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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (VaPro™ Intermittent Catheter), which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed metrics typically associated with AI/software devices.

Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and AI performance metrics are not applicable to this type of submission.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

Not Applicable in the traditional sense of a performance study with specific metrics. The provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than defining and meeting specific quantitative performance acceptance criteria in an AI/Software context.
The "performance" described is primarily functional and safety-related for a physical catheter, evaluated through biocompatibility and product evaluation to support functionality.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a hardware device (catheter) submission. There is no "test set" of data in the context of an AI/Software algorithm. The testing would involve physical samples of the catheter for biocompatibility and functional evaluation. No details on sample sizes for these physical tests are provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a hardware device. There is no ground truth established by experts in the context of diagnostic interpretation or AI model training/testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No adjudication method for a test set is mentioned as this is not an AI/Software device requiring such a process.

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

Not Applicable. This is a physical medical device (catheter), not an AI/Software system. Therefore, no MRMC study or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. For this physical device, "ground truth" would relate to confirmed physical properties, material safety (biocompatibility), and functional performance (e.g., flow rates, lubrication effectiveness) validated against established standards, not diagnostic outcomes.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI/Software system that requires a "training set."

9. How the ground truth for the training set was established

Not Applicable. Same as above, no training set for a physical device.

Information that can be extracted or inferred regarding device evaluation:

Device Performance Reported (for a physical device):
- Biocompatibility: "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."
- Device Functionality: "Product evaluation also supports device functionality."
Predicate Device Equivalence (which implies the new device also meets foundational criteria present in predicates):
- Intended Use: Matches or is highly similar to predicates.
- Condition of Use: Single Use (matches predicates).
- Prelubricated: Yes - by water vapor hydration (similar mechanism to predicates).
- Ready to Use: Yes (similar to Speedicath and Incare, different from Lofric).
- End Design: Funnel (matches predicates).
- Sterile: Yes (matches predicates).
- No-touch design: Yes - contains sleeve (similar to Lofric and Incare, different from Speedicath).
- Lubricant: PVP Based (similar to Lofric and Speedicath, different from Incare).
- Protective Tip: Yes (similar to Incare, different from Lofric and Speedicath).

Conclusion:

The provided 510(k) summary is for a physical medical device (intermittent catheter). The evaluation criteria and "proof" of performance are based on standard engineering tests for physical properties, materials, and biocompatibility, as well as demonstrating substantial equivalence to other legally marketed devices. It does not contain information related to acceptance criteria, study sizes, ground truth establishment, or performance metrics typically associated with AI/Software medical devices.

Summary

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510(k) Summary

Submitted By:	Chris StukelHollister Incorporated2000 Hollister DriveLibertyville, IL 60018847-680-1000
Date Summary Prepared:	August 19, 2009
Device Name:	Classification Name- Urological catheter and accessoriesCommon/Usual Name- Catheter, UrologicalProprietary Name- VaPro™ Intermittent Catheter
Predicate Device:	The VaPro intermittent catheter is substantially equivalentto the following products:
	Product	510(k)
	Astra Tech AB Lofric® Primo™Single Use Urinary Catheter	K050874
	SpeediCath Catheter	K023254
	Incare Advance/Advance PlusIntermittent Catheter	K013483
Device Description:	The VaPro intermittent catheter is a hydrophilic coatedsingle use catheter to be used as a means of managingurinary incontinence by draining urine from the bladder.The catheter comes in a protective sleeve and is offeredwith a protective introducer tip as a way to shield the sterilecatheter from bacteria in the distal urethra during insertion.The packaging contains a vapor strip that hydrates thecatheter coating which then lubricates the catheter. Theouter packaging was designed to facilitate access for thosewith limited dexterity.
Intended Use:	The VaPro intermittent catheter is a flexible tubular devicethat is inserted through the urethra by male, female andpediatric patients who need to drain urine from the bladder.
TechnologicalCharacteristics:	The table below summarizes the technologicalcharacteristics of the device as compared to the predicatedevices.

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Characteristics	VaProStandardwith Tip	Astra Tech ABLofric®Primo™(K050874)	Speedicath(K023254)	IncareAdvance/Advance Plus(K013483)
Intended Use	The VaProintermittentcatheter is aflexibletubulardevice thatis insertedthrough theurethra bymale, femaleand pediatricpatients whoneed todrain urinefrom thebladder.	The LoFricPrimo SingleUse UrinaryCatheter isintended forintermittentcatheterizationof the urethra.	The SpeediCathcatheter isindicated for useby patients withchronic urineretention andpatients with apost voidresidual volume(PVR) due toneurogenic andnon-neurogenicvoidingdysfunction.The catheter isinserted into theurethra to reachthe bladderallowing urine todrain.	Indicated foruse by male,female andpediatricpatients for thepurpose ofbladderdrainage. TheCatheter is aflexible tubulardevice that isinsertedthrough theurethra andused to passfluids to orfrom theurinary tract.
Condition ofUse	Single Use	Single Use	Single Use	Single Use
Prelubricated	Yes-bywater vaporhydration	Yes- by waterhydration	Yes-by salinesolutionhydration	Yes-byhydrogel
Ready to use	Yes	Requiresbursting of watersachet prior touse	Yes	Yes
End Design	Funnel	Funnel	Funnel	Funnel
Sterile	Yes	Yes	Yes	Yes
No touch design	Yes-containssleeve	Yes - by usingexteriorpackaging	No	Yes-containssleeve
Lubricant	PVP Based(polyvinylpyrollidone)Coating	PVP Based(polyvinylpyrrolidone)Coating	PVP Based(polyvinylpyrrolidone)Coating	Hydrogel
Protective Tip	Yes	No	No	Yes

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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.

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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

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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

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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 _

Regulation Number and Section

§ 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.