(314 days)
Not Found
No
The device description focuses on an infrared sensor for automatic dispensing and volume selection, with no mention of AI or ML capabilities. The performance studies also focus on basic functionality and safety standards.
No.
This device is a dispenser for lubricating gel, not the gel itself or a device that directly performs a therapeutic function. Its purpose is to efficiently and hygienically dispense a product used during medical procedures.
No
The device is described as a dispenser for lubricating gel used during medical procedures. Its function is to dispense gel, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical hardware components such as an infrared sensor, battery operation, an optional AC adapter, and a disposable cartridge system. While software is mentioned and validated, it is integral to the function of the physical dispenser, not a standalone software product.
Based on the provided information, the KleenGel hands-free dispenser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- KleenGel Dispenser Function: The KleenGel dispenser's intended use is to dispense lubricating gel for use during physical examinations and procedures. It does not analyze any biological specimens or provide diagnostic information about a patient's health.
- Device Description: The description focuses on the mechanical and electronic aspects of dispensing the gel, not on any analytical or diagnostic capabilities.
- Performance Studies: The performance studies described are related to the dispenser's functionality, safety, and the compatibility of the gel cartridge materials, not on diagnostic accuracy or performance.
- Predicate and Reference Devices: The predicate and reference devices listed are also dispensers for medical substances (oral solution and lubricating jelly), not IVD devices.
Therefore, the KleenGel hands-free dispenser is a medical device, but it falls under a different classification than an IVD. It is a device used to facilitate medical procedures, not to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KYX, KMJ
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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic and rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare providers / physician office or hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible.
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.
1
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
2
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.
4
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.
| Item
Intended Use | KleenGel Dispenser
The KleenGel hands-
free dispenser is used
to dispense lubricating
gel for use by | Predicate
Device:
K980109
The CycloTech
Cyclosporine Oral
Solution Dispenser is
intended to dispense | Referenced
Device:
HR Lubricating
HR Lubricating
Jelly is sterile
lubricating gel for
use by healthcare |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | healthcare providers
when performing
pelvic and rectal
exams and other
procedures requiring
lubricating gel. | SangCya Cyclosporine
Oral Solution USP (for
microdispersion) as
well as display and
store dose size, time to
next dose, remaining
available doses and
doses dispensed. | providers when
performing pelvic
and rectal exams
and other
procedures
requiring
lubricating gel. |
| Mechanism of
dispensing | IR sensor detection to
activate pump | Push button to
activate pump | Designed to be used
with the KleenGel
Dispenser. |
| Power source | Four (4) AA (1.5V)
batteries or
AC adapter | Four (4) AA (1.5V)
batteries | N/A |
| Software | Yes | Yes | N/A |
| Materials | High impact Polystyrene | Molded plastic
outer 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
5
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.