(595 days)
THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS. =THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=
EXEL SECURE TOUCH SAFETY SYRINGE
This document is a 510(k) clearance letter from the FDA for a medical device called the "EXEL Secure Touch Safety Syringe." It does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, or any of the other specific details requested in your prompt regarding artificial intelligence (AI) and its performance.
The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA). This implies that its safety and effectiveness are established through its similarity to existing, approved devices, rather than through a standalone study with performance metrics in the way your prompt describes for an AI-powered device.
Therefore, I cannot provide the requested information from this document. The information you are looking for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in a detailed clinical study report or a 510(k) summary, which is not provided in this regulatory letter.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2003
Mr. Armand Hamid Director Medical Products Division P.O. Box 3194 Culver City, California 90231-3194
Re: K011754
Trade/Device Name: EXEL Secure Touch Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: October 9, 2002 Received: November 21, 2002
Dear Mr. Hamid:
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 - Mr. Hamid
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) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Russer
Susan Runner, DDS, MA Interim 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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Page 1 _ of _ 1 _
510(k) Number (if known):
Device Name: EXEL SECURE TOUCH SAFETY SYRINGE
Indications For Use:
THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS.
=THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Retuar Ciccente
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use / (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).