(80 days)
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No
The 510(k) summary describes a simple air and water spray syringe for dental procedures and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device delivers air and water spray during dental procedures, which is a supportive function rather than a direct therapeutic intervention. It helps facilitate procedures but doesn't treat a condition itself.
No
Explanation: The device is described as an air and water spray syringe intended to deliver air and water spray during dental procedures, which are operational functions, not diagnostic ones. There is no mention of it being used to identify or analyze medical conditions or diseases.
No
The device description explicitly states it is an "air and water spray syringe assembled as a dental handpiece," which is a physical hardware device.
Based on the provided information, the Princess Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver air and water spray during dental procedures." This is a direct interaction with the patient's mouth during a procedure, not the examination of specimens (like blood, urine, tissue) outside the body.
- Device Description: The description reinforces its function as a "dental handpiece" for delivering air and water spray.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing information about a patient's health status based on specimen analysis.
- Using reagents or assays.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Princess Syringe's function is purely mechanical and procedural within the dental setting.
N/A
Intended Use / Indications for Use
The Princess Syringe is an air and water spray syringe assembled as a dental handpiece. It is intended to deliver air and water during dental procedures.
Product codes
EIA
Device Description
The Princess Syringe is an air and water spray syringe assembled as a dental handpiece.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
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Image /page/0/Picture/2 description: The image shows a logo or emblem, possibly for a department or organization. On the left, there's a stylized graphic that resembles a series of curved lines or waves, creating an abstract design. To the right of this graphic, the word "DEPARTMENT" is printed in bold, uppercase letters. The overall impression is that of an official or institutional symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1008 MAY
SODEXCO ·C/O Mr. Gaylen Cox President MEDICAL INNOVATIONS, Incorporated 1450 West 8040 South Sandy, Utah 84088
Re : K980577 Princess Syringe Trade Name: Requlatory Class: I Product Code: EIA Dated: February 12, 1998 February 17, 1998 Received:
Dear Mr. Cox:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Cox
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/4 description: The image shows the logo and contact information for Medical Innovations. The logo features a stylized letter M with a human-like figure incorporated into its design. Below the logo, the text reads "MEDICAL INNOVATIONS" followed by the address "1450 West 8040 South, West Jordan, UT 84088" and the phone numbers "801-255-4677" and "(800) 826-5650".
PAX 001-568-9239
510(k) for Princess Syringe
Statement of Use
The Princess Syringe is an air and water spray syringe assembled as a dental
, and the same of the same in to ded use. It is intended to deliver The Princess Syringe is an all any watch spies of this intended to deliver
handpiece. This device has only one as of the orgal causiv during dental handpiece. I his device has only one michael as a more as a cavity during dental procedures.
SHARON RIVERA
(Division Sign-Off)
(Division of Dental, Infection Control.
and General Hospital, Infection Control, and General Hospital, Infection and General Hospital Concession of 510(k) Number_ K 9)