(85 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and safety features of a reusable sharps container, with no mention of AI or ML technology.
No
The device is a container for collecting and transporting contaminated sharps and does not provide any therapeutic benefit to a patient.
No
The device is a reusable sharps container intended for the collection and transportation of contaminated sharps. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical container made of a container body, lid, chute, and flusher insert. The performance studies also focus on physical properties like puncture resistance, leak resistance, and drop tests, which are characteristic of a hardware device. There is no mention of software components or functionality.
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 "collection and transportation of contaminated sharps" and "used medical sharps." This is a physical containment and disposal function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details a physical container with features for safe disposal and transportation. There is no mention of reagents, assays, or any process that analyzes a biological sample to provide diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific substances or markers
- Providing information for diagnosis, monitoring, or treatment decisions
- Use of reagents or analytical methods
The device is a medical device, specifically a sharps container, but its function is related to waste management and safety, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
80 MMK
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.
When the contents reach the fill line the flusher and lid are engaged into the final secured position.
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 workers in hospitals, clinics, physician offices, dental offices, laboratories, veterinarian offices, and other areas where sharps disposal is needed.
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 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.
Life-cycle testing: Test Standard - CSA Z316.6-07, Clause 6.2, Results - Passed
Vibration testing: Test Standard - 49 CFR 178.608, Results - Passed
Puncture resistance: Test Standard - ASTM F 2132-01, Results - Passed
Leak resistance: Test Standard - Health Devices, Aug-Sept 1993, ECRI, Vol. 22 Nos. 8-9, Results - Passed
Final closure: Test Standard - 49 CFR 178.608, 49 CFR 178.603, 49 CFR 178.606, Results - Passed
Stability testing: Test Standard - AS/NZS 4261:1994 Appendix D, Results - Passed
Handle strength: Test Standard - AS/NZS 4261:1994 Appendix A, Results - Passed
Fill Capacity: Test Standard - CSA Z316.6-07, Clause 6.2.3 and Rehrig Design Verification, Results - Passed
Drop Test (Impact Resistance Test): Test Standard - 49 CFR 178.603, Results - Passed
Stack testing: Test Standard - 49 CFR 178.606, Results - Passed
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
| 510(k) Summary | |
|---|---|
| (21 CFR 807.92) |
JUL 1 2 2013
| Manufacturers Name: | Rehrig Healthcare Systems |
|---|---|
| Official Contact: | Cindy Meissen |
| New Market Development Manager | |
| Rehrig Pacific Company | |
| 1000 Raco Court | |
| Lawrenceville, GA 30046 | |
| (678) 252-2273 | |
| Consultant: | David Olmstead |
| Radnor Group (for Rehrig Pacific) | |
| 614 Hunters Lane | |
| Brentwood, TN 37027 | |
| dco_radnorgroup@comcast.net | |
| 615-210-4698 | |
| 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 II |
| Product Code: 80 MMK | |
| 21 CFR 880.5570 | |
| Predicate Device: | K083511 |
| Industrial 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 178.608 | |
| 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 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
| Design
Performance
Feature | New Rehrig Device
SharpsTankTM | Predicate Device
K083511 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Reusable sharps containers
intended to be used for the
collection and transport of
contaminated sharps and
regulated medical waste. | Reusable sharps containers
intended to be used for the
collection and transport of
contaminated sharps and
regulated medical waste. |
| Drop Test (Impact
Resistance) | Yes | Yes |
| Puncture Resistant | Yes | Yes |
| Overfill detection | Yes | Yes |
| Leak proof on sides
and 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 the
container |
| 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