(74 days)
No
The device description and performance studies focus on the physical properties and performance of a catheter, with no mention of AI or ML.
Yes
The device is described as a "Urology Catheter" intended "to provide an intermittent pathway for draining fluids from the bladder," which is a therapeutic function.
No
Explanation: The device description states its intended use is for "draining fluids from the bladder," which describes a therapeutic or interventional function, not a diagnostic one. There is no mention of it being used to analyze or detect medical conditions.
No
The device description clearly outlines physical components like a PVC catheter tube, PTFE sheath membrane, polyurethane snap ring, and polycarbonate/acrylic guide ring, indicating it is a hardware device.
Based on the provided information, the Memcath Urology Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide an intermittent pathway for draining fluids from the bladder." This is a direct medical intervention on the patient's body for drainage, not for testing or analyzing samples taken from the body.
- Device Description: The description details a physical catheter designed for insertion into the bladder for drainage. It does not mention any components or functions related to analyzing biological samples.
- 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
- Using reagents or assays
- Measuring biomarkers
The device is clearly a medical device intended for direct patient care and treatment (drainage), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.
Product codes
78 EZD, 78 KOD
Device Description
The Memcath Urology Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a PVC catheter tube with pre-loaded, self-deploying PTFE sheath membrane to increase lubricity during insertion. This catheter system also includes a polyurethane snap ring and polycarbonate/acrylic guide ring to secure the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Products were tested for:
- Flow Rate
- Stiffness
- Kink Resistance
- Insertion/Withdrawal load
- Pull Test
- Body Tensile
- Tip Flex
- SAL
- EtO Residuals
All product testing met specifications
Key Metrics
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.
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DEC I 0 1999
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | Memcath Urology Catheter |
| Submitter | Memcath Technologies LLC |
| 1777 Oakdale Avenue | |
| West St. Paul, MN 55118-4031 | |
| 651-450-7400 |
Contact
Marc Jaker Vice President
Intended Use
The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.
Predicate Devices
Sherwood- Davis & Geck Argyle Rob-Nel Urological Catheter, K810216
Device Description
The Memcath Urology Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a PVC catheter tube with pre-loaded, self-deploying PTFE sheath membrane to increase lubricity during insertion. This catheter system also includes a polyurethane snap ring and polycarbonate/acrylic guide ring to secure the sheath.
Materials
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All materials used in the manufacture of the Memcath urology catheter are suitable for this use and have been used in numerous previously cleared products.
Testing
Products were tested for:
- Flow Rate
- Stiffness
- Kink Resistance
- Insertion/Withdrawal load ●
- Pull Test ●
- Body Tensile ●
- Tip Flex .
- SAL ●
- EtO Residuals ●
All product testing met specifications
Summary of Substantial Equivalence
The Memcath is equivalent to the predicate products from Sherwood-Davis & Geck Argyle Rob-Nel Urology Catheter. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. Memcath Technologies believes the Model 101 - 000 - 006 is substantially equivalent to existing legally marketed devices.
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and the commend of the comments of the country
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC I 0 1999
Mr. Marc Jaker Vice President Memcath™ Technologies LLC 1777 Oakdale Avenue West St. Paul, MN 55118-4031 Re: K993226 Memcath™ Urology Catheter Model 101 -000 - 006 Dated: September 24, 1999 Received: September 27, 1999 Regulatory Class: Il 21 CFR §876.5130/Procode: 78 EZD 21 CFR §876.5130/Procode: 78 KOD
Dear Mr. Jaker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act indude 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | MemcathTM Urology Catheter |
| Model 101-000-006 | |
| Indications for Use: | The MemcathTM Urology Catheter is |
| intended to provide an intermittent | |
| pathway for draining fluids from the | |
| bladder. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use V (Per 21 CFR 801.109)
Ulind h. Sypm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K99226
Over-The-Counter Use (Optional Format 1-2-96)
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