(257 days)
Caph sol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by and increating or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is assoc iated with an amelioration of pain.
Capt osol may be used for relief of dryness of the oral mucosa when hyposalivation results from the f )llowing: surgery, radiotherapy near the salivary glands, chemotherapy; infection of dysf inction of the salivary glands; inflammation of the mouth or throat; fever; emotional fact rs such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome; and Bell's Pals /.
Cap 10sol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atro ine or other anticholinergic agents that suppress salivary secretion.
It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.
Caphosol is an clectrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue and throat. Caphosol 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. Patients having this condition are also prome to dental caries and candidal infections.
Caphosol is a partial substitute for natural saliva. Caphosol facilitates chewing and speaking; loosens tough mucus; prevent mucous membrancs from sticking together; helps remove nasal crust and relieve nasal soreness; improves adherence of dentures, and also relieves bad taste. The purpose of this premarket notification is to expand the claims for Caphosol to allow Caphosol to be marketed as an adjunct to standard oral care for treating the mucositis that may be mansed by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol A) and a calcium solution (Caphosol B) which when both ampoule solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions. The solution after mixing the contents of solutions A and B contains:
| Ingredient: | % w/w |
|---|---|
| Dibasic Sodium Phosphate | 0.032 |
| Monobasic Sodium Phosphate | 0.009 |
| Calcium Chloride | 0.052 |
| Sodium Chloride | 0.569 |
| Purified Water | qs ad |
The provided text is for a 510(k) premarket notification for a medical device (Caphosol Artificial Saliva) and describes its intended use, comparison to a predicate device, and the FDA's substantial equivalence determination. It does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a regulatory submission for a device, which typically focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting new clinical study data with performance criteria. The FDA letter explicitly states: "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..." This indicates that the clearance is based on similarity to an existing device, not on new clinical performance data against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. All the fields regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth are not present in the provided document.
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NOV 2 5 2003
Summary of Safety and Effectiveness
Inpharma, AS Caphosol Artificial Saliva
-
- Sponsor's Name
Inpharma As Konnerudgt 27 4035 Drammen Norway
- Sponsor's Name
- US Agent
Bruce R. Manning New England Biomedical Research, Inc. 96 West Main Street Northboro, MA 01532
-
- Date Prepared
November 19, 2003
- Date Prepared
-
- Device Name
Caphosol Artificial Saliva (Additional Indication)
- Device Name
5. "dentification of Logally Marketed Device
Caphosol Artificial Saliva K991938
-
- Device Description
Caphosol is an clectrolyte solution resembling human saliva, designed in part to replace the normal ionic and pH balance in the oral cavity. It is intended as a mouth rinse to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue and throat. Caphosol 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. Patients having this condition are also prome to dental caries and candidal infections.
- Device Description
Caphosol is a partial substitute for natural saliva. Caphosol facilitates chewing and speaking; loosens tough mucus; prevent mucous membrancs from sticking together; helps remove nasal crust and relieve nasal soreness; improves adherence
{1}------------------------------------------------
of dentures, and also relieves bad taste. The purpose of this premarket notification is to expand the claims for Caphosol to allow Caphosol to be marketed as an adjunct to standard oral care for treating the mucositis that may be mansed by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Caphosol is a preparation comprising two separately packaged aqueous solutions, a phosphate solution (Caphosol A) and a calcium solution (Caphosol B) which when both ampoule solutions are combined in equal volumes form a solution supersaturated with respect to both calcium and phosphate ions. The solution after mixing the contents of solutions A and B contains:
| Ingredient: | % w/w |
|---|---|
| Dibasic Sodium Phosphate | 0.032 |
| Monobasic Sodium Phosphate | 0.009 |
| Calcium Chloride | 0.052 |
| Sodium Chloride | 0.569 |
| Purified Water | qs ad |
7. Intended Use
Caphosol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions is temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.
Caphosol may be used for 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; inflammation of the mouth or throat; fever; emotional factors such as fear or anxiety: obstruction of the salivary ducts; Sjögren's syndrome; and Bell's Palsy,
Caphosol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atropine or other anticholineryic agents that suppress salivary secretion.
It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.
8. Comparison of Technological Charactcristics
The current device is identical to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2003
Inpharma A.S. C/O Mr. Bruce Manning President New England Biomedical Research, Incorporated 96 West Main Street P.O. Box 809 Northborough, Massachusetts 01532
Re: K030802
Trade/Device Name: Caphosol Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LFD Dated: August 26, 2003 Received: August 27, 2003
Dear Mr. Manning:
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 such 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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Page 2 - Mr. Manning
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
4.1
Sincerely yours, ·
Simona Buono
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k · Number (if known): K030802 Device Name: Caphoso!
Indications For Use:
Caph sol is indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause and regardless of whether the conditions are temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by and increating or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is assoc iated with an amelioration of pain.
Capt osol may be used for relief of dryness of the oral mucosa when hyposalivation results from the f )llowing: surgery, radiotherapy near the salivary glands, chemotherapy; infection of dysf inction of the salivary glands; inflammation of the mouth or throat; fever; emotional fact rs such as fear or anxiety; obstruction of the salivary ducts; Sjögren's syndrome; and Bell's Pals /.
Cap 10sol is also indicated for dryness of the oral mucosa due to drugs such as antihistamines or atro ine or other anticholinergic agents that suppress salivary secretion.
It may be used as part of an oral hygiene program for patients with dry mouth. Caphosol provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste and to relieve offensive nasal discharge and crusting.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
G
| Prescription Use | OR | Over-The-Counter Use | |||
|---|---|---|---|---|---|
| (Per 21 CFR 801.109) | Robert S Betz for Dr. Susan Junker | ||||
| (Division Sign-Off) | |||||
| Division of Anesthesiology, General Hospital, | |||||
| Infection Control, Dental Devices | |||||
| 510(k) Number | K030802 |
N/A