(64 days)
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 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 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 VaPro Plus has the addition of a collection bag that is connected to the catheter for use when drainage into a suitable receptacle is not feasible or practical.
This document describes a 510(k) premarket notification for the VaPro™ intermittent catheter and VaPro Plus™ intermittent catheter, submitted by Hollister Incorporated. The FDA determined the device is substantially equivalent to legally marketed predicate devices.
The information provided does not describe the acceptance criteria, reported device performance, or a study that specifically proves the device meets acceptance criteria in the manner typically presented for AI/ML devices outlining metrics like sensitivity, specificity, or AUC, as requested in your prompt. This document pertains to the regulatory clearance of a physical medical device (an intermittent catheter), not a software or AI/ML algorithm.
Therefore, many of the specific questions you asked are not applicable to the content of this regulatory submission. However, I can extract the relevant information regarding performance testing that was submitted to the FDA for this device.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria and reported device performance in the format of specific metrics (e.g., accuracy, sensitivity, specificity, etc.) typically associated with AI/ML systems. Instead, the performance evaluations are related to the safety and functionality of the physical catheter.
Summary of Performance Testing Conclusions:
- Biocompatibility: Complied with ISO 10993 standards based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1.
- Product Evaluation: Supports device functionality.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing mentions "biocompatibility testing" and "product evaluation" but does not detail the sample sizes, data provenance, or specific methodologies (like retrospective or prospective studies) in the context of human data. The testing mentioned would likely involve laboratory tests on the device materials and components, not a "test set" of patient data for evaluating an algorithm's performance.
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)
This information is not applicable/not provided. Ground truth establishment by experts, especially in the context of image interpretation or clinical outcomes, is relevant for AI/ML studies. For a physical medical device like a catheter, "ground truth" would relate to its physical properties, material safety, and functional performance, which are assessed through laboratory and possibly limited human user studies, not typically by expert consensus on a "test set" in the radiological or pathological sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are used to resolve discrepancies in expert interpretations when establishing ground truth for evaluating AI/ML algorithms. This concept does not apply to the biocompatibility and functionality testing of a physical medical device as described.
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
This information is not applicable/not provided. MRMC studies are used to evaluate diagnostic imaging systems and AI/ML algorithms in a clinical setting by comparing human reader performance with and without AI assistance. This device is an intermittent catheter, not a diagnostic imaging system or an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. Standalone performance is relevant for AI/ML algorithms. This document concerns a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Performance Testing Conclusions" mentioned:
- Biocompatibility: The "ground truth" would be established by the ISO 10993 standards and FDA guidance (#G95-1), which define acceptable biological responses and material safety profiles. Compliance with these standards is determined through specific laboratory tests, not expert consensus in the clinical sense, pathology, or outcomes data in the usual context of AI/ML evaluation.
- Product evaluation: The "ground truth" for device functionality would be based on engineering specifications and performance requirements relevant to a medical catheter (e.g., flow rates, material tensile strength, durability, ease of use, lubricity).
8. The sample size for the training set
This information is not applicable/not provided. The concept of a "training set" belongs to AI/ML development. This document describes a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, "training set" and its ground truth are concepts for AI/ML.
In summary: The provided document is an FDA 510(k) clearance letter for a physical medical catheter. It describes the device, its intended use, and indicates that biocompatibility and product evaluation were performed to establish substantial equivalence to predicate devices. It does not contain the specific performance metrics or study designs typically requested for AI/ML device evaluations.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
Hollister Incorporated Jeanne Lee Senior Manager, Regulatory Affairs 2000 Hollister Drive Libertyville, IL 60048
Re: K141642
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: June 16, 2014 Received: June 19, 2014
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.
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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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
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Indications for Use
510(k) Number
Device Name
VaPro™ intermittent catheter VaPro Plus™ 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.
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.
| Type of Use | |
|---|---|
| ------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY -------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of Center for Devices and Radiological Health (CDRH)
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510(k) Summary
| Submitted By: | Jeanne LeeHollister Incorporated2000 Hollister DriveLibertyville, IL 60018(t) 847-996-6350(f) 847-918-3981 |
|---|---|
| Date Summary Prepared: | June 16, 2014 |
| Device Name: | Classification Name- Urological catheter and accessoriesCommon/Usual Name- Catheter, UrethralProprietary Name- VaProTM intermittent catheterVaPro PlusTM intermittent catheter |
| Predicate Device: | The VaPro intermittent catheter (with modification) is substantiallyequivalent to its original design, VaPro intermittent catheter,K090960.The VaPro Plus intermittent catheter (with modification) issubstantially equivalent to its original design, VaPro Plusintermittent catheter, K110862. |
| Device Description: | The VaPro intermittent catheter is a hydrophilic coated, single usecatheter to be used as a means of managing urinary incontinenceby draining urine from the bladder. The catheter comes in aprotective sleeve and is offered with a protective introducer tip as away to shield the sterile catheter from bacteria in the distal urethraduring insertion. The packaging contains a vapor strip that hydratesthe catheter coating which then lubricates the catheter. The outerpackaging was designed to facilitate access for those with limiteddexterity.The VaPro Plus has the addition of a collection bag that isconnected to the catheter for use when drainage into a suitablereceptacle is not feasible or practical. |
| Intended Use: | The VaPro intermittent catheter is a flexible tubular device that isinserted through the urethra by male, female, and pediatric patientswho need to drain urine from the bladder.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. |
| TechnologicalCharacteristics: | The table below summarizes the technological characteristics ofthe device as compared to the predicate devices. |
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| Modified Device:VaPro intermittentcatheter | Predicate Device:VaPro intermittentcatheter (K090960) | Modified Device:VaPro Plusintermittent catheter | Predicate Device:VaPro Plusintermittent catheter(K110862) | |
|---|---|---|---|---|
| Intended Use | The VaPro/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. | |||
| Condition ofUse | Single Use | Single Use | Single Use | Single Use |
| Prelubricated | Yes-by water vaporhydration | Yes-by water vaporhydration | Yes-by water vaporhydration | Yes-by water vaporhydration |
| Ready to use | Yes | Yes | Yes | Yes |
| End Design | Funnel | Funnel | Catheter funnelattached to collectionbag | Catheter funnelattached to collectionbag |
| Sterile | Yes | Yes | Yes | Yes |
| No touchdesign | Yes-contains sleeve | Yes-contains sleeve | Yes-contains sleeve | Yes-contains sleeve |
| Lubricant | PVP Based(polyvinylpyrollidone)Coating | PVP Based(polyvinylpyrollidone)Coating | PVP Based(polyvinylpyrollidone)Coating | PVP Based(polyvinylpyrollidone)Coating |
| Protective Tip | Yes | Yes | Yes | Yes |
| Collection Bag | No | No | Yes | Yes |
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.
§ 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.