(70 days)
K943575, 8900MW
Not Found
No
The description details a physical sharps container made of plastic with a locking lid, with no mention of any software, data processing, or AI/ML capabilities.
No.
The device is a sharps container designed for the safe disposal of hazardous sharps, not for treating a condition or disease.
No
Explanation: The device described is a sharps container, designed for the safe disposal of hazardous sharps, not for diagnosing medical conditions.
No
The device is a physical sharps container made of polyethylene plastic with a locking lid, designed for the disposal of hazardous sharps. It is a hardware device, not software.
Based on the provided text, the M500-100 sharps container is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "safe disposal of hazardous sharps" in a medical clinic setting. This is a containment and disposal function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the container (material, lid, size, stability) and its function in holding used syringes and other sharps. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: The text does not mention any components or processes related to testing, analyzing, or diagnosing any medical condition or characteristic using samples from the human body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The M500-100 sharps container's purpose is solely for the safe handling and disposal of medical waste.
N/A
Intended Use / Indications for Use
The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.
Product codes
FMI
Device Description
The M500-100 Sharps Container was compared to the below mentioned predicate containers in that it conforms to the same standards as its predicates. This container was made from polyethylene plastic with a polyethylene locking lid. This container was molded with no side or bottom seams. The predicate devices are also made of premotited polyethylene. The M500-100 has a lid, which locks when shut preventing any leakage or loss of its contents.
The M500-100 is designed to hold up to 30 used syringes of lec to 5cc in size. The syringes are placed into the container in a vertical position sharp side down. Other sharps may be disposed of by dropping them into the opening at the top.
The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table. This container can also be placed in a specially designed wall bracket.
There is a black line on this container to notify the user not to overfill .
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
trained medical personnel in a medical clinic setting
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
In all rest, the M500-100 sharps container met or exceeded the criteria set as pass. These test were conducted using the quidelines of the American Standards for Testing and the British Standards of Testing. This container when filled with water and allowed to stand showed no signs of leaksge from the container. With the lid locked in place and the container filled with syringes the container was dropped from a suspended string 3 feet in the air onto a hard floor. The locked lid did not open up and there were no signs of the contents spilling out or protruding through the bottom. Since syringes are placed into this container sharp side down always in a vertical position, it is unlikely that a sharp could of would protrude through the top.
Key Metrics
Not Found
Predicate Device(s)
K943575, 8900MW
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
MAR 1 3 1998
510(k) Summary
| Company: | Imagination Medical Inc.
12855 Phillips Highway
Jacksonville, Fl. 32256
(904) 268-5531 |
|-----------------|-------------------------------------------------------------------------------------------------|
| Contact: | Mr. Tim Weist |
| Device Name: | M500-100 Sharps Container |
| Common Name: | 1 QT Sharps Container |
| Classification: | 21 CFR 880 Type II |
The M500-100 Sharps Container was compared to the below mentioned predicate containers in that it conforms to the same standards as its predicates. This container was made from polyethylene plastic with a polyethylene locking lid. This container was molded with no side or bottom seams. The predicate devices are also made of premotited polyethylene. The M500-100 has a lid, which locks when shut preventing any leakage or loss of its contents.
The M500-100 is designed to hold up to 30 used syringes of lec to 5cc in size. The syringes are placed into the container in a vertical position sharp side down. Other sharps may be disposed of by dropping them into the opening at the top.
The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table. This container can also be placed in a specially designed wall bracket.
There is a black line on this container to notify the user not to overfill .
Predicate Devices:
- B.D. Home Sharps Container K943575 1
- 2 Sage Sharps Phiebotomy Confiner # 8900MW
Conclusions of Testing:
In all rest, the M500-100 sharps container met or exceeded the criteria set as pass. These test were conducted using the quidelines of the American Standards for Testing and the British Standards of Testing. This container when filled with water and allowed to stand
1
showed no signs of leaksge from the container. With the lid locked in place and the container filled with syringes the container was dropped from a suspended string 3 feet in the air onto a hard floor. The locked lid did not open up and there were no signs of the contents spilling out or protruding through the bottom. Since syringes are placed into this container sharp side down always in a vertical position, it is unlikely that a sharp could of would protrude through the top.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Mr. Tim Weist Director of Safety and Compliance Imaqination Medical Incorporated 12855 Phillips Highway 32256 Jacksonville, Florida
K980003 Re: M500-100 Sharps Container Trade Name: Regulatory Class: II Product Code: FMI February 17, 1998 Dated: February 17, 1998 Received:
Dear Mr. Weist:
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 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 (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 requlation (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
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Page 2 - Mr. Weist
through 542 of the Act for devices under the Electronic enroagn Siz Or on 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 asboring 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
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Page_1_of_1__
510(k) NUMBER (IF KNOWN): K980003
M500-100 Sharps Container DEVICE NAME:_________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental Infection Control
Division of Dental Infection Control, and General Hospital Devices
510(k) Number K980003
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use
(Optional Format 1-2-96)