(108 days)
The Signal Catheter is indicated for urological bladder drainage, with a maximum patient indwelling time of 29 days.
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.
The Signal Catheter is a medical device for urological bladder drainage. Based on the provided 510(k) summary, here's an analysis of its acceptance criteria and the supporting study information:
1. A table of acceptance criteria and the reported device performance:
The document acts as a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and direct performance metrics in a readily quantifiable "reported device performance" table format for a novel performance claim. However, it does indicate the studies performed and their objectives. The "acceptance criteria" here are implicitly linked to compliance with recognized standards and successful demonstration of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Meet biological safety standards for patient-contacting materials. | Patient contacting material was subjected to biocompatibility testing according to the recommendations of ISO 10993-1. (Implies successful completion and meeting the standard's requirements, as it supports substantial equivalence). |
| Dimensional Verification: Conform to design specifications. | Performance testing included dimensional verification. (Implies successful verification that dimensions are as designed and comparable to predicate, as it supports substantial equivalence). |
| Functional and Performance Testing: Device operates as intended, particularly its unique "signal balloon" mechanism to alleviate pressure. | Performance testing included functional and performance testing. The "signal balloon" in the catheter hub inflates during excessive pressure in the retention balloon, alleviating fluid and pressure. This technological characteristic underwent testing to ensure substantial equivalence. (Implies that the mechanism functions as designed and demonstrates comparable performance to predicates in terms of function). |
| Compliance to ASTM F623: Meet standard performance specifications for Foley Catheters. | Performance testing showed compliance to ASTM F623 Standard Performance Specification for Foley Catheter requirements. (Implies successful adherence to all relevant criteria within this standard). |
| Compliance to EN 1616: Meet standards for sterile urethral catheters for single use. | Performance testing showed compliance to EN 1616 Sterile urethral catheters for single use. (Implies successful adherence to all relevant criteria within this standard). |
| Overall Safety and Effectiveness: Does not raise new issues of safety or effectiveness compared to predicates. | The results of these tests indicate that the Signal Catheter is substantially equivalent to the predicate devices. "Based on the testing performed... it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices." (This is the overarching conclusion based on all non-clinical tests). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical (bench) testing. For such tests, the concept of "sample size for the test set" is usually described in terms of the number of tested devices or batches, which is not explicitly provided in this summary. The data provenance (country of origin, retrospective/prospective) is not applicable or provided for these types of non-clinical tests in this summary.
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 to the non-clinical (bench) testing described. "Ground truth" established by experts is typically relevant for clinical studies or studies involving diagnostic accuracy, which were not performed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to the non-clinical (bench) testing described. Adjudication methods are usually used in clinical studies for disagreement resolution among expert readers.
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
No such study was done or is referenced. This device is a catheter, not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests performed:
- Biocompatibility: The "ground truth" is compliance with ISO 10993-1, which is a recognized international standard based on established scientific principles for biological evaluation.
- Dimensional Verification: The "ground truth" is the engineering design specifications and possibly comparative measurements to predicate devices.
- Functional and Performance Testing: The "ground truth" is the designed functional specification of the device (e.g., the signal balloon inflates under specific pressure conditions) and compliance with performance standards like ASTM F623 and EN 1616. These standards themselves define the "ground truth" for acceptable performance.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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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.
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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/MedicalTechnology 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.
§ 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.