(45 days)
Not Found
Not Found
No
The summary describes a standard hypodermic needle and contains no mention of AI, ML, or related concepts.
No
The device is a hypodermic needle intended for injecting or withdrawing fluids, which are procedural actions, not therapeutic outcomes.
No
Explanation: The device, a hypodermic needle, is used for injecting or withdrawing fluids, which are procedures, not diagnostic activities.
No
The device is a hypodermic needle, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." This describes a direct interaction with the body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living organism) to provide information for diagnostic, monitoring, or compatibility purposes. The description of this device does not involve the analysis of such specimens.
Therefore, a hypodermic needle used for injection or withdrawal of fluids from the body is considered a general medical device, not an IVD.
N/A
Intended Use / Indications for Use
Medline Disposable Sterile Hypodermic Needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin
Product codes
FMI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
parts of the body below the surface of the skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three ribbons flowing from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 3 2006
Ms. Lara N. Simmons Corporate Director, Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
Re: K062984
Trade/Device Name: Medline Hypodermic Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 27, 2006 Received: September 29, 2006
Dear Ms. Simmons:
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.
1
Page 2 - Ms. Simmons
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Salitte H. Michieu Omd.
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
Enclosure
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Page Page 2 of
510(k) Number (if known): ____________________
Device Name: Medline Hypodermic Needles Indications for Use:
Medline Disposable Sterile Hypodermic Needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BLOEW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 12-96)
Chm Vm
- 1 a of Anesthesiology, General Hospital, Jon Contici, Dental Devices
大462984