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.

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. 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.

AI/ML Overview

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.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K202073

Device Name NeedleSmart Professional (NS Pro)

Indications for Use (Describe)

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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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

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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
DeviceClassification	Product Code: MTV21 CFR 880.6210	Product Code: MTV21 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 forUse	The NeedleSmartProfessional (NS Pro) is aneedle destruction devicethat is intended for use byindividuals and healthcareprofessionals to safelydestroy 21-25 gaugeneedles between 0.625 ( $5/8$ ")inches to 1.5 ( $1\frac{1}{2}$ ") inchesi.e. approx. 1.6 cm to 3.8cm. The device is for use intreatment settings such astreatment rooms,emergency/trauma rooms,wards, and medicationrooms of Hospitals andOutpatient Clinics/MedicalOffices, Dental Offices, andClinical Laboratories.	This device is indicated foruse by individuals andhealthcare professionals tosafely destroy 18-27 gaugeneedles up to 2 inches(approx. 5 cm). The deviceis for use in treatmentsettings such as treatmentrooms, emergency/traumarooms, wards, andmedication rooms ofHospitals and OutpatientClinics/Medical Offices,Dental Offices, and ClinicalLaboratories.	Similar
OperatingPrinciple andDescription	NS Pro enables singlebutton, one handedoperation.The electrical heating ofneedle metal leads tocompression of molten metalwhich is then allowed to coolonto the end of the needlestub that is collected in aquartz tube.The unit requires regularclean down and replacementof quartz tube every 3months	Sharps Terminator enablessingle button, one handedoperation.The electrical heating ofneedle metal produces swarfthat is collected in tubeThe unit requires swarf tubeto be emptied weekly	Similar
Major Parts/Components	Clamp ElectrodesDC MotorMelt ElectrodeElectrode CarriageAssemblyStepper Motor & Drive BeltSystemQuartz TubeOperating PCBs	Positive and NegativeElectrodesCutting BladeSwarf Container CollectionTubeUV BulbOperating PCB(s)	Different
	Subject DeviceNeedleSmart Professional(NS Pro)	Predicate DeviceSharps Terminator(approved under P120018)	Comparison
Sterility andShelf-life	Not provided sterile. No shelflife claimed	Not provided sterile. No shelflife claimed	Same
Dimensions	Height x width x depth:249.6mm x 139.0mm x144.2mm	Cylindrical construction,approximately 4.5" indiameter and 7" in height.	Different
Needle Range	Gauge: 21-25GLength: 0.625" - 1.5"	Gauge: 18-27GLength: Up to 2"	Similar
Number ofneedle meltsper Charge	At least 100 (assuming 21Gneedles that are 1.5" inlength)	40 to over 200 depending onneedle gauge and length	Similar
Battery Type	Rechargeable7-cell Lithium-Ion (Li-ion)battery pack	RechargeableNickel metal hydride (NiMH)battery	Different
Battery Rating	25.2VDC, 3Ah, 75.6Wh	4.8VDC, 6Ah, 28.8Wh	Different
Power Supply(Charger)	Input: 100-240VAC, 50-60HzOutput: 29.4VDC, 0.56A	Not specified

Table 1: Technological Characteristics Comparison

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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

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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.

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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 Compatibilityevaluation	IEC 60601-1-2	Compliance
System Testing - verification of NSPro initialization, needle meltfunctionality, needle rangespecification, battery capacity,service mode settings, chargingfunction, and display (error/informational screes)		PASS - demonstratingsuccessful verificationand validation of thesoftware
Hardware initialization, needle melthardware checks, and errorconditions testing		PASS - demonstratingsuccessful validation ofthe hardware andfirmware
Hardware and firmware inspectiontesting		PASS - demonstratingsuccessful validation ofthe hardware andfirmware

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 andConclusion
Evaluate the performance ofthe NS Pro device to safelyand effectively melt a rangeof hypodermic needles.50 needles of each gaugeand length combination (total700 needles) were subjectedto the melting processindividually using the NS Prodevice.	NS Pro device shouldprocess needles withsuccess rate of 95% ormore	The needle melt successrate was 97.6% whichmet the acceptancecriteria therebydemonstrating thecapability of the NS Prodevice to safely andeffectively destroyhypodermic needleswithin its specified range.
Test Objective	Acceptance Criteria	Results and Conclusion
Determine whether the NSPro needle melt processproduced harmful or toxicfumes.	There should be noemission of harmful gasin significant enoughquantities which isdeemed hazardous.	The melt process did notresult in emission ofharmful gas in apotentially toxic quantity.
Determine whetherdangerous/ unsafe noise isproduced during theoperation of the NS Pro.	Maximum recordednoise should be withinthe acceptableinstantaneous limit of140dB.	Maximum recorded noiseduring the testing was aninstantaneous value of84.8dB. Therefore, NSPro did not producedangerous noise in anycases.
Determine whether visiblesparking is produced duringthe operation of the NS Pro	No visible sparksproduced external to thedevice throughout thecourse of the testing.	The needle melt processwas performed 10 timesin 5 different NS Prodevices. Visible sparkswere not produced inany cases.
Virolgoical study - Analysisof potential contaminationfrom pathogenicmicroorganisms, with the useof NS Pro device	No dangerous viralaerosols producedNo pathogenic activitydetected on theprocessed needles	The results from firststudy showed noinfectious virus particles(PPV or MuLV) detectedin the test sampledemonstrating that theNS Pro device operationdoes not result inemission of infectiousaerosols.The results from thesecond study confirmedno pathogenic activitywas detected on theprocessed needles

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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.

Regulation Number and Section

§ 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.