(307 days)
Not Found
No
The device description and performance studies focus on the physical properties, biocompatibility, and sterilization of a standard intermittent catheter. There is no mention of AI or ML in the text.
No
The device is described as a catheter used for draining urine, which is a medical intervention but not explicitly described as providing therapy for a disease or condition. Its purpose is to manage urinary incontinence by facilitating urine drainage, rather than treating or curing the underlying condition.
No
The device description states its purpose is to drain urine, which is a therapeutic or management function, not a diagnostic one.
No
The device description clearly indicates it is a physical, sterile, hydrophilic-coated catheter, not a software-only device. The performance studies also focus on physical properties, biocompatibility, and sterilization.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The description clearly states that this device is a catheter used to drain urine from the bladder. It is a physical device inserted into the body for a therapeutic purpose (managing urinary incontinence by draining urine), not for testing or analyzing a sample.
The information provided focuses on the physical properties, sterility, biocompatibility, and packaging of the catheter, which are typical characteristics of a medical device used for a physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
This internittent catheter is a flexible tubular device that is inserted through the urethra by female pediatric patients who need to drain urine from the bladder.
Product codes
EZD
Device Description
The Female IC (not finalized) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Female IC is inserted into the urethra to drain urine from the bladder. This directly hydrated catheter is packaged in a polypropylene/polyethylene case which was designed to be easy to open, close and dispose of, with a discrete consumer design. A "first use label" on the case indicates to the end user if the product was previously opened.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra, Bladder
Indicated Patient Age Range
Female pediatric patients
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)
The physical performance properties of the Intermittent Catheter met all applicable requirements of BS EN ISO 20696:2018, Sterile urethral catheters for single Use.
Biocompatibility testing met the requirements of the following standards: ISO 10993-1:2018, ISO 10993-3:2014, 10993-5:2009, 10993-10:2010, 10993-11:2017, 10993-12:2021, 10993-17:2002, 10993-18:2020.
Sterilization met all requirements of the following FDA-recognized standards: ISO 11137-1: 2006, ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2018, ANSI/AAMI/ISO 11737-2:2019.
Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted in order to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2022
Hollister Incorporated Michelle Schiltz-Taing Regulatory Affairs Manager 2000 Hollister Drive Libertyville, IL 60048
Re: K213575
Trade/Device Name: Female IC (not Finalized) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: August 9, 2022 Received: August 9, 2022
Dear Michelle Schiltz-Taing:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-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-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 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,
for Jessica K. 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
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Indications for Use
510(k) Number (if known) K213575
Device Name
Female IC (not finalized)
Indications for Use (Describe)
This internittent catheter is a flexible tubular device that is inserted through the urethra by female pediatic patients who need to drain urine from the bladder.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
| Applicant: | Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048 |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Schiltz-Taing
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60018
(t) 224-864-0431 |
| Date Prepared: | 13 September 2022 |
| Trade Name: | Female IC (Not Finalized) |
| Common Name: | Catheter, Urethral |
| Product Code/Class: | EZD/Class II |
| Classification Name: | Catheter, Straight |
| Regulation Number: | 21 CFR 876.5130 |
Predicate Device:
Infyna Chic K191633 by Hollister Incorporated. The predicate has not been subject to a design-related recall.
Indications for Use:
This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female pediatric patients who need to drain urine from the bladder.
Description of Applicant Device:
The Female IC (not finalized) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Female IC is inserted into the urethra to drain urine from the bladder. This directly hydrated catheter is packaged in a polypropylene/polyethylene case which was designed to be easy to open, close and dispose of, with a discrete consumer design. A "first use label" on the case indicates to the end user if the product was previously opened.
Technological Characteristics:
The table below summarizes the technological characteristics of the Female IC as compared to the predicate.
4
| | Predicate Device
Infyna Chic
(K191633) | Female IC | Same or Different/Rationale
for No impact to Efficacy or Safety |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | This intermittent catheter is a
flexible tubular device that is
inserted through the urethra by
female patients who need to
drain urine from the bladder. | This intermittent catheter is a
flexible tubular device that is
inserted through the urethra by
female and female pediatric
patients who need to drain
urine from the bladder | No change-additional
verbiage was used to clarify
that "female" includes female
pediatric patients. No impact
to the existing Female IC risk
file was identified and no
additional safety concerns
were added due to the
clarification of the patient
population. |
| Condition of Use | Single Use | | No Change |
| Pre-lubricated | Water vapor hydration | Direct Hydration | Although a different method
of hydration is utilized
between the predicate and
subject device; equivalency of
catheter lubricity is
demonstrated within this
submission |
| Ready to use | Yes | | No Change |
| End Design | Color coded Funnel | | No Change |
| Sterile | Gamma Radiation | E-Beam Radiation | Gamma and E-Beam
sterilization methods are both
forms of radiation
sterilization. The required
Sterility Assurance Level
(SAL) has been validated for
both methods. |
| Hydrophilic Coating | PVP Based (polyvinylpyrrolidone) Coating | | No Change |
| Catheter Eyelets | 2 smooth catheter eyelets | | No Change |
| Not Made with
Natural Rubber Latex | Yes | | No Change |
| Catheter Material | Polyvinyl Chloride (PVC);
phthalate free | Thermo-plastic Elastomer
(TPE); phthalate free, PVC
free) | Catheter material changes has
no impact as both the
predicate and subject device
conform to BS EN 20696. |
| | | | "Sterile urethral catheters for
single use". Biocompatibility
has been assessed and all
requirements have been met |
| Catheter Length | 5 inches | 5.5 inches | The subject device has a
length of 0.5 inches more
than the predicate. No impact
as both the predicate and
subject device conform to BS
EN 20696- "Sterile urethral
catheters for single use"
effective shaft length. |
| Fr Size | Fr 8, 10, 12, 14 | | No Change |
| Environment of Use | Hospital
Home Setting
Public Places | | No Change |
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Brief Description of Non-Clinical Testing:
The physical performance properties of the Intermittent Catheter met all applicable requirements of BS EN ISO 20696:2018, Sterile urethral catheters for single Use.
Biocompatibility testing met the requirements of the following standards:
- . ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- ISO 10993-3:2014. Biological evaluation of medical devices Part 3:Tests for genotoxicity. ● carcinogenicity, and reproductive toxicity.
- 10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●
- 10993-12:2021, Biological evaluation of medical devices Part 12: Sample preparation and ● reference materials.
- 10993-17:2002, Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances.
- 10993-18:2020, Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
Sterilization met all requirements of the following FDA-recognized standards:
- ISO 11137-1: 2006, Sterilization of health care products-Radiation Part 1: Requirements for ● development, validation and routine control of a sterilization process for medical devices.
- ISO 11137-2:2013, Sterilization of health care products Radiation Part 2: Establishing the ● sterilization dose.
- ANSI/AAMI/ISO 11737-1:2018, Sterilization of health care products Microbiological methods ● - Part 1: Determination of a population of microorganisms on products.
6
- ANSI/AAMI/ISO 11737-2:2019, Sterilization of medical devices Microbiological methods -● Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted in order to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment.
Conclusion:
It is concluded that the information supplied in this submission has demonstrated that the Female IC is substantially equivalent to the legally marketed predicate device.