(510 days)
MORPHEUS is an instrument intended solely to be used for anesthetic applications inside the oral region in human beings by dentistry professionals certified by local laws.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a device named "Morpheus," which is a cartridge syringe intended for anesthetic applications in dentistry. This document does not describe any acceptance criteria or a study that proves the device meets specific performance criteria.
The information typically requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is related to the evaluation of AI/ML or diagnostic devices. The "Morpheus" device, as described, is a cartridge syringe, which is a mechanical device, not a diagnostic or AI-powered one. Therefore, the type of performance evaluation and acceptance criteria for such a device would focus on aspects like materials biocompatibility, sterility, dimensions, force required for delivery, leakage, and other physical/mechanical properties, rather than diagnostic accuracy metrics.
The FDA letter essentially states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness. This determination is based on the information provided in the 510(k) submission, which would include testing results relevant to the device's function as a cartridge syringe, but these specific details are not present in the provided FDA letter.
Therefore, I cannot provide the requested information based on the given input. The document does not contain the study details, acceptance criteria, or performance metrics typically associated with the evaluation of AI or diagnostic devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Meibach Tech Limited C/O Mr. Stuart Lee Friedel Davis & Gilbert L.L.P. 1740 Broadway New York, New York 10019
DEC 31 2009
Re: K082249
Trade/Device Name: Morpheus Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: December 23, 2009 Received: December 24, 2009
Dear Mr. Friedel:
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 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- Mr. Friedel
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/Safety/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, a
for
Anthony D. 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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Indications for Use
510(k) Number (if known): K082249
Device Name: MORPHEUS
Indications For Use: MORPHEUS is an instrument intended solely to be used for anesthetic applications inside the oral region in human beings by dentistry professionals certified by local laws.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
841
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K082249
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special 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.