(100 days)
Not Found
No
The 510(k) summary describes a physical catheter device and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device facilitates access and fluid injection for diagnostic or interventional purposes but does not directly treat a medical condition or restore function.
No
The device description states its purpose is to facilitate access to the urinary tract and for fluid injection, which are therapeutic or procedural functions, not diagnostic ones. There is no mention of it being used to identify or analyze a disease or condition.
No
The device description clearly states it is a physical catheter, a hardware component, and does not mention any software functionality.
Based on the provided information, the BackStop Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "facilitating access to the urinary tract" and for "injection of fluid into the urinary tract." This describes a device used within the body for a procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a catheter designed for insertion into the urinary tract, either over a guidewire or through an endoscope. This is a physical medical device used for access and delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (like urine, blood, etc.), performing tests, or providing diagnostic information based on the analysis of these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BackStop Catheter does not fit this description.
N/A
Intended Use / 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.
Product codes
KOD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract
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)
Imager II Urology Torque Catheter Urological Catheter 510(k) Number: 011965
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
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
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.
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
1
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 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.
2
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.
3
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
4
Indications for Use
K090270 510(k) Number (if known):
Device Name: BackStop Catheter
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.
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