(29 days)
VaPro Plus Pocket 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 Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:
- 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
The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter. 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 510(k) summary for the VaPro Plus Pocket Intermittent Catheter, an amendment to an existing device (VaPro Plus intermittent catheter, K141642). The submission primarily addresses changes to the device's packaging, not the device itself. Therefore, the "study" described focuses on testing relevant to these packaging changes rather than a clinical performance study of the catheter's efficacy for urinary drainage.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since the changes were primarily packaging-related, the acceptance criteria are not clinical performance metrics but rather safety and material integrity aspects.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Satisfactory (referencing K141642 for device, new testing for packaging also satisfactory) |
| Sterility | Satisfactory (using Gamma Irradiation per ANSI/AAMI/ISO 11137-1:2006 & 2:2013) |
| Packaging Integrity | Satisfactory (maintains sterile barrier for at least two years) |
| Transportation Impact | Successful results (no impact to safety or efficacy of catheter performance) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for any of the tests. The document only mentions "Biocompatibility was performed on the new packaging," "Sterility testing was performed," "Packaging integrity testing was performed," and "Transportation testing was performed." The specific number of samples or units tested is not provided.
- Data Provenance: Not explicitly stated, as the tests were performed by the manufacturer (Hollister Incorporated). It is an industrial setting rather than a retrospective or prospective clinical study on human subjects from a specific country.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The tests performed (biocompatibility, sterility, packaging integrity, transportation) are laboratory or engineering tests with objective pass/fail criteria, not subjective assessments requiring expert consensus on a "ground truth" derived from patient data.
4. Adjudication method for the test set:
- Not applicable. As described above, the tests are objective laboratory or engineering evaluations, not studies requiring adjudication of human-read results.
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 device is an intermittent catheter, which is a physical medical device for urinary drainage. It is not an AI-powered diagnostic or imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biocompatibility: Ground truth is established by meeting the requirements of ISO 10993 standards, which involve cytotoxicity, sensitization, irritation, and other systemic effects based on material properties and extracts.
- For Sterility: Ground truth is established by demonstrating a Sterility Assurance Level (SAL) usually of 10^-6, meaning a one-in-a-million chance of a non-sterile unit, as per ISO 11137.
- For Packaging Integrity: Ground truth is established by proving the packaging can maintain a sterile barrier over its shelf life through physical and microbial challenge tests (e.g., burst strength, seal integrity, microbial ingress).
- For Transportation Testing: Ground truth is that the device (catheter) functions as intended and is undamaged after simulated shipping conditions.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2015
Hollister Incorporated Jeanne Lee Sr. Manager, Regulatory Affairs 2000 Hollister Drive Libertyville, IL 60048
Re: K152268
Trade/Device Name: VaPro Plus Pocket Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: August 7, 2015 Received: August 11, 2015
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. 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); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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 yours,
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 (if known)
Device Name VaPro Plus Pocket
Indications for Use (Describe)
VaPro Plus Pocket 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | Aug 7, 2015 |
| Device Name: | Classification Name- Urological catheter and accessories |
| Common/Usual Name- Catheter, Urethral | |
| Proprietary Name- VaPro Plus Pocket TM intermittent catheter | |
| Device Class/Product Code: | Urological catheter and accessories are Class II devices per 21 CFR 876.5130. Product code GBM. |
| Predicate Device: | VaPro Plus intermittent catheter, K141642 |
| Device Description: | The VaPro Plus Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:∑ 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 funnelThe packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical. |
| Intended Use: | The 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. |
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Technological The table below summarizes the technological characteristics of Characteristics: the device as compared to the predicate device.
| Modified Device:VaPro Plus Pocketintermittent catheter | Predicate Device:VaPro Plus intermittentcatheter (K141642) | |
|---|---|---|
| Intended Use | The intermittent catheter is a flexible tubular device that isinserted through the urethra by male, female, and pediatricpatients who need to drain urine from the bladder. | |
| Condition of Use | Single Use | Single Use |
| Prelubricated | Yes-by water vaporhydration | Yes-by water vapor hydration |
| Ready to use | Yes | Yes |
| End Design | Funnel | Funnel |
| Sterile | Yes | Yes |
| No touch design | Yes-has protective sleeve | Yes-has protective sleeve |
| CatheterMaterial | PVC (phthalate free) | PVC (phthalate free) |
| Lubricant | PVP Based Coating(polyvinylpyrollidone) | PVP Based Coating(polyvinylpyrollidone) |
| Protective Tip | Yes | Yes |
| Collection Bag | Yes | Yes |
Performance Testing:
There have been no changes to the device, only to the packaging. Therefore, no new biocompatibility testing was performed. For biocompatibility testing on the device in accordance with ISO 10993, please refer to 510(k) K141642. Biocompatibility was performed on the new packaging. This report is available upon request. All results were satisfactory.
Sterility testing was performed using Gamma Irradiation in accordance with Method I validation per ANSI/AAMI/ISO 11137-1:2006 & 2:2013. All results were satisfactory.
Packaging integrity testing was performed to verify the maintenance of the sterile barrier through shelf life. The testing concluded that VaPro Plus Pocket packaging is capable of maintaining a sterile barrier for at least two years.
Transportation testing was performed in order to verify that there is no impact to the safety or efficacy of the catheter performance. The test produced successful results.
Conclusion: Based on the performance testing conducted it is concluded that the modified device, VaPro Plus Pocket, is as safe and effective and performs equivalent to the predicate device.
§ 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.