(23 days)
Not Found
No
The device description and intended use are for a standard urinary catheter, and there is no mention of AI, ML, or any related technologies in the provided text.
No
The device facilitates urine drainage and does not provide therapy to treat a disease or condition.
No
The device is a urinary catheter designed for urine drainage, not for diagnosing a condition.
No
The device description clearly describes a physical, silicone urinary catheter with various hardware features (diameters, length, luer fitting, eyelets, markings, radiopaque line). It is not a software-only device.
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 for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
- This Device's Function: The urinary catheter described is a device that is inserted into the body (in vivo) to drain urine. It is a therapeutic and diagnostic tool used for direct patient care, not for analyzing a specimen in a lab setting.
The description clearly outlines its use for urine drainage and its physical characteristics as a tube inserted into the urethra. This aligns with the definition of a medical device used for direct patient intervention, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
Product codes (comma separated list FDA assigned to the subject device)
GBM
Device Description
The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
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
infants
Intended User / Care Setting
Hospital, sub-acute, and environments where placement of a urinary catheter is required.
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)
None under Section 514
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ProMedic K031409
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/3 description: The image shows a close-up of handwritten text, which appears to be a combination of letters and numbers. The most prominent text is "K060268", written in a bold, somewhat messy style. Below this, there are additional markings and characters that are less clear, possibly including the number "2". The overall impression is that of a quick, handwritten note or label.
Non-Confidential Summary of Safety and Effectiveness
| | Page 1 of 2
30-Jan-06 |
|------------------------------------------------------------------|------------------------------------------|
| Clay Kennard
2909 Browne Stone Rd.
Oklahoma City, OK 73120 | Tel (405) 840-4224
Fax (405) 843-7337 |
| Official Contact: | Clay Kennard |
| Proprietary or Trade Name: | Urinary catheter |
| Common/Usual Name: | Urinary catheter |
| Classification Name: | Catheter, urethral (and Accessories) |
| Predicate Devices: | ProMedic ... K031409 |
Device Description:
The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
| Intended Use: | |
|---|---|
| Indicated Use -- | The urinary catheter is for use with patients requiring urine |
| drainage, with chronic urine retention and with post void residual | |
| volume (PVR). The catheter is inserted into the urethra to reach | |
| the bladder allowing urine to drain. | |
| Environment of Use -- | Hospital, sub-acute, and environments where placement of a |
| urinary catheter is required. |
1
K040268
zq=
Page
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 30-Jan-06
Comparison to Predicate Devices:
| Attribute | Proposed device | Predicate ProMedic
K031409 |
|---------------------------------------------------------------------------------------------------------------------------|-------------------|-------------------------------|
| Intended use | | |
| To be placed into the urethra to permit urine
drainage. | Yes | Yes |
| Intended for single patient use