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510(k) Data Aggregation
(241 days)
The NeedleSmart Professional (NS Pro) is a needle destruction device that is intended for use by individuals and healthcare professionals to safely destroy 21-25 gauge needles between 0.625 (1/2") inches i.e. approx. 1.6 cm to 3.8 cm. The device is for use in treatment rooms, emergency/trauma rooms, wards, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, and Clinical Laboratories.
The NeedleSmart Professional (NS Pro) is a needle destruction device that is intended for use by individuals and healthcare professionals to safely destroy needles. It operates using an internal rechargeable Lithiumion battery pack which can be recharged using the power supply (wall charger) that is provided with the unit. The device is not intended to be used while connected to the charger. The NS Pro is activated when the user applies slight downward force on the syringe to insert the needle in the needle aperture disc in the top of the unit. The needle insertion activates a button beneath the insert disc. The needle is then contained by a hard-wearing quartz tube and a current is passed through the tip of the needle, thereby increasing its temperature. Once the needle has been heated to its melting point, it becomes soft and the melted content is collected within a hemispherical electrode. The molten metal gets compressed into a hemispherical 'stub' which is allowed to cool. It is then removed from the device and disposed into a sharps container.
The provided text describes the non-clinical performance testing for the NeedleSmart Professional (NS Pro) device, which is a sharps needle destruction device. It includes acceptance criteria and the results of various tests.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Evaluate the performance of the NS Pro device to safely and effectively melt a range of hypodermic needles. 50 needles of each gauge and length combination (total 700 needles) were subjected to the melting process individually using the NS Pro device. | NS Pro device should process needles with success rate of 95% or more | The needle melt success rate was 97.6% which met the acceptance criteria thereby demonstrating the capability of the NS Pro device to safely and effectively destroy hypodermic needles within its specified range. |
| Determine whether the NS Pro needle melt process produced harmful or toxic fumes. | There should be no emission of harmful gas in significant enough quantities which is deemed hazardous. | The melt process did not result in emission of harmful gas in a potentially toxic quantity. |
| Determine whether dangerous/ unsafe noise is produced during the operation of the NS Pro. | Maximum recorded noise should be within the acceptable instantaneous limit of 140dB. | Maximum recorded noise during the testing was an instantaneous value of 84.8dB. Therefore, NS Pro did not produce dangerous noise in any cases. |
| Determine whether visible sparking is produced during the operation of the NS Pro. | No visible sparks produced external to the device throughout the course of the testing. | The needle melt process was performed 10 times in 5 different NS Pro devices. Visible sparks were not produced in any cases. |
| Virological study - Analysis of potential contamination from pathogenic microorganisms, with the use of NS Pro device | No dangerous viral aerosols produced. No pathogenic activity detected on the processed needles. | The results from first study showed no infectious virus particles (PPV or MuLV) detected in the test sample demonstrating that the NS Pro device operation does not result in emission of infectious aerosols. The results from the second study confirmed no pathogenic activity was detected on the processed needles. |
| Additional Non-Performance Tests (without explicit "Acceptance Criteria" listed, but "Compliance" indicates meeting an implicit standard) | ||
| Electrical Safety evaluation | Compliance with IEC 61010-1 | Compliance. |
| Safety evaluation of Lithium-Ion (Li-ion) battery pack | Compliance with IEC 62133 | Compliance. |
| Electromagnetic Compatibility evaluation | Compliance with IEC 60601-1-2 | Compliance. |
| System Testing - verification of NS Pro initialization, needle melt functionality, needle range specification, battery capacity, service mode settings, charging function, and display (error/informational screens) | PASS | PASS - demonstrating successful verification and validation of the software. |
| Hardware initialization, needle melt hardware checks, and error conditions testing | PASS | PASS - demonstrating successful validation of the hardware and firmware. |
| Hardware and firmware inspection testing | PASS | PASS - demonstrating successful validation of the hardware and firmware. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Needle melt success rate: 700 needles (50 needles of each gauge and length combination for the stated range of 21-25 gauge needles between 0.625" and 1.5").
- Visible sparking: 50 melts (10 times in 5 different NS Pro devices).
- Noise and Fume emissions, and Virological study: Specific sample sizes for these tests are not explicitly stated beyond "The melt process" or "The results from first study," but appear to be part of the performance bench tests.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be non-clinical performance bench tests. The document does not indicate if the data was retrospective or prospective, but given it's for premarket notification, it's implied to be prospective testing carried out for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth in these non-clinical performance studies is established by quantitative measurements and objective observations (e.g., success rate of melting, decibel levels, chemical analysis for fumes, visible observation for sparks, and laboratory analysis for viral particles). There is no indication that human experts were used to establish the ground truth in the same way they would for, say, image interpretation. The "experts" implied are those conducting the standardized tests and evaluating against objective criteria.
4. Adjudication method for the test set
Not applicable. These are objective non-clinical performance tests, not studies requiring human interpretation or adjudication.
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
Not applicable. This device is a physical sharps destruction device, not an AI-assisted diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone device ("algorithm only" performance in the sense of the device performing its intended function without human intervention during the process itself, beyond activation). The performance tests evaluate the device's ability to destroy needles, manage fumes/noise, and prevent sparking/contamination, which are all inherent functions of the device itself.
7. The type of ground truth used
The ground truth used is primarily based on:
- Objective performance metrics: Success rate calculation (e.g., number of needles successfully melted out of total attempts).
- Standardized measurements: Decibel meter readings for noise, analytical methods for gas detection (fumes), visual inspection for sparking, and laboratory assays for viral particles.
- Compliance with established standards: IEC 61010-1, IEC 62133, IEC 60601-1-2.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this device.
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