(67 days)
Not Found
No
The description details a physical container for sharps disposal and mentions no software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is a sharps container used for the safe disposal of medical sharps, which is a waste management product, not a therapeutic device.
No
The device is a sharps container, used for the safe disposal of medical sharps, rather than for diagnosing any medical condition.
No
The device description clearly indicates it is a physical container made of polypropylene for the disposal of sharps, not a software application.
Based on the provided text, the Noble Sharps container is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "safe disposal of used medical sharps." This is a containment and disposal function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of the container for holding sharps. There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
- Lack of Diagnostic Elements: The text does not mention any components or processes related to in vitro diagnostics, such as reagents, assays, sample analysis, or diagnostic results.
IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment. The Noble Sharps container's purpose is solely for the safe handling and disposal of potentially hazardous medical waste.
N/A
Intended Use / Indications for Use
The Noble Sharps container is a disposable over the counter sharps container that is intended for the safe disposal of used medical sharps. It is intended for use in offices, exam and patient rooms of small quantity healthcare providers such as medical doctors, dentists, and veterinarians. The size of the Sharps Container is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It is designed with 4- individual single use chambers with each holding 1-sharp, with a maximum sharp length of 6 1/8″.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
The Noble Sharps Container are intended to be used at healthcare facilities, including nursing stations, medication carts, laboratories, emergency rooms, treatment rooms, and other small quantity waste generators for the safe disposal of hazardous sharps.
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
Healthcare professional, Healthcare facilities/labs
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)
The Noble Sharps container subjected to puncture resistance testing per ASTM F 2132, topple resistance testing per CSA Z316.6-07, and leakage tests per BS 7320:1990. Noble Sharps Container proves to be substantially equivalent to currently marketed sharps containers.
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.
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
APR - 5 2011
Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness
KI�Oz 62 p 1 of 2
| Submitter Information | Noble Marketing
Jeff Baker
President & CEO
100 East Pine Street, Suite 305
Orlando, FL 32801 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Allison Scott, RAC
Regulatory Consultant
317-569-9500 x106
317-569-9520 (fax)
ascott@ansongroup.com |
| Date | March 30, 2011 |
| Trade Name | Sharps Container |
| Common Name | Container, Sharps |
| Classification Name | MMK |
| Classification Number | 21 CFR 880.5570 |
| Predicate Devices | GongDong K082042 MMK 880.5570 |
| Device Description | The Noble Sharps Container are intended to be used at healthcare facilities,
including nursing stations, medication carts, laboratories, emergency rooms,
treatment rooms, and other small quantity waste generators for the safe
disposal of hazardous sharps. |
| Intended Use | The Noble Sharps container is a disposable over the counter sharps container
that is intended for the safe disposal of used medical sharps. It is intended for
use in offices, exam and patient rooms of small quantity healthcare providers
such as medical doctors, dentists, and veterinarians. The size of the Sharps
Container is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It is
designed with 4- individual single use chambers with each holding 1-sharp, with
a maximum sharp length of 6 1/8". |
| Summary | The Nobles Sharps Container is a single use device designed for the safe
disposal of hazardous sharps. It is designed with 4-chambers, each chamber
will hold one sharps. After each chamber is filled with a sharp, a locking lid is
closed by pressing downward, thus permanently sealing the sharps inside the
container. All materials including the bottom, sides, and locking lid are
manufactured using PP7726 (polypropylene) the same material used in the
predicate device, the GongDong disposable sharps container cleared under
K082042. The size of the Noble Sharps Container is 6 7/16" in height, 4
15/16" in width and 2 7/16" in depth. The Noble Sharps Container proves to
be substantially equivalent to the predicate device. |
1
Comparison to Predicate Devices
The Sharps Container is similar to the predicate in intended use, materials, measuring principle and performance.
| | Noble Sharps Container | GongDong
Disposable Sharp
Container |
|--------------------|---------------------------------------------|------------------------------------------------|
| 510(k) Number | K100262 | K082042 |
| Product Code | MMK | MMK |
| Indication for Use | • Single Use Healthcare
Sharps | • Single Use Healthcare
sharps |
| Target Population | • Healthcare professional | • Healthcare
professional |
| Where used | • Healthcare facilities/labs | • Healthcare
facilities/labs |
| Construction | • Injection molded | • Injection molded |
| Materials | • Polypropylene | • Polypropylene |
| Lid | • Closure by pressing down
on lid secure | • Closure by pressing
down on lid to secure |
| Needle elimination | • By vertical dropping | • By vertical dropping |
Technological Characteristics
Similar to other sharps containers on the market, sharps are inserted through the top in a vertical position with the sharp side down through the hole in which the sharp is inserted. A lid is then closed by pressing the lid downward for permanent closure and containment of sharps.
Performance of Non-Clinical The Noble Sharps container subjected to puncture resistance testing per ASTM F 2132, topple resistance testing per CSA Z316.6-07, and leakage tests per BS 7320:1990. Noble Sharps Container proves to be substantially equivalent to currently marketed sharps containers.
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Noble Marketing C/O Mr. Mark Job Responsible third party Official Regulatory Technology Services, LLC 1394 2511 Street NW Buffalo, Minnesota 55313
APR = 5 201
Re: K110262
Trade/Device Name: Sharps Container Regulation Number: 21 CFR 880,5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: March 24, 2011 Received: March 25, 2011
Dear Mr. Job:
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.
3
Page 2- Mr. Job
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Sincerely yours,
for J
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K110262
Device Name: Sharps Container
Indications For Use:
The Noble Sharps container is a disposable over the counter sharps container that is intended for the safe disposal of used medical sharps. It is intended for use in offices, exam and patient rooms of small quantity healthcare providers such as medical doctors, dentists, and veterinarians. The size of the Sharps Container is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It is designed with 4- individual single use chambers with each holding 1-sharp, with a maximum sharp length of 6 1/8″.
AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elith Fillmore Will
Olvision Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Num