(143 days)
Not Found
No
The device description details a physical sharps container with mechanical features, and there is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML.
No.
The device is a sharps container/disposal system, designed for collecting and disposing of sharps. It does not treat or cure any medical condition.
No
Explanation: The device is described as a "sharps container/disposal system" used for collecting and disposing of medical sharps. Its purpose is containment, not the diagnosis or detection of medical conditions or diseases.
No
The device description clearly details a physical container made of polypropylene plastic with various assembled components, indicating it is a hardware device for sharps disposal.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "sharps container/disposal system" for collecting sharps prior to final disposal. This is a physical containment and disposal function, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description focuses on the physical characteristics of the container (materials, size, opening mechanism, safety features) and its function in collecting sharps. There is no mention of reagents, assays, or any process that would involve testing biological specimens.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
The device is a medical device used for the safe handling and disposal of medical waste (sharps), which is a different category than an IVD.
N/A
Intended Use / Indications for Use
The intended use of this device is to contain used sharps in a puncture resistant container in order to aid the reduction of accidental needlestick injuries.
The Point of Use II Sharps-A-Gator" can be used in any area requiring discarding prior of sharps prior to their final disposal. e g operating room, doctor's office. pediatrics, patient's room, etc.
The Point of Use II Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc
The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.
Product codes
80FMI
Device Description
- Devon's Point of Use II Sharps-A-Gator" wil: be used as a single use only container . for sharps collection/disposal.
- The Point of Use II Sharps-A-Gator® comes in 2 3 -7- 5 gallon and 2.8 +/- 5 gallon . containers. Both container buckets are available in clear. translucent and opaque color versions.
- . The top housing assembly and base are made of polypropylene plastic material and processed through injection molding.
- . The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user.
- . The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit.
- . The Point of Use II Sharps-A-Gator" has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to "flush" sharps that lodge in the tortuous path without reaching into the container
- . The Point of Use II Sharps-A-Gator® moving tortuous path restricts hand entry.
- The Point of Use II Sharps-A-Gator" is made with heavy metal free materials that . are safe to incinerate and autoclave.
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
Not Found
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 following tests assure safety and effectiveness of Graphic Controls, Devon Products Point of Use II Sharps-A-Gator"
- Puncture Resistance test following ASTM Draft # 17 .
- Functional Drop test based on ECRI's guidelines .
- Leak Resistance and Stability based on OSHA 1910 1030 Blood Pathogens Standards requirement
- ln-house assembly and wall thickness verification tests during manufacturing .
- Functional tests during manufacturing +
- Qualifying tests for moving tortuous path .
Point of Use II Sharps-A-Gator" complies with all acceptance criteria listed above
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Point of Use Sharps-A-Gator", Sage In-Room and Sharpstar Disposal System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image shows a stylized letter 'g' in white against a black circular background. The letter 'g' is in a cursive font. The letters 'TM' are in the bottom right corner of the circle.
Graphic Controls
ನ | ()( K ) Summary
. .
510(K) SUMMARY POINT OF USE II SHARPS-A-GATOR®
:
| Date: | October 20, 1996 |
|---|---|
| Manufacturer: | Graphic Controls. Devor Products |
| 9530 DeSoto Avenue | |
| Chatsworth. CA 91311 | |
| Registration # 2020423 | |
| Graphic Controls Devor Products | |
| 456 Lakeshore Drive | |
| Rock Hill, SC 29730 | |
| Registration # 1062224 | |
| Owner/Operator: | Graphic Controls Corporation |
| P.O. Box 1271 | |
| 189 Van Rennselear Street | |
| Buffalo, NY 14240-1271 | |
| Registration # 13-7188 | |
| Contact Person: | George Austria |
| Quality Assurance Manager | |
| Graphic Controls. Devon Products | |
| 9530 DeSoto Avenue | |
| Chatsworth, CA 91311 | |
| Tel. # 818-709-6880 extension 207 | |
| Device Trade Name: | Point of Use II Sharps--Gator™ |
| Common Name: | Sharps Collection/Disposal System |
| Classification Name : | Accessory to Hypodermic Needle, Class II |
Devon
OR Products &
Safety Solutions
1
Page 2 of 4 510(K ; Summary
Regulatory Reference: 80FMI
Predicate Device: Point of Use Sharps-A-Gator" Sage In-Room and Sharpstar Disposal System
Description:
- Devon's Point of Use II Sharps-A-Gator" wil: be used as a single use only container . for sharps collection/disposal.
- The Point of Use II Sharps-A-Gator® comes in 2 3 -7- 5 gallon and 2.8 +/- 5 gallon . containers. Both container buckets are available in clear. translucent and opaque color versions.
- . The top housing assembly and base are made of polypropylene plastic material and processed through injection molding.
- . The top cover includes the top cover housing, moving tortuous path with an actuator, a flapper and a lid. These components are assembled during the manufacturing process. The base is joined with the top cover assembly by the end user.
- . The assembled container can be secured to a locking bracket or into a cabinet, or used as a free standing unit.
- . The Point of Use II Sharps-A-Gator" has a horizontal top load opening and a moving tortuous path with an actuator that enable the user to "flush" sharps that lodge in the tortuous path without reaching into the container
- . The Point of Use II Sharps-A-Gator® moving tortuous path restricts hand entry.
- The Point of Use II Sharps-A-Gator" is made with heavy metal free materials that . are safe to incinerate and autoclave.
Intended Use:
- . The intended use of this device is to contain used sharps in a puncture resistant container in order to aid the reduction of accidental needlestick injuries.
- . The Point of Use II Sharps-A-Gator" can be used in any area requiring discarding prior of sharps prior to their final disposal. e g operating room, doctor's office. pediatrics, patient's room, etc.
Physical/Technical Comparison:
SIMILARITIES:
Point of Use II Sharps-A Gator" (New Device) and Point of Use Sharps-a-Gator" (Predicate Device)
- . have the same intended use
- are manufactured through injection molding .
2
Page 3 of 4 >10(K · Summary
- are made with the same polypropylene materials that contain no heavy metals and ● are safe to incinerate and autoclave
- are both designed with comparable wall thickness .
- are both puncture resistant per ASTM's draft # 17 requirements .
- are both labeled in accordance with OSHA requirements .
- both feature one hand, one step sharps disposing .
- both feature a tortuous path that impedes hand entry �
- both may be used as either wall mounted or floor standing models .
- both have a clear top with clear or opaque base containers .
Point of Use II Sharps-A-Gator" (New Device) and Sage In-Room and Sharpstar sharps disposal system (Predicate Device)
- . have the same intended use
- feature horizontal loading disposal .
- both feature a moving tortuous path that restricts hand entry .
- both feature an override system that enables the user to flush sharps into the . container sharps that may lodge in the tortuous path
- both have the same intended use .
- both have clear top assemblies .
DIFFERENCES
Point of Use II Sharps-A-Gator" (New Device) and Point of Use Sharps-A-Gator" (Predicate Device)
- The new device features a moving tortuous path with an actuator that enables the . user to flush sharps that may lodge in the tortuous path
- The moving tortuous path and flapper of the new device closes the top opening . when sharps are dropped into container
- The new device features no needle unwinder The predicate device features a . manual needle unwinder
The Point of Use II Sharps-A-Gator" (New Device) and Sage In-Room and Sharpstar sharps disposal system (Predicate Device)
- The new device features horizontal top loading disposal while the predicate device . features horizontal front loading disposal
Performance Summary
The following tests assure safety and effectiveness of Graphic Controls, Devon Products Point of Use II Sharps-A-Gator"
- Puncture Resistance test following ASTM Draft # 17 .
- Functional Drop test based on ECRI's guidelines .
3
-
· Leak Resistance and Stability based on OSHA 1910 1030 Blood Pathogens Standards requirement
11 - 1 - 1 - 1 - 1 - 1 - 1 - -
ln-house assembly and wall thickness verification tests during manufacturing .
-
Functional tests during manufacturing +
-
Qualifying tests for moving tortuous path .
Point of Use II Sharps-A-Gator" complies with all acceptance criteria listed above
4
Page 1 of 1
510(K) Number(if known) _ 5 964 387
Device Name; Point of Use II Sharps-A-Gator®
Indication For Use:
The Point of Use II Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc
The Point Of Use II Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE UN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use_