(52 days)
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 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.
This document is a 510(k) summary for the Pluromed 3F BackStop™ Catheter, a urological catheter. It asserts substantial equivalence to a predicate device and outlines performance standards met. However, it does not contain the kind of detailed information about acceptance criteria, specific device performance against those criteria, or the methodology of a study with sample sizes, expert qualifications, or ground truth establishment that would be expected for an AI/ML medical device.
Therefore, many of your requested points cannot be answered from the provided text. This document is a regulatory submission for a physical medical device, not a software or AI/ML device, and thus the type of studies and data provenance you're asking for are not applicable or present here.
Here's what can be extracted based on the provided text, with notes indicating where information is absent for an AI/ML context:
Acceptance Criteria and Device Performance (Not applicable for physical device, but can list standards met)
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| AAMI / ANSI / ISO 11607-1:2006 (Packaging for terminally sterilized medical devices) | Complies (Implied by 510(k) clearance) |
| AAMI / ANSI / ISO 10993-1:2009(E) (Biological evaluation of medical devices) | Complies (Implied by 510(k) clearance) |
| AAMI / ANSI / ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1) | Complies (Implied by 510(k) clearance) |
| AAMI / ANSI / ISO 11137-2:2006 (Sterilization of health care products - Radiation - Part 2) | Complies (Implied by 510(k) clearance) |
Note: For an AI/ML device, this table would typically contain specific performance metrics (e.g., sensitivity, specificity, AUC) and the thresholds for acceptance for those metrics. The provided document details compliance with general medical device standards, not AI-specific performance metrics.
Study Details (Information Not Provided for AI/ML context)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information not provided. This document is for a physical medical device, not an AI/ML product. The 510(k) focuses on substantial equivalence to a predicate device based on design, materials, and intended use, and compliance with general device standards, not a clinical study to evaluate AI performance on a test set.
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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):
- Information not provided. This concept is not applicable to the 510(k) submission for this physical device.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information not provided. This concept is not applicable to the 510(k) submission for this physical device.
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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:
- Information not provided. This is not an AI/ML device; therefore, an MRMC study related to AI assistance would not have been conducted or reported here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information not provided. This is not an AI/ML device, so standalone algorithm performance is not relevant.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information not provided. This concept is not applicable to the 510(k) submission for this physical device. The "truth" for this device would relate to its physical properties, biocompatibility, and functionality as a catheter, which are assessed against engineering standards and bench testing, not against medical ground truth for diagnosis/prognosis.
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The sample size for the training set:
- Information not provided. This is not an AI/ML device; a "training set" doesn't apply.
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How the ground truth for the training set was established:
- Information not provided. This is not an AI/ML device; "ground truth for training" doesn't apply.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (a urological catheter). It outlines standard compliance and claims substantial equivalence to a predicate device (K090270). The questions you've asked are specifically tailored for AI/ML-driven medical devices, and the nature of the traditional medical device submission provided here does not contain such information.
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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.
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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.
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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 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
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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 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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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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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
§ 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.