(276 days)
Not Found
No
The description focuses on the physical characteristics, materials, and performance of a standard intermittent catheter, with no mention of AI or ML capabilities.
Yes.
The device is used to manage urinary incontinence, which is a medical condition, by draining urine from the bladder, thereby providing a therapeutic benefit to the patient.
No
The device is described as an intermittent catheter used to drain urine, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly indicates it is a physical catheter made from Thermo-plastic Elastomer (TPE) and includes details about its physical properties, materials, and packaging. It is a hardware device.
Based on the provided information, 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 described device is an intermittent catheter. Its function is to physically drain urine from the bladder. It is a medical device used for a therapeutic purpose (managing urinary incontinence) and not for analyzing a sample to diagnose or monitor a condition.
- Lack of Diagnostic Elements: The description does not mention any components or processes related to analyzing a biological sample or providing diagnostic information.
Therefore, the Sleeved IC is a medical device, but it falls under a different regulatory category than IVDs.
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)
EZD
Device Description
The Sleeved IC (final name to be determined) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Sleeved IC is inserted into the urethra to drain urine from the bladder. The catheter is available in 16in length. The catheter is available in 12 and 14 Fr sizes. The catheter is provided in a sterile manner, utilization method. The device is made from Thermo-plastic Elastomer (TPE) and is phthalate free and PVC free. This directly hydrated catheter is packaged in a foil 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. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid.
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
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)
The physical performance properties of the Sleeved IC 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.
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 10993-17:2002, 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.
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.
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 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.
December 8, 2022
Hollister Incorporated Sandra Mullen Regulatory Affairs Manager 2000 Hollister Drive Libertyville, Illinois 60048
Re: K220667 Trade/Device Name: Sleeved IC Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter And Accessories Regulatory Class: II Product Code: EZD Dated: November 17, 2022 Received: November 17, 2022
Dear Sandra Mullen:
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 (21 CFR Part
1
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-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 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,
Negeen Haghighi -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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Sleeved IC (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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K220667 Page 1 of 5
510(k) Summary
| Applicant: | Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60048 |
|-----------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sandra Mullen
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60018
(t) +00 353 86 301 1706 |
| Date Prepared: | 7 December 2022 |
|---|---|
| Trade Name : | Sleeved IC (not finalized) |
| Common Name: | Catheter, Straight |
| Classification Number | 21 CFR 876.5130 |
| Classification Name | Urological catheter and accessories |
| Product Code | EZD |
| Product Code Name | Gastroenterology-Urology |
| Regulatory Class | Class II |
Predicate Device:
VaPro2 Intermittent Catheter by Hollister Incorporated. (K180824)
The predicate has not been subject to a design- related recall.
Indications for Use:
This Sleeved IC 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.
Description of Applicant Device:
The Sleeved IC (final name to be determined) is a sterile, hydrophilic-coated, single use catheter with drainage eyelets that is used to manage urinary incontinence. The Sleeved IC is inserted into the urethra to drain urine from the bladder. The catheter is available in 16in length. The catheter is available in 12 and 14 Fr sizes. The catheter is provided in a sterile manner, utilization method. The device is made from Thermo-plastic Elastomer (TPE) and is phthalate free and PVC free. This directly hydrated catheter is packaged in a foil 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. This means that the coated catheter surface is lubricated by direct contact with the hydration fluid.
4
Comparison of Technological Characteristics
The table below summarizes the technological characteristics of the Sleeved IC as compared to the predicate device.
| | Predicate
VaPro 2
Intermittent
Catheter
(K180824) | Sleeved IC | Rationale for no impact to safety and
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. | | There is no change to
Indications for Use including
intended patient population.
Testing provided in relation to
product differences
demonstrate no impact to
device safety, effectiveness or
functionality per the intended
use when compared to
predicate device. |
| Condition of Use | Single Use | | No change |
| Ready to use | Yes | | No change |
| Hydration Method | Water vapor hydration | Direct Hydration | Testing provided shows
differences do not affect the safety
and effectiveness compared to
predicate and reference devices.
Although a different method of
hydration is utilized between the
predicate device and the Sleeved IC,
substantial equivalency of catheter
lubricity is demonstrated via testing. |
| Hydration Fluid | DI Water | Hydration Fluid | Testing provided shows
differences do not affect safety and
effectiveness compared to the predicate
device. |
| Catheter Hydrophilic
Coating | PVP Based (polyvinylpyrollidone) Coating | | The hydrophilic coating on
the predicate and Sleeved
IC is PVP based.
Testing provided shows
differences do not affect the safety
and effectiveness compared to
predicate and reference devices. |
| Catheter Material | Polyvinyl Chloride (PVC);
(Not manufactured with
Phthalates) | Thermoplastic
Elastomer (TPE);
(Not manufactured
with Phthalates or
with PVC) | Testing shows differences in materials
do not affect safety and effectiveness
compared to the predicate device.
Both Sleeved IC and representative
device conform to BS EN 20696 |
| | Predicate
VaPro 2
Intermittent
Catheter
(K180824) | Sleeved IC | Rationale for no impact to safety and
efficacy |
| | | | 'Sterile Urethral Catheters for Single
Use'. |
| | | | Biocompatibility has been assessed and
all requirements met. |
| Catheter length/ Fr.
sizes | Diameter (Fr) - 8, 10, 12, 14
and 16 Length - 16 inches | Diameter (Fr) 12 and 14
Length - 16 inches | The sleeved IC diameter sizes are
within the range of the predicate
product family
No change in catheter length |
| End of catheter
design | Rounded tip | | No change |
| End Design | Color coded funnel | | No change |
| Catheter Eyelets | 2 smooth catheter eyelets | | No change |
| Catheter Color | Opaque | Clear | The appearance of the
catheter tubing does not impact
functionality |
| Not Made with
Natural Rubber
Latex | Yes | | No change |
| Packaging Material | OPA/ALU/PE Foil laminate | PET/ALU/PE 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 | The difference in
Sterilization method does not affect the
safety and effectiveness compared to
the predicate device.
Gamma and E-beam sterilization
methods are both forms of radiation
sterilization.
The required Sterility Assurance Level
(SAL) has been validated for both
methods. |
| Storage Conditions | 15-30°C / 59-86°F | | No change |
| Environment of Use | Hospital
Home Setting
Public Places | | No Change |
5
6
Brief Description of Non-Clinical Testing:
The physical performance properties of the Sleeved IC 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.
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 10993-17:2002, 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
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.
7
Conclusion:
It is concluded that the information supplied in this submission has demonstrated that the Sleeved IC is substantially equivalent to the legally marketed predicate device.