(276 days)
Not Found
No
The device description and intended use clearly define a physical container for sharps disposal, with no mention of software, data processing, or any technology that would incorporate AI or ML.
No
The device is a sharps container, intended for the safe disposal of hazardous medical waste, not for treating any medical condition or disease.
No
Explanation: The device is a sharps container used for the safe disposal of hazardous sharps. It does not perform any diagnostic functions or provide information about a patient's health condition.
No
The device description clearly outlines a physical container made of tinplate steel, Nylon, and polypropylene, with specific dimensions and features for the disposal of medical sharps. This is a hardware device, 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 for the safe disposal of hazardous sharps. This is a containment and safety function, not a diagnostic one.
- Device Description: The description details the physical construction and features related to containing sharps, not analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health.
- Performance Studies: The performance studies focus on the physical integrity and safety features of the container (puncture resistance, leak resistance, impact resistance, stability), which are relevant to its function as a sharps disposal container, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This sharps container does not perform any such function.
N/A
Intended Use / Indications for Use
Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
The OnSite Waste Sharps Container OWTSH-I is constructed using tinplate steel base with a Nylon and polypropylene restrictive lid system. The OnSite Waste Sharps Container OWTSH-I measures 10 1/2" wide x 4 3/4" deep, and tapers to a dimension of 9" wide x 3 1/8 deep. The height of the container is 8 1/4" in height. The OnSite Waste Sharps Container OWTSH-I is equipped with a locking lid that once closed, prevents anyone from opening it either before or after processing.
Labels are on a red background with printed in black text and a bio-hazzard symbol. Labels are adhered to the container at the time of manufacture with the fill line warning printed on the label There is no feature to bend, break, or shear needle, includes blunting of needle in 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
qualified personnel in health care facilities and in other facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.
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)
Non-Clinical Testing:
Puncture Resistance: Passed ASTM F 2132-01 (2008) - "Standard Specification for the Puncture Resistance of Materials used in containers for the Discarded Medical Needles and Other Sharps".
Leak Resistance of bottom and sides: Passed (No Leakage visually observed after 24 hour period when container filled with water).
Impact Resistance: Passed Based on ISO 23907:2012.
Stability: Passed Based on ISO 23907:2012.
No clinical testing was required or performed.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2019
Bluestone Medical, Inc. Jon Bricken President (DBA OnSite Waste Technologies, Inc.) 9 North Main Street East Hampton, New York 11937
Re: K182235
Trade/Device Name: OnSite Waste Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: March 26, 2019 Received: April 15, 2019
Dear Jon Bricken:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182235
Device Name OnSite Waste Sharps Container
Indications for Use (Describe)
Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image is a circular logo with three sections. The top left section is green, the top right section is yellow, and the bottom section is black. The sections are curved and appear to be connected, forming a continuous loop. The logo has a grainy texture.
Bluestone Medical, Inc. 9 North Main Street, suite #7 East Hampton, N.Y. 11937
510(k) Summary
The assigned 510(k) number is: K182235
-
- Date Prepared: May 14, 2019
-
- Submitter's Identification
Bluestone Medical, Inc
Address: 9 North Main Street, suite #7 East Hampton, N.Y. 11937
Contact person: Jon Bricken President
(914)-886-3958
Email: jon.bricken@onsitewaste.com
-
- Name of the Device
Device Name: Sharps Container
- Name of the Device
Trade Name: OnSiteWaste Sharps Container
FDA identification: OWTSH-I
-
- Classification Information:
Product Code: MMK
- Classification Information:
Device Class: Class II
Classification: assessors to hypodermic single lumen needles
Classification Panel: General Hospital
-
- Predicate Device Information:
Trade name: Bradford Wright Sharps Container
- Predicate Device Information:
K182235 1/5
4
Image /page/4/Picture/0 description: The image shows a circular logo with three distinct sections. The sections are colored in green, yellow, and black. The sections are separated by white lines, creating a visually appealing and modern design.
Bluestone Medical, Inc. 9 North Main Street, suite #7 East Hampton, N.Y. 11937
Common name: Sharps Container
Product code: MMK
Classification: Accessory to hypodermic single lumen needles
CFR Reference: 21 CFR880.5570-Class II
Classification: panel: General Hospital
Legally Marketed Predicate Device:
| Company | Product description | 510(k) # |
|---|---|---|
| Bradford Wright Companies, Inc. | Demolizer II Sharps Container | K131708 (Primary Predicate) |
6. Intended use / Indication for Use:
Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and in other facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.
7. Device Description:
The OnSite Waste Sharps Container OWTSH-I is constructed using tinplate steel base with a Nylon and polypropylene restrictive lid system. The OnSite Waste Sharps Container OWTSH-I measures 10 1/2" wide x 4 3/4" deep, and tapers to a dimension of 9" wide x 3 1/8 deep. The height of the container is 8 1/4" in height. The OnSite Waste Sharps Container OWTSH-I is equipped with a locking lid that once closed, prevents anyone from opening it either before or after processing.
2/5 K182235
5
Image /page/5/Picture/0 description: The image is a circular logo with three teardrop-shaped segments. The segments are arranged in a clockwise direction and are colored differently. The top-left segment is a dark green, the top-right segment is a golden yellow, and the bottom segment is black. The segments are arranged in a way that they appear to be rotating around a central point.
Bluestone Medical, Inc. 9 North Main Street, suite #7 East Hampton, N.Y. 11937
Labels are on a red background with printed in black text and a bio-hazzard symbol. Labels are adhered to the container at the time of manufacture with the fill line warning printed on the label There is no feature to bend, break, or shear needle, includes blunting of needle in container.
| Component | Material | Depth
(inches) | Width
(inches) | Height
(inches) |
|---------------------|----------------------|-------------------|-------------------|--------------------|
| Container at Top | Tinplate Steel | 4" | 10" | 8" |
| Container at Bottom | Tinplate Steel | 3" | 9" | N.A. |
| Sharps Chute closed | Molded Polypropylene | 4 3/4" | 10 1/2" | 2 1/4" |
| Sharps Chute alone | Molded Polypropylene | 3 3/4" | 9 1/2" | 2" |
| Top Rim | Molded Polypropylene | 4 3/4" | 10 1/2" | 1/4" |
| Lid Plug | Molded Polypropylene | 3 3/4" | 9 1/4" | 3/4" |
| Sharps Container | Metal & Plastic | 4 3/4" | 10 1/2" | 8 1/4" |
OnSite Waste Sharps Container OWTSH-I
Technological Characteristics 8.
| Element of Comparison | Subject Device | Predicate Device |
|---|---|---|
| Company | Bluestone Medical, Inc. | Bradford Wright Companies, Inc. |
| Device Name | OWTSH-I Sharps Container | BWCSH-i Sharps Container |
| FDA 510(k) Number | K182235 | K131708 |
| Intended Uses | Container is a single- use, | |
| disposable, non-sterile | ||
| container intended to be used | ||
| for health-care purposes for | ||
| safe disposal of hazardous | ||
| sharps such as hypodermic | ||
| needles, syringes, lancets | ||
| and blood needles. | sharps container has a one-gallon fill | |
| line capacity that is intended to be | ||
| used for the safe disposal of hazardous | ||
| sharps. | ||
| Target Population | Healthcare Professionals | Healthcare Professionals |
| Materials | Tin Plate & Plastic | Tin Plate & Plastic |
6
| Element of Comparison | Subject Device | Predicate Device |
|---|---|---|
| Sharps Access | Sharps inserted through the | |
| top | Sharps inserted through the top | |
| Sharps Closure | Lid locked in place | Lid locked in place |
| Impact Resistance | Yes | Yes |
| Puncture Resistance | Yes | Yes |
| Leak Proof | Yes | Yes |
| Non-Sterile | Yes | Yes |
| Single Use | Yes | Yes |
| No features to bend, break | ||
| or shear needle | No Features Present | No Features Present |
| Fill indications | Labeled "Do Not Fill Above | |
| This Line" | Labeled "Do Not Fill Above This Line" | |
| Construction | Injection molded lid and Tin | |
| Plate base | Injection molded lid and Tin Plate base | |
| Dimensions | 10.5"x4.75"x8.25" | 10.5"x4.75"x8.25" |
| Fill Capacity | One US Gallon | One Us Gallon |
- Summary of Non-Clinical Testing 9.
Test Methods:
Puncture Resistance (Performed by and independent materials testing lab) - Passed ASTM F 2132-01 (2008) · "Standard Specification for the Puncture Resistance of Materials used in containers for the Discarded Medical Needles and Other Sharps".
Leak Resistance of bottom and sides - Container is filled with water. No Leakage visually observed after 24 hour period - Passed.
Impact Resistance - Passed Based on ISO 23907:2012
Stability: - Passed Based on ISO 23907:2012
7
10. Discussion of Clinical Tests Performed: There were no clinical testing required to support the medical device.
Conclusions: 11.
The results of the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device
1
ﻳﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
្រព្យ