(67 days)
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″.
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.
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 is a medical device designed for the safe disposal of hazardous sharps. The submission refers to performance testing under recognized standards to demonstrate substantial equivalence to its predicate device.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Puncture Resistance (ASTM F 2132) | Testing performed and deemed substantially equivalent to currently marketed sharps containers. |
| Topple Resistance (CSA Z316.6-07) | Testing performed and deemed substantially equivalent to currently marketed sharps containers. |
| Leakage Tests (BS 7320:1990) | Testing performed and deemed substantially equivalent to currently marketed sharps containers. |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes for the performance tests (ASTM F 2132, CSA Z316.6-07, BS 7320:1990). Given that these are standard tests for physical properties, the sample sizes would typically be defined by the respective standards. The data provenance is not specified beyond the fact that the tests were conducted for the Noble Sharps Container. It's implied to be prospective testing specific to this device.
3. Number of Experts and Qualifications:
Not applicable. This is a medical device focused on physical performance rather than diagnostic accuracy that would require expert human review. The evaluation relies on standardized engineering tests.
4. Adjudication Method:
Not applicable. The performance is assessed through objective physical and mechanical testing as per established standards, not through human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The device is a sharps container, not an imaging or diagnostic device that would involve human readers or AI assistance in interpretation.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the Noble Sharps Container was subjected to specific performance tests (puncture resistance, topple resistance, leakage) independent of human interaction for its intended function.
7. Type of Ground Truth Used:
The ground truth for the performance testing is implicitly defined by the pass/fail criteria and methodologies outlined in the referenced standards: ASTM F 2132, CSA Z316.6-07, and BS 7320:1990. These standards establish objective criteria for puncture resistance, topple resistance, and leakage, respectively.
8. Sample Size for Training Set:
Not applicable. This device is a physical medical device and not an AI/machine learning model, so there is no training set in the conventional sense.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set for this type of device.
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APR - 5 2011
Traditional 510(k) Premarket Notification Summary of Safety and Effectiveness
KI�Oz 62 p 1 of 2
| Submitter Information | Noble MarketingJeff BakerPresident & CEO100 East Pine Street, Suite 305Orlando, FL 32801 |
|---|---|
| Contact Person | Allison Scott, RACRegulatory Consultant317-569-9500 x106317-569-9520 (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 safedisposal of hazardous sharps. |
| Intended Use | The Noble Sharps container is a disposable over the counter sharps containerthat is intended for the safe disposal of used medical sharps. It is intended foruse in offices, exam and patient rooms of small quantity healthcare providerssuch as medical doctors, dentists, and veterinarians. The size of the SharpsContainer is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It isdesigned with 4- individual single use chambers with each holding 1-sharp, witha maximum sharp length of 6 1/8". |
| Summary | The Nobles Sharps Container is a single use device designed for the safedisposal of hazardous sharps. It is designed with 4-chambers, each chamberwill hold one sharps. After each chamber is filled with a sharp, a locking lid isclosed by pressing downward, thus permanently sealing the sharps inside thecontainer. All materials including the bottom, sides, and locking lid aremanufactured using PP7726 (polypropylene) the same material used in thepredicate device, the GongDong disposable sharps container cleared underK082042. The size of the Noble Sharps Container is 6 7/16" in height, 415/16" in width and 2 7/16" in depth. The Noble Sharps Container proves tobe substantially equivalent to the predicate device. |
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Comparison to Predicate Devices
The Sharps Container is similar to the predicate in intended use, materials, measuring principle and performance.
| Noble Sharps Container | GongDongDisposable SharpContainer | |
|---|---|---|
| 510(k) Number | K100262 | K082042 |
| Product Code | MMK | MMK |
| Indication for Use | • Single Use HealthcareSharps | • Single Use Healthcaresharps |
| Target Population | • Healthcare professional | • Healthcareprofessional |
| Where used | • Healthcare facilities/labs | • Healthcarefacilities/labs |
| Construction | • Injection molded | • Injection molded |
| Materials | • Polypropylene | • Polypropylene |
| Lid | • Closure by pressing downon lid secure | • Closure by pressingdown 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.
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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.
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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
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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
§ 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).