(80 days)
No
The device description details a physical, disposable catheter system with a lubricating coating, and there is no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is used for bladder drainage, which is a therapeutic purpose to relieve or manage a medical condition.
No
The device is described as assisting with bladder drainage (therapeutic), not for diagnosing conditions.
No
The device description clearly states it is a physical system consisting of a catheter, saline solution, and collection bag. It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for intermittent catheterization for the purpose of bladder drainage." This is a direct intervention on the patient's body for a therapeutic purpose (draining the bladder).
- Device Description: The device is a catheter system used to physically insert into the urethra and bladder.
- Anatomical Site: The anatomical sites are the urethra and bladder, which are internal to the patient's body.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. This device does not involve the analysis of any such specimens.
The Conveen® EasiCath Set is a medical device used for a therapeutic procedure, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of bladder drainage.
Product codes (comma separated list FDA assigned to the subject device)
78 EZD, 78 KNX
Device Description
The Conveen® EasiCath Set is a single use, disposable system that consists of a sterile polyvinylchloride intermittent catheter, coated with polyvinvlovrrolidone, and a sterile saline solution ampoule all sealed in a urine collection bag. The user twists open the saline ampoule inside the bag and soaks the catheter for 30 seconds. Once wet, the polyvinylpyrrolidone layer binds water molecules to the surface of the catheter creating a smooth lubricating film. The bag is opened and the catheter is inserted into the patent's urethra. The catheter itself is the same design and materials as our current non-coated Conveen® Intermittent Catheters, K896729.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A summary of the safety testing performed on the final sterile PVP coated catheter is listed below:
| Test | Conclusion |
|---|---|
| Intracutaneous Test | No difference in skin reaction was observed at the injection sites of the extracts or the control solutions. Passed the Intracutaneous Test according to USP XXII requirements. |
| Systemic Injection Test | No signs of toxicity were observed in the mice treated with the extract or the control solution. Passed the Systemic Injection Test according to USP XXII requirements |
| Mutagenicity Ames Test | The extracts induced no increase in the number of revertants as compared to the controls. Thus, no detectable mutagenic activity was found of the extracts in the Ames test. |
| Sensitization Guinea Pig Maximization Test | No evidence of delayed contact hypersensitivity was seen after treatment with the extract or the control solution. |
| Cytotoxicity elution Test (L 929 cells) | Passed the Elution Test according to USP XXII requirements (cytotoxicity grade |
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
510(k) Summary Conveen® EasiCath Set
K973076
144
NOV - 6 1997
Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249 Date: August 15, 1997
1. Contact Person
Ms. Sydney Lilly, (770) 426-6362
2. Name of the Medical Device
Classification name: Common/usual name: Proprietary name:
Urological catheter and accessories Intermittent Catheter Conveen® EasiCath Set
3. Device Classification
The Conveen® EasiCath Set has been classified by the FDA under the heading of Urological catheter and accessories as a Class II device.
4. Statement of Substantial Equivalence
The Conveen® EasiCath Set is substantially equivalent to the O'Neil Urinary Catheterization System™ manufactured by Medical Marketing Group, Inc. K910022.
5. Intended Use
The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of bladder drainage.
6. Description of Device
The Conveen® EasiCath Set is a single use, disposable system that consists of a sterile polyviny|chloride intermittent catheter, coated with polyvinvlovrrolidone, and a sterile saline solution ampoule all sealed in a urine collection bag. The user twists open the saline ampoule inside the bag and soaks the catheter for 30 seconds. Once wet, the polyvinylpyrrolidone layer binds water molecules to the surface of the catheter creating a smooth lubricating film. The bag is opened and the catheter is inserted into the patent's urethra. The catheter itself is the same design and materials as our current non-coated Conveen® Intermittent Catheters, K896729.
1
.
1-
:
510(k) Summary Conveen® EasiCath Set
A comparison Matrix for the EasiCath Set versus the Medical Marketing Group, Inc. O'Neil Urinary Catheterization System™ is presented below.
| | Conveen® EasiCath Set | Medical Marketing Group, Inc.
O'Neil Urinary Catheterization
System™ |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K910022 |
| Device
composition | Polyvinylchloride catheter
coated with
polyvinylpyrrolidone, and
sterile saline solution
sealed in a urine collection
bag. | Polyvinylchloride catheter
coated with silicone sealed in
a urine collection bag. |
| Sizes | Female Straight Ch. 8, 10,
12, & 14.
Nelaton Ch. 8,10, 12, 14,
16, & 18.
Pediatric Ch. 6, 8, & 10. | Female Straight - Sizes 6,
8,10, 12, 14, & 16 FR. |
| Function of
device | Inserted into urethra
through urinary tract till
catheter reaches bladder
and allows urine to drain. | Inserted into urethra through
urinary tract till catheter
reaches bladder and allows
urine to drain. |
| Indication for
use | For intermittent
catheterization for the
purpose of bladder
drainage. | For intermittent catheterization
for the purpose of bladder
drainage. |
| Features of
device | Coated catheter and
saline ampoule sealed in
urine collection bag. | Silicone coated catheter
sealed in urine collection bag
with silicone applicator tip. Kit
includes povidone iodine
swabs, gloves, underpad and
tissue. |
| Sterilization | Sterile | Sterile |
| Packaging | Peel Pack | Peel Pack |
・
・.
2
510(k) Summary Conveen® EasiCath Set
Summary of Safety Testing 7.
A summary of the safety testing performed on the final sterile PVP coated catheter is listed below:
| Test | Conclusion |
|---|---|
| Intracutaneous | |
| Test | No difference in skin reaction was observed at the |
| injection sites of the extracts or the control solutions. | |
| Passed the Intracutaneous Test according to USP XXII | |
| requirements. | |
| Systemic Injection | |
| Test | No signs of toxicity were observed in the mice treated |
| with the extract or the control solution. Passed the | |
| Systemic Injection Test according to USP XXII | |
| requirements | |
| Mutagenicity Ames | |
| Test | The extracts induced no increase in the number of |
| revertants as compared to the controls. Thus, no | |
| detectable mutagenic activity was found of the extracts | |
| in the Ames test. | |
| Sensitization | |
| Guinea Pig | |
| Maximization Test | No evidence of delayed contact hypersensitivity was |
| seen after treatment with the extract or the control | |
| solution. | |
| Cytotoxicity elution | |
| Test (L 929 cells) | Passed the Elution Test according to USP XXII |
| requirements (cytotoxicity grade |