(334 days)
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No
The summary does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML medical devices. The device is described as a "self-contained mobile dental cart" for general dentistry and endodontics, which are functions not inherently requiring AI/ML.
No
The device is a mobile dental cart used for general dentistry and endodontic applications, which are typically procedures and not directly therapeutic in nature as defined by medical devices intended to treat or cure a disease or condition. While dental work can alleviate pain or improve health, the device itself is a tool for the practitioner, not a direct therapeutic agent.
No
The description states the device is "used for general dentistry and endodontic applications" and is a "mobile dental cart." There is no indication that it is primarily used to diagnose diseases or conditions, but rather to facilitate dental procedures.
No
The device is described as a "self-contained mobile dental cart," which is a physical piece of equipment, not software.
Based on the provided information, the AMC-20 Mobile Dental Cart is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "general dentistry and endodontic applications." This describes procedures performed directly on a patient, not tests performed on samples taken from a patient outside the body.
- Device Description: It's described as a "self-contained mobile dental cart," which is a piece of equipment used in a clinical setting for dental procedures.
- 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 based on laboratory tests
- Using reagents or test kits
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The AMC-20, as described, is a tool used for performing dental procedures directly on the patient.
N/A
Intended Use / Indications for Use
The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.
Product codes
EIA
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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§ 872.6640 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 wings, body, and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Cherie A. Tregoning Regulatory Affairs Associate Aseptico, Incorporated 8333 216th Street, SE Woodinville, Washington 98072
APR 1 1 201
Re: K101332
Trade/Device Name: AMC-20 Mobile Dental Cart Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 22, 2011 Received: March 24, 2011
Dear Ms. Tregoning:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Tregoning
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Wh for
Anthony Watson, B.S., M.S., M.B.A. 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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Image /page/2/Picture/0 description: The image shows the word "ASEPTICO" in a stylized font. The first letter "A" is connected to a spiral-shaped design on the left side. A line extends from the right side of the word, adding a decorative element to the overall design.
Aseptico Inc., 8333 216th Street SE, Woodinville, WA 98072 U.S.A. Phone: 425.487.3157 FAX: 360.668.8722
Indications for Use
510(k) Number (if known): K101332
Device Name: AMC-20 Mobile Dental Cart
Indications for Use:
The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Susan Renne
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number 1873327