(121 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical function of a Foley catheter, with no mention of AI or ML.
No
The device, a Foley catheter, is used for draining urine, which is a supportive function, not a therapeutic intervention that treats a disease or condition.
No
Explanation: The device description clearly states its purpose is for "urethral catheterization for urological bladder drainage" to "drain urine from the bladder." This is a therapeutic or management function, not a diagnostic one. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly describes a physical medical device (Foley catheter) with hardware components (catheter tube, balloon, deflation mechanism). There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The InnoCare Specialty Foley Catheter is a physical device inserted into the body (urethra and bladder) to drain urine. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is for "urethral catheterization for urological bladder drainage," which is a mechanical function, not a diagnostic test.
Therefore, based on the provided information, the InnoCare Specialty Foley Catheter is a medical device used for drainage, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InnoCare Specialty Foley Catheter is intended for urethral catheterization for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.
Product codes
EZL, SCT
Device Description
The InnoCare Specialty Foley Catheter is a 16 French, two-way silicone Foley catheter for urethral catheterization to drain urine from the bladder. The catheter is retained in the bladder by use of a retention balloon attached to the distal end of the catheter. The device is offered in a straight tip configuration and a Coude tip configuration.
The inflation lumen of the catheter contains a secondary balloon deflation mechanism. This mechanism is designed to provide a fluid escape pathway to allow for balloon deflation in the event of a forced withdrawal or catheter pullout.
The device is provided sterile and for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder, urethra
Indicated Patient Age Range
adult use only
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Device performance data was provided in support of the substantial equivalence determination.
BIOCOMPATIBILITY TESTING:
Biocompatibility testing was conducted per ISO 10993-1:2018. The following tests were conducted:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Subacute Systemic Toxicity
- Genotoxicity
- Implantation
The results of this testing demonstrate that the subject device is biocompatible for its intended use.
Bench Testing:
Bench testing of the subject device included dimensional verification, functional and performance testing per ASTM F623:2019 requirements, simulated use testing of the secondary balloon deflation mechanism and Magnetic Resonance Compatibility testing per FDA Guidance (2023), "Testing and Labeling Medical Devices for Safety in the Maqnetic Resonance (MR) Environment | FDA".
All pre-determined acceptance criteria were met. Performance testing demonstrates that the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness.
Sterility, Packaging and Distribution:
The InnoCare Specialty Foley Catheter was validated to be sterilized using ethylene oxide per ISO 11135:2014. To support the claimed shelf life, performance testing and package integrity testing was conducted following environmental conditioning, simulated distribution and accelerated aging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 18, 2024
InnoCare Urologics, LLC Patrick Mccain VP, QA/RA 7175 SW 47th Street, Suite 207 Miami, Florida 33155
Re: K241424
Trade/Device Name: InnoCare Specialty Foley Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZL, SCT Dated: August 21, 2024 Received: August 21, 2024
Dear Patrick Mccain:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-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
2
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,
Sharon M. Andrews -S
for Jessica N. Nguyen, Ph.D. 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
3
Indications for Use
510(k) Number (if known) K241424
Device Name InnoCare Specialty Foley Catheter
Indications for Use (Describe)
The Inno Care Specialty Foley Catheter is intended for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for InnoCare Urologics. The logo is in blue and features the letters "iu" in a stylized font. The word "InnoCare" is written in a larger font above the word "Urologics". There is a trademark symbol to the right of the word "InnoCare".
Traditional 510(k) Summary
1. Submitter Information
| Applicant Name: | InnoCare Urologics, LLC |
|---|---|
| Applicant Address: | 7175 SW 47th Street, Suite 207 |
| Miami FL 33155, United States | |
| Contact Telephone: | (855) 466-6305 |
| Applicant Contact: | Patrick McCain, VP, QA/RA |
| Contact Email: | pmccain@innocareurologics.com |
| Date Prepared: | May 17, 2024 |
2. DEVICE NAME
| Trade or Proprietary Name: | InnoCare Specialty Foley Catheter |
|---|---|
| Common or Usual Name: | Foley Catheter |
| Classification Regulation: | 21 CFR 876.5130 |
| Device Class: | II |
| Product Code: | EZL (Catheter, Retention Type, Balloon), |
| SCT (Foley Catheters and Accessories with Additional Safety Features) | |
| Panel: | Gastroenterology/Urology |
3. Predicate Device Identification
Predicate Device: Medline Silicone Foley Catheter (K142635)
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Image /page/5/Picture/0 description: The image is a logo for InnoCare Urologics. The logo features the letters "iu" in blue on the left side of the image. To the right of the letters is the text "INNOCARE" in a larger font, and below that is the text "UROLOGICS".
4. Device Description
The InnoCare Specialty Foley Catheter is a 16 French, two-way silicone Foley catheter for urethral catheterization to drain urine from the bladder. The catheter is retained in the bladder by use of a retention balloon attached to the distal end of the catheter. The device is offered in a straight tip configuration and a Coude tip configuration.
The inflation lumen of the catheter contains a secondary balloon deflation mechanism. This mechanism is designed to provide a fluid escape pathway to allow for balloon deflation in the event of a forced withdrawal or catheter pullout.
The device is provided sterile and for single use.
5. Indications For Use
The InnoCare Specialty Foley Catheter is intended for urethral catheterization for urological bladder drainage. The device is indicated for adult use only with a maximum indwell time of no more than 30 days.
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Image /page/6/Picture/0 description: The image contains the logo for InnoCare Urologics. The logo consists of the letters "iu" in blue, with the "i" being a darker shade of blue than the "u". To the right of the letters are the words "INNOCARE" and "UROLOGICS", stacked on top of each other, in a dark blue font. There is a trademark symbol to the right of the word "INNOCARE".
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Comparison Element | Subject Device:
InnoCare Specialty
Foley Catheter | Predicate Device:
Medline Silicone Foley Catheter (K142635) |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The InnoCare Specialty Foley Catheter
is intended for urethral catheterization
for urological bladder drainage. The
device is indicated for adult use only
with a maximum indwell time of no
more than 30 days. | Medline silicone Foley catheters are intended to be
placed in the bladder, through the urethra, to drain
urine into a collection device. Two-way catheters
are intended for urological bladder drainage only.
Three-way catheters are intended for urological
bladder drainage and bladder irrigation. |
| Product Code | EZL, SCT | EZL |
| Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 |
| Prescription use (Rx)/
Over the counter (OTC) | Rx | Rx |
| Indwell Time | No more than 30 days | No more than 30 days |
| Lumen | Two-Way | Two-Way or Three- Way |
| Primary Shaft Material | Silicone | Silicone |
| Catheter Size | 16 Fr | 12 Fr - 24 Fr |
| Catheter Length | 17" | 17" |
| Inflation Volume | 10 mL | 10 mL – 30 mL |
| Balloon Deflation | Via syringe through Luer-activated
valve. | Via syringe through Luer-activated valve. |
| Secondary Balloon
Deflation Mechanism | The inflation lumen of the catheter
contains a secondary balloon deflation
mechanism. This mechanism is
designed to provide a fluid escape
pathway to allow for balloon deflation
in the event of a forced withdrawal or
catheter pullout. | No secondary balloon deflation mechanism. |
| Tip Shapes | Straight,
Coude | Straight,
Coude |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
As evidenced by the above table, both the subject and the predicate devices have intended use, but the subject and the predicate devices have different technological characteristics.
Performance testing was conducted on the subject device, and it was established that the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness.
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Image /page/7/Picture/0 description: The image is a logo for InnoCare Urologics. The logo features the letters "iu" in a stylized font, with the "i" in dark blue and the "u" in light blue. To the right of the letters, the words "INNOCARE" and "UROLOGICS" are stacked on top of each other in dark blue. The letters "TM" are in the upper right corner of the word "INNOCARE".
7. SUMMARY OF NON-CLINICAL TESTING
Device performance data was provided in support of the substantial equivalence determination.
BIOCOMPATIBILITY TESTING:
Biocompatibility testing was conducted per ISO 10993-1:2018. The following tests were conducted:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Subacute Systemic Toxicity
- Genotoxicity
- Implantation
The results of this testing demonstrate that the subject device is biocompatible for its intended use.
Bench Testing:
Bench testing of the subject device included dimensional verification, functional and performance testing per ASTM F623:2019 requirements, simulated use testing of the secondary balloon deflation mechanism and Magnetic Resonance Compatibility testing per FDA Guidance (2023), "Testing and Labeling Medical Devices for Safety in the Maqnetic Resonance (MR) Environment | FDA".
All pre-determined acceptance criteria were met. Performance testing demonstrates that the differences in technological characteristics between the subject and the predicate do not raise different questions of safety or effectiveness.
Sterility, Packaging and Distribution:
The InnoCare Specialty Foley Catheter was validated to be sterilized using ethylene oxide per ISO 11135:2014. To support the claimed shelf life, performance testing and package integrity testing was conducted following environmental conditioning, simulated distribution and accelerated aging.
8. CONCLUSION
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate device.