(85 days)
Rehrig Healthcare Systems SharpsTank™ reusable sharps containers are intended to be used for the collection and transportation of contaminated sharps.
Rehrig Healthcare's reusable 4.9 gallon sharps containers are intended to be used for the collection and transportation of used medical sharps. The containers are intended to be used by healthcare workers in hospitals, clinics, physician offices, dental offices, laboratories, veterinarian offices, and other areas where sharps disposal is needed.
A 4.9 gallon reusable sharps container consisting of the container body, an integrated hinged lid, a torturous path mail chute and flusher insert.
Sharps are deposited into the container by placing the used sharps in the horizontal torturous path mail chute which allows the sharps to drop into the container while keeping fingers and hands away from direct access to the contents in the container. During use the containers can be placed in the optional counter top holder or in the optional wall brackets.
When the contents reach the fill line the flusher and lid are engaged into the final secured position.
The SharpsTank™ Reusable Sharps Container underwent performance testing to demonstrate its safety and effectiveness.
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Criteria | Test Standard | Acceptance Criteria Met (Results) |
|---|---|---|
| Life-cycle testing | CSA Z316.6-07, Clause 6.2 | Passed |
| Vibration testing | 49 CFR 178.608 | Passed |
| Puncture resistance | ASTM F 2132-01 | Passed |
| Leak resistance | Health Devices, Aug-Sept 1993, ECRI, Vol. 22 Nos. 8-9 | Passed |
| Final closure | 49 CFR 178.608, 49 CFR 178.603, 49 CFR 178.606 | Passed |
| Stability testing | AS/NZS 4261:1994 Appendix D | Passed |
| Handle strength | AS/NZS 4261:1994 Appendix A | Passed |
| Fill Capacity | CSA Z316.6-07, Clause 6.2.3 and Rehrig Design Verification | Passed |
| Drop Test (Impact Resistance) | 49 CFR 178.603 | Passed |
| Stack testing | 49 CFR 178.606 | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in terms of patient data or clinical samples. The testing described is for the physical and functional aspects of the container itself, following established engineering and safety standards. Therefore, the "sample size" would refer to the number of containers or components tested for each specific criterion. The document does not explicitly state the number of units tested for each standard.
The data provenance is not applicable in the context of typical clinical studies (e.g., country of origin, retrospective/prospective clinical data) as this pertains to the engineering and regulatory compliance testing of a medical device (sharps container). The standards cited are international (CSA, ASTM, AS/NZS) and US federal regulations (CFR).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided because the "ground truth" for this type of device (a sharps container) is defined by its ability to meet objective, quantifiable engineering and safety standards. Expert consensus, as typically understood in medical imaging or diagnostics, is not relevant for determining if a container is puncture-resistant or leak-proof. The ground truth is established by the specified criteria in each test standard.
4. Adjudication Method for the Test Set:
Not applicable. The performance is determined by passing or failing the objective criteria outlined in each specified test standard, not through an adjudication process involving human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or screening devices where human readers interpret medical data (e.g., images) with and without AI assistance. The SharpsTank™ is a physical medical device (reusable sharps container), not a diagnostic or AI-powered interpretative system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical container, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device's performance testing is adherence to established national and international engineering and safety standards. This includes:
- Engineering Standards: CSA Z316.6-07, ASTM F 2132-01, AS/NZS 4261:1994.
- Federal Regulations: 49 CFR 178.608, 49 CFR 178.603, 49 CFR 178.606.
- Industry Guidance: Health Devices, ECRI.
These standards define the objective performance levels required for attributes like puncture resistance, leak resistance, stability, and impact resistance.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of this device. The SharpsTank™ is a physical product, not an AI or machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
| 510(k) Summary | |
|---|---|
| (21 CFR 807.92) |
JUL 1 2 2013
| Manufacturers Name: | Rehrig Healthcare Systems |
|---|---|
| Official Contact: | Cindy MeissenNew Market Development ManagerRehrig Pacific Company1000 Raco CourtLawrenceville, GA 30046(678) 252-2273 |
| Consultant: | David OlmsteadRadnor Group (for Rehrig Pacific)614 Hunters LaneBrentwood, TN 37027dco_radnorgroup@comcast.net615-210-4698 |
| Device Trade Name: | SharpsTank TM Reusable Sharps Container |
| Device Common Name: | Reusable sharps container |
| Device Classification Name: | Accessory to hypodermic single lumen needle |
| Device Classification: | Class IIProduct Code: 80 MMK21 CFR 880.5570 |
| Predicate Device: | K083511Industrial Water Solutions, Inc. (Sharpsology)Enviro Sharp Solutions 3, reusable sharps container |
Intended Use:
Rehrig Healthcare Systems SharpsTank™ reusable sharps containers are intended to be used for the collection and transportation of contaminated sharps.
Device Description:
A 4.9 gallon reusable sharps container consisting of the container body, an integrated hinged lid, a torturous path mail chute and flusher insert.
Sharps are deposited into the container by placing the used sharps in the horizontal torturous path mail chute which allows the sharps to drop into the container while keeping fingers and hands away from direct access to the contents in the container. During use the containers can be placed in the optional counter top holder or in the optional wall brackets.
{1}------------------------------------------------
When the contents reach the fill line the flusher and lid are engaged into the final secured position.
Performance Testing:
The FDA has not established a performance standard for this product under Section 514. However, the Rehrig Sharps Tank containers comply with criteria identified in FDA guidance document, OSHA blood borne pathogens regulations and Department of Transportation regulations for transporting regulated medical waste.
| Performance Criteria | Test Standard | Results |
|---|---|---|
| Life-cycle testing | CSA Z316.6-07, Clause 6.2 | Passed |
| Vibration testing | 49 CFR 178.608 | Passed |
| Puncture resistance | ASTM F 2132-01 | Passed |
| Leak resistance | Health Devices, Aug-Sept 1993,ECRI, Vol. 22 Nos. 8-9 | Passed |
| Final closure | 49 CFR 178.60849 CFR 178.60349 CFR 178.606 | Passed |
| Stability testing | AS/NZS 4261:1994 Appendix D | Passed |
| Handle strength | AS/NZS 4261:1994 Appendix A | Passed |
| Fill Capacity | CSA Z316.6-07, Clause 6.2.3 andRehrig Design Verification | Passed |
| Drop Test (ImpactResistance Test) | 49 CFR 178.603 | Passed |
| Stack testing | 49 CFR 178.606 | Passed |
Summary of Substantial Equivalence:
The design and functional characteristics of the SharpsTank™ and the predicate device are similar as indicated in the predicate device comparison table below. Both the Rehrig device and the predicate device reusable sharps containers are molded from polymeric materials, and conform to national and/or international standards for puncture resistance, leakage, stability, impact resistance, and life cycle testing.
The Rehrig Pacific SharpsTank™ reusable/disposable sharps container introduces no new questions concerning the safety or effectiveness and performs as well as or better than the predicate device. Therefore, the Rehrig Pacific SharpsTank™ is substantially equivalent to the predicate device (K083511).
{2}------------------------------------------------
| DesignPerformanceFeature | New Rehrig DeviceSharpsTankTM | Predicate DeviceK083511 |
|---|---|---|
| Indications for Use | Reusable sharps containersintended to be used for thecollection and transport ofcontaminated sharps andregulated medical waste. | Reusable sharps containersintended to be used for thecollection and transport ofcontaminated sharps andregulated medical waste. |
| Drop Test (ImpactResistance) | Yes | Yes |
| Puncture Resistant | Yes | Yes |
| Overfill detection | Yes | Yes |
| Leak proof on sidesand bottom | Yes | Yes |
| Closable | Yes | Yes |
| Stable | Yes | Unknown |
| Access | Torturous path | Torturous path |
| Mounting accessory | Available | Available |
| Handling | Handle on the closed lid | Handles on the sides of thecontainer |
| Capacity | 4.9 gallon | 3 gallon |
| Orange label with"BIOHAZARD"warning | Yes | Yes |
| Life-cycle testing | Yes | Yes |
| Life-cycle tracking | Bar code on label | Bar code on label |
| Target Population | Healthcare professionals | Healthcare professionals |
| Reusable | Yes | Yes |
| Material | Plastic | Plastic |
Predicate Device Substantial Equivalence Comparison
:
.
24
·
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 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 an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.
July 12, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Rehrig Pacific Company C/O Mr. David Olmstead The Radnor Group 614 Hunters Lane BRENTWOOD TN 37027
Re: K131087
Trade/Device Name: SharpsTank™ Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hyperdermic single lumen needle Regulatory Class: II Product Code: MMK Dated: April 26, 2013 Received: April 30, 2013
Dear Mr. Olmstead:
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.
{4}------------------------------------------------
Page 2 - Mr. Olmstead
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 of medical devicerelated 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/Resourcesfor You/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/delault: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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Tejashri P
Clinical De
DAGRID
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
FOR
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
K131087 510(k) Number: Not yet assigned
SharpsTankTM Reusable Sharps Container Device Name:
Device Part (Model) Number: Model TS
Indications for Use:
Rehrig Healthcare's reusable 4.9 gallon sharps containers are intended to be used for the collection and transportation of used medical sharps. The containers are intended to be used by healthcare workers in hospitals, clinics, physician offices, dental offices, laboratories, veterinarian offices, and other areas where sharps disposal is needed.
Empty Weight:
5.66 lbs.
Dimensions:
Assembled Container:
15.14"Lx 7.48"W x 19.96"H
Color: Transparent tan with red/orange red label and contrasting Biohazard Symbol
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabe 2013.07 04'00'
(Division Sign-Off) (Division of Anestheslology, General Hospital Division Control, Dental Devices
510(k) Number,
20
§ 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).