(179 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety features of a reusable sharps container, with no mention of AI or ML technology.
No
The device is a container for disposing of medical sharps waste, not for treating any medical condition.
No
The device is a container for storing and transporting medical sharps waste, not for diagnosing medical conditions.
No
The device description clearly states it is a physical container made of injection-molded polypropylene copolymer, which is a hardware component. The performance studies also focus on the physical properties and durability of the container.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "storage and transport for disposal of syringes and other medical sharps waste." This is a physical containment and management function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical characteristics of a container designed for sharps disposal. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical integrity and safety of the container (vibration resistance, impact resistance, leak resistance, puncture resistance, stacking resistance, topple resistance). These are relevant to a sharps container, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, providing diagnostic information, or any other characteristic typically associated with an IVD.
An IVD is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This sharps container does not fit that definition.
N/A
Intended Use / Indications for Use
The Stericy . Sharps Management Service Reusable Sharps Container is intentities for the storage and transport for disposal of syringes and other medical sharps waste.
The Stericycle Sharps Management Service Reusable Sharps Container is available in the following configurations:
- · 2 gallon: 6.9" x 12.3" x 13.9", Red or Yellow color
· 4 gallon: 6.9" x 12.3" x 21.9", Red or Yellow color
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
The Stericycle Sharps Management Service Reusable Sharps Container is a single piece, reusable, sharps container that is intended to be used in health care facilities where medical sharps waste is generated. The container is injection molded of polypropylene copolymer with a uniform nominal thickness of 0.125". The container is available in 2 and 4 gallon sizes and in red or yellow color. The lid of the container is constructed so that the sharps waste is disposed safely and effectively by gravitational force when the waste is placed in the inner tray. The Stericycle Sharps Containers utilize a counterbalanced lid design that acts as a protective barrier to keep sharps objects within the container from coming back up through the lid and anyone from reaching into the container to retrieve sharps waste.
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
health care 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)
The FDA has not established a performance standard for this product under Section 514. However, the Stericycle Sharps Management Service Reusable Sharps Container complies with criteria identified in FDA guidance documents. Occupational Safety and Health Administration (OSHA) standards on blood borne pathogens, as outlined in 29 CFR 1910.1030, Department of Transportation (DOT) regulations controlling the transport of regulated medical waste as outlined in 49 CFR 173.197, and has passed nonclinical performance testing as summarized in the table below.
Testing Type (each test performed on both 2- and 4-gallon Container sizes):
- Life-cycle testing: Subsequent to conditioning of units representative of reprocessing and transport of the 2- and 4-gallon Reusable Sharps Containers, the units were tested and evaluated for the following parameters:
- Vibration Resistance: ISTA 3E, Result: Pass
- Impact Resistance: The filled container maintains its integrity when dropped 4 ft. to a concrete surface and retains its solid contents., Result: Pass
- Leak Resistance: The container loses no liquid over a 24-hour period., Result: Pass
- Needle Puncture Resistance: ASTM F2132-01:2008, Result: Pass
- DOT Vibration Resistance: 49 CFR 178.608, Result: Pass
- DOT Impact Resistance: 49 CFR 178.603, Result: Pass
- DOT Stacking Resistance: 49 CFR 178.606, Result: Pass
- Topple Resistance: AS/NZS 4261:1994, Appendix D, Result: Pass
The collective results of the performance testing demonstrate that the Stericycle Sharps Management Service Reusable Sharps Container meets the established specifications necessary for consistent performance of its intended use throughout its planned lifetime and is substantially equivalent to the predicate device.
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
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER 510(k) PREMARKET NOTIFICATION
510(k) Summary
510(k) Notification K132007
GENERAL INFORMATION
Applicant:
Stericycle, Inc. 28161 Keith Drive Lake Forest, IL 60045 U.S.A. Phone: 847-943-6658 FAX: 800-593-5085
Contact Person:
Lori Adels, PhD Regulatory Consultant Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 Fax: 408-400-0865
Date Prepared: December 27, 2013
DEVICE INFORMATION
Trade Name: Stericycle Sharps Management Service Reusable Sharps Container
Generic/Common Name: Container, Sharps
Classification : 21 CFR§880.5570, Hypodermic single lumen needle. Class II
Product Code: MMK
1
510(k) SUMMARY
PREDICATE DEVICE
- Daniels Sharpsmart™ reusable sharps container (K001337) .
INTENDED USE
The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in health care facilities for the storage and transport for disposal of syringes and other medical sharps waste.
The Stericycle Sharps Management Service Reusable Sharps Container is available in the following configurations:
- 2 gallon: 6.9" x 12.3" x 13.9", Red or Yellow color .
- 4 gallon: 6.9" x 12.3" x 21.9", Red or Yellow color
PRODUCT DESCRIPTION
The Stericycle Sharps Management Service Reusable Sharps Container is a single piece, reusable, sharps container that is intended to be used in health care facilities where medical sharps waste is generated. The container is injection molded of polypropylene copolymer with a uniform nominal thickness of 0.125". The container is available in 2 and 4 gallon sizes and in red or yellow color. The lid of the container is constructed so that the sharps waste is disposed safely and effectively by gravitational force when the waste is placed in the inner tray. The Stericycle Sharps Containers utilize a counterbalanced lid design that acts as a protective barrier to keep sharps objects within the container from coming back up through the lid and anyone from reaching into the container to retrieve sharps waste.
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Stericycle Sharps Management Service Reusable Sharps Container are similar to the predicate device. Performance data are provided to support the determination of substantial equivalence.
SUBSTANTIAL EQUIVALENCE
The intended use for the predicate device is substantially equivalent to the proposed intended use of the Stericycle Sharps Management Service Reusable Sharps Container. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Stericycle Sharps Management Service Reusable Sharps Container is substantially equivalent to the predicate device. Details are provided in the following table.
2
STERICYCLE, INC.
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER
510(k) PREMARKET NOTIFICATION
:
510(k) Summary
| Feature | Stericycle Sharps Management
Service Reusable Sharps Container | Daniels Sharpsmarttm
reusable sharps container |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K132007 | K001337 |
| Indications for Use | Stericycle Sharps Management Service
Reusable Sharps Container is intended
for use in health care facilities for the
storage and transport for disposal of
syringes and other medical sharps waste. | Reusable containers intended to be
used for the disposal of
contaminated medical sharps in
health care facilities. |
| Classification/
Product Code | MMK | MMK |
| Regulation Number | 21 CFR§880.5570,
Hypodermic single lumen needle | 21 CFR§880.5570,
Hypodermic single lumen needle |
| Container
Material | Polypropylene copolymer | Polypropylene copolymer |
| Material Thickness | 0.125" (nominal) | Not available |
| Volume
(Fill Capacity) | 2 gallons
4 gallons | S14: 7.0 quarts (1.8 gallons)
S22: 15.5 quarts (3.9 gallons)
S32: 25.0 quarts (6.3 gallons) |
| Dimensions
(L x W x H) | 2 Gallon: 12.3" x 6.9" x 13.9"
4 Gallon: 12.3" x 6.9" x 21.9" | S14: 13.5" x 6.6" x 11.0"
S22: 13.5" x 6.6" x 17.3" |
| Intended Location
of Use | Health care facilities | Health care facilities |
| Biohazard Waning
Label | Labeled as Biohazard in Fluorescent
orange or orange-red with lettering in
contrasting color | Labeled as Biohazard in Fluorescent
orange or orange-red with lettering
in contrasting color |
| Sharps access and
closure | Gravity-activated | Gravity-activated |
| Closable | Yes | Yes |
| Puncture Resistant | Yes [Test method: ASTM F2132-01
(2008)] | Information not available. |
| Leakproof on Sides
and Bottom | Yes | Yes |
| Impact Resistant | Yes | Yes |
| Vibration Resistant | Yes | Yes |
| Stacking Resistant | Yes | Yes |
| Capable of
maintaining stable,
upright position | Yes | Yes |
| No feature to bend,
break, or shear
needles | No feature | No feature |
| Unwinders | No feature that would recap, remove, or
unwind needle of the hub. | No feature that would recap, remove,
or unwind needle of the hub. |
| Reusable or
Non-reusable | Reusable | Reusable |
| Feature | Stericycle Sharps Management
Service Reusable Sharps Container | Daniels Sharpsmart™
reusable sharps container |
| Performance
Standards | • American Society for Testing and
Materials (ASTM) Consensus
Standards for Puncture Resistance
(ASTM F2132-01:2008) | • Australian/New Zealand Standard
for Reusable containers for
collection of sharp items
(AS/NZS 4261:1994) |
| | • Australian/New Zealand Standard for
Reusable containers for collection of
sharp items (AS/NZS 4261:1994) | • Department of Transportation
(DOT) regulations
(49 CFR 173.197) |
| | • Department of Transportation (DOT)
regulations (49 CFR 173.197) | • Occupational Safety and Health
Administration (OSHA)
bloodborne pathogen standards
(29 CFR 1910.1030) |
| | • Occupational Safety and Health
Administration (OSHA) bloodborne
pathogen standards (29 CFR
1910.1030) | (29 CFR 1910.1030) |
| Features for safe | • Secure closure and puncture resistance | • Secure closure and puncture |
| transport and
re-use | for transport
• Container is permanently marked for
reuse | resistance for transport
• Container is permanently marked
for reuse |
| | • Container is disinfected by Stericycle
prior to reuse | • Container is disinfected prior to
reuse |
| | • Container volume is between 2 and
40 gallons in volume (49 CFR
173.197) | • Container volume is between 2 and
40 gallons in volume (49 CFR
173.197) |
3
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER 510(k) PREMARKET NOTIFICATION
510(k) Summary
4
510(k) SUMMARY
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
The FDA has not established a performance standard for this product under Section 514. However, the Stericycle Sharps Management Service Reusable Sharps Container complies with criteria identified in FDA guidance documents. Occupational Safety and Health Administration (OSHA) standards on blood borne pathogens, as outlined in 29 CFR 1910.1030, Department of Transportation (DOT) regulations controlling the transport of regulated medical waste as outlined in 49 CFR 173.197, and has passed nonclinical performance testing as summarized in the table below.
| Testing Type
(each test performed on both
2- and 4-gallon Container
| sizes) | Test Standard / Description | Result |
|---|---|---|
| Life-cycle testing | Subsequent to conditioning of units representative of reprocessing and | |
| transport of the 2- and 4-gallon Reusable Sharps Containers, the units | ||
| were tested and evaluated for the following parameters: | ||
| • Vibration Resistance | ISTA 3E | Pass |
| • Impact Resistance | The filled container maintains its integrity | |
| when dropped 4 ft. to a concrete surface and | ||
| retains its solid contents. | Pass | |
| • Leak Resistance | The container loses no liquid over a 24-hour | |
| period. | Pass | |
| • Needle Puncture Resistance | ASTM F2132-01:2008 | Pass |
| DOT Vibration Resistance | 49 CFR 178.608 | Pass |
| DOT Impact Resistance | 49 CFR 178.603 | Pass |
| DOT Stacking Resistance | 49 CFR 178.606 | Pass |
| Topple Resistance | AS/NZS 4261:1994, Appendix D | Pass |
The collective results of the performance testing demonstrate that the Stericycle Sharps Management Service Reusable Sharps Container meets the established specifications necessary for consistent performance of its intended use throughout its planned lifetime and is substantially equivalent to the predicate device.
CONCLUSION
The Stericycle Sharps Management Service Reusable Sharps Container shares its design and mechanism of action with the identified predicate device. The results of the bench testing confirm that the Stericycle Sharps Management Service Reusable Sharps Container functions to its specifications, performs as intended, and exhibits the appropriate characteristics of a sharps container. The Stericycle Sharps Management Service Reusable Sharps Container is substantially equivalent to the predicate device in terms of technological characteristics, intended use, and performance. No new issues of safety or effectiveness are raised by the Stericycle Sharps Management Service Reusable Sharps Container.
5
STERICYCLE, INC.
STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAINER 510(k) PREMARKET NOTIFICATION
510(k) Summary
SUMMARY
The Stericycle Sharps Management Service Reusable Sharps Container is substantially equivalent to the predicate device.
6
Image /page/6/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a symbol that resembles a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2013
Experien Group, LLC C/O Dr. Ms. Lori Adels Regulatory Consultant Stericycle, Incorporated 755 North Mathilda Avenue, Suite 100 SUNNYVALE CA 94085
Re: K132007
Trade/Device Name: Stericycle Sharps Management Service Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: MMK Dated: December 3, 2013 Received: December 4, 2013
Dear Dr Adels:
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.
7
Page 2 - Dr. Adels
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 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/ReportalProblem/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/7/Picture/7 description: The image shows the words "Kwame O. Ulmer S.A." in a bold, sans-serif font. The letters are arranged in two lines, with "Kwame" on the top line and "Ulmer" on the bottom line. The letters "O" and "S" are slightly smaller than the other letters. The letters "E.U.L.M.E.R.S.A" are stylized with a dotted pattern.
for
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
8
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) K132007
・
Device Name
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Stericycle Sharps Management Service Reusable Sharps Container
Indications for Use (Describe)
The Stericy . Sharps Management Service Reusable Sharps Container is intentities for the storage and transport for disposal of syringes and other medical sharps waste.
The Stericycle Sharps Management Service Reusable Sharps Container is available in the following configurations:
- · 2 gallon: 6.9" x 12.3" x 13.9", Red or Yellow color
· 4 gallon: 6.9" x 12.3" x 21.9", Red or Yellow color
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X 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)
Sreekanth
Gutala -S
Digitally signed by Sreekanth Gutala -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=200054049
cn=Sreekanth Gutala -S
Date: 2013.12.26 14:48:34 -05'00'
| FORM FDA 3881 (9/13) | Page 1 of 4 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |