(83 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the powder, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for conditions like dryness of the mouth due to various factors, oral mucositis, and to replace normal ionic and pH balance in the oral cavity. It also states its purpose is to provide "relief" of symptoms, which aligns with the definition of a therapeutic device.
No
The document describes Neutrasal® as a powder that becomes a supersaturated calcium and phosphate rinse, designed to treat dryness of the mouth and associated conditions, not to diagnose a medical condition. Its function is therapeutic, maintaining moistness and relieving discomfort.
No
The device description clearly states that Neutrasal® is a powder comprised of chemical ingredients that is dissolved in water to create a rinse. This 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 uses of Neutrasal® are focused on treating or alleviating symptoms related to dry mouth and oral mucositis. It is used to provide moisture, improve oral hygiene, and relieve discomfort. These are therapeutic or palliative uses, not diagnostic ones.
- Device Description: The description details the composition and mechanism of action of Neutrasal® as a rinse that provides calcium and phosphate ions to the oral cavity. This is a treatment mechanism, not a diagnostic one.
- Lack of Diagnostic Claims: There are no claims or descriptions indicating that Neutrasal® is used to diagnose a disease, condition, or state. It does not analyze a sample from the body to provide information about a patient's health.
- Performance Studies: The performance studies described focus on the physical properties and ability to achieve its intended use (e.g., pH, dissolution, supersaturated state, content of active ingredients). These are tests related to the quality and function of the product as a rinse, not its diagnostic accuracy.
- Predicate Devices: The predicate devices listed are "Caphosol ®" and "Artificial Saliva," which are also products used for treating dry mouth and oral conditions, not for diagnosis.
In summary, Neutrasal® is a therapeutic or palliative device used to manage symptoms of dry mouth and oral mucositis. It does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
(OTC): Neutrasal® is indicated for the dryness of the mouth (hyposalivation, xerostomia)
(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.
(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome
Product codes
LFD
Device Description
Neutrasal® is a powder that when dissolved in normal tap water becomes a supersaturated calcium and phosphate rinse. Neutrasal® was designed in part to replace the normal ionic and pH balance in the oral cavity. Neutrasal® also maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the oral mucosa, as well as painful tongue conditions due to hyposalivation.
Neutrasal® facilitates chewing and speaking; loosens tough mucus: prevents mucous membranes from sticking together; and improves adherence of dentures.
Additionally, Neutrasal® can be used as an adjunct to standard oral care for relieving the discomfort associated with oral mucositis that may be caused by high dose chemotherapy or radiation. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Neutrasal® is a comprised of calcium chloride, sodium phosphate and sodium bicarbonate plus inactive ingredients. When Neutrasal® is dissolved in normal tap water, the water becomes supersaturated with both calcium and phosphate ions.
Syloid, an inactive ingredient in Neutrasal, is an amorphous silica that is recommended for free-flow and anti-caking for hydrogscopic food powders, industrial powders and other applications (pharmaceuticals) where humidity must be kept to a minimum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, oral mucosa
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)
The Performance Testing of Neutrasal® included the assessment of the physical properties of Neutrasal® and its ability to achieve its intended use. Bench testing was completed by Scientech Laboratories, Inc., an FDA-approved analytical laboratory testing service as well internal testing done by Bartor Pharmacal. The following bench tests were performed:
- . pH
- Dissolution Tests .
- Activity Testing of Supersaturated State ●
- Content Testing of Active Ingredients .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
5. 510(k) Summary
A. From:
(Agent)
SEP - 2 2009
25 Ravenna Drive Pomona, NY 10970 Invado Pharmaceuticals 914-715-6232 ekobus@invadopharma.com
Edward Kobus
Bartor Pharmacal (Owner) 70 High Street Rye, NY 10580 Frank Bardani, RPh.
B. Trade Name: Neutrasal®
K091718
Common Name: Powder for Supersaturated Calcium Phosphate Rinse
Classification Names:
Saliva, Artificial
- C. Regulatory Information:
Device Class:
Unclassified
Product Code:
LFD
D. Predicates:
Caphosol ®, Artificial Saliva
Product Code: LFD
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E. Device Description:
Neutrasal® is a powder that when dissolved in normal tap water becomes a supersaturated calcium and phosphate rinse. Neutrasal® was designed in part to replace the normal ionic and pH balance in the oral cavity. Neutrasal® also maintains moistness in the oral cavity. It relieves diffuse dryness and fissuring of the oral mucosa, as well as painful tongue conditions due to hyposalivation.
Neutrasal® facilitates chewing and speaking; loosens tough mucus: prevents mucous membranes from sticking together; and improves adherence of dentures.
Additionally, Neutrasal® can be used as an adjunct to standard oral care for relieving the discomfort associated with oral mucositis that may be caused by high dose chemotherapy or radiation. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Neutrasal® is a comprised of calcium chloride, sodium phosphate and sodium bicarbonate plus inactive ingredients. When Neutrasal® is dissolved in normal tap water, the water becomes supersaturated with both calcium and phosphate ions.
Syloid, an inactive ingredient in Neutrasal, is an amorphous silica that is recommended for free-flow and anti-caking for hydrogscopic food powders, industrial powders and other applications (pharmaceuticals) where humidity must be kept to a minimum.
2
| Product | Method of
Use | Applications
per day | Type of
Product | Presentation |
|------------|--------------------------------|-------------------------------------------------------|-------------------------|--------------|
| Neutrasal® | Dissolve
Powder in
Water | 2-10 as
directed by
physician and
indication | Electrolyte
Solution | Non-Sterile |
F. Indications for Use:
(OTC): Neutrasal® is indicated for the dryness of the mouth (hyposalivation, xerostomia)
(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.
(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome
G. Manufacturing
Neutrasal® will be manufactured according to product specifications and under the guidelines of current Good Manufacturing Practices (cGMP). Bartor Pharmacal, owner, is a cGMP-approved manufacturer.
3
Risk analysis has been performed to identify possible failure mode during manufacturing. Manufacturing controls have been developed and implement to address the identified risks factors based on the criticality of failure mode. All established GMPs will assure that device manufactured at Bartor Pharmacal meets all established specifications prior to release and is safe and effective for its intended use.
H. Summary of Non-Clinical Testing: Performance
The Performance Testing of Neutrasal® included the assessment of the physical properties of Neutrasal® and its ability to achieve its intended use. Bench testing was completed by Scientech Laboratories, Inc., an FDA-approved analytical laboratory testing service as well internal testing done by Bartor Pharmacal. The following bench tests were performed:
- . pH
- Dissolution Tests .
- Activity Testing of Supersaturated State ●
- Content Testing of Active Ingredients .
l. Biocompatibility testing
Neutrasal® is technologically identical to the 510(k)-approved product predicate with the exception that Neutrasal® is in a powder from to be reconstituted in water rather than being a pre-made oral solution.
J. GRAS Listing of Ingredients
The EAFUS list of substances contains ingredients added directly to food or medications that FDA has either approved as food additives or listed or affirmed as GRAS (generally recognized as safe). All ingredients contained in Neutrasal® are EAFUS approved food additives labeled as
4
GRAS. Only USP-approved chemicals, with validation, will be used during the manufacturing of Neutrasal®.
K. Other Information
Effervescence has proved it utility as an oral drug delivery system that offers advantages to other forms of drug delivery. Neutrasal® offers more portability because it is more easily transported than liquid medication because no water is added until the product is ready to use. Additionally, Neutrasal® offers improved penetration in to the oral mucosa because of the effervescent formulation enhancement of sodium bicarbonate.
Substantial Equivalence Conclusion L.
The indications of use, technological properties, performance testing for Neutrasal® (Powder for supersaturated calcium phosphate rinse) are substantially equivalent to those of the predicate device Caphosol (supersaturated calcium phosphate rinse). They both share the same labeling and intended uses. Thus, Neutrasal® and Caphosol are substantially equivalent.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus, a symbol associated with medicine and healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Bartor Pharmacal Company, Incorporated C/O Mr. Edward D. Kobus Invado Pharmaceuticals 25 Ravenna Drive Pomona, New York 10970
Re: K091718
SEP - 2 2009
Trade/Device Name: Neutrasal® Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LFD Dated: June 19, 2009 Received: June 23, 2009
Dear Mr. Kobus:
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.
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.
6
Page 2- Mr. Kobus
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/Reporta Problem/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,
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infusion Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number (if known): K091718
Device Name:
Neutrasal®
Indications for Use:
(OTC): Neutrasal® is indicated for the dryness of the mouth (hyposalivation, xerostomia)
(OTC): Neutrasal® is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholinergic agents that suppress salivary secretion.
(OTC): Neutrasal® may be used as part of an oral hygiene program for patients with dry mouth. Neutrasal® also provides intensive hygiene of the oral cavity.
(Rx): Neutrasal® is also indicated as an adjunct to standard oral care in relieving the discomfort associated with oral mucositis that may be caused by radiation.or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
(Rx): Neutrasal® may be used for relief of dryness of the oral mucosa when hyposalivation results from the following: surgery, radiotherapy near the salivary glands, chemotherapy, infection or dysfunction of the salivary glands; fever; emotional factors such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Kee Murley for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091718