(119 days)
pre-amendment device
None
No
The device description and intended use clearly describe a mechanical plug for a urinary catheter with no mention of AI or ML capabilities.
No.
The device facilitates the temporary disconnection of a urinary catheter from a drainage bag and stops urine flow; it does not directly treat a disease or condition. Its purpose is to improve patient comfort and mobility during rehabilitation, not to provide therapy.
No
The device's intended use is to stop the flow of urine from a urinary catheter, facilitating patient mobility and comfort during rehabilitation. It does not diagnose any condition.
No
The device description clearly describes a physical plug with a shut-off valve, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The Quick Disconnect Plug's function is purely mechanical. It is used to physically stop the flow of urine from a urinary catheter. It does not analyze the urine or provide any diagnostic information about the patient's health.
- Intended Use: The intended use is to facilitate patient rehabilitation by allowing temporary disconnection of the drainage bag, not to perform any diagnostic test on the urine.
Therefore, based on the provided information, the Quick Disconnect Plug is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Quick Disconnect Plug is Intended to stop the flow of urine from the urinary catheter to the drainage bag. It is intended for use on a short term basis of no longer than two weeks (14 days) duration. The dally disconnection schedule should not exceed two hours. This device is available sterile for one-time use by physiclan's prescription.
Product codes
78 KNY
Device Description
The Quick Disconnect Plug is designed to facilitate a speedy, comfortable, and safe rehabilitation for patients requiring use of a urinary catheter. The use of a urinary catheter to facilitate drainage from the bladder is usual and customary following most surgery. In using a catheter, it is connected to a collection bag, which becomes a potential physical hazard and a source of discomfort to the patient in attempting to do rehabilitative exercise. The Quick Disconnect Plug allows the patient and/or attending nurse or physician to quickly disconnect the catheter from the drainage bag, leaving one half of the Quick Disconnect Device, which has a shut-off valve built in, in the open end of the catheter and seals off the flow of urine until such time as it is reconnected and the flow is once again resumed between the catheter and the collection bag.
The device is made up of two main components: (1) the body; and (2) the insert with the valve. Also included in the sterilized package is a vinyl tubing coupler.
All components included above are made of non-toxic ingredients that meet USP Class VI requirements. Diagrams, drawings, and photographs of the above components are included and attached to this statement.
One size is adequate to handle catheters up to and including size 26.
Intended use of the device is for one-time use only for short durations of 2 weeks (14 days) or less with a 2-hour disconnection time interval from the bag before reconnection to evacuate the bladder. This is to be sold as a sterile product with a 5-year shelf-life. Corresponding paperwork to substantiate statement is enclosed.
This device is sold with a restriction by order of a physician in accordance with 21 CFR 801.109.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient and/or attending nurse or physician
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)
pre-amendment device
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
Ko23690
Page 1 of 2
510 (K) SUMMARY:
FEB 2 8 2003
The 510 (k) summary of Quick Disconnect Plug connector:
-
. Predicate Device:
The Quick Disconnect Plug is substantially equivalent, but an improvement over the predicate preamendment device, which is a simple urinary catheter plug that stops the flow of urine from leaving the catheter. -
Device Description:
The Quick Disconnect Plug is designed to facilitate a speedy, comfortable, and safe rehabilitation for patients requiring use of a urinary catheter. The use of a urinary catheter to facilitate drainage from the bladder is usual and customary following most surgery. In using a catheter, it is connected to a collection bag, which becomes a potential physical hazard and a source of discomfort to the patient in attempting to do rehabilitative exercise. The Quick Disconnect Plug allows the patient and/or attending nurse or physician to quickly disconnect the catheter from the drainage bag, leaving one half of the Quick Disconnect Device, which has a shut-off valve built in, in the open end of the catheter and seals off the flow of urine until such time as it is reconnected and the flow is once again resumed between the catheter and the collection bag. -
Technical Characteristics:
The device is made up of two main components: (1) the body; and (2) the insert with the valve. Also included in the sterilized package is a vinyl tubing coupler.
All components included above are made of non-toxic ingredients that meet USP Class VI requirements. Diagrams, drawings, and photographs of the above components are included and attached to this statement.
One size is adequate to handle catheters up to and including size 26.
Intended use of the device is for one-time use only for short durations of 2 weeks (14 days) or less with a 2-hour disconnection time interval from the bag before reconnection to evacuate the bladder. This is to be sold as a sterile product with a 5-year shelf-life. Corresponding paperwork to substantiate statement is enclosed.
This device is sold with a restriction by order of a physician in accordance with 21 CFR 801.109.
1
KOJ3890
Page 2 of 2
510 (k) Summary (Continued):
-
. Performance Standards:
None established. -
Sterilization
.
♥
Sterilization will be ETO (ethylene oxide) gas.
Medsource Packaging Concepts is the company who will be packaging the product. Sterilization Services is the sterilization facility who will be processing the product.
Medsource Packaging Concepts (FDA Registration #1125782) is a Manufacturer/ Repacker/Relabeler of finished devices which may be received nonsterile or sterile from the original manufacturer. Sterilization Services of Virginia (FDA Registration #1123137) is a contract sterilization facility located in Richmond, Virginia.
The packaging method has been tested and proven to have a shelf-life of 5 years, and has been transportation tested over the past 15 years, and has shown no damage or deterioration caused by transportation of this product after sterilization.
Labeling and Instruction Sheet.
Labeling and instruction sheet to conform to device labeling guidance (Blue Book Memo G91-1). Picture of label and copy of instruction sheet to be included with this statement.
- Biocompatibility:
Device is made of all USP Class VI material. Bioincompatibility and/or toxicity in using this device is virtually zero. Refer to biocompatibility statement enclosed.
Safety and Effectiveness:
This product is being manufactured and sterilized under government regulated guidelines and should cause no harmful effects to any patient.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
FEB 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Martin Mitchell World Metals Inc. 1020 NE 27th Avenue Pompano Beach, FL 33062 Re: K023690 Trade/Device Name: Catheter Connector Quick Disconnect Plug Regulation Number: 21 CFR§ 876. 5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KNY Dated: February 13, 2003 Received: February 14, 2003
Dear Mr. Mitchell:
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 (PMA), it may be subject to 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 electronic 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO23690 510 (k) Number:
Quick Disconnect Plug Device Name:
Indications for Use:
The Quick Disconnect Plug is Intended to stop the flow of urine from the urinary catheter to the drainage bag. It is intended for use on a short term basis of no longer than two weeks (14 days) duration. The dally disconnection schedule should not exceed two hours. This device is available sterile for one-time use by physiclan's prescription.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kirill A. Lazann
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023690
OR
Prescription Use
(Per 21 CFR 801.109)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________