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. 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.

Kenneth J. Cavanaugh -S

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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The following device model is included in the scope of this 510(k) submission:

Item Number	Description	SheathUsableLength(cm)	FrenchSize	Curve	Number ofElectrodes	Spacing(mm)
D7A20131RT	CristaCathDiagnostic EPCatheter	115	7F	D-Type/Crista	20	1-3-1

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Indications for Use

510(k) Number (if known) K171503

Device Name

Reprocessed CristaCath Diagnostic Electrophysiology (EP) Catheter

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:

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:

May 22, 2017

Device Information:

Trade/Proprietary Name:	Reprocessed CristaCath Diagnostic
	Electrophysiology (EP) Catheter
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
K953768	Cordis Webster A20 DiagnosticDeflectable Tip Catheter	Cordis Webster, Inc.,Biosense Webster

Device Description:

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

ltem Number	Description	SheathUsableLength(cm)	FrenchSize	Curve	Number ofElectrodes	Spacing(mm)
D7A20131RT	CristaCathDiagnostic EPCatheter	115	7F	D-Type/Crista	20	1-3-1

Table 5.1: Item Numbers

Indications for Use:

The Reprocessed CristaCath Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed to facilitate electrograms in the atrial regions of the heart.

Technological Characteristics:

The purpose, design, materials, function, and intended use of the CristaCath Diagnostic 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 CristaCath Diagnostic EP Catheters.

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 CristaCath Diagnostic Electrophysiology (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.

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Innovative Health restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Innovative Health concludes that the Reprocessed CristaCath 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).