(73 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and sterility of a standard intermittent catheter, with no mention of AI or ML.
No.
A therapeutic device is one that treats or prevents a disease or condition, whereas this device is used to drain urine for managing urinary incontinence, which is a supportive function rather than a treatment for a disease.
No
The device is described as an intermittent catheter used for draining urine, which is a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or characterize a disease or condition.
No
The device description clearly outlines physical components of a catheter, including a flexible tube, eyelets, a funnel, and packaging with a water compartment. There is no mention of software as a component of the device itself.
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 does not perform any analysis or testing on a sample of urine or any other bodily fluid.
- Intended Use: The intended use is to manage urinary incontinence by draining urine. This is a physical intervention, not a diagnostic test.
The information provided clearly describes a medical device used for a therapeutic purpose (draining urine), not a diagnostic purpose (analyzing a sample to gain information about a patient's health).
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
GBM
Device Description
The Onli intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:
Σ Ready to use, single use intermittent catheter
Σ Hydrophilic-coated, phthalate free catheter
Σ Two smooth catheter eyelets
Σ Color coded funnel
Σ Not made with natural rubber latex
Σ Gripper on the16-in. catheter to aid with insertion
The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be easy to open and facilitate access to the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
male, female and 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)
Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Results indicate compliance to the standard.
Sterility testing was performed using Gamma Irradiation in accordance with Method I validation per ANSI/AAMI/ISO 11137-1:2006 & 2:2013. All results were satisfactory.
Packaging integrity testing was performed to verify the maintenance of the sterile barrier through shelf life. The testing concluded that Onli packaging is capable of maintaining a sterile barrier for at least two years.
Transportation testing was performed in order to verify that there is no impact to the safety or efficacy of the catheter performance due to the hazards associated with the transportation environment. The test produced successful results.
Conclusion: Based on the performance testing conducted it is concluded that the modified device, Onli intermittent catheter, is as safe and effective and performs equivalent to the predicate device.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Hollister Incorporated Jeanne Lee Sr. Manager, Regulatory Affairs 2000 Hollister Drive Libertyville, IL 60048
Re: K163179 Trade/Device Name: Onli Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: GBM Dated: December 27, 2016 Received: December 29, 2016
Dear Jeanne Lee,
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Charles Viviano -S
For Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image contains the word "Hollister" next to a red logo. The logo is a red geometric shape that looks like a stylized cross or star. The word "Hollister" is written in a simple, sans-serif font.
510(k) Summary
| Submitted By: | Jeanne Lee
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60018
(t) 847-996-6350
(f) 847-918-3981 | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Date Summary Prepared: | November 9, 2016 | |
| Device Name: | Proprietary Name - OnliTM intermittent catheter | |
| | Common/Usual Name - Catheter, Urethral | |
| | Classification Name - Urological catheter and accessories | |
| Device Class: | Class II per 21 CFR 876.5130 | |
| Product Code: | GBM | |
| Predicate Device: | VaPro intermittent catheter, K141642 | |
| Device Description: | The Onli intermittent catheter is a single use catheter to be used as
a means of managing urinary incontinence by draining urine from
the bladder. The catheter has the following elements:
Σ Ready to use, single use intermittent catheter
Σ Hydrophilic-coated, phthalate free catheter
Σ Two smooth catheter eyelets
Σ Color coded funnel
Σ Not made with natural rubber latex
Σ Gripper on the16-in. catheter to aid with insertion
The packaging contains a sealed water compartment chamber of
which the water migrates to the catheter compartment and
lubricates the catheter. The outer packaging was designed to be
easy to open and facilitate access to the catheter. | |
| Intended 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. | |
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Technological Characteristics: The table below summarizes the technological characteristics of the device as compared to the predicate device.
| | Modified Device:
Onli
intermittent catheter | Predicate Device:
VaPro
intermittent catheter
(K141642) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended 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. | |
| Condition of Use | Single Use | Single Use |
| Prelubricated | Yes-by water vapor hydration | Yes-by water vapor hydration |
| Ready to use | Yes | Yes |
| No touch design | No | Yes-has protective sleeve |
| Protective Tip | No | Yes |
| Movable Gripper
(16-in. catheter only) | Yes | No |
| Catheter Material | PVC (phthalate free) | PVC (phthalate free) |
| Lubricant | PVP Based Coating
(polyvinylpyrollidone) | PVP Based Coating
(polyvinylpyrollidone) |
| End Design | Funnel | Funnel |
| Sterilization | Gamma Irradiation | Gamma Irradiation |
Performance Testing:
Biocompatibility testing was performed based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Results indicate compliance to the standard.
Sterility testing was performed using Gamma Irradiation in accordance with Method I validation per ANSI/AAMI/ISO 11137-1:2006 & 2:2013. All results were satisfactory.
Packaging integrity testing was performed to verify the maintenance of the sterile barrier through shelf life. The testing concluded that Onli packaging is capable of maintaining a sterile barrier for at least two years.
Transportation testing was performed in order to verify that there is no impact to the safety or efficacy of the catheter performance due to the hazards associated with the transportation environment. The test produced successful results.
Conclusion: Based on the performance testing conducted it is concluded that the modified device, Onli intermittent catheter, is as safe and effective and performs equivalent to the predicate device.