(241 days)
P120018
Not Found
No
The device description and performance studies focus on the physical process of melting needles using heat and electrical current. There is no mention of AI, ML, image processing, or data-driven decision making.
No
The device is described as a needle destruction device used for safely destroying needles, not for treating any medical condition or patient.
No
The device is described as a "needle destruction device" that safely destroys needles by melting them. It does not perform any diagnostic function.
No
The device description clearly outlines physical hardware components (internal rechargeable Lithiumion battery pack, power supply, needle aperture disc, quartz tube, hemispherical electrode) and describes a physical process of destroying needles through heat. The performance studies also include hardware and firmware testing.
Based on the provided information, the NeedleSmart Professional (NS Pro) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the NS Pro is to physically destroy needles. It does not perform any tests on biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health or condition.
- Device Description: The device description details a mechanical and electrical process for melting needles. It does not describe any components or processes related to analyzing biological specimens.
- Performance Studies: The performance studies focus on the device's ability to successfully melt needles, electrical safety, battery safety, electromagnetic compatibility, and the absence of harmful emissions or infectious aerosols during the melting process. These are all related to the physical function and safety of the device, not diagnostic testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The NS Pro's function is entirely focused on the safe disposal of medical waste (needles).
N/A
Intended Use / Indications for Use
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.
Product codes
MTV
Device Description
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 Lithium-ion 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.
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
individuals and healthcare professionals / treatment rooms, emergency/trauma rooms, wards, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, and Clinical Laboratories.
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
The following non-clinical performance tests were conducted to demonstrate electrical safety and Electromagnetic Compatibility, and to validate the hardware, software, and firmware of the NS Pro device.
- Test Objective: Electrical Safety evaluation, Standard: IEC 61010-1, Results and Conclusion: Compliance
- Test Objective: Safety evaluation of Lithium-Ion (Li-ion) battery pack, Standard: IEC 62133, Results and Conclusion: Compliance
- Test Objective: Electromagnetic Compatibility evaluation, Standard: IEC 60601-1-2, Results and Conclusion: Compliance
- Test Objective: System Testing - verification of NS Pro initialization, needle melt functionality, needle range specification, battery capacity, service mode settings, charging function, and display (error/informational screes), Standard: Not Specified, Results and Conclusion: PASS - demonstrating successful verification and validation of the software
- Test Objective: Hardware initialization, needle melt hardware checks, and error conditions testing, Standard: Not Specified, Results and Conclusion: PASS - demonstrating successful validation of the hardware and firmware
- Test Objective: Hardware and firmware inspection testing, Standard: Not Specified, Results and Conclusion: PASS - demonstrating successful validation of the hardware and firmware
In addition, the following performance bench tests were performed to demonstrate the capability of the NS Pro to destroy (melt) needles.
- Test Objective: 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.
- Acceptance Criteria: NS Pro device should process needles with success rate of 95% or more
- Results and Conclusion: 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.
- Test Objective: Determine whether the NS Pro needle melt process produced harmful or toxic fumes.
- Acceptance Criteria: There should be no emission of harmful gas in significant enough quantities which is deemed hazardous.
- Results and Conclusion: The melt process did not result in emission of harmful gas in a potentially toxic quantity.
- Test Objective: Determine whether dangerous/unsafe noise is produced during the operation of the NS Pro.
- Acceptance Criteria: Maximum recorded noise should be within the acceptable instantaneous limit of 140dB.
- Results and Conclusion: Maximum recorded noise during the testing was an instantaneous value of 84.8dB. Therefore, NS Pro did not produce dangerous noise in any cases.
- Test Objective: Determine whether visible sparking is produced during the operation of the NS Pro
- Acceptance Criteria: No visible sparks produced external to the device throughout the course of the testing.
- Results and Conclusion: The needle melt process was performed 10 times in 5 different NS Pro devices. Visible sparks were not produced in any cases.
- Test Objective: Virolgoical study - Analysis of potential contamination from pathogenic microorganisms, with the use of NS Pro device
- Acceptance Criteria: No dangerous viral aerosols produced. No pathogenic activity detected on the processed needles
- Results and Conclusion: 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.
Key Metrics
Needle melt success rate was 97.6%.
Maximum recorded noise during the testing was an instantaneous value of 84.8dB.
Predicate Device(s)
P120018
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6210 Sharps needle destruction device.
(a)
Identification. A sharps needle destruction device is a prescription device that is intended to destroy needles or sharps used for medical purposes by incineration or mechanical means.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate the following during operation of the device:
(i) The device safely contains or ventilates aerosols or fumes from device operation.
(ii) Excessive heat or sparks are not generated that may injure users or patients.
(iii) Simulated use testing must demonstrate sharps and/or needles are completely destroyed using a range of types and sizes of sharps sufficient to represent actual use.
(iv) Simulated use testing must demonstrate that the device is physically stable on the surface for which it is intended to be mounted to ensure the risk of harm to the patient/user as a result of the device falling is minimized.
(2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in the instructions for use.
(3) Analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device, under conditions which are consistent with the intended environment of device use.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include:
(i) A clear description of the device and its technological features;
(ii) How the device is to be used, including validated cleaning and disinfection instructions;
(iii) Relevant precautions and warnings based on performance and in-use testing to ensure proper use of the device; and
(iv) Instructions to install device in adequately ventilated area and stable area.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
March 25, 2021
NeedleSmart Limited Tom Baker Research & Development Engineer Suite 2B. Stanley Grange Business Park, Ormskirk Road, Knowslev. Prescot. L34 5NB United Kingdom
Re: K202073
Trade/Device Name: NeedleSmart Professional (NS Pro) Regulation Number: 21 CFR 880.6210 Regulation Name: Sharps Needle Destruction Device Regulatory Class: Class II Product Code: MTV Dated: February 12, 2021 Received: February 25, 2021
Dear Tom Baker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202073
Device Name NeedleSmart Professional (NS Pro)
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary - K202073
1. Sponsor/ Applicant
NeedleSmart Limited Suite 2B, Stanley Grange Business Park, Ormskirk Road, Knowsley, Prescot L34 5NB United Kingdom
Tom Baker Research & Development Engineer Phone: +44 (0)151 3150516 Fax: +44 (0)845 2991615 Email: tom.baker@needlesmart.com
Summary Preparation Date: March 23, 2021
Device 2.
| Trade Name | NeedleSmart Professional (NS Pro) |
|---|---|
| Common Name | Sharps Needle Destruction Device |
| Classification Name | Sharps Needle Destruction Device |
| Classification | Class II |
| Product Code | MTV |
| Regulation Number | 21 CFR 880.6210 |
| Review Panel | General Hospital |
Predicate Device 3.
Sharps Terminator (approved under P120018). Note: A Sharps Needle Destruction Device is now regulated under Class 2 and requires a 510(k) submission.
4. Device Description
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.
4
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.
5. Indications for Use
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 (%") inches to 1.5 (1½") inches i.e. approx. 1.6 cm to 3.8 cm. The device is for use in treatment settings such as treatment rooms, emergency/trauma rooms, wards, and medication rooms of Hospitals and Outpatient Clinics/Medical Offices, Dental Offices, and Clinical Laboratories.
6. Technological Characteristics Comparison
The technological characteristics comparison between the NeedleSmart Professional (NS Pro) and the Sharps Terminator is provided in the following table:
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| NeedleSmart Professional | |||
| (NS Pro) | Sharps Terminator | ||
| (approved under P120018) | |||
| Submitter | NeedleSmart Ltd | Sharps Terminator, LLC | |
| Device | |||
| Classification | Product Code: MTV | ||
| 21 CFR 880.6210 | Product Code: MTV | ||
| 21 CFR 880.6210 | Same | ||
| Prescription / | |||
| Over-The- | |||
| Counter (OTC) | |||
| Use | Prescription Use | Prescription Use | Same |
| Subject Device | Predicate Device | Comparison | |
| NeedleSmart Professional | |||
| (NS Pro) | Sharps Terminator | ||
| (approved under P120018) | |||
| Indications for | |||
| Use | 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 ( $5/8$ ") | |||
| inches to 1.5 ( $1\frac{1}{2}$ ") inches | |||
| i.e. approx. 1.6 cm to 3.8 | |||
| cm. The device is for use in | |||
| treatment settings such as | |||
| treatment rooms, | |||
| emergency/trauma rooms, | |||
| wards, and medication | |||
| rooms of Hospitals and | |||
| Outpatient Clinics/Medical | |||
| Offices, Dental Offices, and | |||
| Clinical Laboratories. | This device is indicated for | ||
| use by individuals and | |||
| healthcare professionals to | |||
| safely destroy 18-27 gauge | |||
| needles up to 2 inches | |||
| (approx. 5 cm). The device | |||
| is for use in treatment | |||
| settings such as treatment | |||
| rooms, emergency/trauma | |||
| rooms, wards, and | |||
| medication rooms of | |||
| Hospitals and Outpatient | |||
| Clinics/Medical Offices, | |||
| Dental Offices, and Clinical | |||
| Laboratories. | Similar | ||
| Operating | |||
| Principle and | |||
| Description | NS Pro enables single | ||
| button, one handed | |||
| operation. | |||
| The electrical heating of | |||
| needle metal leads to | |||
| compression of molten metal | |||
| which is then allowed to cool | |||
| onto the end of the needle | |||
| stub that is collected in a | |||
| quartz tube. | |||
| The unit requires regular | |||
| clean down and replacement | |||
| of quartz tube every 3 | |||
| months | Sharps Terminator enables | ||
| single button, one handed | |||
| operation. | |||
| The electrical heating of | |||
| needle metal produces swarf | |||
| that is collected in tube | |||
| The unit requires swarf tube | |||
| to be emptied weekly | Similar | ||
| Major Parts/ | |||
| Components | Clamp Electrodes | ||
| DC Motor | |||
| Melt Electrode | |||
| Electrode Carriage | |||
| Assembly | |||
| Stepper Motor & Drive Belt | |||
| System | |||
| Quartz Tube | |||
| Operating PCBs | Positive and Negative | ||
| Electrodes | |||
| Cutting Blade | |||
| Swarf Container Collection | |||
| Tube | |||
| UV Bulb | |||
| Operating PCB(s) | Different | ||
| Subject Device | |||
| NeedleSmart Professional | |||
| (NS Pro) | Predicate Device | ||
| Sharps Terminator | |||
| (approved under P120018) | Comparison | ||
| Sterility and | |||
| Shelf-life | Not provided sterile. No shelf | ||
| life claimed | Not provided sterile. No shelf | ||
| life claimed | Same | ||
| Dimensions | Height x width x depth: | ||
| 249.6mm x 139.0mm x | |||
| 144.2mm | Cylindrical construction, | ||
| approximately 4.5" in | |||
| diameter and 7" in height. | Different | ||
| Needle Range | Gauge: 21-25G | ||
| Length: 0.625" - 1.5" | Gauge: 18-27G | ||
| Length: Up to 2" | Similar | ||
| Number of | |||
| needle melts | |||
| per Charge | At least 100 (assuming 21G | ||
| needles that are 1.5" in | |||
| length) | 40 to over 200 depending on | ||
| needle gauge and length | Similar | ||
| Battery Type | Rechargeable | ||
| 7-cell Lithium-Ion (Li-ion) | |||
| battery pack | Rechargeable | ||
| Nickel metal hydride (NiMH) | |||
| battery | Different | ||
| Battery Rating | 25.2VDC, 3Ah, 75.6Wh | 4.8VDC, 6Ah, 28.8Wh | Different |
| Power Supply | |||
| (Charger) | Input: 100-240VAC, 50-60Hz | ||
| Output: 29.4VDC, 0.56A | Not specified |
Table 1: Technological Characteristics Comparison
5
6
The intended use of the NeedleSmart Professional (NS Pro) is same as the intended use of the predicate Sharps Terminator as both are needle destruction devices intended for use by individuals and healthcare professionals to safely destroy needles. The operating principle of the NS Pro and the Sharps Terminator is similar as both are portable devices that use electric current for needle destruction. The devices are activated when the user inserts the needle vertically into the aperture in the top of the units. Both devices support one handed operation with a single button press.
The indications for use differ slightly as the NS Pro is intended to destrov 21-25 gauge needles between 0.625 inches and 1.5 inches (approx. 1.6cm to 3.8cm), whereas, the Sharps Terminator is intended to destrov 18-27 gauge needles up to 2 inches (approx. 5 cm).
With Sharps Terminator, the needle is burned away by an electrode down to the hub as it is inserted into the device. Once the syringe/needle combination is fully seated into the device a secondary cutter activates and chops through the needle hub thereby separating the syringe body from any remaining needle stub. The debris (swarf) left from the needle destruction is collected in the swarf collection tube. In contrast, with NS Pro, the inserted needle is contained in a hard-wearing quartz tube. When
7
current passes through the tip of the needle, its temperature increases and makes the metal soft. The needle metal melts and is collected within a hemispherical electrode. The molten metal is then compressed and allowed to cool onto the end of the needle stub, which can then be disposed of into a sharps container. The functional capability of the NS Pro to effectively process and destroy needles is validated through comprehensive hardware, firmware, and software testing.
The Sharps Terminator uses rechargeable Nickel metal hydride (NiMH) battery pack whereas; the NS Pro uses a rechargeable Lithium-ion battery pack. The battery packs can be recharged using the power supplies (chargers) provided with these devices. The Sharps Terminator can be used while left plugged into the charger, or used remotely until the batterv is discharged. However, the NS Pro is only intended to be used on battery power. The Lithium-ion battery pack used in NS Pro complies with IEC 62133.
The Sharps Terminator is able to destroy between 40 to over 200 needles per charge, depending on needle gauge and length burned. The NS Pro can destroy at least 100 needles per charge, assuming 21G needles that are 1.5" in length. The capability of the NS Pro to destroy at least 100 needles per charge is demonstrated through performance testing.
The dimensions of the NS Pro are different compared to Sharps Terminator. Also, the Sharps Terminator intentionally produces high voltage arcs across connection points, while NS Pro produces low voltage reconnection arcs only as by-process. The electrical safety and electromagnetic compatibility of the NS pro has been tested per standards IEC 61010-1 and EN/ IEC 60601-1-2, respectively. Additionally, the power supply (charger) provided with NS Pro meets the requirements of IEC 60601-1.
8
7. Summary of Non Clinical Performance Testing
The following non-clinical performance tests were conducted to demonstrate electrical safety and Electromagnetic Compatibility, and to validate the hardware, software, and firmware of the NS Pro device.
| Test Objective | Standard | Results and Conclusion |
|---|---|---|
| Electrical Safety evaluation | IEC 61010-1 | Compliance |
| Safety evaluation of Lithium-Ion (Li- | ||
| ion) battery pack | IEC 62133 | Compliance |
| Electromagnetic Compatibility | ||
| evaluation | 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 screes) | PASS - demonstrating | |
| successful verification | ||
| and validation of the | ||
| software | ||
| Hardware initialization, needle melt | ||
| hardware checks, and error | ||
| conditions testing | PASS - demonstrating | |
| successful validation of | ||
| the hardware and | ||
| firmware | ||
| Hardware and firmware inspection | ||
| testing | PASS - demonstrating | |
| successful validation of | ||
| the hardware and | ||
| firmware |
In addition, the following performance bench tests were performed to demonstrate the capability of the NS Pro to destroy (melt) needles.
| Test Objective | Acceptance Criteria | Results and
Conclusion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Test Objective | Acceptance Criteria | Results and Conclusion |
| 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. |
| Virolgoical 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 |
9
Clinical Testing
- The submission does not contain any data from clinical testing.
9. Conclusion:
The conclusions drawn from the non-clinical performance tests demonstrate that the NeedleSmart Professional (NS Pro) is as safe, as effective, and performs as well as or better that the legally marketed predicate device, Sharps Terminator.