(54 days)
Not Found
No
The device description details a simple, non-electronic sharps container with no mention of any computational or analytical capabilities.
No.
The device is a sharps container for disposal of contaminated medical waste, not for treating any medical condition or disease.
No.
The device is a sharps container designed for the disposal of contaminated medical sharps; it does not perform any diagnostic function.
No
The device description clearly outlines a physical sharps container made of tin-plated steel with specific dimensions and features, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "disposal of various-sized contaminated medical sharps". This is a waste management function, not a diagnostic one.
- Device Description: The description details a container for holding sharps waste. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of reagents, assays, sample handling for analysis, or any other elements typically associated with IVD devices.
- Predicate Devices: The predicate devices listed are also sharps disposal containers, reinforcing the device's function as a waste management tool.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This sharps container does not perform any such function.
N/A
Intended Use / Indications for Use
The sharps container is intended for the collection of disposable sharps in both clinical and nonclinical healthcare settings, such as laboratories, dentists' offices, doctors' offices, veterinarian offices, corporate clinics, nursing homes, and other types of healthcare centers.
This device is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings.
Product codes
MMK
Device Description
The Demolizer # 47 One-Gallon Point of Generation Sharps Container is a single use, non-sterile, disposable, point of generation sharps container, constructed out of tin-plated steel. The device has a friction fit lid and black foam plastisol sealant for container closure. It is designed to hold contaminated disposable sharps, such as various-sized hypodermic, intravenous syringes or other medical needles, scalpel blades, disposable knives and lancets, and broken glass such as slides, slip covers and ampoules. The device is not a secondary container.
The sharps container is a three-piece construction, one-gallon metal drum with a friction fit lid and sealant used to close the container. The minimum nominal body wall thickness is .0094 inches, and the minimum nominal top/bottom thickness is .0097 inches. The container is opaque and measures 6-5/8 inches wide by 7-7/16 inches in height, with a 2-3/8 inch sharps inlet opening in the center of the top of the container. The lid is 2-3/4 inches in diameter, with a thickness of .0088 inches. Lining the perimeter of the posterior side of the lid is a black foam plastisol which acts as an additional safety seal; this foam ensures a closed container. A built-in vent port, approximately 1 mm in diameter, is located on the top of the sharps container.
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
clinical and nonclinical healthcare settings, such as laboratories, dentists' offices, doctors' offices, veterinarian offices, corporate clinics, nursing homes, and other types of healthcare centers.
clinical and laboratory healthcare settings.
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)
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
SEP 3 0 1998
ATTACHMENT 9
(As required by 21 C.F.R. §§ 807.87(h), 807.92)
- Manufacturer 1.
Contact Person
Thermal Waste Technologies, Inc. 19 Stony Hill Road Bethel, CT 06801 (203) 778-2210
Bill Ransone Vice President Sales & Marketing (203) 778-1039
-
- Device
- Demolizer® #47 One-Gallon Point of Trade or Proprietary Name a. Generation Sharps Container Sharps Container Common Name b. Classification Name Accessory to Hypodermic Needle C. II Classification d.
- Intended Use: The sharps container is intended for the collection of disposable sharps 4. in both clinical and nonclinical healthcare settings, such as laboratories, dentists' offices, doctors' offices, veterinarian offices, corporate clinics, nursing homes, and other types of healthcare centers.
క్ Predicate Devices
The Demolizer # 47 One-Gallon Point of Generation Sharps Container is substantially equivalent to the 1.0 Gallon Leaktight Locking Top Translucent Red Sharps Disposal Container marketed by Post Medical, Inc. (#K925816), and to the 5-Quart Round Sharps Container marketed by Sage Products, Inc. (#K943659).
6.. General Description
The Demolizer # 47 One-Gallon Point of Generation Sharps Container is a single use, non-sterile, disposable, point of generation sharps container, constructed out of tin-plated steel. The device has a friction fit lid and black foam plastisol sealant for container closure. It is designed to hold contaminated disposable sharps, such as various-sized hypodermic, intravenous syringes or other medical needles, scalpel blades, disposable knives and lancets, and broken glass such as slides, slip covers and ampoules. The device is not a secondary container.
1
7. Detailed Description
The sharps container is a three-piece construction, one-gallon metal drum with a friction fit lid and sealant used to close the container. The minimum nominal body wall thickness is .0094 inches, and the minimum nominal top/bottom thickness is .0097 inches. The container is opaque and measures 6-5/8 inches wide by 7-7/16 inches in height, with a 2-3/8 inch sharps inlet opening in the center of the top of the container. The lid is 2-3/4 inches in diameter, with a thickness of .0088 inches. Lining the perimeter of the posterior side of the lid is a black foam plastisol which acts as an additional safety seal; this foam ensures a closed container. A built-in vent port, approximately 1 mm in diameter, is located on the top of the sharps container.
8. Summary of Technological Characteristics
The Demolizer # 47 One-Gallon Point of Generation Sharps Container differs slightly from its predicate devices, in that the Demolizer sharps container is constructed of tinplated steel and lap welded. The two predicate devices are constructed of plastic. Further, unlike the predicate devices, once the Demolizer sharps container is closed, it is resistant to manual opening.
The Demolizer sharps container is similar to the two predicate devices, in that all are single use, disposable, nonsterile, opaque containers of roughly the same capacity, and all feature vertical inlet openings for the disposal of sharps.
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, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
MAR 2 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bill Ransone Vice President Sales & Marketing Thermal Waste Technologies, Incorporated 19 Stony Hill Road Bethel, Connecticut 06801
Re: K982781
Trade/Device Name: Demolizer #47 One-Gallon Point of Generation Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Codes: MMK Dated: August 26, 1998 Received: August 31, 1998
Dear Mr. Ransone:
This letter corrects our substantially equivalent letter of September 30. 1998.
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 (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 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. Ransone
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 continue 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 http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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 tollfree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Syute Y. Mcheioms
Chiu S. 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
4
ATTACHMENT 11
INDICATIONS FOR USE STATEMENT
(REVISION)
Page 1 of 1
3
510(k) Number: K982781 Device Name: Demolizer #47 One-Gallon Point of Generation Sharps Container Indications for Use: This device is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division Infection Control,
and General Hospital Devices
| 510(k) Number | K982781 |
|---|---|
| --------------- | --------- |
| Prescription Use | |
|---|---|
| (Per 21 C.F.R. § 801.109) |
OR
| Over the Counter Use | |
|---|---|
| ---------------------- | -- |