(262 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of a standard intermittent catheter, with no mention of AI or ML capabilities.
No.
The device is described as an intermittent catheter used for draining urine, which is a diagnostic or management tool, not a therapeutic treatment for a disease.
No
Explanation: The device description states its purpose is to "drain urine from the bladder," which is a therapeutic or management function, not a diagnostic one. It does not mention any capabilities for detecting, identifying, or monitoring medical conditions.
No
The device description clearly describes a physical, tubular device made of Thermo-plastic Elastomer (TPE) with drainage eyelets, a hydrophilic coating, and a gripper. It also details physical performance testing and biocompatibility testing, which are characteristic of a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a physical tool (a catheter) inserted into the body to drain urine. It does not analyze or test the urine itself. Its function is purely mechanical and therapeutic.
- Intended Use: The intended use is to drain urine from the bladder, not to perform any diagnostic test on the urine.
Therefore, this intermittent catheter falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
Product codes (comma separated list FDA assigned to the subject device)
GBM
Device Description
The Intermittent Catheter (final name to be determined) is a hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinent Catheter is inserted into the urethra to drain urine from the bladder. The Intermittent Catheter is available in 7 in. and 16 in. lengths. The 7 in. catheter is available in sizes 8, 10, 12, 14 Fr and the 16 in. catheter is available in sizes 8, 10, 12, 14, 16 Fr. The Intermittent Catheter is provided sterile, using e-beam Irradiation sterilization. The device is made from Thermo-plastic Elastomer (TPE), and is phthalate free, PVC free. This directly hydrated catheter is packaged in a peel-able 4 sided pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid in one compartment. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid There is a gripper on the 16 inch catheter to aid with the insertion process, if desired.
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
pediatric, male, female
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. Testing was conducted to support size designation, show equivalence of lubricity, and determination of the catheter, the security of fit of the drainage funnel, flow rate through catheter, kink stability and peak tensile force of urethral catheter.
Biocompatibility testing met the requirements of the following standards: ISO 10993-1:2018, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ISO 10993-12:2021, ISO 10993-17:2002, ISO 10993-18:2020. The following biological endpoints were addressed: cytotoxicity, intracutaneous irritation, vaginal irritation, sensitization, acute systemic toxicity, and subacute systemic toxicity.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 27, 2022
Hollister Incorporated Michelle Schiltz-Taing Regulatory Affairs Manager 2000 Hollister Drive Libertyville, IL 60048
Re: K211436
Trade/Device Name: Intermittent Catheter (not finalized) Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: December 29, 2021 Received: December 30, 2021
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.
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
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
2
Indications for Use
510(k) Number (if known)
Device Name Intermittent Catheter (not finalized)
Indications for Use (Describe)
The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric 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)
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3
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: | January 25, 2022 |
| Trade Name: | Intermittent Catheter (not finalized |
| Common Name: | Catheter, Urethral |
| Product Code/Class: | GBM/Class II |
| Classification Name: | Urological catheter and accessories |
| Classification Number: | 21 CFR 876.5130 |
Predicate Device:
Onli Intermittent Catheter by Hollister Incorporated (K163179)
The predicate device 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 male, female and pediatric patients who need to drain urine from the bladder.
Device Description:
The Intermittent Catheter (final name to be determined) is a hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinent Catheter is inserted into the urethra to drain urine from the bladder. The Intermittent Catheter is available in 7 in. and 16 in. lengths. The 7 in. catheter is available in sizes 8, 10, 12, 14 Fr and the 16 in. catheter is available in sizes 8, 10, 12, 14, 16 Fr. The Intermittent Catheter is provided sterile, using e-beam Irradiation sterilization. The device is made from Thermo-plastic Elastomer (TPE), and is phthalate free, PVC free. This directly hydrated catheter is packaged in a peel-able 4 sided pouch which was designed to be easy to open and to facilitate access to the catheter. The primary pack contains both the catheter assembly and the hydration fluid in one compartment. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid There is a gripper on the 16 inch catheter to aid with the insertion process, if desired.
4
Comparison of Technological Characteristics:
The table below summarizes the technological characteristics of the Intermittent Catheter as compared to the predicate and reference devices.
| | Predicate Onli
K163179 | Intermittent Catheter | Same or Different/Rational for no
impact to efficacy or safety |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The intermittent catheter is a flexible tubular device that is
inserted through the urethra by male, female and pediatric
patients who need to drain urine from the bladder. | | No change |
| Condition of Use | | Single Use | No change |
| Device Material | Polyvinyl Chloride (PVC);
phthalate free funnel and
catheter
Thermo-plastic Elastomer
(TPE); phthalate free,
PVC free gripper | Thermo-plastic Elastomer
(TPE); phthalate free,
PVC free funnel, catheter,
and gripper | Testing shows differences do not
affect safety and effectiveness
compared to the predicate device. |
| Length/Fr Sizes | 7 inches: Fr 8, 10, 12, 14
16 inches: Fr 8, 10, 12, 14, 16 | | No change |
| Gripper on 16 in.
Catheter | Yes | | No change |
| Attachment of
Funnel to
Catheter Tube | Solvent Bonded | Insert molded funnel
(created by a thermal
bond) | Although the attachment of the
funnel to the catheter tube is
different, the differences do not
affect safety and effectiveness
compared to the predicate device. |
| End of Catheter
Design | Rounded tip | | No change |
| End Design | Color-coded funnel | | No change |
| Number of
Eyelets | 2 | | No change |
| Catheter Color | Opaque | Clear | The appearance of the catheter does
not impact functionality. |
| Coating | PVP Based Coating
(polyvinylpyrollidone) | | The Hydrophilic coating on the
predicate and the Intermittent Catheter
is PVP based. Testing shows
differences do not affect safety and
effectiveness compared to the
predicate device. |
| Fluid | DI water | Hydration fluid | Although the hydration fluid is
different between the predicate and the
Intermittent Catheter, testing shows
differences do not affect safety and
effectiveness compared to the
predicate device. |
| Hydration
Method | Vapor Hydration | Direct Hydration | Although a different method of
hydration is utilized between the
predicate device and the Intermittent
Catheter, substantial equivalency of
catheter lubricity is demonstrated
via testing. |
| Packaging
Material | Oriented
Polyamide/Aluminum/Polyethyle
ne (OPA/ALU/PE) foil
(foil laminate) | Polyethlyene
Terephthalate/Aluminum/
Polyethylene
(PET/ALU/PE) foil
(foil laminate) | Testing shows differences do not
affect safety and effectiveness
compared to the predicate device. |
| Sterilization
Method | Gamma Irradiation
Dose 25-40kGy
SAL 10-6 | e-beam Irradiation
Dose 25-65kGy
SAL 10-6 | The difference in sterilization method
does not affect the safety and
effectiveness compared to the
predicate device. |
| Expiration
Dating | 2 years | | No change |
| Storage
Conditions | 15-30°C / 59-86°F | | No change |
5
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. Testing was conducted to support size designation, show equivalence of lubricity, and determination of the catheter, the security of fit of the drainage funnel, flow rate through catheter, kink stability and peak tensile force of urethral catheter.
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
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ●
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin ● sensitization
- ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-12:2021, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 10993-17:2002, Biological evaluation of medical devices Part 17: Establishment of allowable ● limits for leachable substances
- ISO 10993-18:2020, Biological evaluation of medical devices Part 18: Chemical characterization ● of medical device materials within a risk management process
6
The following biological endpoints were addressed: cytotoxicity, intracutaneous irritation, vaginal irritation, sensitization, acute systemic toxicity, and subacute systemic toxicity.
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
- 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 Intermittent Catheter is substantially equivalent to the legally marketed predicate device.