(77 days)
This Device is a Safety Hypodermic Syringe for injection of medicine to patients. This device aids in the prevention of needlestick injuries.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a safety syringe, not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.
Specifically, the document:
- Does not describe acceptance criteria for an AI/ML device.
- Does not report device performance against any such criteria.
- Does not detail any study involving AI/ML.
- Does not mention sample sizes, data provenance, expert qualifications, or adjudication methods.
- Does not refer to MRMC comparative effectiveness studies or standalone algorithm performance.
- Does not discuss ground truth types or how ground truth was established.
- Does not specify training set sizes.
The document is a regulatory approval for a physical medical device (a safety syringe) based on substantial equivalence to a predicate device, as opposed to performance against specific efficacy or accuracy metrics typically associated with AI/ML device studies.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
OCT 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Armand Hamid Director Exelint International Company 5840 West Centinela Avenue Los Angeles, California 90045
Re: K052103
Trade/Device Name: EXEL SecureTouch II Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: July 9, 2005 Received: August 3, 2005
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 Cosmotic 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 cither class II (Spccial 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 mean that + DTT has made statutes and regulations administered by other Federal agencies. or the Fer of any I eachar the Act's requirements, including, but not limited to: registration 1 od inting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (2) - 21 results in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic 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 promaries hourselied 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), n you desire speed to the office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Sudie y. Michael Davis
Chiu Lin, Ph.D. 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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Indications For Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: EXEL SecureTouch II Safety Syringe
Indications For Use:
This Device is a Safety Hypodermic Syringe for injection of medicine to patients. = This device aids in the prevention of needlestick injuries=
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antin D. m
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
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510(k) Number_ KUS219
§ 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).