(83 days)
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No
The device description and performance studies focus on the physical properties and safety of a mechanical prosthesis and removal tool, with no mention of software, algorithms, or data processing.
Yes
The device is indicated for the "temporary management of genuine stress urinary incontinence," which is a therapeutic purpose.
No
This device is a prosthesis designed for the temporary management of genuine stress urinary incontinence, not for diagnosing medical conditions.
No
The device description clearly outlines physical components: a prosthesis made of silicone elastomer and a removal tool made of polypropylene and titanium dioxide. This indicates a hardware-based medical device, not a software-only one.
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 "temporary management of genuine stress urinary incontinence." This describes a physical intervention to support the bladder neck, not a test performed on a sample from the body to diagnose or monitor a condition.
- Device Description: The device is a physical prosthesis inserted into the vagina and a tool for its removal. This is a mechanical device, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) to provide physical support.
N/A
Intended Use / Indications for Use
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is indicated for the temporary management of genuine stress urinary incontinence.
Product codes
85HHW
Device Description
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is identical in all aspects to INTROL* Bladder Neck Support Prosthesis except for the Removal Tool. The Removal Tool is a rod shaped device, about 7 inches in length with a hook at one end and a handle at the opposite end. The handle is marked with a flat surface about 0.25 inch in width and 4 slightly elevated rings, each about 1 inch apart. The flat handle surface is on the same side of the tool as the open portion of the hook. This configuration indicates the direction of the functioning portion of the hook. The rings are present to enhance the grip of the tool and to enable the user to gauge the depth of the tool once it enters the vagina. The hook is designed to easily engage the front portion of the INTROL * Prosthesis's ring. The Removal Tool surface is smooth. The Removal Tool is composed of high density polypropylene and titanium dioxide pigment. INTROL* Bladder Neck Support Prosthesis is made from a medical grade silicone elastomer. The prosthesis is circular and symmetrically shaped with a central aperture and two ridges.
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
Safety tests demonstrate that INTROL* Bladder Neck Support Prosthesis with Removal Tool is non-sensitizing, and non-irritating and suitable for its intended use.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).
0
MAR 1 0 1997
510(k) - INTROL* Bladder Neck Support Prosthesis with Removal Tool
510(k) SUMMARY
page 1 of 2
INTROL* Bladder Neck Support Prosthesis with Removal Tool
1. DATE PREPARED
December 16, 1996
2. SUBMITTER
Johnson & Johnson Medical, Inc. 2500 Arbrook Boulevard, P.O. Box 90130 Arlington, Texas 76004-3130
3. CONTACT
Ralph H. Larsen., (817)784-4993 Sr. Project Manager, Regulatory Affairs
4 NAME OF THE MEDICAL DEVICE
Classification name: Pessary, vaginal Common/usual name: Vaginal Pessary INTROL* Bladder Neck Support Prosthesis with Removal Tool Proprietary name:
ડ. DEVICE CLASSIFICATION
The INTROL* Bladder Neck Support Prosthesis with Removal Tool has been classified by the FDA under the heading of Vaginal Pessary 85HHW as a Class II device.
STATEMENT OF SUBSTANTIAL EQUIVALENCE 6.
INTROL * Bladder Neck Support Prosthesis with Removal Tool is substantially equivalent and identical in function to INTROL Bladder Neck Support Prosthesis marketed by Johnson & Johnson Medical, Inc.
7. INDICATIONS FOR USE
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is indicated for the temporary management of genuine stress urinary incontinence.
PHYSICAL DESCRIPTION 8.
The INTROL* Bladder Neck Support Prosthesis with Removal Tool is identical in all aspects to INTROL* Bladder Neck Support Prosthesis except for the Removal Tool. The Removal Tool is a rod shaped device, about 7 inches in length with a hook at one end and a handle at the opposite end. The handle is marked with a flat surface about 0.25 inch in width and 4 slightly elevated rings, each about 1 inch apart. The flat handle surface is on the same side of the tool as the open portion of the hook. This configuration indicates the direction of the functioning portion of the hook. The rings are present to enhance the grip of the tool and to enable the user to gauge the depth of the tool once it enters the vagina. The hook is designed to easily engage the front portion of the INTROL * Prosthesis's ring. The Removal Tool surface is smooth. The Removal Tool is composed of high density polypropylene and titanium dioxide pigment.
1
INTROL* Bladder Neck Support Prosthesis is made from a medical grade silicone elastomer. The prosthesis is circular and symmetrically shaped with a central aperture and two ridges.
BIOCOMPATIBILITY 7.
Safety tests demonstrate that INTROL* Bladder Neck Support Prosthesis with Removal Tool is non-sensitizing, and non-irritating and suitable for its intended use.