(136 days)
Not Found
No
The summary describes a physical medical device (catheter) and its features, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used for draining urine from the bladder, which is a management tool for urinary incontinence, not a treatment for an underlying medical condition. It does not exert a therapeutic effect on the body.
No
The device description states its purpose is to drain urine from the bladder, which is a treatment or management function, not a diagnostic one.
No
The device description clearly describes a physical, tubular device (catheter) with a hydrophilic coating, protective sleeve, introducer tip, and packaging with a vapor strip. These are all hardware components.
Based on the provided information, the VaPro intermittent catheter 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 direct therapeutic action on the body. IVDs are used to examine specimens (like urine, blood, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical characteristics and function of the catheter for insertion and drainage. There is no mention of analyzing or testing a biological sample.
- Lack of IVD-related terms: The document does not contain any terms typically associated with IVDs, such as "assay," "reagent," "analysis," "diagnosis," "testing," "specimen," etc.
- Anatomical Site: The anatomical sites mentioned (Urethra, Bladder) are where the device is physically inserted and used, not where a sample is collected for analysis.
Therefore, the VaPro intermittent catheter is a medical device used for a therapeutic purpose (urine drainage), not an in vitro diagnostic device.
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.
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.
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)
Biocompatibility testing was performed based on Performance Testing 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.
0
510(k) Summary
| Submitted By: | Chris Stukel
Hollister Incorporated
2000 Hollister Drive
Libertyville, IL 60018
847-680-1000 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Date Summary Prepared: | August 19, 2009 | |
| Device Name: | Classification Name- Urological catheter and accessories
Common/Usual Name- Catheter, Urological
Proprietary Name- VaPro™ Intermittent Catheter | |
| Predicate Device: | The VaPro intermittent catheter is substantially equivalent
to the following products: | |
| | Product | 510(k) |
| | Astra Tech AB Lofric® Primo™
Single Use Urinary Catheter | K050874 |
| | SpeediCath Catheter | K023254 |
| | Incare Advance/Advance Plus
Intermittent Catheter | K013483 |
| 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. | |
| 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. | |
| Technological
Characteristics: | The table below summarizes the technological
characteristics of the device as compared to the predicate
devices. | |
1
| Characteristics | VaPro
Standard
with Tip | Astra Tech AB
Lofric®
Primo™
(K050874) | Speedicath
(K023254) | Incare
Advance/Advance Plus
(K013483) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 LoFric
Primo Single
Use Urinary
Catheter is
intended for
intermittent
catheterization
of the urethra. | The SpeediCath
catheter is
indicated for use
by patients with
chronic urine
retention and
patients with a
post void
residual volume
(PVR) due to
neurogenic and
non-neurogenic
voiding
dysfunction.
The catheter is
inserted into the
urethra to reach
the bladder
allowing urine to
drain. | 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 | Single Use |
| Prelubricated | Yes-by
water vapor
hydration | Yes- by water
hydration | Yes-by saline
solution
hydration | Yes-by
hydrogel |
| Ready to use | Yes | Requires
bursting of water
sachet prior to
use | Yes | Yes |
| End Design | Funnel | Funnel | Funnel | Funnel |
| Sterile | Yes | Yes | Yes | Yes |
| No touch design | Yes-
contains
sleeve | Yes - by using
exterior
packaging | No | Yes-contains
sleeve |
| Lubricant | PVP Based
(polyvinylpyr
ollidone)
Coating | PVP Based
(polyvinylpyrrolid
one)
Coating | PVP Based
(polyvinylpyrrolid
one)
Coating | Hydrogel |
| Protective Tip | Yes | No | No | Yes |
2
Biocompatibility testing was performed based on Performance Testing the United States Food and Drug Administration Office of Conclusions: 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 0 2009
Mr. Chris Stukel Senior Global Regulatory Affairs Analyst Hollister, Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781
Re: K090960
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: August 13, 2009 Received: August 14, 2009
Dear Mr. 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.
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
4
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lammy M. Mouk
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090960
Device Name: VaPro™ 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.
Prescription Use ਮ (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)
Arvark Nha
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _