(22 days)
Not Found
No
The document describes a simple catheter and its mechanical properties, with no mention of AI or ML.
No.
The device's stated indication is for facilitating access and injection into the urinary tract, not for directly treating a disease or condition. It is an access device, not a therapeutic one.
No
The device is described as a catheter used for facilitating access to the urinary tract and for injecting gels or fluids, which are procedural and therapeutic functions, not diagnostic.
No
The device description clearly describes a physical catheter with a lumen, radiopaque tip, stainless steel braid, and luer lock hub, indicating it is a hardware 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 for the injection of gels or fluid. This is a procedural device used within the body, not for testing samples outside the body.
- Device Description: The description details a catheter for insertion into the urinary tract. This aligns with a medical device used for intervention or access, not for diagnostic testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine, blood, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and for delivery.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KOD
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.
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)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 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.
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.
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.
1
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.
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 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
3
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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
4
Indications for Use
510(k) Number (if known):
Device Name: 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.
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)
g
Halet Leum
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110491
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