(73 days)
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.
The Onli 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:
Σ Ready to use, single use intermittent catheter
Σ Hydrophilic-coated, phthalate free catheter
Σ Two smooth catheter eyelets
Σ Color coded funnel
Σ Not made with natural rubber latex
Σ Gripper on the16-in. catheter to aid with insertion
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 easy to open and facilitate access to the catheter.
The provided document is a 510(k) summary for the Onli Intermittent Catheter. It is a submission to the FDA demonstrating substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, most of the requested information (acceptance criteria for an algorithm, study design for AI/ML performance, ground truth, sample sizes for AI/ML training/test sets, expert qualifications, adjudication, MRMC studies, standalone performance) is not applicable to this document. This document describes a medical device, a urological catheter, and its performance characteristics, which are mainly mechanical and biological, not algorithmic.
Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the sense of predefined thresholds for an AI/ML algorithm's performance (e.g., sensitivity, specificity). Instead, it describes performance testing conducted to demonstrate safety and effectiveness for a physical medical device. The "reported device performance" is a statement of compliance or satisfactory results rather than specific numerical metrics.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with G95-1 and ISO 10993 standards | Results indicate compliance to the standard. |
| Sterility | Sterility achieved via Gamma Irradiation per ANSI/AAMI/ISO 11137 | All results were satisfactory. |
| Packaging Integrity | Maintain sterile barrier through shelf life | Capable of maintaining a sterile barrier for at least two years. |
| Transportation | No impact to safety or efficacy due to transport hazards | The test produced successful results. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the document. The tests performed are for a physical medical device (catheter), not an AI/ML algorithm.
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 and not present in the document. Ground truth, in the context of AI/ML, refers to labels for training or testing data, which is not relevant for a physical catheter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present in the document.
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 and not present in the document. An MRMC study is relevant for diagnostic imaging devices often involving AI, not for a urological catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present in the document. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not present in the document.
8. The sample size for the training set
This information is not applicable and not present in the document. There is no AI/ML algorithm with a training set for this device.
9. How the ground truth for the training set was established
This information is not applicable and not present in the document.
In summary: The provided document describes the regulatory submission for a physical medical device, the Onli Intermittent Catheter, demonstrating its substantial equivalence to a predicate device based on various physical and biological performance tests. It does not contain any information related to the development, testing, or performance of an AI/ML algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Hollister Incorporated Jeanne Lee Sr. Manager, Regulatory Affairs 2000 Hollister Drive Libertyville, IL 60048
Re: K163179 Trade/Device Name: Onli Intermittent Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: GBM Dated: December 27, 2016 Received: December 29, 2016
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,
Charles Viviano -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) Summary
| Submitted By: | Jeanne LeeHollister Incorporated2000 Hollister DriveLibertyville, IL 60018(t) 847-996-6350(f) 847-918-3981 | |
|---|---|---|
| Date Summary Prepared: | November 9, 2016 | |
| Device Name: | Proprietary Name - OnliTM intermittent catheter | |
| Common/Usual Name - Catheter, Urethral | ||
| Classification Name - Urological catheter and accessories | ||
| Device Class: | Class II per 21 CFR 876.5130 | |
| Product Code: | GBM | |
| Predicate Device: | VaPro intermittent catheter, K141642 | |
| Device Description: | The Onli intermittent catheter is a single use catheter to be used asa means of managing urinary incontinence by draining urine fromthe bladder. The catheter has the following elements:Σ Ready to use, single use intermittent catheterΣ Hydrophilic-coated, phthalate free catheterΣ Two smooth catheter eyeletsΣ Color coded funnelΣ Not made with natural rubber latexΣ Gripper on the16-in. catheter to aid with insertionThe packaging contains a sealed water compartment chamber ofwhich the water migrates to the catheter compartment andlubricates the catheter. The outer packaging was designed to beeasy to open and facilitate access to the catheter. | |
| Intended Use: | The intermittent catheter is a flexible tubular device that is insertedthrough the urethra by male, female and pediatric patients whoneed to drain urine from the bladder. |
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Technological Characteristics: The table below summarizes the technological characteristics of the device as compared to the predicate device.
| Modified Device:Onliintermittent catheter | Predicate Device:VaProintermittent catheter(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 vapor hydration | Yes-by water vapor hydration |
| Ready to use | Yes | Yes |
| No touch design | No | Yes-has protective sleeve |
| Protective Tip | No | Yes |
| Movable Gripper(16-in. catheter only) | Yes | No |
| Catheter Material | PVC (phthalate free) | PVC (phthalate free) |
| Lubricant | PVP Based Coating(polyvinylpyrollidone) | PVP Based Coating(polyvinylpyrollidone) |
| End Design | Funnel | Funnel |
| Sterilization | Gamma Irradiation | Gamma Irradiation |
Performance Testing:
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.
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 Onli 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 due to the hazards associated with the transportation environment. The test produced successful results.
Conclusion: Based on the performance testing conducted it is concluded that the modified device, Onli intermittent catheter, 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.