(129 days)
For storage and disposal of used sharps devices
The device is a molded plastic container with various features designed to allow the admission of used sharps while preventing the user from coming in contact with the contents of the container. It has provisions for both temporary and permanent closure of the container. When closed permanently, the container is disposed of in accordance with medical waste procedures. The Safety Cradle sharps container utilizes a unique two part design that provides the following features: 1. Unique automatic closure means for the disposal of sharps utilizing a biased flap referred to as the Safety Cradle, a living hinge and a depressable cover that is linked to the biased flap and living hinge. 2. A secondary temporary closure with temporary lock and a handle for safe transport. In between uses, the biased flap and cover provide two barriers of protection against exposure to sharps within the container. 3. Permanent closure when container is full. 4. Highly absorbent pad with gelling compound for fluid control. 5. Left handed and right handed phlebotomy needle extractors. 6. Multiple uses in applications that include a wall mounted container, table mount use and as a free standing container. 7. Safety Cradle feature provides a unique means for a horizontal drop of a sharp.
The document provided is a 510(k) Premarket Notification for a "Safety Cradle® sharps container." This type of document is for a medical device that needs to demonstrate substantial equivalence to a legally marketed predicate device. The information requested in your prompt regarding acceptance criteria, study details, ground truth, and expert involvement is typically found in performance studies for diagnostic or AI-driven medical devices.
The provided text does not contain the detailed performance study information you are asking for because this is a submission for a sharps container, not a diagnostic device that outputs numerical performance metrics against a defined ground truth.
Here's a breakdown based on the information provided and what is missing:
1. Table of acceptance criteria and the reported device performance:
The document focuses on comparing features for substantial equivalence, not quantitative performance against acceptance criteria in the way you might see for an AI algorithm or a diagnostic test. The "performance" here relates to functional characteristics and safety standards.
| Feature / Criteria (Implied) | Predicate Device (Sharp Safe K901321) | Proposed Device (Safety Cradle® K962149) | "Acceptance" (as demonstrated equivalence) |
|---|---|---|---|
| 510(k) Clearance | yes | yes | Met |
| Puncture resistance meets ASTM standards | yes | yes | Met |
| Horizontal drop of sharps | yes | yes | Met |
| Stable in free standing position | yes | yes | Met |
| Leak proof in upright position | yes | yes | Met |
| Potential for fingers to accidentally slip into container | yes | no | Improved (demonstrates superiority) |
| Injection molded parts | no | yes | Improved (new feature) |
| Fill indicator line | no | yes | Improved (new feature) |
| Instructions on container | no | yes | Improved (new feature) |
| Phlebotomy needle extractor(s) | no | yes | Improved (new feature) |
| Nestable | no | yes | Improved (new feature) |
| Sufficient clarity to view fill level (Meets ECRI standards) | no | yes | Improved (new feature) |
| Automatic closure between disposal of sharps | yes | yes | Met |
| Permanent closure when container is full | with tape | yes | Improved (more robust) |
| Handle | no | yes | Improved (new feature) |
| Absorbent pad to resist leakage in positions other than upright | yes | yes | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. For a sharps container, testing would likely involve simulated usage scenarios, material testing, and physical characteristic evaluations, rather than a "test set" of data in the way a diagnostic algorithm would have. The document references ASTM standards for puncture resistance, implying that such tests were conducted to those standards, but details of sample size and provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided and is not applicable in the context of this device. The "ground truth" for a sharps container would be its physical conformance to specifications and safety standards, not a clinical judgment by experts on a dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is not applicable.
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 information is not provided and is not applicable. This is for a physical medical device, not an AI or imaging-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided and is not applicable. This is for a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device would be its adherence to established safety standards (like ASTM for puncture resistance) and functional specifications (e.g., leak-proof in upright position, stable in free-standing position). There's no clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set:
This information is not provided and is not applicable as there is no "training set" for a physical device like this.
9. How the ground truth for the training set was established:
This information is not provided and is not applicable.
Summary:
The provided text is a 510(k) Premarket Notification for a physical medical device (sharps container). It focuses on demonstrating "substantial equivalence" to a predicate device by comparing features and adherence to a general safety standard (ASTM for puncture resistance) and functional design elements. It does not include the detailed performance study data, expert involvement, or algorithm-specific metrics that would be found in submissions for diagnostic or AI-powered devices. Such information is not typically required or relevant for this type of device submission.
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OCT 11 1005
Safety and Effectiveness Summary
for 510(k) Premarket Notification K962149 for Safety Cradle® sharps container
| The manufacturerof record is: | Specialized Health Products Incorporated655 E. Medical DriveBountiful, Utah 84010 |
|---|---|
| Intended Use: | For storage and disposal of used sharps devices |
| Classification Number: | 80MMK |
| Classification Name: | Sharps Container |
| Regulation Number:Class: | 880.5570Class II |
| Common/Usual Name: | Sharps Container |
| Commercial Name: | Safety Cradle® |
| Performance Standards: | None established under section 514. |
| Substantial Equivalence: |
The Safety Cradle sharps container is substantially Equivalent in function to:
Specialized Health Products Incorporated 655 E. Medical Drive Bountiful, Utah Sharp-Safe Sharps disposal Box K901321 (5/11/90)
In developing the information for this submission, the CDRH draft Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers was_referenced.
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DEVICE DESCRIPTION
The device is a molded plastic container with various features designed to allow the admission of used sharps while preventing the user from coming in contact with the contents of the container. It has provisions for both temporary and permanent closure of the container. When closed permanently, the container is disposed of in accordance with medical waste procedures.
The Safety Cradle sharps container utilizes a unique two part design that provides the following features:
-
Unique automatic closure means for the disposal of sharps utilizing a biased flap referred to as the Safety Cradle, a living hinge and a depressable cover that is linked to the biased flap and living hinge.
-
A secondary temporary closure with temporary lock and a handle for safe transport. In between uses, the biased flap and cover provide two barriers of protection against exposure to sharps within the container.
-
Permanent closure when container is full.
-
Highly absorbent pad with gelling compound for fluid control.
-
Left handed and right handed phlebotomy needle extractors.
-
Multiple uses in applications that include a wall mounted container, table mount use and as a free standing container.
-
Safety Cradle feature provides a unique means for a horizontal drop of a sharp.
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PRODUCT COMPARISON
Safety Cradle vs. Sharp Safe
| FEATURE | Predicate DeviceSharp SafeK901321 | Proposed DeviceSafety Cradle®K962149 |
|---|---|---|
| 510(k) Clearance | yes | yes |
| Puncture resistance meets ASTM standards | yes | yes |
| Horizontal drop of sharps | yes | yes |
| Stable in free standing position | yes | yes |
| Leak proof in upright position | yes | yes |
| Potential for fingers to accidentally slip intocontainer | yes | no |
| Injection molded parts | no | yes |
| Fill indicator line | no | yes |
| Instructions on container | no | yes |
| Phlebotomy needle extractor(s) | no | yes |
| Nestable | no | yes |
| Sufficient clarity to view fill level(Meets ECRI standards) | no | yes |
| Closure Mechanisms:Automatic closure between disposal of sharps | yes | yes |
| Permanent closure when container is full | with tape | yes |
| Handle | no | yes |
| Absorbent pad to resist leakage in positionsother than upright | yes | yes |
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ﺳﻤﺴ
§ 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).