(57 days)
Not Found
Not Found
No
The summary describes a simple, single-use urinary catheter made from latex, with no mention of AI, ML, or any computational processing.
Yes
The device is described as an intermittent urinary drainage catheter intended for the drainage of urine from the urinary bladder, which is a therapeutic function.
No
The device is described as an intermittent urinary drainage catheter for urine drainage from the bladder, not for diagnosis.
No
The device description explicitly states it is a physical catheter made from latex using dipping technology, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "drainage of urine from the urinary bladder." This is a physical intervention for removing a bodily fluid, not for analyzing a sample of that fluid to diagnose a condition.
- Device Description: The device is a "urinary drainage catheter." This is a physical tool for facilitating drainage.
- Lack of Diagnostic Activity: There is no mention of the device being used to test or analyze urine or any other biological sample for diagnostic purposes. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
This device is a medical device used for a therapeutic or management purpose (draining urine), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed product is intended for intermittent catheterization on patients who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.
Product codes (comma separated list FDA assigned to the subject device)
78 KOD
Device Description
The Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter is a sterile, single use, intermittent urinary drainage catheter made from latex using dipping technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary 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)
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
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.
Not Found
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
K0412B
Kuy Lopez
JUL - 7 2004 510(k) Summary
In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Tyco Healthcare/Kendall 15 Hampshire Street Mansfield, MA 02048 Date Prepared: May 6, 2004
1. Contact Person
Wei Zhao Senior Specialist, Regulatory Affairs Tvco Healthcare/Kendall Telephone: (508) 261-8404 Fax: (508)261-8461
2. Name of Medical Device
Classification Name: Common or Usual Name: Urological catheter and accessories Urinary Drainage Catheter
3. Identification of Legally Marketed Device
The proposed Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter is substantially equivalent in intended use, function and mode of operation to the Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter, which is legally marketed prior to May 28, 1976.
4. Device Description
The Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter is a sterile, single use, intermittent urinary drainage catheter made from latex using dipping technology.
5. Device Intended Use
The product is intended for intermittent catheterization to drain urine from the urinary bladder. The product is intended for use on patients who are not capable of voluntary urination.
6. Product Comparison
The proposed DOVER® RED RUBBER ROBINSON Catheter is substantially equivalent to the predicate device in that each product has the same intended use and same physical,
1
K04/213
Page 2 of 2
functional and performance characteristics. The proposed and predicate devices are made from the same materials and have the same design.
7. Nonclinical Testing
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
End of Document
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes and a wavy line at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
Ms. Wei Zhao Senior Specialist, Regulatory Affairs Tyco Healthcare The Kendall Company 15 Hampshire Street MANSFIELD MA 02048
Re: K041243
K041243
Trade/Device Name: Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 KOD Dated: June 22, 2004 Received: June 23, 2004
Dear Ms. Zhao:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaon 9 ro(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard) names the Medical Device Amendments, or to connieres prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been rockssined in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mance af the Act include requirements for annual registration, listing of general Controls provisions of the rest 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 your device is classified (500 a0070) ... Existing major regulations affecting your device can be it may be subjoct to adultions, 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 I Toase of actived that I Dr o assumithat your device complies with other requirements of the Act that I Dri has made a asid regulations administered by other Federal agencies. You must of any I ederal blatates and registements, including, but not limited to: registration and listing comply with an the rior requirements, a 801); good manufacturing practice requirements as set (21 CFR Part 007), laboring (27 cegulation (21 CFR Part 820); and if applicable, the clectronic forth in the quality byticles (QS) regions 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to ocgli marketing of substantial equivalence of your device to a legally premarket nothication. The PDA hidding of backlined 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 Park 801), please If you desire specific advice for your device on our car and of the regulation number at the top of the 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 Additionally, 101 questions on the promote on a ...
Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Othice of Compliance at (501) 597-10597. The Part 807.97) you may obtain. Other general by reference to premation (21 or extrained the Act may be obtained from the Division of Strall information on your responsionalities and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-frien Manufacturers, International and Consumior Passession of Schoolson of Schildsmaldsmamain.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
Indication for Use Statement
Ko41243 510(k) Number (if known):
Device Name:
Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter
Indications for Use:
The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed as intended for intermittent catheterization on patients who are not capable of rne product is intonetion. This product is not designed for use as an indwelling catheter.
Please DO NOT Write Below This Line – Continue On Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ X ___ OR OVER-The -Counter Use _____ (Per 21 CFR 801.109)
Nancy C Brogdon
(Division Sign Division of Reproducti va Akda and Radiological I 510(k) Number