(314 days)
The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
The KleenGel Dispenser is a patented automatic dispenser designed to efficiently and hygienically dispense lubricating gel for use by health care providers when performing pelvic and rectal exams or other procedures requiring the use of lubricating gel. The KleenGel Dispenser has an Infrared Sensor for automatic dispensing of lubricating gel onto the providers fingers or on a medical instrument. The unit is designed to be placed on a counter top so it's easily accessible to healthcare providers in exam rooms. The device is battery operated, using four (4) AA (1.5V) batteries. Device also has an optional AC adapter. Sterile Lubricating Gel, (sold separately) is packaged in a 14 oz pre-filled disposable cartridge. Gel is dispensed in 3 volume selections, 1ml, 2ml or 3ml.
This document is a 510(k) Summary for the KleenGel Dispenser, a product intended to hygienically dispense lubricating gel in healthcare settings. It does not describe a study involving an AI algorithm or human readers. Therefore, I cannot extract the information required by your request about AI performance, human reader improvement with AI, or ground truth establishment relevant to AI.
However, I can provide information about the device's acceptance criteria and the non-clinical tests performed, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Safety (Electrical) | Complies with UL61010-1 3rd edition (Safety Requirements for electrical equipment for measurement, control, and laboratory use. Part 1: General Requirements). |
| Software Functionality | "Software Validation Testing was performed to assure that the sensor and measurement features of the dispenser function as intended." |
| Volume Dispensing Accuracy | "The results from the Volume Dispensing Test Protocol demonstrated that the proper amounts of gel were dispensed for each setting each time the sensor was activated." |
| Leachable/Extractable Materials | Complies with USP 661. Results showed "any pharmaceutical preparation based on an aqueous and/or alcoholic matrix will not pick up any significant contamination when stored in these KleenGel Dispenser Cartridge materials." |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes for the "Volume Dispensing Test Protocol" or the "Leachable and Extractable testing." It refers to "bench testing" and "third-party labs" for electrical safety, indicating a controlled environment, but does not specify the provenance of the data in terms of country of origin or whether it was retrospective or prospective in the medical sense as these are non-clinical hardware/software tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI algorithm requiring expert ground truth for diagnostic or prognostic purposes. The "ground truth" for the tests performed relates to engineering specifications and safety standards (e.g., UL standards, USP standards, and the device's own design specifications for dispensing volumes).
4. Adjudication method for the test set
Not applicable. There was no clinical study requiring adjudication of expert opinions.
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 document describes a medical device (a gel dispenser), not an AI algorithm for diagnostic interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. The device's "standalone" performance refers to its mechanical and software functionality, as detailed in the non-clinical tests. The software is integral to the dispenser's function (IR sensor activation, dispensing volume control), but it is not an AI for medical image analysis or diagnosis.
7. The type of ground truth used
The "ground truth" in this context refers to established engineering standards, safety requirements, and the device's design specifications:
- Electrical Safety: UL61010-1 3rd edition standard.
- Software Functionality: Whether the sensor and measurement features performed "as intended" (i.e., met design specifications).
- Volume Dispensing: Whether "proper amounts of gel were dispensed for each setting" (i.e., met pre-defined volume specifications).
- Leachable/Extractable: USP 661 standard for material biocompatibility/inertness.
8. The sample size for the training set
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2015
KleenGel, LLC c/o Ms. Maria Griffin mdi Consultants, Inc 55 Northern Blvd.. Suite 200 Great Neck, New York 11021
Re: K143177
Trade/Device Name: KleenGel Dispenser Regulation Number: 21 CFR 880.6430 Regulation Name: Liquid Medication Dispenser Regulatory Class: I Product Code: KYX, KMJ Dated: August 10, 2015 Received: August 12, 2015
Dear Ms. Griffin:
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.
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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 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 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/Resourcesfor You/Industry/default.htm. 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 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,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K143177
Device Name
KleenGel Dispenser
Indications for Use (Describe)
The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
| 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
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
The assigned 510(k) number is: K143177
1. Submitter's Identification:
KleenGel, LLC 136 NW 16th Street Boca Raton, FL 33432 TEL: (561) 705-0452
Contact Person: Suzanne Mair
Date Summary Prepared: August 7, 2015
- Trade Name of the Device: KleenGel Dispenser 2.
-
- Common or Usual Name: Liquid Medication Dispenser
4. Classification:
| Regulation: | 21CFR 880.6430, Liquid Medication Dispenser |
|---|---|
| Product Code: | KYX, Class I, 510(k) exempt |
Secondary Product Code: KMJ
ട. Predicate Device Information:
Cyclotech Cyclosporine Oral Solution Dispenser - K980109 Referenced device: HR Lubricating Jelly - Preamendment Device
6. Device Description:
The KleenGel Dispenser is a patented automatic dispenser designed to efficiently and hygienically dispense lubricating gel for use by health care providers when performing pelvic and rectal exams or other procedures requiring the use of lubricating gel.
The KleenGel Dispenser has an Infrared Sensor for automatic dispensing of lubricating gel onto the providers fingers or on a medical instrument. The unit is designed to be placed on a counter top so it's easily accessible to healthcare providers in exam rooms. The device is battery operated, using four (4) AA (1.5V) batteries. Device also has an optional AC adapter.
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Sterile Lubricating Gel, (sold separately) is packaged in a 14 oz pre-filled disposable cartridge. Gel is dispensed in 3 volume selections, 1ml, 2ml or 3ml
7. Intended Use:
The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
| ItemIntended Use | KleenGel DispenserThe KleenGel hands-free dispenser is usedto dispense lubricatinggel for use by | PredicateDevice:K980109The CycloTechCyclosporine OralSolution Dispenser isintended to dispense | ReferencedDevice:HR LubricatingHR LubricatingJelly is sterilelubricating gel foruse by healthcare |
|---|---|---|---|
| healthcare providerswhen performingpelvic and rectalexams and otherprocedures requiringlubricating gel. | SangCya CyclosporineOral Solution USP (formicrodispersion) aswell as display andstore dose size, time tonext dose, remainingavailable doses anddoses dispensed. | providers whenperforming pelvicand rectal examsand otherproceduresrequiringlubricating gel. | |
| Mechanism ofdispensing | IR sensor detection toactivate pump | Push button toactivate pump | Designed to be usedwith the KleenGelDispenser. |
| Power source | Four (4) AA (1.5V)batteries orAC adapter | Four (4) AA (1.5V)batteries | N/A |
| Software | Yes | Yes | N/A |
| Materials | High impact Polystyrene | Molded plasticouter case | N/A |
Technological Comparison to Predicate Devices: 8.
Discussion
The intended uses of the KleenGel dispenser and Cyclotech Cyclosporine Oral Solution Dispenser do not differ. Both are designed to dispense a liquid/gel substance in a predetermined amount when the pump mechanism is activated. The predicate device has additional features, which is reflected in the intended use that do not apply to the subject device.
The Kleengel dispenser is only intended for use in a physician office or hospital and the predicate device is intended to be used at home as well.
Both devices dispense gel/solution from specially designed containers that can only be used
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with the specific dispenser. The Kleengel dispenser is activated via a sensor and the Cyclotech Cyclosporine Oral Solution Dispenser is activated when a button is pushed. Each dispenser uses proprietary software. The difference in software and in the activation of the dispensing pump has been successfully validated to assure the specifications have been met.
The Kleengel dispenser also offers an option for use with an AC adapter. The power supply has been tested by a third party lab to assure safety of the device to UL61010-1 3th edition.
The gel that is dispensed from the Kleengel dispenser is identical to the HR Lubricating Jelly that is a preamendment device.
Based on the information contained within the submission, we conclude that the devices are substantially equivalent.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 9. Equivalence are as follows:
Bench testing was performed to assess the functionality of the KleenGel dispenser including:
UL61010-1 3th edition Safety Requirements for electrical equipment for measurement, control, and laboratory use. Part 1: General Requirements
FDA's guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" was used when evaluating the device software. Software Validation Testing was performed to assure that the sensor and measurement features of the dispenser function as intended. The results from the Volume Dispensing Test Protocol demonstrated that the proper amounts of gel were dispensed for each setting each time the sensor was activated.
Leachable and Extractable testing were performed according to USP 661 to evaluate the presence of leachable materials in the KleenGel cartridge system. Results show that any pharmaceutical preparation based on an aqueous and/or alcoholic matrix will not pick up any significant contamination when stored in these KleenGel Dispenser Cartridge materials.
10. Discussion of Clinical Tests Performed:
Clinical testing was not performed.
11. Conclusions:
Based on the information provided in this submission we conclude that the KleenGel Dispenser is substantially equivalent to the predicate.
§ 880.6430 Liquid medication dispenser.
(a)
Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.