(82 days)
Not Found
Not Found
No
The 510(k) summary describes a sharps disposal container, which is a physical device for waste management and does not mention any software, data processing, or AI/ML capabilities.
No
The device is described as a container for collecting used disposable sharps and is used by healthcare providers for waste disposal, not for treating any medical condition or patient.
No
Explanation: The device is described as a container for the collection of used disposable sharps. Its purpose is waste management, not to diagnose any medical condition or disease.
No
The summary describes a container for collecting used disposable sharps, which is a physical 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 for the collection of used disposable sharps within healthcare settings. This is a physical containment and disposal function.
- Device Description: While "Not Found" is listed, the intended use clearly describes a container for sharps disposal.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (or animal body in the case of veterinary use) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, instruments, or systems used for testing blood, urine, tissue, etc.
This device is a sharps disposal container, which is a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
- Used within health care settings (i.e., medical, dental, veterinarian, or other health care facility) for the collection of used disposable sharps.
- Containers are supplied to the health care facilities by BFI representatives.
- Containers are used by health care providers at the point of disposal where potentially infectious sharps' waste is generated.
Product codes
FMI
Device Description
Not Found
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
health care settings (i.e., medical, dental, veterinarian, or other health care facility); health care providers
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)
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of what appears to be an abstract caduceus, a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 1998
BFI Waste Systems of North America, Incorporated ·C/O Mr. A. Wes Siegner Law Offices of Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, DC 20005
Re : K981184 SharpTrack™ Reusable Sharps Container Trade Name: Requlatory Class: II Product Code: FMI Dated: April 1, 1998 Received: April 1, 1998
Dear Mr. Siegner:
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, 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of
1
Page 2 - Mr. Siegner
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sie in privalence 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) 594-4692. 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 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
2
510(k) Number (if known): K981184
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
- Used within health care settings (i.e., medical, dental, -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------veterinarian, or other health care facility) for the collection of used disposable sharps.
- Containers are supplied to the health care facilities by BFI -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------representatives.
- Containers are used by health care providers at the point of -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------disposal where potentially infectious sharps' waste is generated.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chân Sơn
(Division Sign-Off) Division of Dontal, Infection Control, and General Hospital Devices
510(k) Number K981184
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)