SALINUM, ORCLAIR

• K Number: K024148
• Device Name: SALINUM, ORCLAIR
• Manufacturer: SINCLAIR PHARMACEUTICALS, LTD.
• Date Cleared: 2003-09-15 ( 273 days)
• Product Code: LFD
• Regulation Number: N/A
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K981693 , K991938
• Predicate For: K041563 , K051812 , K061331 , K062653 , K071617 , K072306 , K163476

Intended Use

Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging.

Over the counter Labeling stipulates that ORACLAIR has been formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

Device Description

SALINUM® / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysaccharides) from linseed that have lubricating and moistening properties. The product is preserved, buffered and packed in white PET (polyethylene terephthalate) bottles of various sizes with polypropylene disc top caps or single dose (2ml) polythene pipettes in strips of 10 packed in a cardboard carton.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the format requested.

The document is a 510(k) summary for a medical device called SALINUM® / ORACLAIR, an artificial saliva intended for the relief of dry mouth. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria Table and Reported Device Performance: This information is not present. The submission states, "Functional and performance testing has been conducted to assess the safety and effectiveness of SALINUM® and all results are satisfactory." However, it does not specify what those criteria were or detail the performance metrics.
2. Sample Size for Test Set and Data Provenance: No details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.
3. Number of Experts and Qualifications for Ground Truth: Since no performance study against a ground truth is described, there is no mention of experts or their qualifications.
4. Adjudication Method: Not applicable as no adjudication process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study, or any comparison to human reader performance, is mentioned.
6. Standalone Performance Study: While "functional and performance testing" is mentioned, no specific standalone algorithm performance study with detailed results, metrics, or methodology is provided. The submission primarily focuses on equivalence.
7. Type of Ground Truth Used: No ground truth is described for a performance study.
8. Sample Size for Training Set: This is not applicable as SALINUM® / ORACLAIR is a pharmaceutical product (saliva substitute), not an AI/algorithm-based device that would require training data.
9. How Ground Truth for Training Set Was Established: Not applicable for the reasons stated above.

The document is a regulatory submission for a physical medical device (oral solution), not an AI/software device that would typically involve the type of performance evaluation outlined in your request. The "Tests and Conclusions" section simply states that "functional and performance testing has been conducted... and all results are satisfactory," without providing details of these tests, criteria, or results.

Summary

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K024148

Attachment 7 510(k) Summary

December 12, 2002

1. Submission Applicant & Correspondent: Sinclair Pharmaceuticals Limited Name: Address:

Borough Road Godalming Surrey GU7 2AB United Kingdom

Phone No.: [phone] Contact Person: Denise Swift, Director of Regulatory Affairs

2. Name of Device:

SALINUM® OR ORACLAIR

Trade/Proprietary/Model Name: Common or Usual Name: Classification Names:

SALINUM® OR ORACLAIR Dental: Saliva, artificial Dental: Saliva, artificial

• 3. Devices to Which New Device is Substantially Equivalent:
     Gebauer Company: Salivart cleared in 510(k) K981693 and Inpharma AB: Caphosol cleared in 510(k) K991938
• 4. Device Description:
     SALINUM® / ORACLAIR is an oral saliva substitute which contains gel-forming substances (polysaccharides) from linseed that have lubricating and moistening properties. The product is preserved, buffered and packed in white PET (polyethylene terephthalate) bottles of various sizes with polypropylene disc top caps or single dose (2ml) polythene pipettes in strips of 10 packed in a cardboard carton.
• 5. Intended Use of the Device:
     Under the supervision of a healthcare professional, SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging.

Over the counter Labeling stipulates that ORACLAIR has been formulated for the relief of dry

Image /page/0/Picture/19 description: The image shows the text "SEP 1 5 2003" in the upper left corner. Below this is the Sinclair logo. The word "CONFIDENTIAL" is written in a large font at the bottom right of the image.

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CONFIDENTIAL

mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by disease, stress, aging or medication.

• 6. Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
     SALINUM® / ORACLAIR has the same intended/indications for use as the predicate devices Gebauer Company Salivart and Inpharma AB Caphosol.

ProductName	Salinum® /Oraclair	Salivart	Caphosol
Method ofUse	Ready to use	Ready to use	Mix solutionsA & B
# ofapplicationsper day	Take asneeded	Take as needed	Take as needed
Claim	Symptomatictreatment ofxerostomia.	Symptomatictreatment ofxerostomia.	Symptomatictreatment ofxerostomia.
Area of Use	Oral cavity	Oral cavity	Oral cavity
Disease State	Xerostomia	Xerostomia	Xerostomia
Type ofProduct	Solution	Solution	Solution
Presentation	Non Sterile	Non Sterile	Non Sterile

7. Tests and Conclusions:

Functional and performance testing has been conducted to assess the safety and effectiveness of SALINUM® and all results are satisfactory.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2003

Ms. Denise Swift Director of Regulatory Affairs Sinclair Pharmaceuticals Limited Borough Road Godalming Surrey GU7 2AB UNITED KINGDOM

Re: K024148

Trade/Device Name: Salinum® or Oraclair Regulation Number: None Regulation Name: Regulatory Class: Unclassified Product Code: LFD Dated: March 4, 2003 Received: March 6, 2003

Dear Ms. Swift:

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 - Ms. Swift

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runnar

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

Attachment 3 Indications for Use Statement KOZ4148 510(k) Number (if known) SALINUM® / ORACLAIR Device Name Rx labeling: Indications for Use the supervision of a healthcare professional, Under SALINUM® has been formulated for the relief of chronic and temporary xerostomia (dry mouth), which may be a result of disease, medication, oncology therapy, stress or aging. Over the counter labelling ORACLAIR has been formulated for the relief of dry mouth symptoms such as difficulties in swallowing, speech and changes in taste. These symptoms may be brought on by

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K024148

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

disease, stress, aging or medication.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (per 21 CFR 801.109) \

Over-The Counter Use

Regulation Number and Section

N/A