(43 days)
The Med-Lok™ Safety Needle device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Med-Lok™ Safety Needles
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Med-Lok Safety Needle." This document does not contain the kind of information needed to answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based medical device.
The letter confirms substantial equivalence for a physical medical device (a safety needle) based on prior predicate devices, and refers to general controls and regulations. It does not describe any performance studies involving algorithms, AI, or comparative effectiveness with human readers.
Therefore, I cannot provide an answer based on the given input for the following reasons:
- No acceptance criteria for an AI/algorithm: The document does not discuss performance metrics or acceptance thresholds for an AI-powered device.
- No study details: There are no descriptions of a study (clinical or otherwise) that would assess the performance of an algorithm.
- No sample sizes, data provenance, or ground truth information: These details are specific to algorithm validation studies, which are not present in this document.
- No mention of experts or adjudication: These are relevant to establishing ground truth for AI studies, not for the substantial equivalence of a physical needle.
- No MRMC study or standalone performance: These are specific types of studies for AI/algorithm performance that are not mentioned.
The input document is about the regulatory clearance of a physical medical device, not about the validation of an AI/algorithm-based device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
STA-MED, LLC C/O Mr. Randell May President Randall May & Associates 4932 East Holbrook Street Anaheim, California 92807
FFB -8 201
Re: K103781
Trade/Device Name: Med-Lok Safety Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 24, 2011 Received: January 26, 2011
Dear Mr. May:
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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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/CDRHQffices/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,
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 Canter for Devices and
Radiological Health
Enclosure
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Special 510(k) — Med-Lok™ Safety Needles 22 December 2010
Attachment 7
Indications for Use
510(k) Number (if known): Device Name: Med-Lok Safety Needle Indications for Use: The Med-Lok™ Safety Needle device is intended for aspirations and injections of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Prescription Use _ X AND/OR Over-The-Counter Use _
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rell C. Chyp 2/7/11
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K103781
§ 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).