Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.

Device Description

The proposed Multipurpose Drainage Catheter consists of a flexible tube with an open distal tip, drainage holes and a lubricious surface. The distal end of the device has as a pigtail configuration. The proximal hub assembly of the device provides a Luer lock hub to allow the user to connect to a fluid collection device. Accessories include a Metal Stiffening Cannula and Plastic Stiffening Cannula and a Trocar.

AI/ML Overview

This 510(k) summary (K111315) describes a Multipurpose Drainage Catheter. The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/CAD/software device (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices. For a physical medical device like a catheter, "performance data" typically refers to engineering tests and biocompatibility, not clinical efficacy studies with specific performance metrics against a ground truth.

Here's how to interpret the available information in the context of your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria or report device performance in terms of clinical metrics (e.g., sensitivity, specificity, accuracy) because this is a physical medical device, not a diagnostic or AI-driven one.

The "performance data" mentioned in section H refers to:

Results of performance testing: These would typically involve engineering tests to ensure the catheter meets design specifications related to strength, flexibility, flow rates, durability, etc. The document states these "demonstrate safety and effectiveness of the proposed device and substantial equivalence."
Biocompatibility testing: Performed in accordance with ISO 10993-1, which "demonstrate the proposed device is acceptable for its intended use."

Table of Acceptance Criteria and Reported Device Performance (as applicable for this device type):

Acceptance Criteria	Reported Device Performance
Material Safety & Biocompatibility: Device materials are non-toxic, non-irritating, and suitable for human contact.	Biocompatibility testing performed per ISO 10993-1 demonstrated the proposed device is acceptable for its intended use.
Functional Performance: Catheter's physical properties (e.g., flexibility, strength, flow, pigtail formation) meet design specifications and are comparable to predicate devices.	Results of performance testing demonstrate safety and effectiveness of the proposed device and substantial equivalence to predicate devices. (Specific quantitative results are not provided in this public summary).
Sterility: Device can be terminally sterilized and maintain sterility until use.	(Implied by medical device regulations and 510(k) process, but not explicitly detailed in this summary.)
Ease of Use/Design Features: Design allows for intended drainage function and connection to fluid collection.	Device consists of a flexible tube with open distal tip, drainage holes, lubricious surface, pigtail configuration, and a Luer lock hub for connection to a fluid collection device. Accessories include stiffening cannulas and a trocar, similar to predicate devices.

Other Information:

Given the nature of this physical medical device and the type of 510(k) submission, the following information is not applicable or not provided in the document:

Sample size used for the test set and the data provenance: Not applicable for engineering and biocompatibility testing. There isn't a "test set" of clinical cases in the way there would be for an AI device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical interpretation is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/CAD/software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be its physical integrity, material properties, and biocompatibility, verified by engineering standards and lab tests.
The sample size for the training set: Not applicable (no training set for a physical device).
How the ground truth for the training set was established: Not applicable.

Summary

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K111315.
pg 1 of 2

JUN - 8 2011

510(K) SUMMARY

Date prepared: 06-May-2011

A. Sponsor

Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752

B. Contact

Wanda Carpinella Sr. Manager, Global Regulatory Affairs 508-658-7929

C. Device Name

Trade Name: Common/Usual name: Classification Name:

· Lorraine M. Hanley Director, Global Regulatory Affairs 508-658-7945

Multipurpose Drainage Catheter Percutaneous Drainage Catheter GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I GBX-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I FGE-Catheter, Biliary, Diagnostic 21CFR§876.5010, Class II LJE-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Unclassified

D. Predicate Device(s)

Common/Usual name: Classification Name:

Premarket Notification(s):

Multipurpose Drainage Catheter

GBO-Catheter, Nephrostomy GBX-Catheter, Nephrostomy FGE-Catheter, Biliary, Diagnostic LJE-Catheter, Nephrostomy

K093392 K103353

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E. Device Description

F. Intended Use

G. Technological Characteristics

The proposed device has similar materials, design and components and technological characteristics as predicate drainage catheters.

H. Performance Data

Results of the performance 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.

I. Conclusion

Based on responses to questions posed in the FDA's Decision Making Tree, the proposed devices are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized lines representing its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

Ms. Wanda Carpinella Sr. Manager Global Regulatory Affairs Navilyst Medical, Inc. 26 Forest Street MARLBOROUGH MA 01752

JUN - 8 2011

Re: KI11315

Trade/Device Name: Multipurpose drainage catheter Regulation Number: 21 CFR 8876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Codes: FGE, LJE, GBO, and GBX Dated: May 6, 2011 Received: May 10, 2011

Dear Ms. Carpinella:

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

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Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Herbert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if Known): ·

Device Name:

Multipurpose Drainage Catheter

KIII315

Indications for Use:

Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothoraces, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections.

Prescription Use (21 CFR 801 Subpart D) 风 And/Or

AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huld Leena

vision Sign-Off) ion of Reproductive, Gastro-Renal, and gical Devices k) Number

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.