(272 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety features of a sharps container, with no mention of AI or ML technology.
No
The device is a sharps container for the safe disposal of hazardous sharps, not for treating any medical condition or disease.
No
The device is a sharps container, intended for the safe disposal of hazardous sharps, and its description and performance studies relate to its physical properties for containment, not to diagnosing medical conditions.
No
The device is a physical sharps container made of metallic and thermal plastic components, designed for the disposal of hazardous sharps. It is a tangible hardware product, 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 waste management function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and safety features for containing sharps waste (puncture resistance, leak-proof, locking lid, etc.). It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed (Puncture Resistance, Leak-Proof Testing, Impact and Shatter Resistance, and Stability) are all related to the physical integrity and safety of the container for waste disposal. They are not diagnostic performance metrics.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing any kind of diagnostic result.
In summary, the BWCSH-1 sharps container is a medical device used for the safe handling and disposal of medical waste, specifically sharps. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is metallic canister fitted with thermal plastic top and has a orange-red biohazard label adhered to the containers with fill line printed on the front. The BWCSH-1 device is for single use, disposable and is not a secondary container. The BWCSH-1 sharps container dimensions are 10.5 inches in width at the top, 4.75 inches deep and 8.25 inches in height. BWCSH-1 sharps container weighs 1.075 pounds when empty.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is stable, puncture resistant, impact and shatter resistant, and leak-proof on the sides and bottom. The BWCSH-1 container is fitted with a rotating top, allowing safe one-handed disposal of used sharps. The container has a locking tamper resistant plastic lid that once snapped in place, cannot be manually removed. Labels are orange-red with black text and a black biohazard symbol printed on a white background. Labels are adhered to the containers at the time of manufacture with the fill line printed. The BWCSH-1 device is for single use, disposable and is not a secondary container.
The BWCSH-1 sharps container three main components are nested together to reduce storage and shipping requirements. The rotating top is made with uncolored translucent material. The translucent nature of the product allows for a visual determination of content level. The bottom of the rotating top's internal chute matches the fill line to physically prevent over filling.
The BWCSH-1 device underwent and passed performance testing that consisted of confirming its key safety and reliability aspects. The following four types of performance tests were performed:
. Puncture Resistance Testing - According to ASTM F2132-01(2008);
Leak-Proof Testing According to 29 CFR 1910.1030(d)(2)(viii)(c); .
. Impact and Shatter Resistance -; According to ISO 23907:2012 and
Stability According to 29 CFR 1910.1030(d)(4)(iii)(A)(2)(ii). .
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
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)
Performance testing was conducted to demonstrate compliance with recognized consensus standards (ASTM F2132-01, ISO 23907:2012, and OSHA regulations 29 CFR Part 1910:1030).
Study Type: Performance Testing (Bench) - Product Testing
Tests performed: Puncture Resistance, Leak Resistance of bottom and sides, Impact Resistance, Stability.
Key Results: All tests were passed, demonstrating equivalent performance to predicate devices and raising no new issues of safety and effectiveness.
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
K 131708 Traditional 510(k) Submission
510(k) SUMMARY
MAR(0 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92
Preparation Date: February 24, 2014
ADMINISTRATIVE INFORMATION
Submitted by: Bradford Wright Companies, Inc. Organization Number: 338046 . PIN: MD6068894-956733 SBD135362 4092 Orchard Way Lake Oswego, OR 97035-1871 Phone/Fax: (503) 635-6908 Email: info@bradfordwright.com
Contact Person: Mike DeMello President Email: miked@bradfordwright.com
DEVICE IDENTIFICATION
| 510(k) Number: | K131708 |
|---|---|
| Device Name: | BWCSH-1 |
| Common Name: | Sharps Container |
| Classification Name: | MMK |
| Accessory to hypodermic single lumen needles | |
| CFR Reference: | 21CFR 880.5570- Class II |
| Classification Panel: | General Hospital |
This submission is the first and only existing FDA filing by this manufacturer. We have never marketed the device in the U.S.
1
Indications for Use:
The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is metallic canister fitted with thermal plastic top and has a orange-red biohazard label adhered to the containers with fill line printed on the front. The BWCSH-1 device is for single use, disposable and is not a secondary container. The BWCSH-1 sharps container dimensions are 10.5 inches in width at the top, 4.75 inches deep and 8.25 inches in height. BWCSH-1 sharps container weighs 1.075 pounds when empty.
Predicate Device:
| 510(k) Number: | K982781 |
|---|---|
| Trade Name of Device: | Demolizer #47 1 Gal. Point of Generation Sharps Container |
| Common Name: | Sharps Container |
| Classification Name: | MMK |
| Accessory to hypodermic single lumen needles | |
| CFR Reference: | |
| Classification Panel: | General Hospital |
Legally Marketed Equivalent Devices:
| Product | Company | 510(k) # |
|---|---|---|
| Demolizer | ||
| #47 1 Gallon Point of | ||
| Generation Sharps | ||
| Container | Thermal Waste | |
| Technologies, Inc. | K982781 | |
| B-D GuardianTM | ||
| Nestable Sharps | ||
| Collectors | Becton Dickinson & Co. | K 943575 |
2
DEVICE DESCRIPTIVE INFORMATION
Product Description:
The BWCSH-1 sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is stable, puncture resistant, impact and shatter resistant, and leak-proof on the sides and bottom. The BWCSH-1 container is fitted with a rotating top, allowing safe one-handed disposal of used sharps. The container has a locking tamper resistant plastic lid that once snapped in place, cannot be manually removed. Labels are orange-red with black text and a black biohazard symbol printed on a white background. Labels are adhered to the containers at the time of manufacture with the fill line printed. The BWCSH-1 device is for single use, disposable and is not a secondary container.
The BWCSH-1 sharps container three main components are nested together to reduce storage and shipping requirements. The rotating top is made with uncolored translucent material. The translucent nature of the product allows for a visual determination of content level. The bottom of the rotating top's internal chute matches the fill line to physically prevent over filling.
The BWCSH-1 device underwent and passed performance testing that consisted of confirming its key safety and reliability aspects. The following four types of performance tests were performed:
- . Puncture Resistance Testing - According to ASTM F2132-01(2008);
- Leak-Proof Testing According to 29 CFR 1910.1030(d)(2)(viii)(c); .
- . Impact and Shatter Resistance -; According to ISO 23907:2012 and
- Stability According to 29 CFR 1910.1030(d)(4)(iii)(A)(2)(ii). .
| Product
Description | Access
opening
size | Access
opening and
closure | Overall
Size
L x W x H
(inches) | Weight
(pounds) | Capacity at
full line |
| ------------------------ | --------------------------- | ---------------------------------- | ------------------------------------------ | -------------------- | -------------------------- |
|---|
General Specification Table
3
Bradford Wright Companies, Inc.
| Component | Material | Depth
(inches) | Width
(inches) | Height
(inches) |
|---------------------|----------------------|-------------------|-------------------|--------------------|
| Canister at Top | Tinplate Steel | 4" | 10" | 8" |
| Canister Bottom | Tinplate Steel | 3" | 9" | N.A. |
| Sharps Chute closed | Molded Polypropylene | 4 ¾" | 10 ½" | 2 ¼" |
| Sharps Chute alone | Molded Polypropylene | 3 ¾" | 9 ½" | 2" |
| Top Rim | Molded Polystyrene | 4 ¾" | 10 ½" | ¼" |
| Lid Plug | Molded Polystyrene | 3 ¾" | 9 ¾" | ¾" |
| Sharps Container | Metal & Plastic | 4 ¾" | 10 ½" | 8 ¼" |
Table showing sharps container component dimensions:
BWCSH-1 Sharps Container
Revision 4 Page 7 of 40
4
PREDICATE DEVICES:
(K982781) Demolizer # 47 One-Gallon Point of Generation Sharps Container by Thermal Waste Technologies, Inc. and (K943575) B-D Guardian TM Nestable Sharps Collectors by Becton Dickinson & Co. are substantially equivalent to the applicant's BWCSH-1 Sharps Container.
| Element of
Comparison | Subject Device | Predicate Device
#1 | Predicate Device
#2 |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Bradford Wright
Companies, Inc. | Thermal Waste
Technologies, Inc. | Becton Dickinson
& Co. |
| Device Name | BWCSH-1 Sharps
Container | Demolizer # 47
One-Gallon Point
of Generation
Sharps Container | B-D Guardian™
Nestable Sharps
Collectors |
| FDA 510(k) Number | K131708 | K982781 | K943575 |
| Intended Use(s) | BWCSH-1 sharps
container is
intended to be used
for the safe disposal
of hazardous
sharps. | Intended for the
disposal of various-
sized contaminated
medical sharps
(including needles,
syringes, slides,
and ampoules) in
clinical and
laboratory
healthcare settings. | B-D sharps
containers are
intended to be used
for the safe disposal
of hazardous sharps |
| Target Population | Healthcare
professional | Healthcare
professional | Healthcare
professional |
| Where Used | Healthcare
Facilities | Intended for
clinical, nonclinical
healthcare settings
such as
laboratories,
dentists' office,
doctor's office,
corporate clinics
and nursing homes. | Healthcare
Facilities |
| Material | Polypropylene,
Polystyrene &
Tinplate steel | Tinplate steel | Polypropylene |
| Sharps Access | Sharps inserted
through the top | Sharps inserted
through the top | Sharps inserted
through the top |
| Sharps Closure | Lid is locked in
place for removal | Closure feature is
closed then locked | Flaps are closed
and locked in place |
| | | in place for
removal | for removal |
| Impact Resistance | Yes | Not tested | Yes |
| Puncture Resistance | Yes | Yes | Yes |
| Leak Proof | Yes | Yes | Yes |
| Non-sterile | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes |
| Capable of
maintaining a stable,
upright position | Yes | Not tested | Yes |
| No features to bend,
break, or shear
needle. | No Feature Present | No Feature Present | No Feature Present |
| Reusable Sharps
Containers | Labeling is "Single
Use | Labeling is "Single
Use | Labeling is "Single
Use |
| Overfill Indication | Labeled "Do Not
Fill Above This
Line" | Labeled "Do Not
Fill Above This
Line" | "Do Not Overfill"
or "Fill to this
Level Only" is
labeled or
embossed on the
container at the
location of the
overfill. Labeling
includes a "Fill
Line" |
| Clarity | Each Container has
a minimum of one
translucent
component, either
base or top | Temporary/Perman
ent Opening for
visual inspection. | Each Collector has
a minimum of one
translucent
component, either
base or top |
| Construction | Injection Molded
Lid and Rotating
top and 2 piece
seamed &glued
tinplate base | 3 piece seamed
&glued tinplate | Injection Molded
Containers, Lids
and Closure |
| Dimensions | 10.5 inches by 4.75
inches by 8.25
inches | 6.5 inches in
diameter by 8
inches | 12 inches by 13.5
inches by 6 inches |
| Fill Capacity | One US gallon | One US gallon | 7.6 Liters (2.01 US
gallons) |
Comparison table with predicate device:
BWCSH-1 Sharps Container
5
:
.
6
SUBSTANTIAL EQUIVALENCE DISCUSSION of Similarities and Differences:
The BWCSH-1 Sharps Container is similar to both the Demolizer # 47 One-Gallon Point of Generation Sharps Container and the B-D Guardian™ Nestable Sharps Collectors in:
- . Intended use
- . Target Population
- . Materials
- . Design
- t Performance testing
Intended use comparison:
The intended use of the new BWCSH-1 Sharps Container is the same as both predicate devices. BWCSH-1 sharps container is intended to be used for the safe disposal of hazardous sharps.
Design and Material Comparison:
The design and functional characteristics of the BWCSH-1 Sharps Container and both predicate devices are similar. The BWCSH-1 Sharps Container and the B-D Guardian™ Nestable Sharps Collectors predicate device's parts are nestable, whereas the Demolizer # 47 One-Gallon Point of Generation Sharps Container is not. When assembled all form a single unit. BWCSH-1 Sharps Container and the B-D Guardian™ Nestable Sharps Collectors predicate device both have features to prevent contact between user and the contents and all are designed for a visual determination of the maximum capacity. None of the devices have features that bend, break, or shear needles. BWCSH-1 Sharps Container and both predicate devices are all designed for single use by a locking feature in the lids and closure or access door. BWCSH-1 Sharps Container's lid and sharps chute as well as the B-D Guardian 101 Nestable Sharps Collectors predicate device are constructed of polymeric materials which are injection molded. The material of construction differs from the B-D Guardian™ Nestable Sharps Collectors is the BWCSH-1 Sharps Container's lower canister is made of seamed and glued tin plated steel same as the whole Demolizer # 47 One-Gallon Point of Generation Sharps Container predicate device. BWCSH-1 Sharps Container and the predicate devices all allow for a visual determination of content level.
Summary of Non-Clinical Performance Bench Testing:
Performance Standards:
The Recognition Number 6-215 identifies ASTM F2132-01 (reapproved 2008), "Standard Specifications for puncture Resistance of Materials Used for the Collection for Discarded Medical Needles and Other Sharps."
7
Bradford Wright Companies, Inc.
The Recognition Number 6-293 identifies ISO 23907 First Edition 2012-09-01. "Sharps injury protection - Requirements and test methods - Sharps containers"
The performance testing demonstrates compliance with the recognized consensus standards. ASTM F2132-01 (reapproved 2008), "Standard Specifications for puncture Resistance of Materials Used for the Collection for Discarded Medical Needles and Other Sharps" and the applicable portions of ISO 23907 First Edition 2012-09-01. "Sharps injury protection - Requirements and test methods - Sharps containers"
In addition the relevant FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(k)] Submission for Sharps Collectors dated October 1993", was used to identify applicable physical and mechanical features of the BWCSH-1 Sharps Container and predicate devices. All applicable standards have been used to show that the BWCSH-1 Sharps Container is substantially equivalent to the appropriately listed predicate devices.
The performance testing summary demonstrates substantial equivalence between the BWCSH-1 Sharps Container and the predicate devices. The BWCSH-1 Sharps Container has been tested by appropriate methods with respect to the relevant standards: FDA recognized ASTM standards F2132-01 and OSHA regulations 29 CFR Part 1910:1030. No new issues of safety and effectiveness were raised with the testing performed, and the BWCSH-1 Sharps Container is considered substantially equivalent to its predicate device.
Performance Testing (Bench) - Product Testing
The BWCSH-1 Sharps Container incorporates equivalent collector design features and performance characteristics. The results of the product performance testing demonstrated equivalent performance to the predicate device performance and no new issues were raised.
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 - Passed
Impact Resistance - Passed Based on ISO 23907:2012
Stability: - Passed
BWCSH-1 Sharps Container
Revision 4 Page 11 of 40
8
Bradford Wright Companies, Inc.
Conclusion:
The performance testing summary demonstrates substantial equivalence between the BWCSH-1 Sharps Container and the predicate devices. BWCSH-1 Sharps Container has been tested by appropriate methods with respect to the relevant standards. FDA recognized ASTM standards F2132-01. No new issues of safety and effectiveness were raised with the testing performed and the BWCSH-1 Sharps Container is considered substantially equivalent to its predicate device.
*B-D Guardian™ Nestable Sharps Collector is a registered trademark of Becton Dickinson and Company.
BWCSH-1 Sharps Container
9
Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or being supported by three abstract shapes. The logo is printed in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2014
Bradford Wright Companies, Inc. Mr. Mike DeMello President 4092 Orchard Way Lake Oswego, OR 97035
Re: K131708
Trade/Device Name: BWCSH-1 Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Sharps Container Regulatory Class: II Product Code: MMK December 31, 2013 Dated: Received: January 28, 2014
Dear Mr. DeMello:
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.
10
Page 2 - Mr. DeMello
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours.
Image /page/10/Picture/8 description: The image contains a combination of text and graphic elements. The text includes the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." There is also the acronym "DAGRID" present. The image also contains a decorative graphic element on the left side.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K131708
Device Name BWCSH-1 sharps container
Indications for Use (Describe)
The BWCSH-1 sharps container has a one-gally that is intended to be used for the safe disposal of hazardous sharps. The BWCSH-1 sharps container is metallic canister fitted with thermal plastic top and has a orange-red biohazard the containers with fill line printed on the BWCSH-1 device is for single use, disposable and is not a secondary container. BWCSH-1 sharps container dimensions are 10.5 inches in width at the top, 4.75 inches in height. BWCSH-1 sharps container weighs 1.075 pounds when empty.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . : ...
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth 2014.03.09 (
FORM FDA 3881 (9/13)