(39 days)
Bard® Urinary Drainage Bag with Anti-reflux Chamber
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No
The device description and performance studies focus on the physical characteristics and functionality of a urinary drainage bag, with no mention of AI or ML.
No
The device is described as a "Bedside Drainage Bag" indicated for the collection of urinary drainage. It does not actively treat or alleviate a medical condition; its primary function is containment.
No
Explanation: The device is a urine collection bag designed for drainage, not for identifying a disease or condition. Its functions include collection, preventing backflow, and allowing urine sampling, which are related to management rather than diagnosis.
No
The device description clearly describes a physical bag, tubing, valves, and connectors, indicating it is a hardware device for collecting urinary drainage.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the collection of free flowing urinary drainage." This describes a device used to collect a biological sample (urine) from the body, not a device used to perform a test on a biological sample in vitro (outside the body).
- Device Description: The description details a collection bag, tubing, valves, and a sample port. These are components for collecting and managing urine drainage, not for performing diagnostic tests on the urine itself.
- Lack of Diagnostic Function: There is no mention of any component or function that analyzes the urine or provides diagnostic information. The sample port is for collecting a sample, which could then be used for an IVD test, but the bag itself is not performing the test.
- Performance Studies: The performance studies focus on the physical integrity and function of the bag (bursting, impact, leakage, valve function, tensile strength, weld integrity), which are relevant to a collection device, not a diagnostic device.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is solely for collection.
N/A
Intended Use / Indications for Use
Both devices are indicated for use in the collection of free flowing urinary drainage. Both devices function in the same manner: they collect and contain urine.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each stèrile bag is fitted with a permanently welded 55 inch inlet tube containing a universal connector which connects to an indwelling or external catheter. The Bedside Drainage Bag (Sterile) has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and, a sample port used for urine sampling is integrated into the universal connecter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The components of ProSys™ Bedside Drainage Bag (Sterile) have been subjected to extensive biocompatibility testing with results which demonstrate that the components are acceptable for use. All testing indicates that the components are non-irritating, non-sensitizing and non-cytotoxic.
Process validation testing performed on ProSys™ Bedside Drainage Bag (Sterile) included tests for resistance to bursting, resistance to impact, and for leakage. Additionally, the anti-reflux valve, tensile strength and outline weld integrity were also tested. All components performed at an acceptable level and the test results appear in Item 5a.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Bard® Urinary Drainage Bag with Anti-reflux Chamber
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.
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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).
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§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/0 description: The image shows the text "K960949 510(k) Premarket Notification ProSys™ Bedside Drainage Bag (Sterile)". The text "K960949" is in a larger font size than the rest of the text. The text "510(k) Premarket Notification" is below the text "K960949". The text "ProSys™ Bedside Drainage Bag (Sterile)" is below the text "510(k) Premarket Notification".
APR 1 9 1996
ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ Bedside Drainage Bag (Sterile). ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each stèrile bag is fitted with a permanently welded 55 inch inlet tube containing a universal connector which connects to an indwelling or external catheter. The Bedside Drainage Bag (Sterile) has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and, a sample port used for urine sampling is integrated into the universal connecter.
ProSys™ Bedside Drainage Bag (Sterile) is substantially equivalent to Bard® Urinary Drainage Bag with Anti-reflux Chamber. Both devices are indicated for use in the collection of free flowing urinary drainage. Both devices function in the same manner: they collect and contain urine.
The components of ProSys™ Bedside Drainage Bag (Sterile) have been subjected to extensive biocompatibility testing with results which demonstrate that the components are acceptable for use. All testing indicates that the components are non-irritating, non-sensitizing and non-cytotoxic.
Process validation testing performed on ProSys™ Bedside Drainage Bag (Sterile) included tests for resistance to bursting, resistance to impact, and for leakage. Additionally, the anti-reflux valve, tensile strength and outline weld integrity were also tested. All components performed at an acceptable level and the test results appear in Item 5a.
comparison of the indication for use, the components, functions and র্ব characteristics of ProSys™ Bedside Drainage Bag (Sterile) and the Bard® Urinary Drainage Bag with Anti-reflux Chamber indicates that these products are substantially equivalent.
ProSys™ -Trademark of E. R. Squibb & Sons, Inc. Bard®Dispoz-A-Bag® -Registered Trademark of C.R. Bard, Inc. Flip-Flo™ -Registered Trademark of C.R. Bard, Inc.