(84 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 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. VaPro 2 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)
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, (Standard and Pocket), was designed to facilitate access for those with limited dexterity. The Pocket version was designed to be discreet and easy to store.
This document is a 510(k) premarket notification for a medical device called the "Vapro 2 Intermittent Catheter." It is a request to the FDA to determine if the new device is substantially equivalent to legally marketed predicate devices.
The information provided here concerns the performance of a physical medical device (a catheter), not a software or AI-driven device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., accuracy, sensitivity, specificity, human reader improvement) is not applicable here.
The document discusses non-clinical testing to demonstrate performance and safety, which is standard for physical medical devices but doesn't align with the detailed AI/software performance metrics requested in the prompt.
Therefore, I cannot provide the requested information regarding AI/software performance metrics from this document because it is about a physical medical device and not an AI/software device.
However, I can extract information about the non-clinical testing performed for this physical device:
-
Acceptance Criteria & Reported Performance (Non-Clinical Physical Properties):
- Physical Performance Properties: VaPro 2 "met all applicable requirements of EN 1618, EN 1616 and EN 13868." (Specific thresholds not detailed in this summary).
- Biocompatibility Testing: VaPro 2 "met the requirements of ISO 10993-1, 10993-11 and 10993-12." (Specific thresholds not detailed in this summary).
- Sterilization: VaPro 2 "met all requirements of ISO 11137-1, ISO 11137-2, AAMI/ANSI/ISO 11737-1 and AAMI/ANSI/ISO 11737-2." (Specific thresholds not detailed in this summary).
-
Sample Size Used for Test Set and Data Provenance: Not applicable in the AI/software context. For physical device testing, sample sizes would be determined by the specific ISO/EN standards cited, but these details are not provided in this summary.
-
Number of Experts, Qualifications, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Sample Size, Training Set Ground Truth: These questions are specifically tailored to AI/software performance evaluation and are not relevant or described in this document about a physical medical device. The "ground truth" for a physical catheter's performance is typically established by laboratory testing against engineering specifications and international standards.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure. The FDA part of the logo has the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 22, 2018
Hollister Incorporated Michelle Schiltz-Taing Regulatory Affairs Manager 2000 Hollister Drive Libertyville, IL 60048
Re: K180824
Trade/Device Name: Vapro 2 Intermittent Catheter Regulation Number: 21 CFR& 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: June 8, 2018 Received: June 11, 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 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.
{1}------------------------------------------------
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.
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 medical devices and radiation-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.
Timothy Martin -S 2018.06.22 08:48:43 -04'00'
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
{2}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K180824 |
|---|---|
| Device Name | Vapro 2 Intermittent Catheter |
| 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.
| FORM FDA 3881 (7/17) | Page 1 of 2 |
|---|---|
| PSC Publishing Services (301) 443-6740 EF |
TET TO BS ADS A
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the Hollister logo. The logo consists of a red, stylized cross-like symbol on the left and the word "Hollister." in gray on the right. The logo is simple and modern.
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:Trade Name:Common Name:Product Code/Class:Classification Name: | 05 June 2018VaPro 2TM Intermittent CatheterCatheter, UrethralGBM/Class IIUrological catheter and accessories |
Predicate Device:
CFR:
VaPro 2 Intermittent Catheter is substantially equivalent to its original design: VaPro Intermittent Catheter, K141642 by Hollister Incorporated
21 CRF 876.5130
Reference Device:
VaPro Pocket, K143594 by Hollister Incorporated for VaPro 2 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 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. VaPro 2 has the following features:
- Hydrophilic-coated PVC catheter (phthalate free) ●
- Two smooth catheter eyelets ●
- Protective sleeve ●
{4}------------------------------------------------
- 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)
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, (Standard and Pocket), was designed to facilitate access for those with limited dexterity. The Pocket version was designed to be discreet and easy to store.
Technological Characteristics:
The table below summarizes the technological characteristics of VaPro 2 Intermittent Catheter as compared to the predicate device VaPro.
| VaPro Intermittent Catheter(K141642) | VaPro 2 | |
|---|---|---|
| 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) |
Brief Description of Non-Clinical Testing:
The physical performance properties of VaPro 2 met all applicable requirements of EN 1618, EN 1616 and EN 13868.
Biocompatibility testing met the requirements of ISO 10993-1. 10993-11 and 10993-12.
Sterilization met all requirements of ISO 11137-1, ISO 11137-2, AAMI/ANSI/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 Intermittent Catheter is equivalent to the legally marketed device VaPro 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.