(258 days)
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 intended for "symptomatic treatment of xerostomia" and is described as relieving and treating symptoms of dry mouth, which are therapeutic claims.
No
The device is intended for symptomatic treatment and relief of xerostomia symptoms, acting as a saliva substitute, rather than for diagnosing a condition.
No
The device description clearly states that the product is a "specially formulated saliva substitute" containing physical substances like moisturizers, humectants, proteins, and enzymes. This indicates a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly state the device is for the symptomatic treatment of xerostomia (dry mouth) and to relieve symptoms. This is a therapeutic or palliative function, not a diagnostic one.
- Device Description: The description details the product as a "saliva substitute" with moisturizing, lubricating, and soothing properties. This aligns with a treatment for a condition, not a test to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on biocompatibility, stability, and irritation, which are relevant for a topical or oral therapeutic product, not a diagnostic test.
- Predicate Devices: The predicate devices listed (Oral Balance Gel, Biotène® Dry Mouth Oral Rinse, Biotène® Moisturizing Mouth Spray) are all products intended for the relief of dry mouth symptoms, further supporting the non-diagnostic nature of this device.
In summary, the device's function is to alleviate the symptoms of dry mouth, which is a therapeutic purpose, not a diagnostic one.
N/A
Intended Use / Indications for Use
Relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness.
Product codes
LFD
Device Description
Oral7TM products are specially formulated saliva substitutes which contain moisturizers, humectants, proteins and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth. The Oral7TM products are listed in Table 5-3.
Oral7TM Moisturizing Gel: 1.6 fluid ounces (48 mL) in plastic aluminum barrier laminate tube with membrane
Oral7TM Moisturizing Mouthwash: 8.5 and 16.9 fluid ounces (250 and 500 mL, respectively) in white, polyethylene terephalate bottles
Oral7TM Moisturizing Mouth Spray: 1.5 fluid ounces (44 mL) in white, polyethylene terephalate bottles
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)
Nonclinical Testing: Biocompatibility testing for the final finished devices was conducted according to ISO 10993-1. Testing for cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) were completed. The cytotoxicity testing showed mild reactivity, which was not unexpected due to the known sensitivity/nature of the test (i.e., use of bare cells) and the presence of lysozyme, lactoperoxidase, mentha piperita and potassium thiocyanate in the formulations. The mild reactivity of the formulations supports the use in the proposed indication and does not impact safe use of the formulations. The sensitization and oral mucosal irritation testing demonstrated that the formulations are non-sensitizing and non-irritating.
Clinical Testing: The submission does not contain clinical testing.
Bench Testing: Stability testing has been conducted on three (3) batches each of Oral7™ Moisturizing Gel and Oral7™ Moisturizing Mouthwash. Oral7TM Moisturizing Mouth Spray has the identical formulation as Oral7™ Moisturizing Mouthwash. Both formulations are filled into polyethylene terephalate bottles; therefore, stability data for the Oral7™ Moisturizing Mouthwash support the shelf-life of Oral7™ Moisturizing Mouth Spray. The data demonstrate that there are no significant changes in any of the product characteristics over the three year period of study for Oral7TM products. Available data support a three (3) year shelf-life for the Oral7TM products.
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.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three profiles of human faces incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2015
J.C.E.C. Company, Inc. c/o Ms. Elizabeth N. Dupras, RAC B&H Consulting Services, Inc. 50 Division Street, Suite 206 Somerville, NJ 08876
Re: K142549
Trade/Device Name: Oral7™ Moisturizing Gel Oral7™ Moisturizing Mouthwash Oral7TM Moisturizing Mouth Spray Regulation Number: Unclassified Regulation Name: Saliva, Artificial Product Code: LFD Dated: April 24, 2015 Received: April 27, 2015
Dear Ms. Dupras:
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/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
Enclosure
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Indications for Use
510(k) Number (if known) K142549
Device Name
Oral7™ Moisturizing Gel, Oral7™ Moisturizing Mouthwash and Oral7™ Moisturizing Mouth Spray
Indications for Use (Describe)
mulianone of obe (2006. Bo
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY 212 10
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
5. 510(k) SUMMARY (K142549)
5.1. Submitter Information
● Sponsor
J.C.E.C. Company, Inc. (doing business as Fountain Health Care, LLC) 12 Frieda Lane Kendall Park, NJ 08824
John Canvin President
Phone: (908) 420-3759 email: canvinj@comcast.net
Regulatory Agent ●
B&H Consulting Services, Inc. 50 Division Street Suite 206 Somerville, NJ 08876
Primary Contact:
Elizabeth N. Dupras, RAC Phone: 908-704-1691, ext. 288 908-704-1693 Fax: email: edupras@bhconsultingservices.com
Date of Summary ●
21 May 2015
5.2. Device Name
The proposed Oral7TM devices are outlined in Table 5-1.
Proposed Oral7TM Device Names Table 5-1:
| Proprietary Name | Common/Usual Name | Classification Name (Product
Code) |
|----------------------------------|--------------------|---------------------------------------|
| Oral7TM Moisturizing Gel | Saliva, Artificial | Saliva, Artificial (LFD) |
| Oral7TM Moisturizing Mouthwash | Saliva, Artificial | Saliva, Artificial (LFD) |
| Oral7TM Moisturizing Mouth Spray | Saliva, Artificial | Saliva, Artificial (LFD) |
Regulatory Class: Unclassified Product Code: LFD
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Equivalent Device Identification 5.3.
The primary predicate device for Oral7™ Moisturizing Gel is Oral Balance Gel (K061331); the primary predicate device for Oral7™ Moisturizing Mouthwash and Oral77™ Moisturizing Mouth Spray is Biotène® Dry Mouth Oral Rinse (K101477).
The formulation of Oral7™ Moisturizing Mouthwash is identical to the formulation of Oral7™ Moisturizing Mouth Spray. The products have the same intended use, technical characteristics and physiological purpose; the only difference is in the mode of delivery. Therefore, Biotène® Moisturizing Mouth Spray (K103745) is a reference predicate for Oral7™ Moisturizing Mouth Spray.
The predicate devices are outlined in Table 5-2.
| Product | Notification Holder | 510(k) Number |
|---|---|---|
| Primary Predicates | ||
| Oral Balance Gel | Laclede, Inc. | K061331 |
| Biotène® Dry Mouth Oral Rinse | GlaxoSmithKline Consumer | |
| Healthcare | K101477 | |
| Reference Predicate | ||
| Biotène® Moisturizing Mouth | ||
| Spray | GlaxoSmithKline Consumer | |
| Healthcare | K103745 |
Table 5-2: Predicate Devices
5.4. Device Descriptions
Oral77M products are specially formulated saliva substitutes which contain moisturizers, humectants, proteins and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth. The Oral77M products are listed in Table 5-3.
Table 5-3: Oral7™ Product Presentations
| Product | Presentation |
|---|---|
| Oral7TM Moisturizing Gel | 1.6 fluid ounces (48 mL) in plastic aluminum barrier laminate tube with |
| membrane | |
| Oral7TM Moisturizing Mouthwash | 8.5 and 16.9 fluid ounces (250 and 500 mL, respectively) in white, |
| polyethylene terephalate bottles | |
| Oral7TM Moisturizing Mouth Spray | 1.5 fluid ounces (44 mL) in white, polyethylene terephalate bottles |
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5.5. Intended Use
The intended use of the devices is symptomatic treatment of xerostomia.
Indications for Use: Relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness.
5.6. Comparison Table
A comparison of the Oral7™ products and the primary and reference predicate devices is provided in Table 5-4.
| Parameter | Primary Predicate Devices | Reference Predicate Device | ||||
|---|---|---|---|---|---|---|
| Gel | Mouthwash and Mouth Spray/ | |||||
| Oral Rinse | Mouth Spray | |||||
| Oral7TM | Oral Balance | |||||
| (K061331) | Oral7TM | Biotène® | ||||
| (K101477) | Oral7TM | Biotène® | ||||
| (K103745) | ||||||
| Intended Use | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | Symptomatic | |||||
| treatment of | ||||||
| xerostomia | ||||||
| Method of Use | Ready to use | |||||
| gel | Ready to use | |||||
| gel | Ready to use | |||||
| liquid | Ready to use | |||||
| liquid | Ready to use | |||||
| spray | Ready to use | |||||
| spray | ||||||
| Applications/Day | As needed | As needed | As needed | As needed | As needed | As needed |
| Disease State | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia | Xerostomia |
| Area of Use | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity | Oral cavity |
| Type of Product | Gel | Gel | Liquid | Liquid | Liquid | Liquid |
| Presentation | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
Comparison of Oral7™ Products to the Primary and Reference Predicate Table 5-4: Devices
5.7. Summary of Testing
5.7.1. Nonclinical Testing
Biocompatibility testing for the final finished devices was conducted according to ISO 10993-1. Testing for cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) were completed. The cytotoxicity testing showed mild reactivity, which was not unexpected due to the known sensitivity/nature of the test (i.e., use of bare cells) and the presence of lysozyme, lactoperoxidase, mentha piperita and potassium thiocyanate in the formulations. The mild reactivity of the formulations supports the use in the proposed indication and does not impact safe use of the formulations. The sensitization and oral mucosal irritation testing demonstrated that the formulations are non-sensitizing and non-irritating.
5.7.2. Clinical Testing
The submission does not contain clinical testing.
6
5.7.3. Bench Testing
Stability testing has been conducted on three (3) batches each of Oral7™ Moisturizing Gel and Oral7™ Moisturizing Mouthwash. Oral7TM Moisturizing Mouth Spray has the identical formulation as Oral7™ Moisturizing Mouthwash. Both formulations are filled into polyethylene terephalate bottles; therefore, stability data for the Oral7™ Moisturizing Mouthwash support the shelf-life of Oral7™ Moisturizing Mouth Spray.
The data demonstrate that there are no significant changes in any of the product characteristics over the three year period of study for Oral7TM products. Available data support a three (3) year shelf-life for the Oral7TM products.
Conclusion 5.8.
The subject Oral71M products have the same materials (i.e., moisturizers, humectants, proteins and salivary enzymes) as the primary predicate devices. All ingredients in the Oral77M products are commonly used for their intended functions at equivalent or higher levels than in the proposed formulation.
In addition, the Oral7™ products have the same intended use and the same technological properties as the primary and reference predicate devices. The Oral7™ products were shown to be safe for the intended use in tests for cytotoxicity, sensitization and irritation.
The materials and manufacturing/processing of the Oral7™ products are the same as the primary predicate devices; therefore, there is no impact on safety and effectiveness of the subject devices.
Given the similarities in chemical composition, available delivery forms and physical properties between the Oral71M products and the Biotene primary and reference predicate devices, Oral7™ Moisturizing Gel, Oral7™ Moisturizing Mouthwash and Oral7™M Moisturizing Mouth Spray are as safe and as effective as the primary and reference predicate devices.