(66 days)
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No
The device description and performance studies focus on the physical properties and biocompatibility of a self-adhering external catheter, with no mention of AI or ML.
No
This device is a male external catheter used for managing urinary incontinence, which is a supportive rather than a therapeutic function.
No
Explanation: The device description states it is a "one-piece self-adhering male external catheter" intended for the "management of male urinary incontinence." There is no mention of it being used to diagnose conditions, analyze medical data, or provide diagnostic information.
No
The device description explicitly states it is a "one-piece self-adhering male external catheter," which is a physical hardware device, not software.
Based on the provided information, the ProSys™ SAMEC™ LA is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the management of male urinary incontinence." This describes a device used externally on the body to manage a physical condition, not a test performed on samples taken from the body to diagnose or monitor a disease.
- Device Description: It is described as a "one-piece self-adhering male external catheter." This is a physical device applied to the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The performance studies mentioned focus on the biocompatibility of the materials, which is relevant for a device that comes into contact with the skin, not for an IVD.
N/A
Intended Use / Indications for Use
The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ SAMECTM LA under the ConvaTec ProSys™ product line of incontinence products.
ProSys™ SAMEC™ LA is intended for use in the management of male urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
ProSys™ SAMEC™ LA is not significantly different from other one-piece self-adhering male external catheters used in the management of male urinary incontinence.
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)
Biocompatibility testing demonstrated that the adhesive material used in ProSys™ SAMECTM LA is safe for human use. The adhesive material is non-toxic, non-sensitizing and resulted in a Primary Irritation Index of 0.25, where an index between 0 and 2 is classified as mildly irritating. Typically, any material which results in a Primary Irritation Index of 2 or less can be considered to have passed the Skin Irritation Test. In this case, the Primary Irritation Index of 0.25 is well within the range of acceptable values.
Biocompatibility testing demonstrated that the latex rubber is non-toxic, non-irritating, and non-sensitizing. The latex rubber did not pass Cytotoxicity (Agar Overlay or MEM Elution) testing. These test results are expected due to the fact that latex rubber is the positive control for these tests. According to USP guidelines, dilutions may be performed to determine a material's endpoint if it fails the MEM Elution test initially. The MEM Elution was repeated with a dilution of 1:32 latex rubber and passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Irritation Index of 0.25
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.
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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/1 description: The image shows the text 'K963265' in a handwritten style. Below this, the text 'ProSys™ SAMEC™ LA 510(k) Premarket Notification' is printed in a smaller, more formal font. The text appears to be part of a document or label, possibly related to a product or regulatory submission.
ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ SAMECTM LA under the ConvaTec ProSys™ product line of incontinence products.
ProSys™ SAMEC™ LA is intended for use in the management of male urinary incontinence. This device is not significantly different from other one-piece self-adhering male external catheters used in the management of male urinary incontinence. ProSys™ SAMECTM LA is substantially equivalent to Mentor Urology, Inc.'s Freedom Cath® Self-Adhering Male External Catheter. The indications and contraindications for ProSys™ SAMECTM LA are substantially equivalent to Freedom Cath® and other latex self-adhering male external catheters.
Biocompatibility testing demonstrated that the adhesive material used in ProSys™ SAMECTM LA is safe for human use. The adhesive material is non-toxic, non-sensitizing and resulted in a Primary Irritation Index of 0.25, where an index between 0 and 2 is classified as mildly irritating. Typically, any material which results in a Primary Irritation Index of 2 or less can be considered to have passed the Skin Irritation Test. In this case, the Primary Irritation Index of 0.25 is well within the range of acceptable values.
Biocompatibility testing demonstrated that the latex rubber is non-toxic, non-irritating, and non-sensitizing. The latex rubber did not pass Cytotoxicity (Agar Overlay or MEM Elution) testing. These test results are expected due to the fact that latex rubber is the positive control for these tests. According to USP guidelines, dilutions may be performed to determine a material's endpoint if it fails the MEM Elution test initially. The MEM Elution was repeated with a dilution of 1:32 latex rubber and passed.
The results of all testing are provided in Item 5.
Based upon the above information, ProSys™ SAMEC™ LA is substantially equivalent to Freedom Cath®.