(108 days)
Not Found
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI/ML algorithms or data processing.
No
This device is a drainage catheter, not a therapeutic device. Its primary function is to drain urine from the bladder. While it has a unique signal balloon feature to manage pressure, this is a safety mechanism related to its drainage function, not a therapeutic intervention.
No
The device is described as a catheter for urological bladder drainage, and its function is to drain urine. While it has a 'signal balloon' to indicate pressure issues, this is a mechanical safety feature, not a diagnostic one that provides information about a disease or condition. The intended use is for drainage, not for identifying a medical condition.
No
The device description clearly states it is a physical catheter with a balloon mechanism, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "urological bladder drainage." This is a direct interaction with the patient's body to perform a physical function (draining urine).
- Device Description: The description details a physical catheter designed for insertion into the body to drain fluid.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. This device does not perform any such analysis of a specimen.
The Signal Catheter is a medical device used for a therapeutic purpose (draining the bladder), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Signal Catheter is indicated for urological bladder drainage, with a maximum patient indwelling time of 29 days.
Product codes
EZL
Device Description
The Signal Catheter is a 16 French, 2-way silicone Foley catheter, designed to be inserted into the bladder through the urethra to drain urine. The unique signal balloon included in the catheter hub is designed to inflate during excessive pressure in the retention balloon. This typically occurs when the retention balloon is constricted and cannot be inflated at the nominal inflation pressure of the catheter. In this case, the signal balloon inflates to alleviate the fluid and resulting pressure in the retention balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder / urethra (for insertion)
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
Non-clinical testing included:
Biocompatibility: Patient contacting material was subjected to biocompatibility testing according to the recommendations of ISO 10993-1 Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process.
Performance testing: The performance testing of the subject device included dimensional verification, functional and performance testing, and compliance to ASTM F623 Standard Performance Specification for Foley Catheter requirements and EN 1616 Sterile urethral catheters for single use.
Key results: The results of these tests indicate that the Signal Catheter is substantially equivalent to the predicate devices.
No clinical data was submitted.
Key Metrics
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.
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January 10, 2019
Safe Medical Design % Allison Komiyama, PhD, RAC Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110
Re: K182635
Trade/Device Name: Signal Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZL Dated: December 12, 2018 Received: December 13, 2018
Dear Allison Komiyama:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182635
Device Name Signal Catheter
Indications for Use (Describe)
The Signal Catheter is indicated for urological bladder drainage, with a maximum patient indwelling time of 29 days.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K182635
DATE PREPARED
January 9, 2019
MANUFACTURER AND 510(k) OWNER
Safe Medical Design 2722 Fulton Street, San Francisco, CA 94118, USA Telephone: Official Contact: Raymond "Buzz" Bonneau, President
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: akomiyama@AcKnowledge-RS.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Signal Catheter |
|---|---|
| Common Name: | Catheter, Retention Type, Balloon |
| Regulation Number: | 21 CFR 876.5130 |
| Regulation Name: | Urological Catheter and Accessories |
| Class: | II |
| Product Code: | EZL |
| Premarket Review: | ODE/DRGUD/ULDB |
| Review Panel: | Gastroenterology/Urology |
PREDICATE DEVICE IDENTIFICATION
The Signal Catheter is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K172422 | Kohli Urinary Drainage Catheter/Nellie Medical, LLC | ✓ |
| K941488 | Devmed Double Balloon Urological Catheter/Medical | |
| Technology Development Corp. |
The predicate devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The Signal Catheter is a 16 French, 2-way silicone Foley catheter, designed to be inserted into the bladder through the urethra to drain urine. The unique signal balloon included in the catheter hub is designed to inflate during excessive pressure in the retention balloon. This
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typically occurs when the retention balloon is constricted and cannot be inflated at the nominal inflation pressure of the catheter. In this case, the signal balloon inflates to alleviate the fluid and resulting pressure in the retention balloon.
INDICATIONS FOR USE
The Signal Catheter™ is indicated for urological bladder drainage, with a maximum patient indwelling time of 29 days.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
SMD believes that the Signal Catheter is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has similar dimensions, and uses similar materials as the devices cleared in K172422 and K941488. The subject device has the same intended use and similar technological characteristics (two-way silicone catheter with retention balloon for bladder drainage) to the devices cleared in K172422. The main difference with the devices cleared in K172422 and K941488 is the addition of a non-patient contacting signal balloon in the catheter hub. The signal balloon is designed to alleviate the pressure in the retention balloon when it is constricted and cannot be inflated at the nominal inflation pressure of the catheter. This technological characteristic has undergone testing to ensure that the device is substantially equivalent to the predicates.
SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate safety based on current industry standards:
Biocompatibility: Patient contacting material was subjected to biocompatibility testing according to the recommendations of ISO 10993-1 Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process
Performance testing: The performance testing of the subject device included dimensional verification, functional and performance testing, and compliance to ASTM F623 Standard Performance Specification for Foley Catheter requirements and EN 1616 Sterile urethral catheters for single use.
The results of these tests indicate that the Signal Catheter is substantially equivalent to the predicate devices.
SUMMARY OF CLINICAL TESTING
There was no clinical data submitted in order to demonstrate substantial equivalence.
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CONCLUSION
Based on the testing performed, including biocompatibility testing, dimensional verification, functional and performance testing, and compliance to ASTM F623 and EN 1616 requirements, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Signal Catheter are assessed to be substantially equivalent to the predicate devices.