(139 days)
Not Found
No
The device is a simple aluminum container for sharps disposal and the summary contains no mention of AI or ML.
No.
This device is a sharps container designed to safely store and transport used needles and syringes, preventing accidental punctures. Its purpose is to mitigate risk for law enforcement officials encountering sharps, rather than to treat, diagnose, or cure a disease or condition for a patient.
No
The device description clearly describes a physical aluminum container for sharps disposal, not a software product.
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 containment and disposal of sharps (needles and syringes) encountered by Law Enforcement Officials. This is a physical containment and disposal function, not a diagnostic test performed on biological samples.
- Device Description: The device is a physical container designed for holding and disposing of sharps. It does not involve any reagents, assays, or procedures for analyzing biological specimens.
- Lack of IVD Characteristics: The description 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 analytes
- Diagnosis, monitoring, or screening of diseases or conditions
- Use of reagents or test kits
The device is clearly a sharps container, which falls under a different regulatory category than IVDs. The performance studies described relate to the physical integrity and puncture resistance of the container, not the accuracy or reliability of a diagnostic test.
N/A
Intended Use / Indications for Use
This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently ancounter syringes and other sharps during searches of suspects, vahicles, property or location.
Product codes
Not Found
Device Description
A ans piece aluminum container designed for the wate and examinated needles and syringes. Container is designed of thin walled puncture resistant 6081 aluminum with a screw on leak proof lld. Container is designed to held up to two (2) 1cc syringes and is completely disposable in accordance with local and state regulations.
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
Law Enforcement Agencies, Law Enforcement Officials
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
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Summary of Performance Studies
6081 aluminum has a shear rate of 2000 PSI with a wall thickness of .007 and a bases of .cz, it would take 3 lbs of direct pressure for a needle to penetrate this container. Test were designed to demonstrate when a 1cc Insulin avringe with a .5 inch needle of .014 OD thickness collabes. It was found that in every altuation that the needle bent when .632 ounces and broke at .7 oz of direct pressure was applied. At this amount of oresure it was deternined that the needle would not pensiver. Needles are also placed in the container in an upright posture placing the sharp at the container.
A shake test at 10 revolutions showed that the needles were completely bont but, allowed no penetration through the sides or the bottom of the container.
Key Metrics
Not Found
Predicate Device(s)
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
K 963830
FEB 1 0 1997
510(k) Summary
Imagination Medical Inc. Company: 12856 Philips Highway Jacksonville Fi. 32256 (904) 266-6631
Mr. Gary Burdette Cantact:
Device Name: SC001 Shares Container
Common Name: Sharps Container
Classification Name: 21 CFR 880. Type II
Date of Summary Submission: December 9, 1996
Predicats Devices:
The SC001 is compared to the below mentioned containers to the same standards as its predicates. This container is made from aluminum with a water tight acrow on lid. The mature resistant. The aredicate devices are maded plastic compared to our product which is nade of 6081 aluminum. Beth companison models have tight fitting plastic lide and are disposal. Our product has a aluminum ecrew on lid which is tight fitting and prevents leakage of the contents.
Testing:
6081 aluminum has a shear rate of 2000 PSI with a wall thickness of .007 and a bases of .cz, it would take 3 lbs of direct pressure for a needle to penetrate this container. Test were designed to demonstrate when a 1cc Insulin avringe with a .5 inch needle of .014 OD thickness collabes. It was found that in every altuation that the needle bent when .632 ounces and broke at .7 oz of direct pressure was applied. At this amount of oresure it was deternined that the needle would not pensiver. Needles are also placed in the container in an upright posture placing the sharp at the container.
A shake test at 10 revolutions showed that the needles were completely bont but, allowed no penetration through the sides or the bottom of the container.
In conclusion it is felt that our product meets and exceeds the standards adopted by FDA and is substantially equivalent to other legally marketed sharps containers.
1
Description of Device;
A ans piece aluminum container designed for the wate and examinated needles and syringes. Container is designed of thin walled puncture resistant 6081 aluminum with a screw on leak proof lld. Container is designed to held up to two (2) 1cc syringes and is completely disposable in accordance with local and state regulations.
Intent for Use:
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This container is for use by Law Enforcement Agencies. Law Enforcement Officials who frequently ancounter syringes and other sharps during searches of suspects, vahicles, property or location.