Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications.

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

Device Description

The Exodus Drainage Catheter consists of a radiopaque polyurethane catheter. The distal end of the catheter is configured as a locking pigtail and is coated with GLYCE hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distal tip. The Exodus Array Multipurpose Drainage Catheter (when applicable) and the Exodus Believe Biliary Catheter include a polymer marker to assist with catheter placement.

The proposed Exodus Drainage Catheters will include the following accessories: a metal cannula and a plastic cannula (all product offerings) and a 0.038" trocar needle (in multipurpose offerings only).

AI/ML Overview

The provided text is a 510(k) Summary for the Exodus Drainage Catheters. This document details the substantial equivalence of new drainage catheters to previously marketed predicate devices. It focuses on device description, intended use, technological characteristics, and performance data to demonstrate safety and effectiveness.

However, it does not include the type of study that would typically generate acceptance criteria and performance metrics for a diagnostic AI device. The document describes physical and chemical performance tests for a physical medical device (catheter), not a digital or AI-based diagnostic tool.

Therefore, I cannot fulfill your request for specific acceptance criteria and study details related to an AI device's performance based on the provided text. The information required (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not available in this type of FDA submission for a catheter.

Here's how I would describe the current information, acknowledging its limitations for an AI device:

Based on the provided K152069 510(k) Summary for the Exodus Drainage Catheters, the device is a physical medical device (catheter), not an AI-based diagnostic tool. Therefore, the information requested regarding acceptance criteria and study details for an AI device's performance (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not applicable or available in this document.

The document details performance testing for the physical attributes and biological compatibility of the catheter.

1. Table of Acceptance Criteria and Reported Device Performance (for a physical catheter):

The 510(k) summary lists the types of performance tests conducted for the Exodus Drainage Catheters to demonstrate substantial equivalence to a predicate device (K093392). While specific quantitative acceptance criteria and detailed reported performance values are not explicitly stated in this high-level summary, the document indicates that the results "demonstrate safety and effectiveness of the proposed device and substantial equivalence."

Acceptance Criteria Category	Types of Performance Testing Reported	General Outcome (as stated in document)
Material Properties & Strength	Tensile Testing	Demonstrated safety and effectiveness
Device Integrity	Catheter Surface, RO Marker Band Scrape Test, Fluid Leak Testing, Aspiration Strength, Catheter Column Strength, Suture Force to Pigtail	Demonstrated safety and effectiveness
Visibility & Functionality	Radiopacity Testing, Flow Rate Testing, Coating Lubricity, Pigtail Diameter	Demonstrated safety and effectiveness
Biocompatibility	Biocompatibility Testing per ISO 10993-1	Acceptable for its intended use
Compatibility	Catheter Compatibility	Demonstrated safety and effectiveness

2. Sample size used for the test set and the data provenance: Not applicable. This summary describes physical testing of devices, not a study involving a "test set" of patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for patient images/data is not relevant to the physical and biological testing of a catheter.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving reader adjudication of diagnostic output.

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: Not applicable. This document pertains to a physical medical device (catheter) and does not describe an AI system's performance or human-AI interaction.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device and testing. The "ground truth" for catheter performance relates to established engineering standards, material specifications, and biological safety standards (e.g., ISO 10993-1).

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized depiction of three human profiles merging into a single form, often interpreted as representing health, humans, and services. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem.

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

September 24, 2015

Navilyst Medical, Inc. Michael P. Hanley Specialist 1, Regulatory Affairs 26 Forest Street Marlborough, MA 01752

Re: K152069

Trade/Device Name: Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE, LJE, GBO Dated: July 23, 2015 Received: July 29, 2015

Dear Michael P. Hanley,

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.

{1}------------------------------------------------

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-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.

Sincerely vours.

Jeffrey W. Cooper -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152069

Device Name

Exodus Array Multipurpose Drainage Catheters Exodus Nuance Nephrostomy Drainage Catheters Exodus Believe Biliary Drainage Catheters

Indications for Use (Describe)

Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary - Exodus Drainage Catheters

A. Sponsor

Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752

B. Contact

Michael P. Hanley Specialist I, Global Regulatory Affairs 508-658-7983

C. Device Name

Trade Name:

Common/Usual Name:

Classification Name:

Classification Panel: Pro Code:

D. Predicate Device(s)

Predicate 510(k) Trade Name:

Common/Usual Name: Classification Name:

Classification Panel: Pro Code: Reference 510 (k)s

Wanda Carpinella Director, Global Regulatory Affairs 508-658-7929

Exodus Array Multipurpose Drainage Catheter Exodus Nuance Nephrostomy Drainage Catheter Exodus Believe Biliary Drainage Catheter

Biliary, Nephrostomy, Multipurpose Percutaneous Drainage Catheters

. FGE - Catheter, Biliary, Diagnostic 21 CFR §876.5010, Class II
LJE - Catheter, Nephrostomy Pre-Amendment, unclassified
GBO - Catheter, Nephrostomy, General & Plastic Surgery 21 CFR§878.4200, Class I

Gastroenterology - Urology FGE, LJE, GBO

K093392

Exodus Multipurpose Drainage Catheter Exodus Nephrostomy Drainage Catheter Exodus Biliary Drainage Catheter

Percutaneous Drainage Catheter

. FGE - Catheter, Biliary, Diagnostic 21 CFR §876.5010, Class II
LJE Catheter, Nephrostomy Pre-. Amendment, unclassified
GBO Catheter, Nephrostomy, General & ● Plastic Surgery 21 CFR§878.4200, Class I
GBX Catheter, Nephrostomy, General & ● Plastic Surgery 21 CFR§878.4200, Class I

Gastroenterology - Urology FGE, LJE, GBO K103353,K141335,K951475,K053245

{4}------------------------------------------------

E. Device Description

F. Intended Use/Indications for Use

The proposed Exodus Drainage Catheter has the following Indications for Use:

. Exodus Array Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, and other general purpose drainage applications
Exodus Nuance Nephrostomy Drainage Catheters are intended for percutaneous drainage of ● fluid collections in the urinary system.
Exodus Believe Biliary Drainage Catheters are intended for percutaneous drainage of the biliary ● tree.

G. Summary of Similarities and Differences in Technological Characteristics and Performance

The proposed Exodus Drainage Catheter is substantially equivalent to the Navilyst Medical Percutaneous Drainage Catheter. When compared to the predicate, the proposed Exodus Drainage Catheters have similar materials, design, components, fundamental technology, and operating principles and the same indications for use. The modifications from the predicate device include: new catheter material and polymer marker band; addition 6F sizes; and 15cm as shortest catheter length. These similarities and differences are illustrated in the following table.

Comparison of Proposed Exodus Drainage Catheters
And Predicate Percutaneous Drainage Catheter
Characteristic	Proposed Exodus Drainage Catheters	Predicate Drainage Catheter (K093392)
Types of Catheters	Multipurpose Drainage CatheterNephrostomy Drainage CatheterBiliary Drainage Catheter	Multipurpose Drainage CatheterNephrostomy Drainage CatheterBiliary Drainage Catheter
Shaft Materials	Blended:Carbothane 55D (70%)Carbothane 95A (30%)	Co-extruded:Carbothane 55D (inner layer)Carbothane 85A (outer layer)
Shaft Depth Markers	Yes	Yes
Proximal Hub Assembly	SureTwist Hub lockingMechanism	SureTwist Hub lockingMechanism
Distal Hydrophilic Coating	Yes	Yes
Distal Configuration	Locking Pigtail	Non-LockingLocking Pigtail
Sizes	6, 8, 10, 12 &14 French	8, 10, 12, &14 French
Radiopaque Marker	Yes:	Yes

{5}------------------------------------------------

Comparison of Proposed Exodus Drainage CathetersAnd Predicate Percutaneous Drainage Catheter
Characteristic	Proposed Exodus Drainage Catheters	Predicate Drainage Catheter (K093392)
	Polymer Marker band on selectMultipurpose Catheters and allBiliary Drainage Catheters	Platinum / Iridium RO marker onall Biliary Drainage only
Useable Length	15 cm25 cm35 cm	20 cm25 cm35 cm
Included Insertion Accessories	Plastic Stiffening Cannula,Metal Stiffening CannulaTrocar	Plastic Stiffening Cannula,Metal Stiffening CannulaTrocar
Packaging	Tyvek/Mylar (PET/LDPE) Pouch	Tyvek/Mylar (PET/LDPE) Pouch
Sterilization Method	Ethylene oxide	Ethylene oxide

H. Performance Data

The performance evaluation of the proposed Exodus Drainage Catheter included testing conducted in accordance to the following FDA Guidance Documents, and international standards: Results of this testing demonstrate safety and effectiveness of the proposed device and substantial equivalence. Results of biocompatibility testing performed in accordance with ISO 10993-1 demonstrate the proposed device is acceptable for its intended use.

Tensile Testing
. Catheter Surface
RO Marker Band Scrape Test ●
Radiopacity Testing ●
Flow Rate Testing ●
Fluid Leak Testing
Aspiration Strength
. Catheter Column Strength
Coating Lubricity
Pigtail Diameter
Suture Force to Pigtail
Catheter Compatibility ●
Biocompatibility Testing per ISO 10993-1 ●

I. Conclusion

Based upon successful results of testing and responses to questions posed within FDA's 510(k) Decision-Making Tree, the proposed device is determined to be substantially equivalent.

Regulation Number and Section

§ 876.5010 Biliary catheter and accessories.

(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.