(23 days)
The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
This document is a 510(k) premarket notification for a Pediatric Urinary Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information cannot be directly extracted or is not applicable in the context of this type of regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study endpoint. Instead, the comparison to the predicate device serves as the primary means of demonstrating safety and effectiveness. The "Proposed device" column acts as the "reported device performance" in this context, showing that its attributes match or are equivalent to the predicate.
| Attribute | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Intended use | ||
| Placed into urethra for urine drainage | Yes | Yes |
| Single patient use < 30 days | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population infants | Yes | Yes |
| Environment of Use (Hospital, sub-acute, etc.) | Yes | Yes |
| Design Features | ||
| Various diameters (3.5 to 8 Fr) | 3.5, 5, 6.5, 8 Fr - Yes | 3.5, 5, 6.5, 8 Fr |
| Standard female luer connector | Yes | Yes |
| Two (2) eyelet holes near tip | Yes | Yes |
| Radiopaque line entire length | Yes | Yes |
| Markings along tubing length | Yes | Yes |
| Materials | ||
| Tubing - Silicone, Connector - PP | Yes | Yes |
| Packaging | ||
| Sterile | Yes | Yes |
| Performance | ||
| None under Section 514 | Yes | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document does not describe a clinical study with a "test set" in the traditional sense of evaluating performance. The submission relies on a comparison of device characteristics and intended use to a legally marketed predicate device. Therefore, information about sample size, data provenance, or study design for performance evaluation is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. As there is no clinical study with a "test set" requiring ground truth establishment, this information is not provided. The "ground truth" for this submission is the characteristics and regulatory status of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical study with a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a urinary catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context is the regulatory approval and established characteristics of the identified predicate device (ProMedic, Inc. Urinary Catheter – K031409). The equivalence is established by demonstrating that the proposed device has the same intended use, technological characteristics (materials, design features, sterility), and performs similarly to this predicate device.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not a machine learning or AI-based device. The submission relies on demonstrating similarity to a predicate device, not on data-driven model training.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/3 description: The image shows a close-up of handwritten text, which appears to be a combination of letters and numbers. The most prominent text is "K060268", written in a bold, somewhat messy style. Below this, there are additional markings and characters that are less clear, possibly including the number "2". The overall impression is that of a quick, handwritten note or label.
Non-Confidential Summary of Safety and Effectiveness
| Page 1 of 230-Jan-06 | |
|---|---|
| Clay Kennard2909 Browne Stone Rd.Oklahoma City, OK 73120 | Tel (405) 840-4224Fax (405) 843-7337 |
| Official Contact: | Clay Kennard |
| Proprietary or Trade Name: | Urinary catheter |
| Common/Usual Name: | Urinary catheter |
| Classification Name: | Catheter, urethral (and Accessories) |
| Predicate Devices: | ProMedic ... K031409 |
Device Description:
The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.
| Intended Use: | |
|---|---|
| Indicated Use -- | The urinary catheter is for use with patients requiring urinedrainage, with chronic urine retention and with post void residualvolume (PVR). The catheter is inserted into the urethra to reachthe bladder allowing urine to drain. |
| Environment of Use -- | Hospital, sub-acute, and environments where placement of aurinary catheter is required. |
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K040268
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Page
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 30-Jan-06
Comparison to Predicate Devices:
| Attribute | Proposed device | Predicate ProMedicK031409 |
|---|---|---|
| Intended use | ||
| To be placed into the urethra to permit urinedrainage. | Yes | Yes |
| Intended for single patient use < 30 days | Yes | Yes |
| Prescription | Yes | Yes |
| Intended population infants | Yes | Yes |
| Intended Environment of Use - Hospital, sub-acuteor environments where placement of urinarycatheters is required. | Yes | Yes |
| Design Features | ||
| Provided in various diameters from 3.5 to 8 Fr | 3.5, 5, 6.5, 8 Fr | 3.5, 5, 6.5, 8 Fr - Yes |
| Standard female luer connector | Yes | Yes |
| Two (2) eyelet holes near tip | Yes | Yes |
| Radiopaque line entire length of tubing | Yes | Yes |
| Markings along the length of the tubing | Yes | Yes |
| Materials | ||
| Tubing - Siliconeand Connector - PP | Yes | Yes |
| Packaging | ||
| Sterile | Yes | Yes |
| Performance | ||
| None under Section 514 | Yes | Yes |
Differences between Other Legally Marketed Predicate Devices
There are no significant differences between the intended device and the predicate -- ProMedic, Inc. Urinary Catheter – K031409.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - PUBLIC HEALTH SERVICE - USA" written around the edge. In the center of the seal is an abstract image of an eagle with its wings spread, with three wavy lines extending from the eagle's body. The seal is black and white.
FEB 2 4 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Clay Kennard 2909 Browne Stone Road OKLAHOMA CITY OK 73120
Re: K060268
Trade/Device Name: Pediatric Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: January 30, 2006 Received: February 1, 2006
Dear Mr. Kennard:
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 (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 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.
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This letter will allow you to begin marketing your device as described in your Section 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 onc of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincercly 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
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Page 1 of 1
| 510(k) Number: | K060268 (To be assigned) |
|---|---|
| Device Name: | Pediatric Urinary Catheter |
| Indications for Use: | The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain. |
Prescription Use XX (Part 21 CFR 801 Subpart D)
.....
or
Over-the-counter use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadn
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devices " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
§ 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.