Reprocessed Electrophysiology Catheter

• K Number: K153153
• Device Name: Reprocessed Electrophysiology Catheter
• Manufacturer: INNOVATIVE HEALTH, LLC
• Date Cleared: 2016-03-14 ( 133 days)
• Product Code: NLH
• Regulation Number: 870.1220

Intended Use

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.

Predicate Devices

K113213, K093376, K081258

Reference Devices

K112292

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a reprocessed electrophysiology mapping catheter and its compatibility with a navigation system. There is no mention of AI or ML in the device description, intended use, or performance studies. The studies focus on physical and electrical performance, not algorithmic capabilities.

Therapeutic

No
The device is indicated for electrophysiological mapping (recording or stimulation only) of the heart, which is a diagnostic procedure, not a therapeutic one.

Diagnostic

Yes

The device is indicated for "electrophysiological mapping of the heart, i.e. recording or stimulation only" and is "designed to obtain electrograms in the atrial regions of the heart," which are diagnostic activities.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with electrodes, a circular spine, and a Nitinol loop design. This is a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "multiple electrode electrophysiological mapping of the heart, i.e. recording or stimulation only." This involves directly interacting with the patient's heart to record electrical signals or stimulate the tissue.
• Device Description: The device is a catheter designed to be inserted into the heart to obtain electrograms.
• Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease. This device is used in vivo (within the body) to directly interact with and measure electrical activity of the heart.

The device is a therapeutic and diagnostic medical device used in vivo, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.)

Product codes (comma separated list FDA assigned to the subject device)

NLH

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 guiding 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

atrial regions of the heart / cardiac structures of the heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

• 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
  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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113213, K093376, K081258

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K112292

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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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

1

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 [phone] or [phone] 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 [phone] or [phone] 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 | Item
Number | Number of
Electrodes | Electrode
Spacing (mm) | Loop
Diameter
or Curve
(mm) | French
Size | Length
(cm) |
|----------------------------------------------------------------|----------------|-------------------------|---------------------------|--------------------------------------|----------------|----------------|
| Lasso Nav
eco Fixed
Diagnostic
EP 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 2515
Nav eco
Variable
Diagnostic
EP 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)

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.)

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 [phone] (cell) [phone] (office) [phone] (fax) [e-mail]

Date prepared:

October 30, 2015

Device Information:

| Trade/Proprietary Name: | Reprocessed LASSO® NAV eco and LASSO 2515 NAV
eco 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 Variable
Catheter 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 Variable
Electrophysiology Catheter	Stryker Sustainability
Solutions

Device Description:

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

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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.

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.