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

The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (Nav) capabilities 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 NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are designed to facilitate electrophysiological mapping of the atria of the heart. They are deployed in the right or left atrium through an 8F guiding sheath. These deflectable catheters consist of a circular spine on the distal tip with platinum/iridium electrodes that can be used for stimulation and recording.

Models designated as NAV are compatible with the Carto® 3 EP Navigation System.

AI/ML Overview

The provided text is a 510(k) summary for reprocessed medical devices, specifically electrophysiology catheters. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel efficacy through clinical studies of an AI algorithm. Therefore, many of the requested elements for AI device performance studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and details on training sets) are not applicable or extractable from this document.

The document primarily outlines non-clinical testing to ensure the reprocessed devices maintain their original functionality and safety.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present or not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative acceptance criteria with corresponding reported performance values in the way one would for an AI algorithm's diagnostic metrics. Instead, it refers to validation of functional performance, cleaning, sterilization, biocompatibility, and packaging. The "reported device performance" is a general statement that the reprocessed devices "perform as originally intended."

Criteria Type	Description	Reported Performance (Summary)
Functional Performance	Bench testing through simulated use, visual inspection, fatigue testing, and function testing to ensure the device performs as originally intended.	"Performance testing shows the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters to perform as originally intended."
Cleaning Validation	Validation of the cleaning procedures.	Performed and validated.
Sterilization Validation	Validation of the sterilization procedures (ISO 11135, USP <71>).	Performed and validated.
Biocompatibility Testing	Testing for biological compatibility (ISO 10993-1).	Performed.
Ethylene Oxide Residual Testing	Testing for residual ethylene oxide (ISO 10993-7).	Performed.
Packaging Validation	Validation of the device packaging (ASTM D 4169, ASTM F 88, ASTM F 2096).	Performed and validated.
Shelf Life Validation	Validation of the device shelf life (ASTM F 1980).	Performed.
Manufacturing Process	Includes visual and validated functional testing of 100% of products reprocessed. Device rejected from further reprocessing after maximum of one (1) reprocessing cycle.	Validated testing performed on 100% of reprocessed products. Reprocessing limited to one cycle per device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "Representative samples" but does not specify the number of samples used for any of the non-clinical tests. The tests are benchtop, laboratory-based tests of the reprocessed physical device, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. Ground truth in the context of expert review for AI algorithms is not relevant here. The "ground truth" for these tests would be established by validated test methods and reference standards for the physical and chemical properties of the device (e.g., sterility, material strength).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or expert review for diagnostic tasks, neither of which are described here.

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 information is not applicable/not provided. This document describes the reprocessing of physical medical devices, not an AI algorithm. Therefore, no MRMC study or AI assistance is mentioned or relevant.

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

This information is not applicable/not provided. This document describes the reprocessing of physical medical devices, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable/not provided in the context of AI studies. For the functional and safety testing of the reprocessed catheters, the "ground truth" is based on established industry standards and validated test methodologies for medical device performance, sterility, biocompatibility, and integrity.

8. The sample size for the training set

This information is not applicable/not provided. This document does not describe an AI algorithm that requires a training set.

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

This information is not applicable/not provided. This document does not describe an AI algorithm that requires a training set.

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

June 23, 2016

Sterilmed. Inc. Patricia Kaufman Regulatory Affairs Specialist 5010 Cheshire Parkway, Suite 2 Plymouth, Minnesota 55446

Re: K153006

Trade/Device Name: Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Catheter Electrophysiology (EP) Catheters (See attached list of models) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: NLH Dated: May 23, 2016 Received: May 24, 2016

Dear Patricia Kaufman:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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,

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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Catheter	Model	Poles	Loop		Curve	ElectrodeSpacing (mm)	Shaft
			Diameter (mm)	Profile (F)			Profile (F)	Length (cm)
LASSO 2515 NAV eco Variable Catheter
1	D134301	20	25 - 15	4	D	2-6-2	7	115
2	D134302	10	25 - 15	4	D	8	7	115
LASSO NAV eco Catheter
3	D134901	10	15	4.5	D	4.5	7	115
4	D134902	20	15	4.5	D	4.5 pairs	7	115
5	D134903	10	20	4.5	D	6.0	7	115
6	D134904	20	20	4.5	D	6.0 pairs	7	115
7	D134905	10	25	4.5	D	8.0	7	115
8	D134906	20	25	4.5	D	8.0 pairs	7	115
9	D134909	10	20	4.5	D	6.0	7	115

K153006 MODELS INTENDED FOR REPROCESSING

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Indications for Use

510(k) Number (if known) K153006

Device Name

Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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2. 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT	Sterilmed, Inc.5010 Cheshire Pkwy N, Suite 2Plymouth, MN 55446www.sterilmed.comTel: (888) 541-0078
OFFICIALCORRESPONDENT	Patricia F. KaufmanSterilmed, Inc.5010 Cheshire Pkwy N, Suite 2Plymouth, MN 55446pkaufman@sterilmed.comTel: (763) 488-3211Fax: (763) 488-3350
DATE PREPARED	12 October 2015
TRADE NAME	Reprocessed LASSO NAV eco and Reprocessed LASSO2515 NAV eco Variable Electrophysiology (EP) Catheters
COMMON NAME	Electrophysiology Diagnostic Catheters
510(K) NUMBER	K153006
DEVICE CLASSIFICATION	Name: Catheter, Recording, Electrode, ReprocessedRegulation No: §870.1220Product Code: NLHClass: IIPanel: Cardiovascular
PREDICATE DEVICE	Lasso 2515 NAV eco Variable Catheter, Lasso NAV ecoCatheter - K113213

SUBSTANTIALLY EQUIVALENT TO:

The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are substantially equivalent to the single use Biosense Webster Lasso 2515 NAV eco Variable Catheter and Lasso NAV eco Catheter in intended use and technological features.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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Models designated as NAV are compatible with the Carto® 3 EP Navigation System.

	CatheterModel	Poles	Loop		Curve	ElectrodeSpacing (mm)	Shaft
			Diameter (mm)	Profile (F)			Profile (F)	Length (cm)
LASSO® 2515 NAV eco Variable Catheter
1	D134301	20	25 - 15	4	D	2 - 6 - 2	7	115
2	D134302	10	25 - 15	4	D	8	7	115
LASSO® NAV eco Catheter
3	D134901	10	15	4.5	D	4.5	7	115
4	D134902	20	15	4.5	D	4.5 pairs	7	115
5	D134903	10	20	4.5	D	6.0	7	115
6	D134904	20	20	4.5	D	6.0 pairs	7	115
7	D134905	10	25	4.5	D	8.0	7	115
8	D134906	20	25	4.5	D	8.0 pairs	7	115
9	D134909	10	20	4.5	D	6.0	7	115

The following models are the subject of this submission:

INDICATIONS FOR USE:

The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. stimulation and recording only. The catheter is designed to obtain electrograms in the atrial regions of the heart.

The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters with navigation (NAV) capabilities 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.)

TECHNICAL CHARACTERISTICS:

The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are identical to the predicate devices in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation.

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PERFORMANCE STANDARDS:

No applicable performance standards have been issued under 514 of the Food, Drug and Cosmetic Act for a Catheter, Recording, Electrode, Reprocessed §870.1220.

FUNCTIONAL AND SAFETY TESTING:

Representative samples of Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of 100% of products reprocessed. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are reprocessed no more than one (1) time. Each device is marked and tracked through each reprocessing cycle. After the device has reached the maximum number of reprocessing cycles (1), the device is rejected from further reprocessing. Reprocessing is performed only by the manufacturer Sterilmed.

SUMMARY OF NONCLINICAL TESTING:

Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP <71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D 4169, ASTM F 88, ASTM F 2096), and shelf life validation (ASTM F 1980). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, fatigue testing, and function testing. Performance testing shows the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters to perform as originally intended.

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

Sterilmed concludes that the Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are safe, effective, and substantially equivalent to the predicate devices, Biosense Webster Lasso Catheters (K113213), as described in this premarket notification submission. The Reprocessed LASSO NAV eco and Reprocessed LASSO 2515 NAV eco Variable Electrophysiology (EP) Catheters are substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues.

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).