(100 days)
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No
The summary describes a simple external catheter for urine drainage and contains no mention of AI, ML, or any related technologies.
No
A therapeutic device is one that treats a disease or condition. This device is for managing urinary incontinence, which is a symptom and not for treating its underlying cause. It facilitates drainage but does not modify a bodily function or treat a disease.
No
The device is described as an external male catheter for managing urinary incontinence and facilitating urine drainage, which is a therapeutic or management function, not a diagnostic one.
No
The device description clearly states it is an "external male catheter," which is a physical hardware device.
Based on the provided information, the BioDerm® EID® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "management of urinary incontinence in males" and "facilitates urine drainage into a urine collection bag." This describes a device that interacts with the body externally to collect a bodily fluid, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description "MALE EXTERNAL INCONTINENCE DEVICE" further reinforces its external, non-diagnostic nature.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Mentioning any form of analysis or testing of a sample.
Therefore, the BioDerm® EID® is a medical device, but it falls under a different classification than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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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 results of the biocompatibiliy tests show the device to be safe for its intended purpose.
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.
Hollister PolyTech™
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.
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Image /page/0/Picture/1 description: The image shows the word "BIODERM" in a stylized font. The letters are white and have a slightly distressed or textured appearance. The word is set against a black, oval-shaped background, which gives the impression of a logo or brand name. The overall design is simple yet bold, with a focus on the text.
JAN 1 0 1997
EXHIBIT 10.1: BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE
510(k) SUMMARY
Submitted by: Eric Flam, Ph.D. NTL Associates, Inc. East Brunswick, NJ 08816 (908)390-5656 October 1 ,1996
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Device Name: BioDerm® EID® MALE EXTERNAL INCONTINENCE DEVICE
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(a) Indications for Use
The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag. -
(b) Biocompatibility The results of the biocompatibiliy tests show the device to be safe for its intended purpose.
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(c) Substantial Equivalence
The BioDerm® EID® male external catheter is substantially equivalent to the Hollister PolyTech™, non-latex, self-adhesive urinary external catheter predicate device.
BioDerm, Inc. • 11300 49th St. N., Suite B, Clearwater, Fl. 34622 • 813-573-2866 • Fax 813-573-3448