(223 days)
Not Found
Not Found
No
The summary describes a physical acrylic device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as being used in the "treatment of medically diagnosed migraine pain" and for "relieving bruxism and temporomandibular joint syndrome," which indicates a therapeutic purpose.
No
Explanation: The device is described as an acrylic splint used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states it is an "acrylic device," indicating a physical hardware component.
Based on the provided information, the DSG Relaxer Splint is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- DSG Relaxer Splint Description: The description clearly states it is an "acrylic device" used for treating migraine pain, tension-type headaches, bruxism, and TMJ syndrome. It is a physical device applied to the body, not a test performed on a sample.
- Lack of IVD Indicators: The provided text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection of biomarkers or analytes.
- Use of reagents or assays.
- Laboratory testing.
Therefore, the DSG Relaxer Splint falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DSG Relaxer Splint is an acrylic device to be used in the treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches and relieving bruxism and temporomandibular joint syndrome through the reduction of trigeminally innervated muscular activity.
Product codes
MQC
Device Description
The DSG Relaxer Splint is an acrylic device to be used in the treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches and relieving bruxism and temporomandibular joint syndrome through the reduction of trigeminally innervated muscular activity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol that resembles a stylized caduceus, with three wavy lines representing the staff and a head-like shape at the top.
Public Health Service
MAR 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sentage Corporation D/B/A/ Dental Services Group C/O Mr. G. Brent Connor Robins, Kaplan, Miller & Ciresi L.L.P. 1801 K Street, N.W., Suite 1200 Washington, D.C. 20006-1307
Re: K022627
Trade/Device Name: DSG Relaxer Splint Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MQC Dated: December 20, 2002 Received: December 20, 2002
Dear Mr. Connor:
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.
1
Page 2 - Mr. Connor
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
Sincerely yours.
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
2
510(k) Number (if known):_K022627
Device Name: DSG Relaxer Splint
Indications For Use:
The DSG Relaxer Splint is an acrylic device to be used in the treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches and relieving bruxism and temporomandibular joint syndrome through the reduction of trigeminally innervated muscular activity.
(No applicable mandatory performance standards or special controls exist for this device.)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Ken Mulvey for MSD
Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
Ward 45637900.1
510(k) Number. K022621