(29 days)
None
No
The device description and performance studies focus on the physical characteristics, materials, and packaging of a standard intermittent catheter, with no mention of AI or ML capabilities.
No
The device is used to drain urine for managing urinary incontinence, which is a supportive and management function rather than a direct therapeutic intervention to treat a disease or condition.
No
The device is an intermittent catheter for draining urine, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components such as a catheter, eyelets, protective sleeve, introducer tip, funnel, and packaging with a water compartment. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The VaPro Plus Pocket intermittent catheter is a device inserted into the body (through the urethra) to drain urine. It is a therapeutic and management device, not a diagnostic one. It does not analyze a sample in vitro to provide diagnostic information.
- Intended Use: The intended use is to "drain urine from the bladder," which is a physical action, not a diagnostic test.
- Device Description: The description focuses on the physical components and function of the catheter for urine drainage.
- Performance Studies: The performance studies mentioned relate to biocompatibility, sterility, packaging integrity, and transportation, all of which are relevant to a medical device inserted into the body, but not to the performance of an in vitro diagnostic test.
Therefore, the VaPro Plus Pocket intermittent catheter is a medical device used for managing urinary incontinence through drainage, and it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VaPro Plus Pocket 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 Plus Pocket 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:
∑ hydrophilic-coated PVC catheter (phthalate free)
∑ Two smooth catheter eyelets
∑ protective sleeve
∑ protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion
∑ color coded funnel
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 discreet, easy to store, easy to open and facilitate access to the catheter. 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
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)
There have been no changes to the device, only to the packaging. Therefore, no new biocompatibility testing was performed. For biocompatibility testing on the device in accordance with ISO 10993, please refer to 510(k) K141642. Biocompatibility was performed on the new packaging. This report is available upon request. All results were satisfactory.
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 VaPro Plus Pocket 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. The test produced successful results.
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.
VaPro Plus intermittent catheter, K141642
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 circumference. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2015
Hollister Incorporated Jeanne Lee Sr. Manager, Regulatory Affairs 2000 Hollister Drive Libertyville, IL 60048
Re: K152268
Trade/Device Name: VaPro Plus Pocket Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: August 7, 2015 Received: August 11, 2015
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 yours,
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
2
Indications for Use
510(k) Number (if known)
Device Name VaPro Plus Pocket
Indications for Use (Describe)
VaPro Plus Pocket 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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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: | Aug 7, 2015 |
| Device Name: | Classification Name- Urological catheter and accessories |
| | Common/Usual Name- Catheter, Urethral |
| | Proprietary Name- VaPro Plus Pocket TM intermittent catheter |
| Device Class/Product Code: | Urological catheter and accessories are Class II devices per 21 CFR 876.5130. Product code GBM. |
| Predicate Device: | VaPro Plus intermittent catheter, K141642 |
| Device Description: | The VaPro Plus Pocket 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:
∑ hydrophilic-coated PVC catheter (phthalate free)
∑ Two smooth catheter eyelets
∑ protective sleeve
∑ protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion
∑ color coded funnel
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 discreet, easy to store, easy to open and facilitate access to the catheter. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical. |
| 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. |
4
Technological The table below summarizes the technological characteristics of Characteristics: the device as compared to the predicate device.
| | Modified Device:
VaPro Plus Pocket
intermittent catheter | Predicate Device:
VaPro Plus 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 |
| End Design | Funnel | Funnel |
| Sterile | Yes | Yes |
| No touch design | Yes-has protective sleeve | Yes-has protective sleeve |
| Catheter
Material | PVC (phthalate free) | PVC (phthalate free) |
| Lubricant | PVP Based Coating
(polyvinylpyrollidone) | PVP Based Coating
(polyvinylpyrollidone) |
| Protective Tip | Yes | Yes |
| Collection Bag | Yes | Yes |
Performance Testing:
There have been no changes to the device, only to the packaging. Therefore, no new biocompatibility testing was performed. For biocompatibility testing on the device in accordance with ISO 10993, please refer to 510(k) K141642. Biocompatibility was performed on the new packaging. This report is available upon request. All results were satisfactory.
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 VaPro Plus Pocket 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. The test produced successful results.
Conclusion: Based on the performance testing conducted it is concluded that the modified device, VaPro Plus Pocket, is as safe and effective and performs equivalent to the predicate device.