(28 days)
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VaPro™ Plus Intermittent Catheter:
The document provided is a 510(k) Summary for the VaPro™ Plus Intermittent Catheter,
which primarily aims to demonstrate substantial equivalence to previously cleared predicate
devices. As such, the information typically requested for AI/ML device evaluations (e.g.,
detailed performance metrics, sample sizes for test/training sets, expert qualifications for
ground truth, MRMC studies) is not present. This type of submission focuses on
demonstrating that the new device has the same intended use and similar technological
characteristics to existing devices, and that any differences do not raise new questions of
safety or effectiveness.
Therefore, the requested information cannot be fully provided based on the given text.
However, I can extract the information that is present and explain why other details are
missing in this specific context.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implicit via Substantial Equivalence): The primary acceptance
criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally
marketed predicate device. This means the device must have the same intended use and the
same technological characteristics, or, if there are differences in technological
characteristics, these differences must not raise different questions of safety and
effectiveness, and the device must be safe and effective.
The performance is implicitly measured against the predicate devices for each
characteristic.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (VaPro™ Plus) |
|---|---|---|
| Intended Use | Same as predicate | Shared with predicate devices: flexible tubular device, inserted through urethra by male, female, and pediatric patients to drain urine from bladder. |
| Condition of Use | Single Use | Single Use |
| Prelubricated | Yes | Yes - by water vapor hydration |
| Ready to use | Yes | Yes |
| End Design | Funnel / Catheter funnel attached to collection bag | Catheter funnel attached to collection bag |
| Sterile | Yes | Yes |
| No touch design | Yes (contains sleeve) | Yes - contains sleeve |
| Lubricant | PVP Based Coating / Hydrogel | PVP Based (polyvinylpyrollidone) Coating |
| Protective Tip | Yes | Yes |
| Collection Bag | Yes / No (depending on specific predicate model) | Yes |
| Biocompatibility | Compliance to ISO 10993 and G95-1 | Compliance to standard |
| Functionality | Supports device functionality | Product evaluation supports device functionality |
Study Proving Acceptance Criteria:
The study that proves the device meets the (implicit) acceptance criteria for a 510(k)
submission is the "Performance Testing," which consists of:
- Biocompatibility testing: Performed based on FDA G95-1 and ISO 10993 standards.
- Product evaluation: To demonstrate device functionality.
The submission concludes that "Results indicate compliance to the standard" for
biocompatibility and "Product evaluation also supports device functionality." This is the
evidence presented to support the device's acceptable performance and safety/effectiveness
relative to its substantial equivalence claim.
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified in the provided document. The 510(k)
summary focuses on substantial equivalence of design and materials, not clinical
performance metrics derived from a "test set" in the context of AI/ML or diagnostic
device evaluation. - Data provenance: Not specified. Biocompatibility and product functionality testing
are typically performed in a laboratory setting, not with human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. This information pertains to expert-defined
ground truth, which is not relevant for the type of testing (biocompatibility,
functionality) described for this device. - Qualifications of experts: Not applicable for the reasons above.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There is no "test set" in the AI/ML or
diagnostic sense requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No. This is not an AI-assisted diagnostic or imaging device, so MRMC
studies are not relevant. This is a physical medical device (catheter). - Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- Type of ground truth: For biocompatibility, the "ground truth" is compliance with
established international standards (ISO 10993) and FDA guidance (G95-1). For
functionality, it's meeting predefined engineering specifications and functional tests
for the catheter. There is no "expert consensus," "pathology," or "outcomes data" in
the traditional sense used as ground truth for this type of device submission.
8. The sample size for the training set
- Sample size for the training set: Not applicable. This is not an AI/ML device, so
there is no "training set."
9. How the ground truth for the training set was established
- How ground truth was established: Not applicable.
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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 StukelHollister Incorporated2000 Hollister DriveLibertyville, IL 60018847-680-1000 | ||||||
|---|---|---|---|---|---|---|---|
| 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 tothe following products: | ||||||
| Product 510(k) VaPro™ Intermittent Catheter K090960 Incare Advance/Advance PlusIntermittent Catheter K013483 | |||||||
| Device Description: | The VaPro Plus intermittent catheter is a hydrophilic coatedsingle use catheter to be used as a means of managing urinaryincontinence by draining urine from the bladder. The cathetercomes in a protective sleeve and is offered with a protectiveintroducer tip as a way to shield the sterile catheter from bacteriain the distal urethra during insertion. The packaging contains avapor strip that hydrates the catheter coating which thenlubricates the catheter. The outer packaging was designed tofacilitate access for those with limited dexterity. The catheter isconnected to a collection bag for use when drainage into asuitable receptacle is not feasible or practical. | ||||||
| Intended Use: | The VaPro Plus intermittent catheter is a flexible tubular devicethat is inserted through the urethra by male, female and pediatricpatients 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 devices.
| Characteristics | VaPro Plus | VaPro Intermittent | Incare Advance/ |
|---|---|---|---|
| Intermittent Catheter | Catheter | Advance Plus | |
| (K090960) | (K013483) | ||
| Intended Use | The VaPro Plusintermittent catheter is aflexible tubular device thatis inserted through theurethra by male, femaleand pediatric patients whoneed to drain urine fromthe bladder. | The VaPro intermittentcatheter is a flexibletubular device that isinserted through theurethra by male, femaleand pediatric patientswho need to drain urinefrom the bladder. | Indicated for use by male,female and pediatricpatients for the purpose ofbladder drainage. TheCatheter is a flexibletubular device that isinserted through the urethraand used to pass fluids to orfrom the urinary tract. |
| Condition ofUse | Single Use | Single Use | Single Use |
| Prelubricated | Yes-by water vaporhydration | Yes-by water vaporhydration | Yes-by hydrogel |
| Ready to use | Yes | Yes | Yes |
| End Design | Catheter funnel attached tocollection bag | Funnel | Advance - FunnelAdvance Plus - Catheterfunnel inserted intocollection bag |
| Sterile | Yes | Yes | Yes |
| No touchdesign | 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- AdvanceYes- 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.
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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
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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
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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
§ 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.