The 3F BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of gels, such as BackStop™, or fluid into the urinary tract.

Device Description

The BackStop Catheter is a 100cm, 3 French, single lumen catheter with a radiopaque tip that facilitates access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of a ureteroscope and is advanced through the urinary tract to the desired location. Once in place, fluid may be injected via the catheter.

The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.

AI/ML Overview

The provided document is a 510(k) summary for the "BackStop Catheter." It describes a medical device, its intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness. However, this document does not contain information about acceptance criteria or a study that uses a test set, ground truth established by experts, or any of the other specific details requested in your prompt.

The document details non-clinical bench testing, which is focused on the device's physical performance and does not involve human subjects or the evaluation of an algorithm against a ground truth.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance against a test set, expert involvement, or comparative effectiveness studies, as these data points are not present in the provided text.

The closest information available is:

"Acceptance Criteria": Not explicitly stated in terms of performance metrics or thresholds.
"Reported Device Performance": Stated as "Results of bench testing have established the device as safe and effective for its intended use, which is identical to that of the predicate device."
"Study that proves the device meets the acceptance criteria": A series of non-clinical bench tests were performed to demonstrate equivalence to a predicate device.

Here's a breakdown of why I cannot populate the table or answer the specific questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	"Results of bench testing have established the device as safe and effective for its intended use, which is identical to that of the predicate device."

Details of non-clinical tests performed:

Catheter hub-to-shaft tensile strength
Catheter pressure during gel delivery
Catheter Burst/Leak Pressure
Catheter Insertion Force
Catheter Column Strength
Shaft Tensile Strength
Catheter Hub Testing

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 available in the provided document. The tests were non-clinical bench tests, not involving patient data or a "test set" in the context of an algorithm or clinical study. Samples were accelerated aged at T=7 months, T=13 months, and T=37 months.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable/available. There was no "ground truth" derived from experts for a test set, as this was non-clinical bench testing.

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

This information is not applicable/available. There was no "adjudication method" for a test set, as this was non-clinical bench testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a physical catheter, not an AI-assisted diagnostic tool.

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

A standalone performance study of an algorithm was not performed or mentioned. The device is a physical catheter.

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

There was no "ground truth" of this nature used. The testing focused on physical and mechanical properties against pre-defined engineering specifications or comparisons to the predicate device.

8. The sample size for the training set

This information is not applicable/available. There was no "training set," as this was non-clinical bench testing of a physical device, not an algorithm.

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

This information is not applicable/available. There was no "ground truth for a training set."

Summary

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4110491

MAR 1 6 201

510(k) Summary Safety and Effectiveness Data Summary

Prepared By:

Pluromed, Inc. 25-H Olympia Avenue Woburn, MA 01801

Telephone Number: Fax Number:

Contact Person:

781.932.0574 419.828.6350

James Wilkie jwilkie@pluromed.com

Date Prepared:

March 7, 2011

BackStop Catheter

Urological Catheter

BackStop Catheter 510(k) Number: K103349

Urological Catheters and Accessories

Proprietary Name: Common Name: Classification Name:

Substantial Equivalence:

Classification: Requlation Number:

876.5130 KOD

Class II

Description of Device:

Product Code:

Intended Use:

Substantial Equivalence:

The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.

The modified device is identical to, and has the same technological characteristics as the predicate device, except for some of the materials of construction and the method of sterilization.

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Results of bench testing have established the device as safe and effective for its intended use, which is identical to that of the predicate device.

Non-Clinical Data:

Pluromed has conducted the following non-clinical performance tests, with samples accelerated aged at T=7 months, T=13 months and T=37 months, in support of the changes in materials and method of sterilization to the proposed BackStop Catheter.

. Catheter hub-to-shaft tensile strength
. Catheter pressure during gel delivery
. Catheter Burst/Leak Pressure
. Catheter Insertion Force
. Catheter Column Strength
. Shaft Tensile Strength
. Catheter Hub Testing

Conclusions: The results of the non-clinical performance tests demonstrate the equivalence of the modified BackStop Catheter to the predicate device. The proposed BackStop Catheter is considered safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle with three lines representing its wings.

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

Mr. James Wilkie Vice President. Operations Pluromed, Inc. 25-H Olympia Avenue WOBURN MA 01801

MAR 1 6 201

Re: K110491

Trade/Device Name: BackStop Catheter Regulation Number: 21 CFR $876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: February 16, 2011 Received: February 22, 2011

Dear Mr. Wilkie:

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 mav 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,

Hubert Lemon 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):

K110491

Device Name: BackStop Catheter

Indications for Use:

Prescription Use V

AND/OR

Over the Counter Use __

(21 CFR 807 Subpart C)

(21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Halet Leum

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110491

Page 1 of 1

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.