The 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 fluid into the urinary tract.

Device Description

The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter 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 text describes the BackStop Catheter and outlines its substantial equivalence to a predicate device based on performance standards and a description of the device itself. However, it does not contain a study that establishes specific acceptance criteria for device performance or provides data on how the device meets those criteria.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or details about a comparative effectiveness study.

Here's what I can extract from the provided text about the device and its regulatory submission:

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

This information is not present in the provided document. The document lists performance standards related to packaging, biological evaluation, and sterilization, which are general manufacturing and safety standards, not specific performance criteria for the device's function (e.g., access facilitation, fluid injection).

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

This information is not present in the provided document. The document describes the device and its indications but does not offer any data from a test set.

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 present in the provided document. There is no mention of a test set or ground truth establishment.

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

This information is not present in the provided document. There is no mention of any test set or adjudication.

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 present in the provided document. The BackStop Catheter is a urological catheter, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with human readers and AI assistance would not be applicable.

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

This information is not present in the provided document. As a physical medical device, the concept of "standalone algorithm only" performance does not apply.

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

This information is not present in the provided document. No ground truth is mentioned.

8. The sample size for the training set:

This information is not present in the provided document. No training set is mentioned as this is a physical medical device, not an AI model.

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

This information is not present in the provided document. No training set or ground truth for it is mentioned.

Summary of what is available in the text:

Proprietary Name: BackStop Catheter
Classification Name: Urological Catheters and Accessories
Common Name: Urological Catheter
Classification: Class II
Regulation Number: 876.5130
Product Code: KOD
Indications for Use: "The 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 fluid into the urinary tract."
Description of Device: "The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter 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."
Performance Standards (General Device Manufacturing/Safety):
- AAMI / ANSI / ISO 11607-1:2006 (Packaging)
- AAMI / ANSI / ISO 10993-1:2003(E) (Biological evaluation)
- AAMI / ANSI / ISO 11137-1:2006 (Sterilization - development, validation)
- AAMI / ANSI / ISO 11137-2:2006 (Sterilization - dose)
Predicate Device: Imager II Urology Torque Catheter (510(k) Number: K011965)

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of indications, technological characteristics, and conformance to recognized safety and manufacturing standards, rather than providing detailed clinical study results with specific performance thresholds.

Summary

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510(k) Summary Safety ad Effectiveness Data Summary

Prepared By:

Telephone Number: Fax Number:

Contact Person:

Proprietary Name: Classification Name: Common Name:

Classification: Regulation Number: Product Code:

Indications for Use:

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

781-932-0574 419-828-6350

James Wilkie jwilkie@pluromed.com

BackStop Catheter Urological Catheters and Accessories Urological Catheter

Class II 876.5130 78 KOD

Performance Standards:

Recognition Number 14-193: AAMI / ANSI / ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, 3ed.

Recognition Number 2-98: AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices -- Part 1: Evaluation and testing.

Recognition Number 14-224: AAMI / ANSI / ISO 11137-1:2006, Sterilization of health care

MAY 15 2009

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products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

Recognition Number 14-225: AAMI / ANSI / ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.

Substantial Equivalence:

Description of Device:

Imager II Urology Torque Catheter Urological Catheter 510(k) Number: 011965

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.

MAY 15 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090270

Trade/Device Name: BackStop Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: May 4, 2009 Received: May 6, 2009

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 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 (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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

[signature]

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K090270 510(k) Number (if known):

Device Name: BackStop Catheter

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X : (21 CFR 801 Subpart D)

AND/OR

Over the Counter Use

(21 CFR 807 Subpart C)

hymn Dathan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

01 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.