(150 days)
Not Found
Not Found
No
The description focuses on the mechanical design and function of a sharps container, with no mention of AI or ML.
No
The device is a container for disposing of medical sharps, not for treating a disease or condition.
No
Explanation: The device is a sharps container, used for the disposal and containment of contaminated medical sharps. It does not perform any diagnostic function such as identifying, confirming, or ruling out a disease or condition.
No
The device description clearly outlines a physical container made of injection-molded polypropylene, indicating it is a 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 enclosure during transport to disposal. This is a physical containment and disposal function.
- Device Description: The description details a physical container and lid designed for safe handling and disposal of sharps.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or other substances to perform tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This sharps container does not perform any such function.
N/A
Intended Use / Indications for Use
Our Horizontal Entry Sharps Containers provide a receptacle for used, contaminated medical Sharps and for enclosure during transport to ultimate disposal.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
Our Horizontal Entry Sharps Container consists of an injection-molded polypropylene container fitted with a snap-on, leakresistant, poly-propylene lid. The lid has a "mail-box" style raised opening into which the sharps are dropped horizontally. When the container is full, a unique butterfly closure system closes to prevent over-filling and to prevent access to the sharps inside.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K970383 ATTACHMENT 5, Rev. 1
70383 3 JUL * 3 1997
510 (k) SUMMARY
THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990.
Summary of Safety & Efficacy: Horizontal Entry Sharps 510 (k) Container
Custom Medical Plastics, Inc. 11811 Calhoun Road Submitted By: Omaha, NE 68122 (402) 691-2855 Daniel R. Brown, President Contact: Date Prepared: December 24, 1996 (Ammended April 4, 1997)
Our Horizontal Entry Sharps Container consists of an injectionmolded polypropylene container fitted with a snap-on, leakresistant, poly-propylene lid. The lid has a "mail-box" style raised opening into which the sharps are dropped horizontally. When the container is full, a unique butterfly closure system closes to prevent over-filling and to prevent access to the sharps inside.
Sharps Containers are classified as a Class II accessory to a hypodermic needle (21 CFR Section 880.5570); Panel 80 FMI.
Our Horizontal Entry Sharps Container is substantially equivalent to Horizontal 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 mechanism for inserting the sharps in a horizontal plane and a lid to secure the opening when the container has been filled. Our Horizontal Entry Sharps Containers, along with the Sage and Sherwood Containers also feature a wall mount bracket and a locking mechanism to secure the container, thus preventing unauthorized access or removal.
Our Horizontal 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 incineration. When incinerated in compliant medical waste incinerators, these sharps containers do not present any environmental hazards resulting from plastics combustion.
Our Horizontal 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUM SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its head and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel R. Brown ·President Custom Medical Plastics, Incorporated and 14315 "C" Circle Omaha, Nebraska 68144
JUL - 3 1997
Re : K970383 Trade Name: Sharps Container Requlatory Class: II Product Code: FMI Dated: May 14, 1997 Received: May 20, 1997
Dear Mr. Brown:
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, Drug, 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 reqistration, 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 regulations 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 - Mr. Brown
through 542 of the Act for devices under the Electronic chrough Siz on on ontrol 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 ▽DA 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 complianse as (advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to 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.fdaa.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K970383 ATTACHMENT 4, Rev. 1
Page 1 of 1
K970383 510(k) Number:
Device Name: Sharps Container
Indications For Use:
Our Horizontal 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)
CORH, office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, infection Cotro!,
and General Hospita! Devices
510(k) Number K970383
Prescription Use __ OR Over-the-Counter Use X
(Per 21 CFR 801.109) (Optional Format 1-2-96)