(147 days)
Ecoship Disposable Sharps Container is intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal of hazardous sharps. The single-use device is intended for "Overthe-Counter" use. The container is eventually disposed of through a mail-back system or otherwise in accordance with local regulations. The manufacturer's bracket is required if the device is used on medication carts or in emergency vehicles.
Ecoship Disposable Sharps Containers are single-use sharps containers designed for point-first disposal of sharps. The containers are intended for over-the-counter use for the safe disposal of sharps, i.e. articles that can penetrate human skin. This definition includes, but is not limited to needles, scalpels, syringes with needles, disposable scissors, suture needles, stylets, trocars and broken test tubes. The containers are intended to be used in supervised areas of human and veterinary healthcare facilities. These areas may include nursing stations, laboratories, dental offices, physician offices, clinics, emergency rooms, surgical rooms, treatment rooms, research facilities, veterinarian practices and other small quantity waste generators. The devices are also intended to be used in healthcare facility mail-back programs and in home healthcare by clinical staff.
Two Ecoship Disposable Sharps Container models are described in this submission:
- D2-ES is 2 liters with fill capacity of 1.5 liters .
- o Tare: 192 grams (6.77 oz)
- o Dimensions: (L) 142 mm x (W) 142 mm x (H) 151 mm
- D4-ES is 4 liters with fill capacity of 3 liters .
- o Tare: 304 grams (10.72 oz)
- Dimensions: (L) 142 mm x (W) 142 mm x (H) 303 mm o
The document provided is a 510(k) summary for the Ecoship Disposable Sharps Container, filed by Daniels Sharpsmart, Inc. This summary outlines the device's intended use, description, equivalence to marketed devices, and performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Method (Reference Standard) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Puncture Resistance (CSA Z316.6-07) | Force required to puncture container sections > 20 N | Met: Puncture resistance of each section was greater than 20 N. |
| Toppling Resistance (CSA Z316.6-07) | Container remains standing after tilting to a 15° angle. | Met: Container remained standing after being tilted to a 15° angle with nominal capacity of representative sharps material. |
| Toppling Resistance (ISO 23907) | Container does not slide and remains standing after tilting to a 15° angle. | Met: Container did not slide and remained standing after being tilted to a 15° angle using worst-case challenge configurations with nominal capacity of representative sharps material. |
| Impact Resistance (CSA Z316.6-07) | Containers do not rupture, tear, crack, open, or leak after dropping from ≥ 1 meter. | Met: Five containers did not rupture, tear, crack, open, or leak when conditioned at 23°C and dropped in a specific orientation from a height of no less than 1 meter. |
| Cold Impact Resistance (CSA Z316.6-07) | Containers do not rupture, tear, crack, open, or leak after dropping from ≥ 1.2 meters at -18°C. | Met: Five containers did not rupture, tear, crack, open, or leak when conditioned at -18°C and dropped in a specific orientation from a height of no less than 1.2 meters. |
| Handle Strength (CSA Z316.6-07) | Container remains intact, and handle does not rupture, tear, crack, or separate for 1 hour. | Met: Container remained intact and the handle did not rupture, tear, crack, or separate from the container after suspending for 1 hour with nominal capacity of material (bulk density 1 kg/liter). |
| Drop Test (UN Recommendations on the Transport of Dangerous Goods – Model Regulations, Part 6) | Containers are not damaged after dropping from ≥ 1.2 meters at -18°C. | Met: Six containers were not damaged when conditioned at -18°C and dropped in one of two specific orientations from a height of no less than 1.2 meters, filled to 95% capacity with polycarbonate granules. |
| Stacking Test (UN Recommendations on the Transport of Dangerous Goods – Model Regulations, Part 6) | Containers are not damaged after being stacked with an 81 kg mass for 24 hours. | Met: Three empty containers were not damaged after an 81 kg mass was applied to the top of the stack for 24 hours at room temperature. |
| Vibration Test (49 CFR Part 178.608) | Containers do not rupture, leak, or deteriorate after 60 minutes of vibration at room temperature. | Met: Three containers did not rupture, leak or deteriorate after being vibrated (25 mm peak to peak at a frequency inducing 1.6 mm displacement) for 60 minutes at room temperature, filled to 95% capacity. |
| Conformity to US OSHA 29 CFR 1910.1030 Bloodborne Pathogens | Device conforms to regulations. | Met: The devices conform to regulations per US OSHA 29 CFR 1910.1030 Bloodborne Pathogens. |
2. Sample sizes used for the test set and the data provenance:
- Puncture Resistance: "various sections of a container" (specific number not given).
- Toppling Resistance (CSA Z316.6-07): "a container" (singular).
- Toppling Resistance (ISO 23907): "a container" (singular).
- Impact Resistance: Five containers.
- Cold Impact Resistance: Five containers.
- Handle Strength: "a container" (singular).
- Drop Test: Six containers.
- Stacking Test: Three empty containers.
- Vibration Test: Three containers.
Data Provenance: The tests described are "non-clinical data submitted, referenced, or relied upon" for the 510(k) submission. These are laboratory-based engineering and physical tests, not human or patient data. The reference standards are international and national standards (CSA, ISO, UN, CFR), implying the tests were conducted under controlled laboratory conditions, likely in a prospective manner for the purpose of this submission. The country of origin of the testing is not explicitly stated but is implicitly tied to the manufacturer (Daniels Sharpsmart, Inc. in Chicago, IL, USA, with representatives in San Diego, CA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes physical engineering tests on a medical device (a sharps container), not diagnostic or clinical accuracy studies that would require expert-established ground truth. The "ground truth" for these tests is defined by the objective pass/fail criteria of the referenced engineering standards.
4. Adjudication method for the test set:
This information is not applicable for these types of physical engineering tests. Adjudication methods like "2+1" typically apply to cases where human interpretation or consensus is required (e.g., in medical image reading). For these tests, the outcome is objectively measured against a predefined standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a physical sharps container, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers or AI assistance was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical product and does not involve an algorithm or AI. The tests described are for the physical integrity and performance of the container itself.
7. The type of ground truth used:
For all the tests described, the "ground truth" is established by the objective, empirically measurable criteria defined within the referenced international and national engineering standards (CSA Z316.6-07, ISO 23907, UN Recommendations on the Transport of Dangerous Goods – Model Regulations, 49 CFR Part 178.608, and US OSHA 29 CFR 1910.1030). These standards specify the methodology and acceptable limits for each physical property being tested.
8. The sample size for the training set:
This is not applicable. The device is a physical product, and the described tests are performance validation tests, not machine learning model training.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set mentioned or implied for a physical device like a sharps container.
§ 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).