(209 days)
Not Found
None
No
The summary describes a device for cleaning dental instruments and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or validation.
No.
The device is described as being for "internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments," indicating it is for maintaining instruments, not for direct therapeutic use on a patient.
No
The device, Care3 Plus, is intended for internal cleaning and maintenance of rotating dental and surgical instruments. It does not perform any diagnostic function but rather a maintenance function for medical devices.
No
The device description and intended use clearly indicate a device for cleaning and maintaining physical dental and surgical instruments, implying a hardware component is involved in the cleaning process. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments." This describes a process for maintaining medical devices, not for performing tests on biological samples to diagnose diseases or conditions.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly intended for the maintenance of dental and surgical instruments, which falls under the category of medical device maintenance equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Care3 Plus is intended for internal cleaning, i e , purging of old lubricant, for the maintenance of rotating dental and surgical instruments
NOTE Care3 Plus should be used with only pre-cleaned dental handpieces and before they are sterilized
Nakanishi proposes that Care3 Plus carry the following label
CAUTION Federal (US) law restricts the use of this device to licensed professionals
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes
EFB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nakanishi Incorporated C/O Mr Keith A Barritt Fish & Richardson P C 1425 K Street, North West, 11th Floor Washington, DC 20005
JAN 21 2009
K081811 Trade/Device Name Care3 Plus Regulation Number 21 CFR 872 4200 Regulation Name Dental Handpiece and Accessories Regulatory Class I Product Code EFB Dated December 19, 2008 Received December 22, 2008
Dear Mi Barntt
Re
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 - Mi Barritt
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 himited 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premailed notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometice's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISION of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Aristoteles de Anima fer
Ginette Y Michaud, M D Acting Director DIVISION of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) _
Device Name Care3 Plus
Indications For Use
Care3 Plus is intended for internal cleaning, i e , purging of old lubricant, for the maintenance of rotating dental and surgical instruments
NOTE Care3 Plus should be used with only pre-cleaned dental handpieces and before they are sterilized
Nakanishi proposes that Care3 Plus carry the following label
CAUTION Federal (US) law restricts the use of this device to licensed professionals
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Kuase
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
4-1
510(k) Number KCS 181