(27 days)
This 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 2 Plus and VaPro 2 Plus Pocket is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Plus and VaPro 2 Plus Pocket has the following features:
- 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
- Available with a Firmer Style Catheter (Standard packaging only with packaging differentiated as F-Style)
- Urine Collection bag
The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store.
The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
The provided text describes the regulatory clearance of a medical device, the VaPro 2 Plus and VaPro 2 Plus Pocket intermittent catheters, based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document is a 510(k) summary for a urological catheter, which is a physical medical device. The "brief description of non-clinical testing" mentions standards for physical performance (e.g., EN 1618, ISO 8669-2), biocompatibility (ISO 10993 series), and sterilization (ISO 11137 series). These are standard tests for physical medical devices to ensure safety and function, but they are not related to artificial intelligence performance, diagnostic accuracy, or human-algorithm interaction.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance.
- Type of ground truth used.
- Sample size for training set.
- How ground truth for the training set was established.
This document is focused on the regulatory clearance process for a physical medical device and asserts substantial equivalence, not the performance evaluation of an AI-powered diagnostic or assistive tool.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 18, 2018
Hollister Incorporated Michelle Schiltz-Taing Regulatory Affairs Manager 2000 Hollister Drive Libertyville, IL 60048
Re: K183253
Trade/Device Name: ValPro 2 Plus and VaPro 2 Plus Pocket Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: November 19, 2018 Received: November 27, 2018
Dear Michelle Schiltz-Taing:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (reporting of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for 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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| 510(k) Number (if known) | K183253 |
|---|---|
| Device Name | VaPro 2 Plus and VaPro 2 Plus Pocket |
| Indications for Use (Describe) | This 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
ริสวเขตสิริ คลุกเบิน ตินิค HT JAヨH สิต สิโน ที่ 143MT ค.ศ. 1977 ludications for Use
See PRA Statement below.
Expiration Date: 06613012020
For
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510(k) Summary
| Applicant: | Hollister Incorporated2000 Hollister DriveLibertyville, IL 60048 |
|---|---|
| Contact Person: | Michelle Schiltz-TaingHollister Incorporated2000 Hollister DriveLibertyville, IL 60018(t) 847-680-2122 |
| Date Prepared: | 17 December 2018 |
| Trade Name: | VaPro 2 PlusTM and VaPro 2 Plus PocketTM |
| Device Common Name: | Catheter, Urethral |
| Classification Name: | Urological catheter and accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | GBM |
| Device Class: | II |
| Review Panel: | Gastroenterology/Urology |
Predicate Device:
VaPro 2 Intermittent Catheter, K180824 by Hollister Incorporated.
Reference Devices:
VaPro K141642 by Hollister Incorporated for VaPro 2 Plus. VaPro Plus Pocket K152268 by Hollister Incorporated for VaPro 2 Plus Pocket.
Indications for Use:
This 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.
Description of Applicant Device:
The VaPro 2 Plus and VaPro 2 Plus Pocket is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Plus and VaPro 2 Plus Pocket has the following features:
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- 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
- Available with a Firmer Style Catheter (Standard packaging only with packaging ● differentiated as F-Style)
- . Urine Collection bag
The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store.
The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
Technological Characteristics:
| Subject DeviceVaPro 2 PlusVaPro 2 Plus Pocket | Predicate DeviceVaPro 2 (K180824) | |
|---|---|---|
| Indication for Use | This 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 | |
| Pre-lubricated | Yes-by water vapor hydration | |
| Ready to use | Yes | |
| End Design | Funnel | |
| Sterile | Yes - Gamma Irradiation | |
| No touch design | Yes - contains sleeve | |
| Hydrophilic Coating | PVP Based (polyvinylpyrollidone) Coating | |
| Protective Introducer Tip | Yes | |
| Protective Cap | Yes | |
| Catheter Material | PVC (phthalate free) | |
| Urine Collection Bag | Yes | No |
The table below summarizes the technological characteristics of VaPro 2 Plus and VaPro 2 Plus Pocket as compared to the predicate device VaPro 2 Intermittent Catheter.
Brief Description of Non-Clinical Testing:
The physical performance properties of VaPro 2 Plus and VaPro 2 Plus Pocket met all applicable requirements of EN 1618, EN 1616, EN 13868, ISO 8669-2 and ASTM-D1003-13.
Biocompatibility testing met the requirements of ISO 10993-1, 10993-5 and 10993-12.
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Sterilization met all requirements of ISO 11137-1, ISO 11137-2, AAMVANSI/ISO 11737-1 and AAMI/ANSI/ISO 11737-2.
Conclusion:
It is concluded that the information supplied in this submission has demonstrated that VaPro 2 Plus and VaPro 2 Plus Pocket is substantially equivalent to the legally marketed device VaPro 2 Intermittent Catheter.
§ 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.