(28 days)
No
The description focuses on the physical design, materials, and intended use of a catheter, with no mention of AI or ML technologies.
Yes
The device is used to drain urine from the bladder, which is a therapeutic intervention for patients with urinary incontinence.
No
The device is described as an intermittent catheter used for draining urine, not for diagnosing medical conditions.
No
The device description clearly describes a physical, tubular catheter with a hydrophilic coating, protective sleeve, introducer tip, and collection bag, indicating it is a hardware medical device.
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, which is a physical intervention for managing urinary incontinence. It does not involve testing or analyzing biological samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and function of the catheter for urine drainage. There is no mention of reagents, assays, or any components used for in vitro testing.
- Lack of IVD-Specific Information: The document does not include any information typically found in IVD submissions, such as:
- Specific analytes being measured.
- Performance characteristics related to diagnostic accuracy (sensitivity, specificity, etc.).
- Details about sample types (urine, blood, etc.) being tested.
- Information about the testing methodology.
This device is clearly a medical device used for a therapeutic/management purpose, not an in vitro diagnostic purpose.
N/A
Intended Use / Indications for Use
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
GBM
Device Description
The VaPro Plus 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 catheter is connected to a collection bag 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, 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)
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)
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/0 description: The image shows the Hollister logo. The logo consists of a geometric symbol on the left and the word "Hollister" on the right. The geometric symbol is a stylized representation of a cross or star, formed by intersecting lines. The word "Hollister" is written in a bold, sans-serif font.
510(k) Summary
APR 2 6 2011
| Submitted By: | Chris Stukel
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60018
847-680-1000 | | | | | | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Date Summary Prepared: | March 24, 2011 | | | | | | |
| Device Name: | Classification Name- Urological catheter and accessories | | | | | | |
| | Common/Usual Name- Catheter, Urethral | | | | | | |
| | Proprietary Name- VaPro™ Plus Intermittent Catheter | | | | | | |
| Predicate Device: | The VaPro Plus intermittent catheter is substantially equivalent to
the following products: | | | | | | |
| | Product 510(k) VaPro™ Intermittent Catheter K090960 Incare Advance/Advance Plus
Intermittent Catheter K013483 | | | | | | |
| Device Description: | The VaPro Plus 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 catheter is
connected to a collection bag for use when drainage into a
suitable receptacle is not feasible or practical. | | | | | | |
| Intended Use: | 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. | | | | | | |
.
1
Technological Characteristics: The table below summarizes the technological characteristics of the device as compared to the predicate devices.
| Characteristics | VaPro Plus | VaPro Intermittent | Incare Advance/ |
|---|---|---|---|
| Intermittent Catheter | Catheter | Advance Plus | |
| (K090960) | (K013483) | ||
| Intended Use | 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. | 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. | Indicated for use by male, | ||
| female and pediatric | |||
| patients for the purpose of | |||
| bladder drainage. The | |||
| Catheter is a flexible | |||
| tubular device that is | |||
| inserted through the urethra | |||
| and used to pass fluids to or | |||
| from the urinary tract. | |||
| Condition of | |||
| Use | Single Use | Single Use | Single Use |
| Prelubricated | Yes-by water vapor | ||
| hydration | Yes-by water vapor | ||
| hydration | Yes-by hydrogel | ||
| Ready to use | Yes | Yes | Yes |
| End Design | Catheter funnel attached to | ||
| collection bag | Funnel | Advance - Funnel | |
| Advance Plus - Catheter | |||
| funnel inserted into | |||
| collection bag | |||
| Sterile | Yes | Yes | Yes |
| No touch | |||
| design | Yes-contains sleeve | Yes-contains sleeve | Yes-contains sleeve |
| Lubricant | PVP Based | ||
| (polyvinylpyrollidone) | |||
| Coating | PVP Based | ||
| (polyvinylpyrollidone) | |||
| Coating | Hydrogel | ||
| Protective Tip | Yes | Yes | Yes |
| Collection Bag | Yes | No | No- Advance |
| Yes- Advance Plus |
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.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christine Stukel Sr. Global Regulatory Affairs Analyst Hollister, Inc. 2000 Hollister Drive LIBERTYVILLE IL 60048-3781
APR 2 6 2011
Re: K110862
Trade/Device Name: VaPro™ Plus Intermittent Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: March 24, 2011 Received: March 29, 2011
Dear Ms. Stukel:
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 of medical device-related
3
Page 2
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Remmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K |10 86 Z
Device Name: VaPro™ Plus Intermittent Catheter
Indications for Use:
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.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ductive. Gastro-Renal, and 510(k) Numb
Page 14 of 43
VaPro™ Plus Special 510(k) Submission