(64 days)
Not Found
No
The summary describes a physical medical device (catheter) for draining urine and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a means of managing urinary incontinence by draining urine, which is a supportive rather than therapeutic function.
No
Explanation: The device is described as an intermittent catheter used for draining urine from the bladder, which is a therapeutic function, not a diagnostic one. It manages urinary incontinence, it does not diagnose it.
No
The device description clearly describes a physical, tubular device (catheter) and its associated components (protective sleeve, introducer tip, collection bag), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The VaPro and VaPro Plus intermittent catheters are used to drain urine directly from the bladder by being inserted into the urethra. This is a physical intervention performed within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to manage urinary incontinence by draining urine, not to diagnose a condition or provide information about a person's health through testing of a sample.
The provided text clearly describes a device for a physical procedure (catheterization) and not a diagnostic test.
N/A
Intended Use / Indications for Use
The VaPro™ 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.
The VaPro Plus™ 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 VaPro intermittent catheter is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity.
The VaPro Plus has the addition of a collection bag that is connected to the catheter for use when drainage into a suitable receptacle is not feasible or practical.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra (for insertion)
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)
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.
Product evaluation also supports device functionality.
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.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
Hollister Incorporated Jeanne Lee Senior Manager, Regulatory Affairs 2000 Hollister Drive Libertyville, IL 60048
Re: K141642
Trade/Device Name: VaPro™ intermittent catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: June 16, 2014 Received: June 19, 2014
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Benjamin R. Fisher -S
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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Indications for Use
510(k) Number
Device Name
VaPro™ intermittent catheter VaPro Plus™ intermittent catheter
Indications for Use
The VaPro™ 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.
The VaPro Plus™ 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 | |
|---|---|
| ------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY -------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of Center for Devices and Radiological Health (CDRH)
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:
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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: | June 16, 2014 |
| Device Name: | Classification Name- Urological catheter and accessories
Common/Usual Name- Catheter, Urethral
Proprietary Name- VaProTM intermittent catheter
VaPro PlusTM intermittent catheter |
| Predicate Device: | The VaPro intermittent catheter (with modification) is substantially
equivalent to its original design, VaPro intermittent catheter,
K090960.
The VaPro Plus intermittent catheter (with modification) is
substantially equivalent to its original design, VaPro Plus
intermittent catheter, K110862. |
| Device Description: | The VaPro intermittent catheter is a hydrophilic coated, single use
catheter to be used as a means of managing urinary incontinence
by draining urine from the bladder. The catheter comes in a
protective sleeve and is offered with a protective introducer tip as a
way to shield the sterile catheter from bacteria in the distal urethra
during insertion. The packaging contains a vapor strip that hydrates
the catheter coating which then lubricates the catheter. The outer
packaging was designed to facilitate access for those with limited
dexterity.
The VaPro Plus has the addition of a collection bag that is
connected to the catheter for use when drainage into a suitable
receptacle is not feasible or practical. |
| Intended Use: | The VaPro 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.
The VaPro Plus 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. |
| Technological
Characteristics: | The table below summarizes the technological characteristics of
the device as compared to the predicate devices. |
4
| | Modified Device:
VaPro intermittent
catheter | Predicate Device:
VaPro intermittent
catheter (K090960) | Modified Device:
VaPro Plus
intermittent catheter | Predicate Device:
VaPro Plus
intermittent catheter
(K110862) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use | The VaPro/VaPro Plus 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 | Single Use | Single Use |
| Prelubricated | Yes-by water vapor
hydration | Yes-by water vapor
hydration | Yes-by water vapor
hydration | Yes-by water vapor
hydration |
| Ready to use | Yes | Yes | Yes | Yes |
| End Design | Funnel | Funnel | Catheter funnel
attached to collection
bag | Catheter funnel
attached to collection
bag |
| Sterile | Yes | Yes | Yes | Yes |
| No touch
design | Yes-contains sleeve | Yes-contains sleeve | Yes-contains sleeve | Yes-contains sleeve |
| Lubricant | PVP Based
(polyvinylpyrollidone)
Coating | PVP Based
(polyvinylpyrollidone)
Coating | PVP Based
(polyvinylpyrollidone)
Coating | PVP Based
(polyvinylpyrollidone)
Coating |
| Protective Tip | Yes | Yes | Yes | Yes |
| Collection Bag | No | No | Yes | Yes |
Performance Testing Conclusions:
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.
Product evaluation also supports device functionality.