K Number
K103349
Device Name
BACKSTOP CATHETER
Manufacturer
Date Cleared
2011-01-07

(52 days)

Product Code
Regulation Number
876.5130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 Pluromed 3F BackStop™ Catheter is a 100 cm, 3F, single lumen, radiopaque catheter that facilitates access to the urinary tract. The catheter may be inserted over a guidewire or through the working channel of an ureteroscope and is advanced through the urinary tract to the desired location in the ureter. Once in place fluid or gels, such as BackStop™, 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.
More Information

No
The summary describes a physical catheter and its intended use for accessing the urinary tract. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.

No.
The device facilitates access to the urinary tract and allows for injection of gels or fluid; it does not directly treat a disease or condition for therapeutic benefit.

No

The device is described as facilitating access to the urinary tract for injection of fluids or gels, not for diagnosing conditions.

No

The device description clearly describes a physical catheter, which is a hardware component, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to facilitate access to the urinary tract and inject substances. This is a therapeutic or procedural use, not a diagnostic one.
  • Device Description: The description details a catheter used for physical access and delivery of substances within the body. This aligns with a medical device used for intervention, not for analyzing samples outside the body.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are specifically designed for these purposes.

Therefore, the 3F BackStop Catheter is a medical device used for a procedural purpose within the urinary tract, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Pluromed 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.

Product codes

78 KOD

Device Description

The Pluromed 3F BackStop™ Catheter is a 100 cm, 3F, single lumen, radiopaque catheter that facilitates access to the urinary tract. The catheter may be inserted over a guidewire or through the working channel of an ureteroscope and is advanced through the urinary tract to the desired location in the ureter. Once in place fluid or gels, such as BackStop™, 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urinary tract, ureter

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K090270

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Section 5. 510(k) Summary

Safety and Effectiveness Data Summary
JAN - 7 2011

Prepared By:Pluromed Inc.
25-H Olympia Avenue
Woburn, MA 01801
Telephone Number:781-932-0574
Fax Number:419-828-6350
Contact Person:James Wilkie
jwilkie@pluromed.com
Proprietary Name:3F BackStop™ Catheter
Classification Name:Urological Catheters and Accessories
Common Name:Urological Catheter
Classification:Class II
Regulation Number:876.5130
Product Code:78 KOD

Indications for Use The Pluromed 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.

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

1

K103349

Recognition Number 2-98: AAMI / ANSI / ISO 10993-1:2009(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 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: Pluromed BackStop™ Catheter, K090270.

Description of Device: The Pluromed 3F BackStop™ Catheter is a 100 cm, 3F, single lumen, radiopaque catheter that facilitates access to the urinary tract. The catheter may be inserted over a guidewire or through the working channel of an ureteroscope and is advanced through the urinary tract to the desired location in the ureter. Once in place fluid or gels, such as BackStop™, 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.

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which 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

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

JAN - 7 2011

Re: K103349

Trade/Device Name: 3F BackStop Catheter Regulation Number: 21 CFR 8876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: KOD Dated: November 12, 2010 Received: November 16. 2010

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 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 CFFR 1000-0050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers0ffices/CDRHOffices/ucm1727 Cr KT for for for for 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default:htm.

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

Sincerely yours,

Hubert Humphrey

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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K103349

JAN - 7 2011

Section 4. Indications for Use

510(k) Number (if known):

Device Name: 3F BackStop Catheter

Indications for Use:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

AND/OR

8

Over the Counter Use _

(21 CFR 807 Subpart C)

(21 CFR 801 Subpart D)

Arni Bi-Wiao

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103349