(187 days)
Bard® Touchless® Plus Unisex Intermittent Catheter, MMG/O'Neil® Sterile Field Urinary Intermittent Catheter System
No
The summary describes a mechanical catheter system and does not mention any AI or ML components or functions.
No.
Therapeutic devices are used to treat or alleviate a medical condition, whereas this device is used for drainage and collection of urine, which is a supportive rather than therapeutic function in itself.
No
The device is described as a catheter system used to drain and collect urine, not to diagnose a condition.
No
The device description clearly states it is a sterile, disposable device composed of physical components: an introducer, drainage catheter, and urine collection bag. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- UNI-GARD QUIK CATH™ function: The UNI-GARD QUIK CATH™ is a device used to drain urine from the bladder and collect it. It is a physical device inserted into the body for a therapeutic purpose (draining the bladder) and a collection purpose. It does not perform any testing or analysis of the urine itself to diagnose a condition.
The description clearly indicates it's a catheter system for urine drainage and collection, which falls under the category of medical devices used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The UNI-GARD QUIK CATH™ is indicated for use to drain urine from the bladder and collect the urine from the bladder in a bag. uthe UNI-GARD QUIK CATH™ is a unisex intermittent unitized catheter system.
Product codes
Not Found
Device Description
The UNI-GARD QUIK CATH™ is a sterile, disposable device composed a introducer with lubricant, drainage catheter and urine of collection bag. The introducer containing the lubricant is pressed into the urethral meates until it stops. The catheter is advanced through the introducer and reservoir of lubricant while perforating the introducer tip to enter the urethra. The catheter is advanced until it reaches the bladder and urine begins to flow through the catheter into the urinary collection baq.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra, urethral meatus, urethral canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Bard® Touchless® Plus Unisex Intermittent Catheter, MMG/O'Neil® Sterile Field Urinary Intermittent Catheter System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
NOV 1 9 1996
SPECTRUM MedSystems Corporation 81n3 UNI-GARD QUIK CATH™ 510(K) Notification
SPECTRUM MedSystems Corporation
2166 Michelson Drive Irvine, CA 92715 Telephone 714/442-8400
Fax 714/442-8410
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Submitter:
SPECTRUM MedSystems Corporation 2166 Michelson Drive Irvine, California 92715
Contact Name: Thomas L. Hursman (714) 442-8410 Fax Number: Phone Number: (714) 442-8400
Date: May 6, 1996
UNI-GARD QUIK CATH™ Name of Device: Common Name : Intermittent Urinary Catheter Classification Name: Urological Catheter and Accessories (21 CFR 876.5130)
The legally marketed devices to which SPECTRUM MedSystems İs claiming equivalence[807.92(a)(3)] is the Bard® Touchless® Plus Unisex Intermittent Catheter and the MMG/O'Neil® Sterile Field Urinary Intermittent Catheter System.
Description of the Device [807.92(a) (4)].
The UNI-GARD QUIK CATH™ is a sterile, disposable device composed a introducer with lubricant, drainage catheter and urine of collection bag. The introducer containing the lubricant is pressed into the urethral meates until it stops. The catheter is advanced through the introducer and reservoir of lubricant while perforating the introducer tip to enter the urethra. The catheter is advanced until it reaches the bladder and urine begins to flow through the catheter into the urinary collection baq.
Intended Use of the Device [807.92(a)(5)].
The UNI-GARD QUIK CATH™ is indicated for use to drain urine from the bladder and collect the urine from the bladder in a bag. uthe UNI-GARD QUIK CATH™ is a unisex intermittent unitized catheter system.
Technological Characteristics of Device Versus Predicate Device [807.92(a) (6) ] .
The basic clinical approach to bladder drainage using the UNI-GARD QUIK CATH™ and the predicate devices is the same. The Bard and MMG products use a catheter, urinary drainage bag, KY Jelly as the lubricate on exterior of the catheter and in the cap, a insertion tip or introducer tip and removable cover guard or catheter cap to form their catheter system. The design improvements over the predicate devices have been aimed at simplifying the designs,
1
K961906 PLO 3
SPECTRUM MedSystems Corporation UNI-GARD QUIK CATH™ 510(K) Notification
extending the shelf life, improvinq the erqonomics of the user when introducing the urine drainage catheter into the urethra, enlarqing the urine collection bag to accommodate the largest of bladder drainage and increasing the length of the catheter to allow complete discharqe of the bladder.
The UNI-GARD QUIK CATH™ design is simpler by eliminating the need for a removable protective guard or cap. The protective cap on the predicate devices is filled with gel lubricant and when dropped accidently by the user can contaminant the gel used to lubricate the introducer. The sealed catheter introducer used in the UNI-GARD QUIK CATH™ has been designed to eliminate this possibility of contamination by functioning as a lubricate reservoir, a sterile barrier and a introducer. The catheter introducer places a thin medical grade lubricant film onto the catheter as it passes through the introducer lubricant reservoir. The predicate devices are prelubricated with large amounts of gel material deposited on the exterior of the catheter that ends up in the urethra meatus and urethral canal. The distal tip of the SPECTRUM catheter introducer is punctured by the catheter as it advances through the sealed catheter introducer tip. The tip seal on the introducer is broken
after the introducer tip positions the catheter in the urethra. The catheter penetrated the distal urethra and bypasses contact with the urethral meatus to reduce the risk of infection.
Reducing the number of parts making up a medical device improves ergonomics and the ease-of-use. the UNI-GARD QUIK CATH™ accomplishes this objective with the eliminate of the cap and bag retainer ring used in constructing the predicate devices.
Extending the shelf life of the pre-lubricated predicate device products will be accomplished by substituting Medical Grade Dow Corning Polydimethylsiloxene lubricant for the traditional KY Jelly. The KY Jelly has a basic composition of chlorhexidine gluconate, glucono delta lactone, glycerin, hydroxyethyl cellulose, methyl parabin, water and sodium hydroxide. The gel is basically a water miscible gel of hydroxyethyl cellulose and upon sitting in a Tyvek pouch over time, the water evaporates and the hydroxyethyl cellulose precipitates as a powder. KY Jelly, once a lubricant then, converts to a grit after dehydration.
The UNI-GARD QUIK CATH™ contains the Polydimethylsiloxene lubricant within the pre-lubrication and primary reservoirs of the catheter introducer. The catheter and introducer when assembled together create a reservoir which resists desiccation and provide several years of shelf-life in dry storage (Refer to Attachment 2). This is in contrast to drainage catheter assemblies, such as the present predicate devices which have utilized water-based lubricants such as KY Jelly having shelf storage lives in dry storage of less then one year.
2
1961906 Por 3 SPECTRUM MedSystems Corporation UNI-GARD QUIK CATH™ 510(K) Notification
The UNI-GARD QUIK CATH™ will use a 1800 cc collection bag rather than an 1100 cc or 1500 cc bag as used by the predicate devices. This will eliminate the use of a second catheter system to perform the additional drainage of the largest of bladders. The catheter length has also been increased by three inches to a final length of 20 inches to allow complete drainage of the bladder.