(105 days)
No
The summary describes a standard intermittent urinary catheter made of PVC and references biocompatibility testing. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device is a catheter used for draining urine, which is a supportive or maintenance function, not one that directly treats a disease or condition.
No
Explanation: The device is described as an intermittent urinary drainage catheter used to drain urine from the urinary bladder. Its purpose is to facilitate urination for patients not capable of voluntary urination, not to diagnose a condition.
No
The device description explicitly states it is a catheter extruded from PVC material, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical drainage of urine from the urinary bladder. This is a direct intervention on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a catheter, a physical tool for drainage.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine itself for diagnostic markers), using reagents, or providing diagnostic information. The purpose is purely mechanical drainage.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for 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.
The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed active intermittent catheterization on patients who are not capable of rno production. This product is not designed for use as an indwelling catheter.
Product codes
78 KOD
Device Description
The Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter is a sterile, single use, Intermittent urinary drainage catheter extruded from thermo-sensitive Polyvinyl chloride (PVC) material.
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)
Nonclinical Testing
Biocompatibility testing 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)
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
510 (k) Summary
K040897
Page 1 of 2
JUL 2 0 2004
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: March 29, 2004
1. Contact Person
Wei Zhao Senior Specialist, Regulatory Affairs Tyco 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® ROB-NEL Catheter is substantially equivalent in intended use, function and mode of operation to the Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter, which is currently marketed under 510(K) number K810216.
4. Device Description
The Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter is a sterile, single use, Intermittent urinary drainage catheter extruded from thermo-sensitive Polyvinyl chloride (PVC) material.
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.
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6. Product Comparison
..............................................................................................................................................................................
K040897
Page 2 of 2
The proposed DOVER® ROB-NEL Catheter is substantially equivalent to the predicate device in that each product has the same intended use and same physical, 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 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
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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird in the center. The text is difficult to read due to the image quality, but it appears to be the name of an organization or agency. The bird symbol is composed of three curved lines, suggesting movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 0 2004
Ms. Wei Zhao Senior Regulatory Specialist Tyco Healthcare The Kendall Company 15 Hampshire Street MANSFIELD MA 02048
Re: K040897
Trade/Device Name: Tyco Healthcare/Kendall DOVER® ROB-NEL 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 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 Section 510(k) I his leter will anow you to begal marked of substantial equivalence of your device to a legally prematication. The PDF and 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 If you desire specific advice to your as the following numbers, based on 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 Audulation of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Office of Comphanos at (2017-724tion" (21CFR Part 807.97) you may obtain. Other gencral by relection on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Solless http://www.fda.gov/cdrf/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
and the comments of the comments of the comments of
Indication for Use Statement
510 (k) Number (if known): K 040897
Device Name:
Tyco Healthcare/Kendall DOVER® ROB-NEL Catheter
Indications for Use:
The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed active intermittent catheterization on patients who are not capable of rno production. 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 _____________________________ (Per 21 CFR 801.109)
Nancy c Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040897