(88 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly "Not Found".
No
This device is for irrigation, not for treating any specific disease or condition, which would make it a therapeutic device.
No
The "Intended Use / Indications for Use" states that the device is for "infusion of sterile solutions into the bladder to cleanse (evacuate) the contents of the bladder" and for "continuous irrigation of the bladder" during surgery. These are therapeutic and procedural uses, not diagnostic.
No
The device description clearly outlines physical components such as tubing, spikes, clamps, and a drip chamber, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the infusion of sterile solutions into the bladder for cleansing and continuous irrigation during surgery. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details components for fluid delivery and control (tubing, spikes, clamps, drip chamber, catheter adapter). These are consistent with a device used for irrigation, not for analyzing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for a therapeutic/procedural purpose.
N/A
Intended Use / Indications for Use
A urological irrigation system is intended for the infusion of sterile solutions into the bladder to cleanse or evacuate the contents of the bladder. Medline Y-Type TUR/Bladder Irrigation Set is indicated for use in transurethral resection (prostate or bladder surgery) as a means of continuous irrigation of the bladder. This product contains natural rubber latex which may cause allergic reactions in some individuals. For use with sterile saline or sterile water only. Do not use with plasma products. Not intended for reuse.
Medline Y-Type TUR/Bladder Irrigation Set is Intended for the infusion of sterile solutions into the bladder to cleanse (evacuate) the contents of the bladder. It is also indicated for use in the bladder to election (prostate or bladder surgery) as a means of continuous irrigation of the bladder. It is intended to be used with sterile solutions only. Not intended for reuse.
Product codes (comma separated list FDA assigned to the subject device)
LJH 78
Device Description
This device is comprised of vinyl tubing with a catheter adapter at one end and "spikes" with protectors at the "Y" shaped end. There are pinch clamps on each of the "Y" shaped ends below the spikes. On the single tubing there is a drip chamber. Directly below the drip chamber is a roller clamp. There is a latex rubber connecting tube, approximately 5-6 inches in length attached to the catheter adapter. This latex rubber tubing is removable.
Medline Y-Type TUR/Bladder Irrigation set is similar to other Y-Type TUR/Bladder Irrigation sets currently being marketing. They are made of smooth vinyl tubing, have pinch and roller clamps, spikes with protectors and a catheter adapter. The significant difference is the length of the latex tubing and the length of the vinyl tubing.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS - K970946
May 6, 1997
SUBMITTER INFORMATION: Medline Industries, Inc. One Medline Place Mundelein, IL 60060 1-847-949-3109 Establishment Registration Number: 1417592 Christine Galea, Corporate Regulatory Affairs Associate Contact Person:
REGULATORY INFORMATION
| Device Name: | Y-Type TUR/Bladder Irrigation Set |
|---|---|
| Proprietary: | Medline Y-Type TUR/Bladder Irrigation Set |
| Common: | Urological Irrigation System and/or Tubing Set |
| Panel: | 78 Gastroenterology & Urology |
| Class: | II |
| Procode/Classification: | LJH 78 (Unclassified) |
| Special Controls: | None established |
DEVICE DESCRIPTION:
This device is comprised of vinyl tubing with a catheter adapter at one end and "spikes" with protectors at the "Y" shaped end. There are pinch clamps on each of the "Y" shaped ends below the spikes. On the single tubing there is a drip chamber. Directly below the drip chamber is a roller clamp. There is a latex rubber connecting tube, approximately 5-6 inches in length attached to the catheter adapter. This latex rubber tubing is removable.
INTENDED USE:
A urological irrigation system is intended for the infusion of sterile solutions into the bladder to cleanse or evacuate the contents of the bladder. Medline Y-Type TUR/Bladder Irrigation Set is indicated for use in transurethral resection (prostrate or bladder surgery) as a means of continuous irrigation of the bladder. This product contains natural rubber latex which may cause allergic reactions in some individuals. For use with sterile saline or sterile water only. Do not use with plasma products. Not intended for reuse.
SUBSTANTIAL EQUIVALENCE
Medline Industries, Inc. claims substantial equivalence to Vital Concepts, K934382 and Baxter Healthcare's Y-Type TUR/Bladder Irrigation Set, which is pre-amendment exempt.
Medline Y-Type TUR/Bladder Irrigation set is similar to other Y-Type TUR/Bladder Irrigation sets currently being marketing. They are made of smooth vinyl tubing, have pinch and roller clamps, spikes with protectors and a catheter adapter. The significant difference is the length of the latex tubing and the length of the vinyl tubing.
1
Image /page/1/Picture/16 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 10 1997
Ms. Christine Galea Corporate Regulator - Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486 Re: K970946
Medline Y - Type TUR/Bladder Irrigation Set --------Dated: May 29, 1997 Received: May 30, 1997 Regulatory class: unclassified Product code: 78 LJH
公 Dear Ms. Galea:
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 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 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 conceming 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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/dsmamain.html".
Sincerely yours,
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproductive, Abdominal, Ear, Nose and Throath and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1
510(k) Number (if known): K970946
Device Name: Medline Y-Type TUR/Bladder Irrigation Set
Indications For Use:---------
Medline Y-Type TUR/Bladder Irrigation Set is Intended for the infusion of sterile solutions into the bladder to cleanse (evacuate) the contents of the bladder. It is also indicated for use in the bludder to election (prostrate or bladder surgery) as a means of continuous irrigation of the bladder.
It is intended to be used with sterile solutions only. Not intended for reuse.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
Robert D. Sather/
(Division Sign-Off)
(Optional Format 1-2-96)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K970946
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