(258 days)
Intended Use: Symptomatic treatment of xerostomia.
Indications for Use: Relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Oral7™ Moisturizing Gel, Mouthwash, and Mouth Spray:
Important Note: This document is a 510(k) summary, which is a premarket notification for devices that are "substantially equivalent" to legally marketed predicate devices. It primarily focuses on demonstrating equivalence rather than proving the device's efficacy through extensive clinical trials. Therefore, many of the typical acceptance criteria and study details for novel or high-risk devices will not be present.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" is demonstrated through non-clinical and bench testing, focusing on safety and technological similarity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic/non-harmful when in contact with the body. | Cytotoxicity: Mild reactivity observed, attributed to known sensitive test nature and presence of lysozyme, lactoperoxidase, mentha piperita, and potassium thiocyanate. This was deemed acceptable as it does "not impact safe use." Sensitization: Non-sensitizing. Oral Mucosal Irritation: Non-irritating. |
| Stability/Shelf-life: Maintain product characteristics over time. | No significant changes in product characteristics over a three-year period for Oral7™ Moisturizing Gel and Mouthwash. The Mouthwash data supports the shelf-life for the Mouth Spray due to identical formulation and bottle type. Conclusion: Data supports a three (3) year shelf-life. |
| Compositional Equivalence: Similar materials, humectants, proteins, and enzymes to predicate devices. | Oral7™ products utilize the same materials (moisturizers, humectants, proteins, salivary enzymes) as primary predicate devices. All ingredients are commonly used for their intended functions at equivalent or higher levels than in the proposed formulation. |
| Intended Use Equivalence: Same indications for use as predicate devices. | The intended use and indications for use ("symptomatic treatment of xerostomia," "relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness") are identical to the predicate devices. |
| Technological Characteristics Equivalence: Similar physical properties, method of use, application frequency, disease state, and area of use. | Oral7™ products share the same technological properties (ready-to-use gel/liquid/spray, as needed application, for xerostomia, oral cavity use, non-sterile presentation) as the primary and reference predicate devices (Oral Balance Gel (K061331) and Biotène® Dry Mouth Oral Rinse (K101477)/Biotène® Moisturizing Mouth Spray (K103745)). Physical properties and available delivery forms are similar to predicate devices. |
| Safety and Effectiveness Equivalence: Demonstrated to be as safe and effective as predicate devices. | Based on similarities in chemical composition, available delivery forms, physical properties, nonclinical testing (biocompatibility), and shared intended use, the Oral7™ products are considered "as safe and as effective" as the primary and reference predicate devices. No adverse effects were reported from the nonclinical tests that would preclude safe use. Materials and manufacturing are same as predicates, with no impact on safety and effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set: The "test set" in this context refers to the samples of the Oral7™ products used for nonclinical (biocompatibility) and bench (stability) testing.
- Biocompatibility Testing: The number of samples/replicates used for ISO 10993-1, -5, and -10 testing is not specified in the summary document. It's typically done on representative finished devices.
- Stability Testing: Three (3) batches each of Oral7™ Moisturizing Gel and Oral7™ Moisturizing Mouthwash were tested.
- Data Provenance: Not explicitly stated, meaning a specific country of origin for test specimens or an explicit retrospective/prospective design is not detailed in this summary. Biocompatibility and stability testing are generally prospective tests conducted specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The ground truth for biocompatibility is established by standardized laboratory tests (e.g., cell cultures for cytotoxicity, animal models for sensitization) and recognized international standards (ISO 10993). The ground truth for stability is established by analytical chemistry and physical property measurements over time. No human experts establish a "ground truth" in the way they would for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used when multiple human readers independently evaluate data (e.g., medical images) and their interpretations need to be reconciled to form a definitive "ground truth." This submission involves laboratory and bench testing, not subjective human evaluation of product performance in a clinical context.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a diagnostic aid (often AI) on human reader performance. This device is a therapeutic product (saliva substitute) and not a diagnostic tool where human interpretation of cases is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a physical product (gel, mouthwash, spray), not a software algorithm.
7. The Type of Ground Truth Used
- Biocompatibility: The ground truth is based on established international standards (ISO 10993) and their defined criteria for cytotoxicity, sensitization, and irritation.
- Stability: The ground truth is based on analytical chemistry and physical property measurements defined in product specifications and monitored over time. This determines if the product remains within acceptable limits.
- Equivalence: The overarching "ground truth" for the submission is the predicate device's known safety and effectiveness as previously cleared by the FDA. The Oral7™ products' ground truth is its demonstrated similarity in intended use, technological characteristics, and safety profile to these established predicates.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established for it.
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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.
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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 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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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 (ProductCode) |
|---|---|---|
| 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 ConsumerHealthcare | K101477 |
| Reference Predicate | ||
| Biotène® Moisturizing MouthSpray | GlaxoSmithKline ConsumerHealthcare | 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 withmembrane |
| 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 | Symptomatictreatment ofxerostomia | Symptomatictreatment ofxerostomia | Symptomatictreatment ofxerostomia | Symptomatictreatment ofxerostomia | Symptomatictreatment ofxerostomia | Symptomatictreatment ofxerostomia |
| Method of Use | Ready to usegel | Ready to usegel | Ready to useliquid | Ready to useliquid | Ready to usespray | Ready to usespray |
| 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.
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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.
N/A