(16 days)
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No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI/ML terms or functionalities.
No
The device is a leg bag used for the collection of urine in patients with urinary incontinence. It manages the condition by containing urine but does not treat or alleviate the underlying medical condition of urinary incontinence.
No
Explanation: The device is a leg bag for collecting urine in patients with urinary incontinence. It is a management device, not a diagnostic one, as it does not diagnose or detect a condition.
No
The device description clearly details physical components such as a leg bag, inlet tube, connector, straps, drainage valve, anti-reflux valve, and sample port. It also mentions bench testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the management of urinary incontinence." This describes a device used to collect and manage bodily fluid, not to perform a diagnostic test on a sample of that fluid.
- Device Description: The description details a leg bag for collecting urine, including features like an inlet tube, drainage valve, anti-reflux valve, and sample port. While a sample port is mentioned, its purpose is for collecting a sample, not for the device itself to perform a diagnostic test on that sample.
- Lack of Diagnostic Function: There is no mention of the device analyzing urine or providing any diagnostic information based on the urine collected. IVD devices are designed to perform tests on samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions.
The device is a medical device used for managing a physical condition (urinary incontinence) by collecting and containing urine. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
management of urinary incontinence.
Product codes
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Device Description
ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing which is available in a volume capacity of 500ml. Each non-sterile bag is fitted with a permanently welded adjustable inlet tube with a self-packaged connector which connects to an external catheter. The inlet tube is available in one (1) size, 600mm to accommodate patient preference. Fabric straps are used to secure the leg bag in place. The leg bag 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 connector.
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)
Bench testing performed on ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing included tests for connector strength of attachment, resistance to impact, and for leakage. Additionally, the anti-reflux valve was 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)
ProSys™ Leg Bag (Non-Sterile)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image shows a handwritten number, "K962604", in black ink on a white background. The numbers are written in a bold, slightly stylized font. The number is likely a serial number or some other type of identification code.
510(k) Premarket Notification ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing
ITEM 8: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing which is available in a volume capacity of 500ml. Each non-sterile bag is fitted with a permanently welded adjustable inlet tube with a self-packaged connector which connects to an external catheter. The inlet tube is available in one (1) size, 600mm to accommodate patient preference. Fabric straps are used to secure the leg bag in place. The leg bag 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 connector.
ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing is substantially equivalent to ProSys™ Leg Bag (Non-Sterile). Both devices are indicated for the management of urinary incontinence. Both devices function in the same manner: they collect and contain urine. Both systems are reusable.
The components of ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing have been subjected to extensive biocompatibility testing with results which demonstrate that the components are acceptable for use. One cytotoxic result was noted for the fabric leg bag straps and this result is further explained in Item 5b. All other testing indicates that the components are non-irritating or negligibly irritating, non-sensitizing and non-cytotoxic.
Bench testing performed on ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing included tests for connector strength of attachment, resistance to impact, and for leakage. Additionally, the anti-reflux valve was also tested. All components performed at an acceptable level and the test results appear in Item 5a.
A comparison of the indications for use, the components, functions and characteristics of ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing and the ProSys™ Leg Bag (Non-Sterile) indicates that these products are substantially equivalent
ProSys™
- Trademark of E.R. Squibb & Sons, Inc