(62 days)
Not Found
Not Found
No
The description focuses on a mechanical sharps management system and does not mention any computational or data-driven capabilities.
No
The device is described as a "sharps management system" for safety, not for treating a medical condition.
No
The device is described as a "sharps management system" for needle encapsulation, not for diagnosing medical conditions.
No
The device description clearly describes a physical sharps management system that encapsulates needles, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "sharps management system that fully encapsulates the needle of a luce-look syringe." This is a physical device designed to prevent needlestick injuries after a syringe has been used.
- Device Description: The description reinforces its function as a physical containment system for used needles and syringes.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease or impairment. IVDs are used to perform tests on biological samples (like blood, urine, tissue, etc.) to gain diagnostic information.
The Needle Guard is a safety device for handling contaminated sharps, not a diagnostic tool.
N/A
Intended Use / Indications for Use
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luer-lock syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and needles up to and including a length of one and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of contamination. The NEEDLE GUARD can be disposed, along with the syringe, into a large sharps container and/or red biohazard bag.
Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard.
The device is for use by health care professionals in hospitals and private practices, research laboratories, specialized medicine applications, clinics, nursing homes, home care HIV/AIDS and needle exchange programs, dental offices, veterinarians, mortuaries.
Product codes
FMI
Device Description
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luer-lock syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and needles up to and including a length of one and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of contamination. The NEEDLE GUARD can be disposed, along with the syringe, into a large sharps container and/or red biohazard bag.
Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals in hospitals and private practices, research laboratories, specialized medicine applications, clinics, nursing homes, home care HIV/AIDS and needle exchange programs, dental offices, veterinarians, mortuaries.
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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes above a wavy line.
Public Health Service
DEC 22 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PDMP, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue SE Grand Rapids, Michigan 49548
Re: K042907
Trade/Device Name: Needle Guard Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 10, 2004 Received: December 13, 2004
Dear Mr. Devine:
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 - Mr. Devine
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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runser
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
2
Indications for Use
510(k) Number (if known): K042907
Device Name: Needle Guard
Indications for Use:
NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and NEEDLE GUARD is an morvidual set occapsulates the needle of a luce-look syringe.
syringe sharps management system that fully encapsulates the needle luce look syringe sharps management system that tally encaple syringe body or needle lucr-lock. The Needle Guard Will accept any standard disposations any syringe without a mechanical safety Standard syrings and needle mer-lock are details and necdles up to and including device and one-half inches (1 ½"). It is a one-handed procedure that is used a length of one and one-half ments (1 77 ). Tr a Cities of procedure. The NEEDLE GUARD can be immediately atter the use of the syrings at polices promote of promotion and syringes, into a large sharps container and/or red biohazard bag.
Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inscrted into Needle Guard.
The device is for use by health care professionals in hospitals and private practices research a laboratories, specialized medicines applications, clinics, nursing homes, home care and a laboratories, specialized medically applications, childes, thereases and exchange programs, dental offices, veterinarians, mortuaries.
Caution: U.S.A. law restricts this device to sale by or on the order of a physician.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
in Ome
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(Civision Sian-Off) Civision of Anesthesiology, General Hospital, Infection Control Denta, Devices
:10(k) Number_ky423947