(75 days)
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No
The summary describes a disposable prophy angle for polishing teeth, a purely mechanical function, and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML medical devices.
No
The device is used to polish tooth surfaces during a prophylaxis treatment, which is a preventive procedure, not a therapeutic one aimed at treating a disease or condition.
No
Explanation: The device is described as a "Disposable Prophy Angle" used "to polish the tooth surfaces of a patient" during a "prophylaxis treatment." This function is for cleaning and polishing, not for detecting, identifying, or monitoring a disease or condition.
No
The device description and intended use clearly indicate a physical, disposable prophy angle used for polishing teeth, which is a hardware device.
Based on the provided information, the SplatrFree Swangle 360 Disposable Prophy Angle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "polish the tooth surfaces of a patient during a prophylaxis treatment." This is a direct treatment applied to the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Anatomical Site: The anatomical site is "tooth surfaces," which are part of the patient's body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the SplatrFree Swangle 360 Disposable Prophy Angle is a medical device used for a dental procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient.
Product codes
EFS
Device Description
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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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§ 872.6510 Oral irrigation unit.
(a)
Identification. An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1
Ms. Kim Sullivan VP of Regulatory and Research Smart Practice 3400 East McDowell Road Phoenix, Arizona 85008-7899
Re: K023232
Trade/Device Name: SplatrFree Swangle 360 Disposable Prophy Angle Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFS Dated: September 23, 2002 Received: September 27, 2002
Dear Ms. Sullivan:
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. sullivan
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. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Petru Carinte for
Timothy A. Ulatowski 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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Statement of Indications for Use
The SplatrFree Swangle 360 Disposable Prophy Angle is to be used during a prophylaxis treatment to polish the tooth surfaces of a patient. .
Susan Rinn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K023232