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.

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

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

Device Description

The proposed percutaneous 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 either a pigtail or J-Tip configuration. Some catheter models have a radiopaque marker to aid the user in placement. 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 some sets include an additional Trocar.

AI/ML Overview

The provided text is a 510(k) summary for the NMI PDC II percutaneous drainage catheter and related FDA correspondence. It discusses the device's description, intended use, technological characteristics, and a conclusion of substantial equivalence to predicate devices based on performance data. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria for device performance, the study used to prove it, sample sizes, ground truth establishment, or expert involvement.

The document only states, "The proposed drainage catheters were tested and compared to predicate devices. 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."

This is a general statement indicating that testing was performed, but it does not provide:

A table of acceptance criteria and reported device performance.
Sample sizes used for the test set or data provenance. (The document does not mention data being "provenced" in terms of country of origin or retrospective/prospective nature regarding clinical performance data for the device itself, only biocompatibility.)
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size. (This device is a physical catheter, not an AI or diagnostic imaging device where MRMC studies are typically performed).
If a standalone (algorithm only) performance study was done. (Again, not applicable to a physical medical device like a catheter).
The type of ground truth used.
The sample size for the training set. (Not applicable as this is not an AI/algorithm-based device).
How the ground truth for the training set was established. (Not applicable).

In summary, the provided text does not contain the granular detail about performance criteria, study design, statistical analysis, or expert involvement that you are asking for. The 510(k) submission process for this type of device (a medical catheter) focuses on demonstrating substantial equivalence to a predicate device through engineering tests (e.g., mechanical performance, biocompatibility) rather than clinical performance metrics typically associated with diagnostic algorithms or AI.

Summary

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

pg 1 of 2

K103353

510(k) Summary for the NMI PDC II

JAN 1 4 2011

Date prepared: 15-November-2010

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

To be determined

Percutaneous Drainage Catheter

FGE-Catheter, Biliary, Diagnostic 21CFR §876.5010, Class II

LJE-Catheter, Nephrostomy, General & Plastic Surgery

21CFR8878.4200, Unclassified

GBX-Catheter, Nephrostomy, General & Plastic Surgery

21CFR§878.4200, Class I

GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I

D. Predicate Device(s)

Common/Usual name: Classification Name:

Premarket Notification(s):

- - - - -- -- -- -- -- -- -- -- -- -- -- --NMI PDC

FGE-Biliary Catheter and Accessories 21CFR 8800.5010, Class II K093392 LJE-Catheter, Nephrostomy, General & Plastic Surgery 21CFR §878.4200, Unclassified GBX-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I GBO-Catheter, Nephrostomy, General & Plastic Surgery 21CFR§878.4200, Class I

5-2

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

K103353
pg 2 of 2

E. Device Description

F. Intended Use

l Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis, e.g., abscesses, cysts, pneumothorax, biliary, nephrostomy, urinary, pleural empyemas, lung abscess, and mediastinal collections.
। Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.
Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree. ।

G. Technological Characteristics

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

H. Performance Data

The proposed drainage catheters were tested and compared to predicate devices. 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.

I. Conclusion

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

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

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

JAN 1 4 2011

Re: K103353

Trade/Device Name: NMI Percutaneous Drainage Catheter (PDC) II Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: December 16, 2010 Received: December 17, 2010

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 i 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

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

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 1,000-0050.

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.html for the Center for Devices and Radiological Health's (CDRH's) Office of Coopliance. 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 Small Manufacturers, International and Consumer Assistance at its tolloffree mber (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lewin 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

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

Indications for Use

510(k) Number (if Known):

Device Name:

NMI Percutaneous Drainage Catheter (PDC) II

Indications for Use:

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

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

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

K 103158

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 8

Concurrence of CDRH, Office of Device Evaluation (ODE)

ಸಿ

Heidi Lemur to

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.