(266 days)
Urological catheter is intended for drainary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.
The Subject Device is a single-use, 2-way Foley catheter that is constructed of medical grade silicone. It incorporates two (2) lumens, one for inflation/deflation of the other for drainage of the urinary tract. The balloon, at the distal end of the catheter, is inflated to the labeled fill volume and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the 2-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The Subject Device is packaged inside a perforated plastic sleeve that is inserted into a sterile barrier pouch. Ten (10) units are packaged into a carton, which is the saleable unit. The Subject Device is terminally sterilized via Ethylene Oxide (EO). The Subject Device will be initially offered in 14. 16. 18Fr sizes. The entire length of the Subject Device is disposable. The Subject Device is not sold as a set, there are no accessories or components included.
This document is a 510(k) premarket notification for a urological catheter. It describes the device, its intended use, and compares it to a predicate device. It also summarizes the evaluations performed to demonstrate substantial equivalence.
Based on the provided text, the questions regarding acceptance criteria and study proving device performance (specifically for an AI/ML medical device, as implied by the detailed questions about data, ground truth, experts, and MRMC studies) cannot be fully answered. The document describes a traditional medical device (Foley catheter) and its clearance process, which relies on physical and functional performance testing, rather than an AI/ML algorithm requiring large datasets and expert ground truth.
Here's why many of your questions are not applicable to this specific submission and what information is available:
This document describes a physical medical device (Foley Catheter), not an AI/ML medical device. Therefore, many of your questions related to AI/ML specific evaluations (such as data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable.
However, I can extract information relevant to the type of device discussed.
1. A table of acceptance criteria and the reported device performance
The document states that "The test program was performed in accordance to FDA guidance and recognized performance states, which includes the following: Biocompatibility, Sterilization, Packaging Integrity (i.e., Sterile Barrier), Transportation, Performance/Functionality." It then concludes, "Successful results were achieved with all evaluations conducted."
While specific numerical acceptance criteria (e.g., "burst pressure > X psi") and detailed performance data (e.g., "average burst pressure = Y psi") are not explicitly listed in this summary, the general categories of testing and the affirmation of "successful results" serve as the summary of performance meeting acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Successful results achieved |
| Sterilization | Successful results achieved |
| Packaging Integrity (Sterile Barrier) | Successful results achieved |
| Transportation | Successful results achieved |
| Performance/Functionality | Successful results achieved |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the performance testing (e.g., number of catheters tested for burst strength, or number of sterility tests). It also does not discuss data provenance in terms of country of origin or retrospective/prospective, as these are typically considerations for clinical data in software/AI submissions, not physical device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically understood in AI/ML (e.g., expert labels on images) is not relevant to the physical performance testing of a Foley catheter. Performance tests are typically conducted according to standardized engineering protocols (e.g., ASTM F623).
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple human readers/experts in AI/ML ground truth establishment. This is not relevant for physical device testing.
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 a physical medical device, 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 a standalone algorithm.
7. The type of ground truth used
For physical devices, "ground truth" refers to established physical, chemical, and biological performance standards and validated test methodologies (e.g., ASTM F623 for performance, ISO standards for biocompatibility/sterilization). The document states: "The test program was performed in accordance to FDA guidance and recognized performance states." This implies compliance with such standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device, and the concept of "ground truth for a training set" (in the context of AI/ML) does not apply.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
April 21, 2020
Pathway, LLC Aaron Rogers Director of Regulatory and Quality 8779 Cottonwood Avenue, Suite 105 Santee, CA 92071
Re: K192034 Trade/Device Name: HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: March 19, 2020 Received: March 23, 2020
Dear Aaron Rogers:
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. Although this letter refers to your product as a device, please be aware 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling
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(21 CFR Part 801); medical device reporting (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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Purva Pandya Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192034
Device Name
HYDROPHILIX 100% Silicone 2-Way Foley Catheter, 14Fr/10cc HYDROPHILIX 100% Silicone 2-Way Foley Catheter, 16Fr/5cc HYDROPHILIX 100% Silicone 2-Way Foley Catheter, 18Fr/10cc
Indications for Use (Describe)
Urological catheter is intended for drainary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.
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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K192034 page 1 of 3
Image /page/3/Picture/1 description: The image contains the logo for Hydrophilix. On the left is a blue hexagon shape with a circular design in the middle. To the right of the shape is the company name, HYDROPHILIX, in blue font.
Image /page/3/Picture/2 description: The image shows the word "pathway" in lowercase letters, with a stylized logo to the right of the word. The logo consists of two curved shapes, one above the other, forming a diamond-like shape. The text and logo are in a gray color. The image appears to be a logo or branding element.
510(K) SUMMARY - K192034
Submitter Information
| Company Name: | Hydrophilix, Inc. |
|---|---|
| Company Address: | 12100 Wilshire BlvdSuite 800Los Angeles, CA 90025 |
| Contact Person: | Aaron RogersPathway, LLC.Director of Regulatory & Quality(619) 415-0103arogers@pathwaynpi.com |
| Date: | April 21, 2020 |
| Device Identification | |
| Device Trade Name: | HYDROPHILIX 100% Silicone 2-Way FoleyCatheter, 14Fr/10ccHYDROPHILIX 100% Silicone 2-Way FoleyCatheter, 16Fr/5ccHYDROPHILIX 100% Silicone 2-Way FoleyCatheter, 18Fr/10cc |
| Common Name: | Foley Catheter |
| Classification Name: | Urological catheter and accessories |
| Classification Number: | 876.5130 |
| Regulatory Class: | Class II |
| Product Code(s): | EZL |
| Product Code Name: | Catheter, Retention Type, Balloon |
| Advisory Panel: | Gastroenterology/Urology |
Identification of Predicate Device
| Predicate Device | ||||
|---|---|---|---|---|
| Device Name | Regulation No. | Product Code | 510(K) Number | Clearance Date |
| Bardex Lubi-Sil Foley Catheter | 876.5130 - Urological catheter and accessories | EZL | K984084 | February 1, 1999 |
Device Description
The Subject Device is a single-use, 2-way Foley catheter that is constructed of medical grade silicone. It incorporates two (2) lumens, one for inflation/deflation of the other for drainage of the urinary tract.
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The balloon, at the distal end of the catheter, is inflated to the labeled fill volume and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the 2-way valve connection.
The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector.
The Subiect Device is packaged inside a perforated plastic sleeve that is inserted into a sterile barrier pouch. Ten (10) units are packaged into a carton, which is the saleable unit. The Subject Device is terminally sterilized via Ethylene Oxide (EO).
The Subject Device will be initially offered in 14. 16. 18Fr sizes. The entire length of the Subject Device is disposable. The Subject Device is not sold as a set, there are no accessories or components included.
Indications for Use
Urological catheter intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.
| Comparison Table - Subject and Predicate Devices | ||
|---|---|---|
| ComparisonFeature | Subject Device | Predicate Device |
| Indications for Use | Urological catheter intended for drainage ofthe urinary tract. Catheterization isaccomplished through the urinary tract.Intended population is adults and pediatrics. | Used in the drainage and/or collectionand/or measurement of urine. Generally,drainage is accomplished by inserting thecatheter through the urethra and into thebladder. However, drainage is sometimesaccomplished by suprapubic or otherplacement of the catheter, such as anephrostomy tract. |
| Type | 2-way with inflation and drainage lumens | 2-way with inflation and drainage lumens |
| Size/Balloon Size | 14Fr/10cc | 8, 10Fr/3cc Balloon |
| 16Fr/5cc | 12-24Fr, even sizes/5cc Balloon | |
| 18Fr/10cc | 16-24Fr, even sizes/30cc Balloon | |
| Material | Silicone, Medical Grade | Silicone, High Grade |
| PerformanceStandard | ASTM F623 | ASTM F623 |
| Single-Use? | Yes | Yes |
| Prescription Use? | Yes | Yes |
| Sterile? | Yes | Yes |
Comparison of Technological Characteristics with Predicate Device
Summary of Evaluations Performed
The test program was performed in accordance to FDA guidance and recognized performance states, which includes the following:
- Biocompatibility
- Sterilization
- Packaging Integrity (i.e., Sterile Barrier) ●
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K192034 page 3 of 3
- Transportation .
- Performance/Functionality .
Successful results were achieved with all evaluations conducted.
Conclusion
The Subject Device has demonstrated it is substantially equivalent to the commercially available predicate.
§ 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.