The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheters are indicated for multiple electrode electrophysiological mapping of the heart, i.e. recording or stimulation only. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheters are designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed LASSO NAV and Reprocessed LASSO 2515 NAV eco Variable Catheters provide location information when used with compatible CARTO 3 EP Navigation Systems. (These catheters are not compatible with CARTO 3 EP Navigation Systems prior to Version 2.3.)

Device Description

The Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter have been designed to facilitate electrophysiological mapping of the atria of the heart with the CARTO 3 EP Navigation System and a reference device. Both catheters are deployed in the right or left atrium through an 8F quiding sheath. Both deflectable catheters consists of a 4.5 F (Lasso NAV eco) or 4 F (LASSO NAV eco Variable) circular spine on the distal tip, with platinum/iridium electrodes that can be used for stimulation and recording.

The Reprocessed LASSO 2515 NAV eco Variable Catheter features a Nitinol loop design that allows the expansion and contraction of the loop to custom-fit veins with different sizes, ranging from 25mm to 15mm diameter (± 15%).

The Reprocessed LASSO NAV eco Catheter is a fixed catheter with three fixed catheter sizes, namely 15, 20, 25 mm loop sizes to accommodate different vein sizes, Each loop size will be available with either 10 or 20 electrodes.

AI/ML Overview

This document is a 510(k) premarket notification for a reprocessed medical device, specifically the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheter. The purpose of this type of submission is to demonstrate that a new or reprocessed medical device is substantially equivalent to a predicate device already legally marketed. Therefore, the "study" referred to in the prompt is actually the bench and laboratory testing performed to demonstrate that the reprocessed device is as safe and effective as the original, legally marketed predicate device.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format for each performance metric, nor does it provide specific numerical results for each test. Instead, it lists the types of tests performed and concludes that the reprocessed devices are "as safe and effective as the predicate devices."

However, based on the types of functional and safety testing listed, we can infer the general categories of acceptance criteria:

Acceptance Criteria Category	Reported Device Performance (Implied)
Biocompatibility	Met accepted standards.
Cleaning Validation	Adequately cleaned for reprocessing.
Sterilization Validation	Adequately sterilized.
Functional Testing	Functions identically to predicate.
Visual Inspection	Free from visible defects.
Dimensional Verification	Within specified dimensions.
Electrical Performance	Electrical characteristics match predicate.
Simulated Use	Performs as expected in simulated scenarios.
Mechanical Characteristics	Mechanical properties (e.g., flexibility, durability) match predicate.
Electrical Safety Testing	Meets electrical safety standards.
Dielectric and Current Leakage	Within acceptable limits.
Packaging Validation	Maintains sterility and device integrity.

Note: The document explicitly states: "The purpose, design, materials, function, and intended use of the Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter are identical to the predicate devices. There are no changes to the claims, clinical applications, patient population, performance specifications, or method of operation." This implies that the acceptance criteria for the reprocessed device would be to meet the specifications and performance of the original, new device.

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

Sample Size:
- The document does not specify the sample size (number of reprocessed catheters) used for any of the individual tests. It only states that "Bench and laboratory testing was conducted."
Data Provenance:
- The testing was conducted by Innovative Health, LLC., based in Scottsdale, Arizona, USA. The data would therefore be considered prospective as it was generated specifically for this 510(k) submission to demonstrate the performance of the reprocessed devices.

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

This question is not applicable in the context of this device. This is a reprocessed electrophysiology catheter, and the "ground truth" for its performance is established by comparing its physical and functional characteristics to the original, new device specifications and performance. There isn't a "test set" of clinical data for which experts establish a diagnostic ground truth, as would be the case for an AI-powered diagnostic device.

4. Adjudication Method for the Test Set

Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are making interpretations (e.g., reading medical images) and their decisions need to be reconciled to establish a ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically used for diagnostic or imaging devices to assess the performance of different readers or different technologies (e.g., with or without AI assistance) on a set of cases. This document concerns the reprocessing of an electrophysiology catheter, which is an interventional/diagnostic tool, not an imaging interpretation device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This question applies to AI algorithms. The device in question is a physical medical catheter.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device is the established specifications and performance characteristics of the legally marketed predicate devices (the original, new LASSO NAV eco and LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters). The testing aims to demonstrate that the reprocessed device performs equivalently to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth in that context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure. The symbol is composed of three stylized profiles facing to the right, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the seal.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2016

Innovative Health, LLC Rafal Chudzik Director of Engineering 1435 North Hayden Road, Suite 100 Scottsdale, Arizona 85257

Re: K153153

Trade/Device Name: Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (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: February 5, 2016 Received: February 8, 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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.

Sincerelv vours.

Mitchell Stein

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	Number ofElectrodes	ElectrodeSpacing (mm)	LoopDiameteror Curve(mm)	FrenchSize	Length(cm)
Lasso Naveco FixedDiagnosticEP Catheter	D134901	10	4.5	15	7	115
	D134902	20	4.5 pairs	15	7	115
	D134903	10	6.0	20	7	115
	D134904	20	6.0 pairs	20	7	115
	D134905	10	8.0	25	7	115
	D134906	20	8.0 pairs	25	7	115
Lasso 2515Nav ecoVariableDiagnosticEP Catheter	D134301	20	2-6-2	25-15	7	115
	D134302	10	8.0	25-15	7	115

Reprocessed Single-Use Device Models Included in Clearance:

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Indications for Use

510(k) Number (if known)

K153153

Device Name

Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable 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:

Rafal Chudzik Director of Engineering (602) 326-7716 (cell) (480) 525-6006 (office) (844) 965-9359 (fax) rchudzik@innovative-health.com

Date prepared:

October 30, 2015

Device Information:

Trade/Proprietary Name:	Reprocessed LASSO® NAV eco and LASSO 2515 NAVeco Variable Electrophysiology (EP) Catheter
Common Name:	Electrophysiological Mapping 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
K113213	LASSO® 2515 NAV eco VariableCatheter and LASSO® NAV eco Catheter	Biosense Webster
K093376	LASSO® NAV Catheter	Biosense Webster
K081258	Variable LASSO® NAV Catheter,Models: D-1290-01, D-1290-2	Biosense Webster

Reference Device:

510(k) Number	510(k) Title	Reprocessor
K112292	Reprocessed 2515 NAV VariableElectrophysiology Catheter	Stryker SustainabilitySolutions

Device Description:

Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter

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Indications for Use:

Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter

The Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter are indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. These catheters are designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter provide location information when used with compatible CARTO EP Navigation Systems. (These catheters are not compatible with CARTO 3 EP Navigation Systems prior to Version 2.3).

Note: Only the catheter is the subject of this submission. Any other related equipment is not included in the scope of this submission.

Technoloqical Characteristics:

The purpose, design, materials, function, and intended use of the Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter 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 LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter. This included the following:

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Biocompatibility ●
Cleaning Validation .
Sterilization Validation .
Functional Testing ●
- Visual Inspection ●
- Dimensional Verification
- Electrical Performance ●
- Simulated Use .
- Mechanical Characteristics ●
- Electrical Safety Testing
- Dielectric and Current Leakage .
. Packaging Validation

The Reprocessed LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter 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 LASSO 2515 NAV eco Variable Catheter and Reprocessed LASSO NAV eco Catheter 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).