(210 days)
K.142549, K061331
No
The device description and performance studies focus on the chemical composition and physical properties of a saliva substitute, with no mention of AI or ML technologies.
Yes
The device is described as relieving and treating symptoms of dry mouth, indicating a therapeutic purpose to address a medical condition.
No
Justification: The device's intended use is to relieve symptoms of dry mouth, not to diagnose a condition. It is a symptom-management product.
No
The device description clearly states the product is a mouthwash and mouthspray supplied in physical bottles, indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve symptoms of dry mouth, refresh, moisturize, clean, and soothe oral irritation and dryness. This is a therapeutic and symptomatic relief purpose, not a diagnostic one.
- Device Description: The device is described as a saliva substitute containing moisturizers, humectants, and salivary enzymes. This composition is designed to provide physical relief and lubrication, not to detect or measure substances in vitro.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like saliva, blood, etc.) to diagnose a condition or provide information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility, physical properties (pH, viscosity, specific gravity), and stability. These are typical evaluations for a therapeutic or symptomatic relief device, not an IVD which would focus on analytical and clinical performance related to diagnosis.
- Predicate Devices: The predicate devices listed (Biotene Moisturizing Mouthspray and Mouthwash) are also products intended for the symptomatic relief of dry mouth, not for in vitro diagnostic purposes.
In summary, the device's function is to provide relief for a symptom (dry mouth) through physical and moisturizing properties, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and oral dryness.
Product codes (comma separated list FDA assigned to the subject device)
LFD
Device Description
Salivea Dry Mouth Mouthwash and Salivea Dry Mouth Mouthspray are specially formulated saliva substitute which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth.
The Salivea Dry Mouth MouthSpray is supplied in non-pressurized pump action spray white Polyethylene terephthalate bottle.
The Salivea Dry Mouth Mouthwash is supplied in white Polyethylene terephthalate bottle.
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)
Biocompatibility was established through testing generally following ISO 10993, and includes Mucosal Irritation, Sensitization, and Oral toxicity testing. The results met the acceptance criteria of testing.
- Mucosal irritation (ANSI/ADA/ISO993-10)
- Sensitization (M&K, GPMT / ISO993-10)
- Oral toxicity (ANSI/ADA/ISO10993-5)
Physical testing includes pH, Viscosity and Specific gravity. Comparative physical properties testing with predicate device was performed and results were comparable.
Real time stability testing on physical properties i.e., Appearance, pH, viscosity and specific gravity were examined and met acceptance criteria.
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.
K.142549, K061331
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 11, 2018
Laclede, Inc. Rajvinder Atwal QA Manager 2103 E. University Dr. Rancho Dominguez, California 90220
Re: K180680
Trade/Device Name: Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray Regulatory Class: Unclassified Product Code: LFD Dated: September 5, 2018 Received: September 6, 2018
Dear Rajvinder Atwal:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S3
forTina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Salivea Dry Mouth Mouthwash and Salivea Dry Mouth Mouth Spray.
Indications for Use (Describe)
Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and oral dryness.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 (k) Summary
| Submission By: | Laclede, Inc. |
|---|---|
| Address: | 2103 E. University Drive |
| Rancho Dominguez, Ca 90220 | |
| Telephone: | 310-605-4280 |
| Facsimile: | 310-605-4288 |
| Contact Name: | Michael A. Pellico, President |
| Email: | mpellico@laclede.com |
Date 510(k) Summary Prepared: September 13, 2018
| Trade Name/Device Name: | SALIVEA DRY MOUTH MOUTHWASH
SALIVEA DRY MOUTH MOUTHSPRAY |
|-------------------------|-------------------------------------------------------------|
| Regulation Number: | Unclassified |
| Regulation Name: | Saliva, Artificial |
| Product Code: | LFD |
Primary Predicate Device:
BIOTENE MOISTURIZING MOUTHSPRAY, GSKCH, K103745 BIOTENE DRY MOUTH MOUTHWASH, GSKCH, K101477
Reference Predicate Device:
Oral 7 Moisturizing Spray and Mouthwash, J.C.E.C Company Inc., K.142549 Oral Balance Gel, Laclede, Inc., K061331
Device Description:
Salivea Dry Mouth Mouthwash and Salivea Dry Mouth Mouthspray are specially formulated saliva substitute which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth.
The Salivea Dry Mouth MouthSpray is supplied in non-pressurized pump action spray white Polyethylene terephthalate bottle.
The Salivea Dry Mouth Mouthwash is supplied in white Polyethylene terephthalate bottle.
Indications for Use:
Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and oral dryness.
Substantial Equivalence:
Salivea products have the same intended use, technical characteristics and physiological purpose. Any minor variations in formula/composition are to allow proper dispensing and use of product and do not affect the function, indications, or equivalency of proposed product.
4
| Product | Salivea Dry
Mouthwash | Biotene Dry
Mouthwash
(K101477) | Salivea Dry
MouthSpray | Biotene
Moisturizing
Mouthspray
(K103745) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Method of Use | Ready to use
liquid | Ready to use
liquid | Ready to use
spray | Ready to use
spray |
| Applications
per Day | As needed | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity |
| Type
of
Product | Liquid | Liquid | Liquid | Liquid |
| Indications
of
Use | Supports
Saliva's Natural
Defense,
Refresh Breath,
moisturizes,
gently cleans
and soothes Dry
Oral Irritations. | Relieves the
symptoms of
dry mouth,
refresh,
moisturize,
clean, soothe
oral
irritation
and
lubricate
oral dryness. | Relieve the
symptoms of
Dry Mouth,
instantly
moisturizes
&
hydrates dry
tissue, refreshes
breath
and
soothes
irritation. | Relieves the
symptoms of
dry mouth,
refresh,
moisturize,
clean, soothe
oral
irritation
and
lubricate
oral dryness. |
| Presentation | Non-Sterile,
PET bottle | Non-Sterile,
PET bottle | Non-Sterile,
PET bottle | Non-Sterile,
PET bottle |
Discussion and conclusions from the Nonclinical Testing:
Biocompatibility was established through testing generally following ISO 10993, and includes Mucosal Irritation, Sensitization, and Oral toxicity testing. The results met the acceptance criteria of testing.
- · Mucosal irritation (ANSI/ADA/ISO993-10)
- · Sensitization (M&K, GPMT / ISO993-10)
- · Oral toxicity (ANSI/ADA/ISO10993-5)
Physical testing includes pH, Viscosity and Specific gravity. Comparative physical properties testing with predicate device was performed and results were comparable.
Real time stability testing on physical properties i.e., Appearance, pH, viscosity and specific gravity were examined and met acceptance criteria.
Conclusion:
The subject Salivea Products has same materials (i.e., moisturizers, humectants and salivary enzymes) as the primary predicate devices. All ingredients in the Salivea products are commonly used for their intended functions. Salivea products have the same intended use and the same technological properties as primary and reference predicate devices. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.