(35 days)
Not Found
No
The device description focuses on the physical components and function of a urinary catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are related to biocompatibility, not algorithmic performance.
No
This device is a catheter used to drain urine from the bladder, which is a diagnostic or assistive function, not a therapeutic treatment for a disease or condition.
No.
The device is described as a urethral urinary catheter used for bladder drainage and urine collection, not for diagnosis.
No
The device description clearly outlines a physical catheter with accessories, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is a medical device used to physically drain urine from the bladder. It is a mechanical intervention, not a test performed on a sample.
- Intended Use: The intended use clearly states "requiring bladder drainage" and "unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode." This describes a therapeutic or management function, not a diagnostic one.
- Device Description: The description details the physical components and how the device is used for drainage. There is no mention of analyzing a sample or providing diagnostic information.
Therefore, the Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
Product codes
78 EZL, EZD
Device Description
The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.
The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.
The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethral, Bladder
Indicated Patient Age Range
male, female and pediatric patients
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)
Mentor has performed biocompatibility testing on the SCHG:
Cytotoxicity (Agar Diffusion – ISO Method): The catheter portion of the test article did not induce cytotoxicity. The introducer tip portion did introduce cytotoxicity; however, the reactivity was less that a Grade 2 (mild reactivity). Therefore, the test article does meet the criteria of this test.
Guinea Pig Maximization (Saline and Vegetable Oil Extracts): There were no signs of sensitization observed in guinea pigs treated with the test article. Therefore, the test article is not considered to elicit contact dermal allergenicity.
Systemic Toxicity (Acute Systemic Injection with Saline and Vegetable Oil Extracts: The test article met the requirements of the systemic injection test.
Acute Vaginal Irritation: The test article meets the requirements of the vaginal irritation test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
OCT 1 1 2005
Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92
The assigned 510(k) number is: K052440
| Contact Person: | Donna A. Crawford
Director, Domestic Regulatory Submissions
Mentor Corporation
201 Mentor Drive
Santa Barbara, CA 93111 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:
FAX: | 805-879-6304
805-879-6015 |
December 30, 2004 Date Prepared:
Device Name and Classification
| Trade Name: | Mentor Self-Cath® Hydrogel™ Intermittent Urethral
Urinary Catheter |
|----------------------|-----------------------------------------------------------------------|
| Common Name: | Urinary Catheter |
| Classification Name: | Urological Catheter and Accessories |
| Product Code: | 78 EZL |
Manufacturer
Mentor Minnesota 1601 West River Road North Minneapolis, MN 55411
Device Description
The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.
The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and
1
potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.
The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.
Substantial Equivalence Claim
Mentor Corporation believes the proposed Mentor SCHG is substantially equivalent in form and function to Mentor's Self-Cath Plus Catheter and the Self-Cath Closed System, which were cleared under 510(k)s K003874 and K003873, respectively.
Indications for Use
The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
Summary of Testing
Mentor has performed biocompatibility testing on the SCHG:
Cytotoxicity (Agar Diffusion – ISO Method): The catheter portion of the test article did not induce cytotoxicity. The introducer tip portion did introduce cytotoxicity; however, the reactivity was less that a Grade 2 (mild reactivity). Therefore, the test article does meet the criteria of this test.
Guinea Pig Maximization (Saline and Vegetable Oil Extracts): There were no signs of sensitization observed in guinea pigs treated with the test article. Therefore, the test article is not considered to elicit contact dermal allergenicity.
Systemic Toxicity (Acute Systemic Injection with Saline and Vegetable Oil Extracts: The test article met the requirements of the systemic injection test.
Acute Vaginal Irritation: The test article meets the requirements of the vaginal irritation test.
2
Image /page/2/Picture/2 description: The image shows a logo with the words "Department of Health" written around the perimeter of a circle. Inside the circle is a symbol that appears to be three curved lines that are stacked on top of each other. The logo is black and white.
OCT 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna A. Crawford Director, Domestic Regulatory Submissions Mentor Corporation 201 Mentor Drive SANTA BARBARA CA 93111
Re: K052440
Trade/Device Name: Mentor Self-Cath® HydroGel™ Intermittent Urinary Catheter Regulation Number: 21 CFR $876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: September 23, 2005 Received: September 26, 2005
Dear Ms. Crawford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yours of substantial equivalence of your device to a legally prematics notification: "The FDF milling ------------------------------------------------------------------------------------------------------------------------------------proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acries for your are of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, proase note togetting the regulation on your responsibilities under the Act from the 807.37). " Ou may ootan other gallerial and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
KOS2440
Device Name: Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter
Indications For Use:
The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symons
(Division Sign. Off.)
(Division Sign-Off) Division of Reproductive, and Radiological De 510(k) Number
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