(212 days)
The Rüsch Brillant Silicone Foley is used to drain fluids to and from the urinary tract.
The Rusch Brillant Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes of this product are used with a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as requested.
Based on the provided 510(k) summary for the Rüsch Brillant Silicone Foley catheter, there is no information about a study proving the device meets specific performance-based acceptance criteria in the context of AI/software device evaluation.
The document is a traditional 510(k) for a physical medical device (a catheter), which focuses on substantial equivalence to a predicate device rather than performance metrics of an AI algorithm. Therefore, many of the requested fields are not applicable in this context.
Here's an attempt to answer the questions based on the available information, noting where information is absent or irrelevant to AI/software performance studies:
**1. A table of acceptance criteria and the reported device performance**
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material & Design | Equivalent to predicate devices (Porgés Foley Catheter) in: | The silicone catheter with silicone balloon, ported distal tip, and silicone funnel is equivalent to predicate devices. |
| - Catheter material | Silicone | |
| - Balloon material | Silicone | |
| - Tip design | Ported distal tip | |
| - Funnel design | Silicone funnel | |
| Intended Use | Used to drain fluids to and from the urinary tract. | The device is described for this intended use. |
| Sterility | Sterile | Device is described as sterile. |
| Single Use/Disposable | Single use, disposable | Device is described as single use, disposable. |
| Mechanical Features | - Retention balloon mechanism | Present (inflates/deflates with sterile water). |
| - Lumens | One for drainage, second for balloon inflation/deflation. (Some models have a third for flushing). | |
| - Eye holes | Two opposite eye holes at distal end for drainage. | |
| - Connectors | Connecting funnel and Luer activated valve at opposing end. | |
| Sizing | Available in sizes 8 Fr to 26 Fr. | Available in sizes 8 Fr to 26 Fr. |
| Pediatric Use | Stylet used with pediatric sizes | Pediatric sizes use a stylet. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a physical medical device (catheter) and does not involve a "test set" of data for evaluating an AI or software algorithm. The evaluation is based on substantial equivalence to a predicate device, material properties, and manufacturing controls.
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 above, there is no "test set" or "ground truth" establishment in the context of an AI/software performance study for this device. The regulatory review focuses on engineering, materials, and clinical equivalence rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Any "ground truth" related to this physical device would refer to established engineering standards, material specifications, and clinical performance of the predicate device, not ground truth for an AI assessment.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
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510 (k) Summary
Submitter Name, Address, and Date of Submission. 1.
Mr. James R. Whitney Group Regulatory Affairs Associate JAN - 8 1998 Willy Rüsch AG Group Tall Pines Park Jaffrey, New Hampshire 03452
(603) 532-7706 Telephone:
..
Same as above Contact :
Name of the Device, Common, Proprietary (if Known), and 2. Classification.
Classification Name: Urological Catheter
Common Name: Foley Catheter
Proprietary Name: Rüsch Brillant Silicone Foley
Identification of the legally marketed device to which 3. the submitter claims equivalence.
The Rusch Brillant Silicone Foley is substantially equivalent to the Porgés.
4 . Description of the Device.
The Rusch Brillant Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes of this product are used with a stylet that is
inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr.
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Intended Use of the Device. 5.
The Rusch Brillant Silicone Foley is used to drain fluids to and from the urinary tract.
Summary of Technological Characteristics. ର .
The following technological characteristics are the same as or equivalent to predicate devices:
The silicone catheter with silicone balloon, ported distal tip, and silicone funnel is equivalent to predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452
Re: K972184 Rüsch Brilliant Silicone Folev Catheter Dated: December 8, 1997 Received: December 9, 1997 Regulatory class: II 21 CFR §876.5130/Product codes 78 EZL
Dear Mr. Whitney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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. Intelling, and prohibitions 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fallure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for-devices under Radiation Control provisions, Tor other Federal laws or regulations.
This letter will allow you to begin marketing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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, "Misbanding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
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The Rüsch Brillant Silicone Foley is used to drain fluids to and from the urinary tract.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Dobeat D thing/ (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972184 |
| Prescription Use | / (Per 21 CFR 801.109) |
|---|---|
| ------------------ | --------------------------------------------------------------------------------------------------------------------------------- |
OR
| Over-The-Counter Use | ____________________ |
|---|---|
| ---------------------- | ---------------------- |
§ 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.