(150 days)
Not Found
Not Found
No
The summary describes a physical container for sharps disposal and makes no mention of AI or ML technology.
No
The device is a container for disposing of contaminated medical sharps and does not provide any therapeutic benefit to a patient.
No
Explanation: The device is a sharps container used for the disposal of contaminated medical sharps. Its purpose is containment and transport, not diagnosis.
No
The device description clearly states it is an injection-molded polypropylene container with a lid, indicating it is a physical hardware 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 provide a receptacle for used medical sharps and for their transport to disposal. This is a physical containment and disposal function, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a container with a lid. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
Therefore, this device falls under the category of a medical device for the safe handling and disposal of medical waste, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
Product codes
FMI
Device Description
Our Vertical Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a tabs down, leakresistant, polypropylene lid. The lid has a chimney-type opening into which the sharps are dropped vertically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
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
K970398 K970398 ATTACHMENT 5, Rev. 1 JUL - 3 1997
510 (k) SUMMARY
THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990.
510 (k) Summary of Safety & Efficacy Vertical Entry Sharps Container
Custom Medical Plastics, Inc. 11811 Calhoun Road Submitted By: Omaha, NE 68122 (402) 691-2855
Daniel R. Brown, President Contact:
December 24, 1996 (Amended April 4, 1997) Date Prepared:
Our Vertical Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a tabs down, leakresistant, polypropylene lid. The lid has a chimney-type opening into which the sharps are dropped vertically.
Sharps Containers are classified as a Class II accessory to a hypodermic needle (21 CFR Section 880.5570); Panel 80 FMI.
Our Vertical Entry Sharps Container is substantially equivalent to Vertical Entry Sharps Containers manufactured by Sage Products Inc. and Sherwood Medical. These containers are all made of polypropylene by the injection molding process. They feature a chimney-type opening which better protects user's fingers when depositing sharps.
Our Vertical Entry Sharps Container provides a receptacle for used, contaminated sharps and for enclosure during transport to ultimate disposal. The product labeling includes a cautionary statement that the "container is puncture-resistant, but not entirely puncture-proof. To avoid the possibility of accidental sticks, do not overfill, inspect unit before handling and handle with care." Final disposal is typically accomplished by When incinerated in compliant medical waste inincineration. cinerators, these Sharps Containers do not present any environmental hazards resulting from plastics combustion.
Our Vertical Entry Sharps Container will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUM SERVICES USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel R. Brown ·President Custom Medical Plastics, Incorporated 14315 C Circle 68144 Omaha, Nebraska
JUL - 3 1997
Re : K970398 Sharps Container Trade Name: Requlatory Class: II Product Code: FMI May 14, 1997 Dated: Received: May 16, 1997
Dear Dr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Dr. Smith
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K970398 ATTACHMENT 7, Rev. 1
Page 1 of 1
510(k) Number (if known): Unknown
Device Name: Sharps Container
Indications For Use:
Our Vertical Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Info and General Hospita 5 ! (Xk) Number Over-the-Counter Use / OR Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)