(186 days)
The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Not Found
Please note that the provided document is a 510(k) clearance letter from the FDA for a medical device (a Foley catheter with a temperature sensor). This type of document does not contain the detailed study information, acceptance criteria, or performance metrics that would be generated by a clinical or performance study.
The FDA 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against specific acceptance criteria. Therefore, most of the requested information regarding study details, ground truth, and sample sizes will not be present in this document.
However, I can extract the following relevant information and explain why other requested details are not available:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed reported device performance in this format. The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same design, materials, and intended use, and performs as safely and effectively as the predicate. Performance data, if submitted, would be intended to support this equivalence, not necessarily to meet pre-defined, publicly disclosed acceptance criteria in the manner one might find for a novel drug or a high-risk device requiring a PMA.
The closest to "performance" mentioned is in the "Indications for Use" section (Page 3), which states: "The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals." This is a statement of intended function, not a quantitative performance metric.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. The 510(k) clearance letter itself does not include details about specific test set sample sizes or data provenance. Such information would be part of the predicate device's historical data or a new device's performance testing reports, which are part of the full 510(k) submission, but not typically summarized in the clearance letter.
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)
This information is not applicable and therefore not available in the provided document. This device is a physical medical device (Foley catheter with temperature sensor), not an AI or diagnostic imaging device that would require expert-established ground truth for a test set. Its performance relies on physical specifications, material compatibility, and temperature sensing accuracy, not on interpretations of complex data by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not available. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, often in diagnostic imaging or clinical trials where multiple experts assess the same cases. This is not relevant for a physical device like a Foley catheter.
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
This information is not applicable and therefore not available. An MRMC study is relevant for diagnostic performance, particularly with AI assistance, where different readers analyze cases. This device is a physical catheter, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This information is not applicable and therefore not available. A "standalone algorithm" is not relevant for a physical medical device like a Foley catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Again, the concept of "ground truth" as it applies to AI diagnostics or complex clinical endpoints is not directly applicable to this device in the context of this 510(k) letter. For a Foley catheter with a temperature sensor, "ground truth" would be related to:
- Physical measurements: Accuracy of the temperature sensor against a calibrated standard.
- Biocompatibility: In vitro and in vivo testing for material safety.
- Mechanical integrity: Tensile strength, balloon inflation/deflation, tip integrity, etc.
- Sterility: Confirmation of sterility.
These types of "ground truth" are established through engineering testing, laboratory standards, and biocompatibility assessments, not typically through expert consensus on clinical cases or pathology. The document does not detail these specific test methods or their "ground truth" establishment.
8. The sample size for the training set
This information is not available in the provided document and likely not applicable in the context of this device. Training sets are relevant for machine learning algorithms. This device is a conventional medical device, not an AI/ML product.
9. How the ground truth for the training set was established
This information is not applicable and therefore not available, for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name encircling the image and an abstract symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The symbol is a stylized representation of an eagle or bird-like figure with three wing-like shapes above a wavy line, possibly representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
T 16 2007
Dr. Wei Zhao Manager, Regulatory Affairs Tyco Healthcare The Kendall Company 15 Hampshire Street MANSFIELD MA 02048
Re: K071049
Trade/Device Name: Dover® 100% Silicone Foley Catheter with Temperature Sensor Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: August 27, 2007 Received: August 28, 2007
Dear Dr. 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 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.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Page 2
Enclosure
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Tyco Healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature Sensor
Indication for Use Statement
510 (k) Number (if known):
Device Name:
Tyco Healthcare/Kendall DOVER® 100% Silicone Foley Catheter with Temperature Sensor
Indications for Use:
The proposed catheters are intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. General drainage is accomplished by inserting the catheter through the urethra and into the urine bladder. The catheter is retained in the bladder by inflation of balloon. Drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
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)
Valind Hennen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.