(83 days)
Not Found
Not Found
No
The summary describes a disposable tubing set for an irrigation/suction system and makes no mention of AI or ML technology.
No.
The device is used to infuse sterile irrigant solution during examinations, which is a diagnostic procedure, not a therapeutic one.
No
This device is a tubing set for infusing sterile solutions during examinations. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description explicitly mentions physical components (tubing set made of PVC, silicone, polyolefin, and Makrolon) and its intended use involves the infusion of sterile irrigant solution, which is a physical process. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to infuse sterile irrigant solution into the ureter and urinary tract during a medical procedure (ureterorenoscopic examinations). This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a tubing set for delivering fluid into the body. This aligns with a procedural device, not a device used to analyze samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.
Product codes
78 LJH
Device Description
The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter and urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Not Found
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
Image /page/0/Picture/0 description: The image shows a logo for "mtp technical promotion". The logo is in black and white and features the letters "mtp" in a stylized font. The word "technical" is written in a smaller font below the letters "mtp", and the word "promotion" is written below that. The logo is set against a dark background. There is also a number written above the logo, "K990909".
JUN 9 1999
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of MTP's knowledge.
| Applicant: | mtp medical technical promotion gmbh
p.o. box 4529 • d-78510 tuttlingen
tel.: +49/7461/96630 - 0
fax: +49/7461/96630 - 25 |
|------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
(310) 410-2769 |
Device Identification: Common Name: Irrigation Tubing Set
Trade Name: (optional) MTP Uropump Disposable Tubing Set
Indication: The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.
Device Description: The MTP Uropump Disposable Tubing Set is intended for use by qualified surgeons in the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations. The body contact materials are PVC, silicone, polyolefin, and Makrolon.
Substantial Equivalence: The MTP Uropump Disposable Tubing Set is substantially equivalent to the predicate device since the basic features, design and intended uses are the same.
Signed:
:
Kevin Kennan
Kevin Kennan
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 1000
MTP Medical Technical Promotion GmbH c/o Mr. Kevin Kennan P.O. Box 1954 Culver City, CA 90232
Re: K990909 MTP UroPump Disposible Tubing Set Dated: February 26, 1999 Received: March 18, 1999 Unclassified Product Code: 78 LJH
Dear Mr. Kennan:
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 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 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance 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
2
Image /page/2/Picture/0 description: The image is a dark, rectangular logo with rounded corners. The logo features the letters 'mtp' in a stylized font, with the 't' being white and the 'm' and 'p' being outlined. Below the letters, the word 'technical' is written in a smaller font, and below that, the word 'promotion' is written in an even smaller font. The background of the logo is dark, with a line of small white dots along the top edge.
510(k) Number (if known):
Device Name: Uropump Disposable Tubing Set
TRAFFACTA--------------------------------------------------------------------------------------------------------------------------------------------------------------------
Indications for Use: The MTP Uropump Disposable Tubing Set is intended to be utilized with the Karl Storz Uropump Irrigation/Suction System for the infusion of sterile irrigant solution into the ureter and urinary tract during ureterorenoscopic examinations.
(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:
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
000003
510(k) Number