(135 days)
K041153 Sharps Away™ Locking Disposal Cup
Not Found
No
The summary describes a mechanical device for sharps disposal and does not mention any AI or ML components or functionalities.
No.
The device is a sharps container designed to safely transport and dispose of contaminated sharps, not to treat or cure any medical condition.
No
The device is described as a "needle protection device" and a "sharps container" for holding and transporting contaminated sharps for disposal. Its purpose is to minimize contamination and safely dispose of sharps, not to diagnose a condition.
No
The device description clearly indicates it is a physical container ("single use device that holds a single contaminated sharp") and mentions physical components like a "Safe-Lock Lid" and "plastic". There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform any such examination or analysis of biological samples.
- The intended use of this device is for the safe transport and disposal of contaminated sharps (specifically insulin syringes). Its function is purely mechanical and related to containment and safety, not diagnosis or monitoring of a medical condition through in vitro testing.
The description clearly states its purpose is to hold and lock a single contaminated sharp for safe transport and disposal. This falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
On the Go Sharps Container is designed as a single use device that holds a single contaminated sharp. The contaminated sharp is placed into the container and immediately locked using the Safe-Lock Lid. Once closed the device can not be opened thereby minimizing the risk of contamination.
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
personal use only; not for professional use or use in professional healthcare facilities.
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)
Simulated use studies confirmed that people with different educational background can successfully use the On The Go Sharps Container in accordance with instructions provided.
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.
K041153 Sharps Away™ Locking Disposal Cup
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
510 (K) SUMMARY
Date of Summary
July 12, 2007
Product Name:
On the Go Sharps Transport and Disposal with Safe-Lock™
Sponsor & Manufacturer:
MedPort, LLC 23 Acorn Street Providence, RI 02903
Correspondent:
Fran WhitE MDC Associates, LLC 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device: K041153 Sharps Away™ Locking Disposal Cup
Product Description:
On the Go Sharps Container is designed as a single use device that holds a single contaminated sharp. The contaminated sharp is placed into the container and immediately locked using the Safe-Lock Lid. Once closed the device can not be opened thereby minimizing the risk of contamination.
1
Intended Use:
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
Performance Characteristics:
Simulated use studies confirmed that people with different educational background can successfully use the On The Go Sharps Container in accordance with instructions provided.
Once locked the device can not be opened. The contaminated sharp does not penetrate the plastic, thereby providing a safe method for transporting contaminated sharps to a site for disposal.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Public Health Service
JUL 1 3 2007
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDport, Incorporated C/O Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, Massachusetts 01915
Re: K070577
Trade/Device Name: On the Go Sharps Transport & Disposal with Safe-LockTM Lid Single Use Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: June 28, 2007 Received: July 2, 2007
Dear Ms. White:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. White
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276- 0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K070577
Device Name: On the Go Sharps Transport & Disposal with Safe-Lock™ lid Single use sharps container
Indications For Use:
The On the Go Sharps Transport & Disposal is intended as a single use, needle protection device. The device is intended to hold only one contaminated sharp. The device is designed for use with Insulin syringes. It is intended to be sold Over-the-Counter for personal use only; not for professional use or use in professional healthcare facilities.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shuli A. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K021522