(184 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.
Yes.
The device is used to drain urine from the bladder, which alleviates a medical condition (urinary incontinence) and therefore fits the definition of a therapeutic device.
No
The provided text describes an intermittent catheter which is a device used to drain urine from the bladder. It is a therapeutic or management device, not a diagnostic one.
No
The device description clearly indicates it is a physical, flexible tubular device (catheter) made from Thermo-plastic Elastomer (TPE) and includes physical components like drainage eyelets and packaging. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain urine from the bladder by inserting a flexible tubular device through the urethra. This is a direct interaction with the body for a therapeutic purpose (managing urinary incontinence by draining the bladder), not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical characteristics and function of a catheter for draining urine. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical and biological properties of the catheter itself (strength, flow rate, biocompatibility, sterilization, packaging), not on the accuracy or reliability of any diagnostic measurements or analyses.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other components typically associated with IVD devices.
In summary, the Sleeved IC 2 is a medical device used for a therapeutic purpose (urine drainage), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), & Sleeved IC 2 Plus Pocket (16" and 8"): 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.
Sleeved IC 2 Pocket (8"): This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (pediatric) patients who need to drain urine from the bladder.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The Sleeved IC 2 (not finalized) catheters are:
- E-beam sterilized.
- Hydrophilic-coated, single use catheter.
- Have two drainage eyelets that is used to manage urinary incontinence.
- The Sleeved IC is inserted into the urethra to drain urine from the bladder.
- Available in 16 inch and 8 inch lengths.
- Available in various Fr sizes ranging from Fr 08 through Fr 16.
- Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC.
- Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter.
- Lubricated by direct contact with the hydration fluid.
- Available with and without integrated urine collection bag.
- Available in pocket and straight packaging configurations.
- Environment of use: hospital, home setting, public places.
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
male, female and pediatric patients; female and female paediatric (pediatric) patients
Intended User / Care Setting
Hospital, Home Setting, Public Places
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)
Brief Description of Non-Clinical Testing:
The physical performance properties of the Sleeved IC 2 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 strength of the catheter, security of fit of the drainage funnel, flow rate through catheter, catheter kink stability and peak tensile force. Testing of the urine collection bag was conducted to verify that the liquid would flow into the collection bag within 1 minute and to confirm sufficient flowrate.
Biocompatibility testing met the following requirements:
- 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 10993-23, Biological evaluation of medical devices - Part 23 Tests for irritation
The following biological endpoints were addressed: cytotoxicity, 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
Both package integrity testing and bench performance testing were completed to support shelf life.
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.
Packaging met all requirements of the following FDA recognized standards:
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: Requirements for ● materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: Validation ● requirements for forming, sealing and assembly process
- ASTM F2096-11(2019) Standard test method for detecting gross leaks in packaging internal ● pressurization (bubble test)
- ASTM F88/F88M-21 Standard test method for seal strength of flexible barrier materials
- ASTM F88/F88M-23 Standard test method for seal strength of flexible barrier materials ●
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 3, 2024
Hollister Incorporated Michelle Schiltz-Taing Regulatory Affairs Manager 2000 Hollister Drive Libertyville, Illinois 60048
Re: K233524
Trade/Device Name: Sleeved IC 2 Family: Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Received: April 2, 2024
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 (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.
1
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).
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 QS 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.
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 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
| Submission Number (if known) | K233524/S001 |
|---|---|
| Device Name | Sleeved IC 2 Family |
| Sleeved IC 2 SWT (Name not Finalized) | |
| Sleeved IC 2 Plus (Name not Finalized) | |
| Sleeved IC 2 Pocket (Name not Finalized) | |
| Sleeved IC 2 Plus Pocket (Name not Finalized) | |
| Indications for Use (Describe) | Sleeved IC 2 SWT (16" and 8"), Sleeved IC 2 Plus (16" and 8"), Sleeved IC 2 Pocket (16"), & |
| Sleeved IC 2 Plus Pocket (16" and 8"): | |
| 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. | |
| Sleeved IC 2 Pocket (8"): | |
| This intermittent catheter is a flexible tubular device that is inserted through the urethra by female and female paediatric (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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/1 description: The image contains the Hollister logo. The logo consists of a red, geometric symbol resembling a stylized cross or asterisk on the left. To the right of the symbol is the word "Hollister" in a gray, sans-serif font. The overall design is clean and corporate.
510(k) Summary
| Applicant: | Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048 |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michelle Schiltz-Taing
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048
(t) 224-864-0431 |
| Date Prepared:
Trade Name:
Common Name:
Product Code/ Class: | 22 April 2024
Sleeved IC 2 (Not finalized)
Catheter, Urethral
EZD (catheter, straight)/Class II |
Classification Name: CFR:
Predicate Device:
Sleeved IC by Hollister Incorporated. (K220667)
The predicate has not been subject to a design- related recall.
Indications for Use:
| Sleeved IC 2 | Sleeved IC 2 Plus | Sleeved IC 2 Pocket | Sleeved IC 2 Plus Pocket |
|---|---|---|---|
| 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. | 16 Inch | ||
| This intermittent catheter is a | |||
| flexible tubular device that is | |||
| inserted through the urethra | |||
| by male, female and | |||
| paediatric (pediatric) patients | |||
| who need to drain urine from | |||
| the bladder. | 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. | |||
| 8 inch | |||
| This intermittent catheter is a | |||
| flexible tubular device that is | |||
| inserted through the urethra | |||
| by female and female | |||
| paediatric (pediatric) patients | |||
| who need to drain urine from | |||
| the bladder. |
Urological catheter and accessories
21 CFR 876.5130
5
Description of Applicant Device:
The Sleeved IC 2 (not finalized) catheters are:
- E-beam sterilized. ●
- Hydrophilic-coated, single use catheter. .
- Have two drainage eyelets that is used to manage urinary incontinence. ●
- The Sleeved IC is inserted into the urethra to drain urine from the bladder. ●
- . Available in 16 inch and 8 inch lengths.
- Available in various Fr sizes ranging from Fr 08 through Fr 16.
- Are made from Thermo-plastic Elastomer (TPE); not made with phthalates and not made with PVC.
- Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter.
- Lubricated by direct contact with the hydration fluid. ●
- Available with and without integrated urine collection bag. ●
- Available in pocket and straight packaging configurations.
- . Environment of use: hospital, home setting, public places.
Comparison of Technological Characteristics:
The table below summarizes the technological characteristics of the Sleeved IC 2 as compared to the predicate device.
| | Sleeved IC
Predicate K220667 | Sleeved IC 2 | Same or Different/
Rationale for no
impact to safety or
efficacy |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication 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.
8-inch Sleeved IC 2 Pocket:
This intermittent catheter is a flexible tubular device that is inserted through
the urethra by female and female paediatric (pediatric) patients who need to
drain urine from the bladder. | | No change
The 8-inch Sleeved IC2
Pocket has the same
indication for use but
focuses on a subset of
the population.
There is no effect to the
safety or efficacy or to
the intended use. |
| Condition of
Use | | Single Use | No change |
| Ready to use | | Yes | No change |
| Hydration
Method | | Direct hydration | No change |
| Hydration
Fluid | | Hydration Fluid | No change |
| Catheter
hydrophilic
coating | | PVP Based (polyvinylpyrollidone) Coating | No change |
| Catheter
Material | | Thermoplastic Elastomer (TPE); not made with phthalates, not made with
PVC | No change |
| | Sleeved IC
Predicate K220667 | Sleeved IC 2 | Same or Different/
Rationale for no
impact to safety or
efficacy |
| Catheter
length/ Fr. sizes | Diameter (Fr) 12 and 14
Length - 16 inches | Diameter (Fr) 08-16
Length - 16 inches and 8 Inches | Different
The additional Fr sizes
and catheter length meet
the same requirements
as the predicate device.
(ISO 20696)
There is no effect to
safety or efficacy or to
the intended use. |
| End of catheter
design | | Rounded tip | No change |
| End Design
(Straight) | | Color coded funnel | No change |
| End Design
(Plus) | N/A | Urine collection bag | Different
The urine collection bag
was added for user
convenience. The
materials used in the
collection bag have
been assessed for
biocompatibility and
tested to verify
sufficient flowrate of
urine into the collection
bag.
There is no effect to
safety or efficacy or to
the intended use. |
| Catheter
Eyelets | | 2 smooth catheter eyelets | No change |
| Catheter Color | | Clear | No change |
| Not Made with
Natural Rubber
Latex | | Yes | No change |
| Packaging
Material | | Aluminium Foil Laminate | No change |
| Sterilization
Method | | e-beam Irradiation Dose 25-65kGy SAL 10-6 | No change |
| Storage
Conditions | | 15-30°C / 59-86°F | No Change |
| | Sleeved IC
Predicate K220667 | Sleeved IC 2 | Same or Different/
Rationale for no
impact to safety or
efficacy |
| Environment of
Use | | Hospital
Home Setting
Public Places | No Change |
6
7
K220667 Page 4 of 5
Brief Description of Non-Clinical Testing:
The physical performance properties of the Sleeved IC 2 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 strength of the catheter, security of fit of the drainage funnel, flow rate through catheter, catheter kink stability and peak tensile force. Testing of the urine collection bag was conducted to verify that the liquid would flow into the collection bag within 1 minute and to confirm sufficient flowrate.
Biocompatibility testing met the following requirements:
- . 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 10993-23, Biological evaluation of medical devices - Part 23 Tests for irritation
The following biological endpoints were addressed: cytotoxicity, 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
8
Both package integrity testing and bench performance testing were completed to support shelf life.
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.
Packaging met all requirements of the following FDA recognized standards:
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: Requirements for ● materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: Validation ● requirements for forming, sealing and assembly process
- ASTM F2096-11(2019) Standard test method for detecting gross leaks in packaging internal ● pressurization (bubble test)
- ASTM F88/F88M-21 Standard test method for seal strength of flexible barrier materials
- ASTM F88/F88M-23 Standard test method for seal strength of flexible barrier materials ●
Conclusion:
It is concluded that the information supplied in this submission has demonstrated that the safety and effectiveness of the Sleeved IC 2 is substantially equivalent to the cleared predicate device.