(84 days)
Not Found
No
The description focuses on a microprocessor-driven pump with user-set parameters, not on adaptive or learning algorithms.
Yes
The device is intended for "dry mouth therapy" and aims to provide "immediate and effective relief," which are therapeutic goals.
No
Explanation: The device is described as a therapy device ("Dry mouth therapy") that releases water for relief. There is no mention of it acquiring or analyzing physiological information or making medical determinations.
No
The device description explicitly lists hardware components such as a microprocessor, rechargeable battery, water container, pump, pump controller, and mouthpiece.
Based on the provided information, the XEROS Dry Mouth Pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease, monitoring a condition, or screening for risks.
- XEROS Dry Mouth Pump Function: The description clearly states the device's purpose is to deliver water to the mouth for dry mouth relief. It is a therapeutic device that directly interacts with the body (delivering moisture to the oral cavity) rather than analyzing a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the XEROS Dry Mouth Pump falls under the category of a therapeutic or palliative medical device, not an IVD.
N/A
Intended Use / Indications for Use
The XEROS Dry Mouth Pump is intended as dry mouth therapy for chronic dry mouth caused by radiation therapy treatment by adding moisture to the mouth for immediate and effective relief.
Dry mouth therapy for chronic dry mouth caused by radiation therapy treatment by adding moisture to the mouth for immediate and effective relief
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
The XEROS Dry Mouth Pump is a microprocessor driven device which releases small amounts of water for a user-set duration at user-set intervals. It includes a rechargeable battery, water container, pump, and pump controller. The mouthpiece is a small comfortable fitting sponge attached to 1/8" tubing. All components of the XEROS Dry Mouth Pump are placed within a waist pack. It can be worn around the waist, on the shoulder, or placed on the nightstand for example.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
APR - 8 2011
Lorin Technologies Corporation
KIIO III
.
510(k) Notification
510(k) Submission
TRADITIONAL Submission Date: 01/10/11
XEROS DRY MOUTH PUMP artificial saliva
510(k) Summary Submitted by
| Owner's Name | Lorin Technologies Corporation |
|---|---|
| Address | 436 Woodland Drive |
| Swansboro, NC 28584-9418 | |
| Phone | 919-341-4128 |
| Facsimile | 831-307-6220 |
| Contact Person | Vladimir "Al" Toman |
| Preparation Date | October 8, 2010 |
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
1
orin Technologies Corporation
510(k) Notification 510(k) Submission
TRADITIONAL Submission Date: 01/10/11
XEROS DRY MOUTH PUMP artificial saliva
510(k) Summary Device Naming
| Trade Name | XEROS Dry Mouth Pump
XEROS-1 | |
|---------------------|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Artificial saliva | |
| Classification Name | Device | Saliva, Artificial |
| | Review Panel | Dental |
| | Product Code | LFD |
| | Unclassified Reason | Pre-Amendment |
| | Submission Type | 510(k) |
| | Device Class | Unclassified |
| | TPLC | (see ref 1) |
| | GMP Exempt? | No |
| | Recognized Consenous
Standard | (see ref 2)
Recognition Number 4-179:
ISO 7405:2008, Dentistry -
Evaluation of biocompatibility
of medical devices used in
dentistry. (Dental/ENT)
Unclassified Saliva, Artificial
Class U |
| | Third Party Review | Not Third Party Eligible |
ref 2: http://www.accessdata.fda.gov/scripts/drfm/crocs/dr/Pro-12-1
807.92(a){2)
5.2
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
lorintechnologies.com
2
Lorin Technologies Corporation
TRADITIONAL Submission Date: 01/10/11
XEROS DRY MOUTH PUMP artificial saliva
510(k) Summary Predicates
| vicks powershot dry
| throat & mouth relief | the procter & gamble co. | K091419 | 08/28/2009 |
|---|---|---|---|
| tgo spray | laboratoires carilene | ||
| s.a.s. | K051812 | 10/21/2005 |
ref: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
807.92(a){3)
.
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
3
Image /page/3/Picture/0 description: The image shows the logo of Lorin Technologies Corporation. The logo consists of a stylized letter 'L' on the left, followed by the text 'Lorin Technologies Corporation'. The text is in a simple, sans-serif font and is black.
XEROS DRY MOUTH PUMP artificial saliva
TRADITIONAL Submission Date: 01/10/11
510(k) Summarv Description of the device as found in device labeling
The XEROS Dry Mouth Pump is a microprocessor driven device which releases small amounts of water for a user-set duration at user-set intervals. It includes a rechargeable battery, water container, pump, and pump controller. The mouthpiece is a small comfortable fitting sponge attached to 1/8" tubing. All components of the XEROS Dry Mouth Pump are placed within a waist pack. It can be worn around the waist, on the shoulder, or placed on the nightstand for example.
How the device functions 1
The vessel is filled with water. The device is turned on and either the Day Mode or Night Mode is selected. The sponge-tip foam mouthpiece is wetted and then placed into the user's mouth where it is most comfortable.
The device is completely programmable designed to best fit the activity in which the user is engaged. It will pump water for the number of seconds the user presets the duration in the desired mode (Day or Night). It will pump that same amount of water at the number of minutes the user presets the interval in the desired mode. The process will continue until the device is turned off.
The user can push the BOOST button at anytime it is needed to deliver a preset amount of water measured in duration of seconds or the BOOST button can be depressed to activate pumping until it is released.
Scientific concepts that form the basis for the device
The concept of the device is simply to get water from a vessel container into the oral cavity of the user hands-free. Radiation caretakers advise their patients to sip water whether it be straight or a saline solution . Saliva is 99% water3. These two statements form the basis for the device. However because sipping water from a bottle is not feasible while sleeping, engaged in physical activity, or speaking, using scientific logic, we enhance this concept by making the sipping of water hands-free, A peristaltic pump is incorporated to sip the water from the bottle into the oral cavity by way of a conduit. Like the predicates the XEROS-1 uses a positive displacement Unlike the predicates the XEROS-1 pump is motorized whereas the pump. predicates rely on manual hand motion.
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
5.4
1- Proposed Labeling page 13.2
2- Nurse Ann, Craven Regional Medical Center RDO, 2000 Neuse Boulevard, New Bern, NC 28560
3- http://www.answers.com/topic/what-is-the-composition-of-saliva
4
Image /page/4/Picture/0 description: The image shows the logo of Lorin Technologies Corporation. The logo consists of the company name in a simple, sans-serif font. The word "Lorin" is followed by "Technologies Corporation", with the first letter of each word capitalized. To the left of the company name is a simple graphic element.
XEROS DRY MOUTH PUMP artificial saliva
510(k) Notification 510(k) Submission
TRADITIONAL Submission Date: 01/10/11
510(k) Summary Significant physical and performance characteristics
The device is designed to be as compact and weight-light as possible. The device components are contained within a waist pack, each in their own compartment. The only requirement of the battery is that it must be rechargeable. At the present a gel cell is being used however as battery technology advances it will be replaced by a much lighter and less bulky (less physical mass) battery such as a lithium cell based battery. The water bottle container is polyethylene, same as the Vicks Power-shot predicate. The bottle being used is 6 ounces based on typical usage calculations and actual studies to verify those calculations. However, the bottle size can be upsized or down-sized without adversely effecting the function of the XEROS-1. The pump is a peristaltic positive displacement pump chosen in design because the water does not come into direct contact with any of the pump components. The pump being low voltage makes it possible to be portable. Pump technology is advancing and a smaller pump profile is being considered which will not only be more electronically efficient it will be lighter in weight and size. The last component contained within the waist pack is the controller. It resides in a mesh outer pocket so that it is visible but yet obscure. With practice, the user can use the controller without actually looking at it. The buttons are designed to be operable by touch. Striking any of the buttons by mistake will neither cause harm to the user nor adversely effect the use of the XEROS Dry Mouth Pump. The controller contains two simple circuits 1) one to recharge the battery (and to shutdown if the battery is not recharged) and 2) one to program and operate the pump. The tubing from the discharge side of the pump and the removable foam sponge-tip mouthpiece assembly are the only components not in the waist pack during operation. The discharge tubing is Tygon® Medical/Surgical Tubing S-50-HL. The only component of the XEROS-1 that comes into contact with the oral cavity is the disposable foam sponge-tip mouthpiece assembly. It consists of the foam sponge-tip (toothette swab standard 10993-5 for the biological evaluation of medical devices), tubing (Tygon® Medical/Surgical Tubing S-50-HL), and female luer. The mouthpiece assembly is designed to be easily replaced by turning the luer a quarter turn and switching out mouthpieces. 807.92(a)(4)
ર .5
t: 919-341-4128 f: 831-307-6220 atoman@ec.rr.com
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
5
Lorin Technologies Corporation
XEROS DRY MOUTH PUMP artificial saliva
TRADITIONAL Submission Date: 01/10/11
510(k) Summary Intended Use
The XEROS Dry Mouth Pump is intended as dry mouth therapy for chronic dry mouth caused by radiation therapy treatment by adding moisture to the mouth for immediate and effective relief.
5.6
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
6
Lorin Technologies Corporation
TRADITIONAL Submission Date: 01/10/11
XEROS DRY MOUTH PUMP artificial saliva .
510(k) Summary Technological Characteristics
The XEROS Dry Mouth Pump device applies moisture to the mucus membrane of the mouth as a liquid by means of a positive displacement pump. By coating and moistening it treats dry mouth and provides immediate relief.
The XEROS-1 is in comparison with the predicates as shown in the table below.
| XEROS-1 | Vicks Powershot | TGO Spray(R) | |
|---|---|---|---|
| Intended Use | Symptomatic Treatment | ||
| of xerostomia | Symptomatic Treatment | ||
| of xerostomia | Symptomatic Treatment | ||
| of xerostomia | |||
| Method of Use | Ready to use liquid | Ready to use liquid | |
| spray | Ready to use liquid | ||
| spray | |||
| Applications per Day | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral Cavity | Oral Cavity | Oral Cavity |
| Dispensed | Positive Displacement | ||
| Pump | Positive Displacement | ||
| Pump | Positive Displacement | ||
| Pump | |||
| Presentation | Non-Sterile | Non-Sterile | Non-Sterile |
| 807.92(a)(6) |
The data provided for XEROS Dry Mouth Pump device support the conclusion that it
is substantially equivalent to the cited predicate devices.
5.7
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
lorintechnologies.com
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Al Toman President Lorin Technologies Corporation 436 Woodland Drive Swansboro, North Carolina 28584
APR - 8 2011
Re: K110116 Trade/Device Name: XEROS Dry Mouth Pump Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: January 11, 2011 Received: January 14, 2011
Dear Mr. Toman:
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.
8
Page 2- Mr. Toman -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Lorin Technologies Corporation
XEROS DRY MOUTH PUMP artificial saliva
TRADITIONAL Submission Date: 01/10/11
510(k) Number (if known):
Device Name:
XEROS Dry Mouth Pump
Indications for Use:
Dry mouth therapy for chronic dry mouth caused by radiation therapy treatment by adding moisture to the mouth for immediate and effective relief
Prescription Use NO Over-The-Counter Use (Part 21 CFR 801 Subpart AND/OR YES D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Susan Lyons
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110416
Lorin Technologies Corporation 436 Woodland Drive Swansboro, NC 28584-9418
4.1