(152 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical container for medical sharps, with no mention of any software, data processing, or AI/ML capabilities.
No
Explanation: The device is a sharps container, designed for the disposal of contaminated medical sharps, not for treating or diagnosing any medical condition.
No
Explanation: The device is described as a receptacle for used medical sharps, intended for containment and transport to disposal. This function does not involve diagnosing any medical condition or disease.
No
The device description clearly indicates physical dimensions and weight, describing a tangible container, 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 act as an enclosure for transport. This is a physical containment and disposal function.
- Device Description: The description details the physical characteristics of the containers (dimensions, color, weight).
- 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.
- Any reagents, calibrators, or controls typically associated with IVD tests.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic or other health-related information. Sharps containers are for the safe handling and disposal of medical waste, not for diagnostic testing.
N/A
Intended Use / Indications for Use
Medine Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
Product codes
MMK
Device Description
Medline 1 Qt:Sharps Container: Dimensions - 95 x 95 x 153mm Color - Red Base, White Translucent Top Empty Weight - 107g
Medline 5 Qt Sharps Container: Dimensions - 265 x 113 x 233mm Color - Red Base, White Translucent Top Empry Weight - 360g
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)
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 consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2014
Medline, Industries Incorporated Mr. Timur Selimkhanov Quality Assurance Manager One Medline Place Mundelein, IL 60060
Re: K132767
Trade/Device Name: Medline Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: December 6, 2013 Received: December 24, 2013
Dear Mr. Selimkhanov:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Selimkhanov
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Image /page/1/Picture/7 description: The image shows a signature and some text. The text includes "Sincerely yours," "Tejashri Purohit-Sheth, M.D.," "Clinical Deputy Director," and "DAGRID." There is also the word "FOR" at the bottom right of the image. The signature is illegible.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last paga.
了
510(k) Number (if known) K132767
Device Name
Medline IQt Sharps Container, Medline SQt Sharps Container
Indications for Use (Describe)
Medine Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
Medline 1 Qt:Sharps Container: Dimensions - 95 x 95 x 153mm Color - Red Base, White Translucent Top Empty Weight - 107g
Medline 5 Qt Sharps Container: Dimensions - 265 x 113 x 233mm Color - Red Base, White Translucent Top Empry Weight - 360g
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[2] Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not WRITE BELOW THIS LINE – continue on a separate page if needed.
の中国のアイミリアのREDAVUSE ONLY。 『『『『』『『』『『』『『』『『』『『』『『』『 Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Flizabeth 2014.01.
FORM FDA 3881 (9/13)
Page 1 of 2
PSC Publishing Services (531) 111-6742 EP
Aug. 15, 1944
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