SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting, Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

Device Description

SafeR® (SafeR Syringe and SafeR Sting) is an automatically retractable safety syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling. SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand. Its intended condition is sterile, single use, for hospital or home use.

AI/ML Overview

The furnished text is a 510(k) summary for the SafeR Syringe and SafeR Sting, a medical device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for a new AI/Machine Learning diagnostic device. Therefore, a direct answer to your request for acceptance criteria and study data proving the device meets acceptance criteria for an AI/ML device cannot be fully extracted from this document.

However, I can extract the acceptance criteria related to the performance of this specific medical device (a syringe and needle) and how it was proven to meet these.

Here's an analysis based on the provided text, reinterpreting your request in the context of this device:

Acceptance Criteria and Device Performance (based on Non-Clinical Performance Testing):

The "acceptance criteria" for this device are defined by its conformity to various international ISO standards for syringes, needles, and safety features. The core of the performance testing is to demonstrate that the SafeR Syringe and SafeR Sting meet these established standards, thus proving its safety and effectiveness relative to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical thresholds and exact measured performance values for each. Instead, it refers to compliance with established industry standards. The "Reported Device Performance" is consistently stated as "Conformity to [ISO Standard]" or "Meets requirements."

Test (Acceptance Criteria Defined by Standard)	Reference Standard Requirement(s)	Reported Device Performance
Syringe Properties
Syringe Visual Inspection	ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016	Device meets requirements.
Dimensional Verification	ISO 7886-1:2017, ISO 7864:2016	Device meets requirements.
Syringe pH verification	ISO 7886-1:2017	"The pH value of distilled water exposed to the finish syringe product does not change more than 1 unit." (This is a specific criterion, implying compliance was met).
Extractables Metals	ISO 7886-1:2017	"overall content of metals (lead, tin, zinc and iron) does not exceed 5mg/kg." (This is a specific criterion, implying compliance was met).
Lubricant amount	ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016	"Less than 0.25mg/cm2 as per ISO 7886-1 requirements." (This is a specific criterion, implying compliance was met).
Volume Verification and Dead Space	ISO 7886-1:2017	"Dead space lower than upper specification given in ISO 7886-1." (This is a specific criterion, implying compliance was met).
Air Leakage	ISO 7886-1:2017	"Safer Syringes are free from air and liquid leakage." (This is a specific criterion, implying compliance was met).
Piston operating force	Not explicitly stated	Device meets requirements (implied by "functional performance testing" and SE conclusion).
Liquid Leakage	ISO 7886-1:2017	"Safer Syringes are free from air and liquid leakage." (This is a specific criterion, implying compliance was met).
Sub-atmospheric pressure air leakage	ISO 80369-7:2021	Device meets requirements.
Resistance to separation from axial load	ISO 80369-20:2015	Device meets requirements.
Resistance to separation from unscrewing	Not explicitly stated	Device meets requirements (implied by "functional performance testing" and SE conclusion).
Barrel performances	ISO 7886-1:2017	"Barrel flanges sizes are adequate to enable the syringe to be held securely according to ISO 7886-1." and "Safer Syringes are free from air and liquid leakage and there is no plunger stopper detachment as per ISO 7886-1 requirements." (Specific criteria, implying compliance).
Other Syringe Characteristics (Transparency, Gradation, Tolerance, Scale)	ISO 7886-1:2017	All stated as conforming to ISO 7886-1 requirements.
Needle Properties
Needle pH verification	ISO 7864:2016	Device meets requirements.
Corrosion resistance	ISO 9626:2016	Device meets requirements.
Needle point	ISO 7864:2016	"needle point is sharp and free from defects." (Specific criterion, implying compliance).
Needle outer surface	ISO 7864:2016	"needle surface is smooth and free from defects." (Specific criterion, implying compliance).
Needle bonding strength	ISO 7864:2016	"needle-hub bonding strengths are higher than the specification given in the standard." (Specific criterion, implying compliance).
Needle Penetration and Drag Force	Not explicitly stated	Device meets requirements (implied by "functional performance testing" and SE conclusion).
Safety Features
Sharp Injury protection feature activation	ISO 23908:2011, ISO 7886-4:2018	Device conforms to these standards.
Access the device in the safe mode	ISO 23908:2011	Device meets requirements.
Packaging & Biocompatibility
Visual Inspection for Packaging	ASTM F1886/F1886M-16	Device meets requirements.
Bubble leak test	UNI EN ISO 11607-1:2021, ASTM F2096-11 (2019)	"The test results showed that the device package can maintain its integrity."
Peeling strength seal bond	ASTM F88-F88M -15	Device meets requirements.
Biological evaluation	ISO10993-1, ISO10993-5, ISO10993-10, ISO10993-11	"The results of the biocompatibility testing confirm that SafeR Syringe and SafeR Sting are biocompatible in compliance for indirect blood path with limited contact duration <24hrs. Cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, and particulate testing per USP <788> were provided for both components."
Sterilization	ISO 11135	"SAL 10-6 EO sterilization according to ISO 11135" was performed and passed.
Ethylene Oxide residuals	ISO 10993-7	"EO residue and Endotoxin did not exceed the limits of relevant Standards."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific non-clinical test. It generally refers to "Performance tests (bench)" and "test results." The provenance of the data is not mentioned in terms of country of origin or whether it was retrospective or prospective, as these terms are more relevant for clinical studies than bench testing of a physical device. All tests appear to be conducted in a laboratory/bench setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The "ground truth" for the performance of a physical medical device (syringe and needle) is established through objective, quantifiable measurements against engineering specifications and international standards (e.g., ISO, ASTM), rather than expert consensus on subjective interpretations (as would be the case for AI/ML diagnostic imaging).

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for studies where human expert disagreement needs to be resolved (e.g., in medical image interpretation for AI ground truth). For bench testing of a physical product against standards, the measurements are objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No. This type of study is specifically designed to evaluate the performance of diagnostic systems (often AI-assisted) where human readers interpret cases. The SafeR Syringe and SafeR Sting is a physical medical device, not a diagnostic imaging AI/ML product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical product, not an algorithm. Its performance is inherent in its design and manufacturing, tested through objective bench testing.

7. The Type of Ground Truth Used:

The ground truth is based on objective measurements against established engineering specifications and international standards (ISO, ASTM). For example, for "Lubricant amount," the ground truth is "< 0.25mg/cm2 as per ISO 7886-1 requirements." For "Biocompatibility," the ground truth is "compliance for indirect blood path with limited contact duration <24hrs" as per ISO 10993.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML product; therefore, it does not have a "training set" in the computational sense. Its design and manufacturing processes are refined through engineering principles and quality control.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set." The design and manufacturing are based on established engineering principles and confirmed through rigorous bench testing against international performance standards.

Summary

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December 29, 2022

Roncadelle Operations srl Massimo Rossi Quality & Regulatory Manager Via Renolda 10 Castel Mella (Brescia), Lombardia 25030 Italy

Re: K221981

Trade/Device Name: SafeR Syringe and SafeR Sting Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG. FMI. FMF Dated: November 16, 2022 Received: December 1, 2022

Dear Massimo Rossi:

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

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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 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,

Image /page/1/Picture/5 description: The image shows the name Courtney Evans -S on the left side of the image. On the right side of the image, it says "Digitally signed by Courtney Evans -S Date: 2022.12.29 10:45:46 -05'00'". The image appears to be a digital signature.

For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K221981

Device Name SafeR Syringe and SafeR Sting

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 K221981

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

1. Submitter Information

Company:	Roncadelle Operations srlVia Renolda 10Castel Mella (Brescia), Lombardia 25030ItalyTelephone: + 39 030 672 4322
Contact:	Massimo RossiQuality & Regulatory ManagerRoncadelle Operations srlVia Renolda 10Castel Mella (Brescia), Lombardia 25030ItalyTelephone: + 39 030 672 4322massimo.rossi@roncadelle-operations.com
Date Summary Prepared:	December 27, 2022

2. Device Name and Classification

Trade Name:	SafeR Syringe and SafeR Sting
Common Name:	Safety syringe and retractable needle
Classification Name:	Syringe, Antistick
Review Panel:	General Hospital
Regulation:	880.5860
Class:	Class II
Product Code:	MEG, FMI, FMF

3. Predicate Device

The SafeR Syringe and SafeR Sting is equivalent to the WTF SECURA SYRINGE AND NEEDLE (K132120), manufactured by BEIJING WANTEFU MEDICAL APPARATUS Co., Ldt..

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4. Indication for use

SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM). intradermal and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation, and it is not intended to come in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

5. Device Description

SafeR® system is composed by a body syringe (SafeR Syringe) and a needle group (SafeR Sting). SafeR Syringe and SafeR Sting are 2 (two) products, packaged and sold separately, but designed to be coupled for use. Before use, the end user needs to assemble the body syringe and needle group through a clockwise rotation. Body syringe and needle group are connected by means of a threaded connection and conical mating surfaces between Screw Connector and Barrel. Geometry of the threaded connection was designed to ensure appropriate coupling only between SafeR Sting screw connector and SafeR Syringe barrel. Once assembled with its needle (SafeR Sting), incorporates a passive safety mechanism which retracts and contains the contaminated needle into a hollow stem of the plunger after use, aiding in the prevention of possible infections due to needle stick injuries and syringe reuse. Needle retraction is activated by the syringe user with one hand.

Its intended condition is sterile, single use, for hospital or home use.

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6. Substantial Equivalence Comparison

Substantial Equivalence Table
Characteristic	Proposed Device: SafeR Syringeand SafeR Sting	Primary Predicate Device:WTF SECURA SYRINGEAND NEEDLE (K132120)	Same /Similar/Different
Intended Use	SafeR® (SafeR Syringe andSafeR Sting) is an automaticallyRetractable Safety Syringe, it isintended to provide a safe,accurate and reliable method forthe aspiration of fluids and for theinjection of fluids immediatelyafter filling. It is intended to beused for the administration ofmedications (intramuscular (IM),intradermal (ID) andsubcutaneous(SC)). The syringe, onceassembled with its needle,incorporates a passive safetymechanism which retracts andcontains the contaminated needleafter use, aiding in the preventionof possible infections due toneedle stickinjuries and syringe re-use.Needle retraction is activated bythe syringe user with one hand.	The WTF Secura Syringe (withneedle) is used for aspiration offluids from vials and ampoulesand a variety of fluid injectionsbelow the surface of the skin.The WTF Secura Syringe (withneedle) has a manuallyattached WTF SecuraRetracting Needle. The WTFSecura Syringe (with needle)contains an inner passive safetymechanism used to allow theWTF Secura Retracting Needleto be retracted inside theplunger rod of the syringewhen operator's thumb forcereleased. After activation theneedle is fully contained insidethe syringe guarding againstaccidental needlesticks duringnormal handling and disposalof the used needle/ syringecombination.	Similar(Intended use ofsubject devicefalls within theintended use ofpredicate device)
IndicationforUse	SafeR® is an automaticallyRetractable Safety Syringe, it isintended to provide a safe,accurate and reliable method forthe aspiration of fluids and for theinjection of fluids immediatelyafter filling. It is intended to beused for the administration ofmedications (intramuscular (IM),intradermal (ID) andsubcutaneous (SC)).SafeR® system is provided in 2separate parts: SafeR Syringe andthe needle group SafeR Sting.Before use, the end user needs toassemble syringe and needlegroup.The syringe, once assembled withhis needle, incorporates a passivesafety mechanism which retractsand contains the contaminatedneedle after use, aiding inprevention of possible infectiondue to needlestick injuries andsyringe re-use. Needle retractionis activated by the syringe userwith one hand.SafeR Sting blunt fill needle isdesigned only for drugpreparation and it is not intendedto come in contact with humanbody.SafeR Syringe with SafeR Stingmaintain standard injectiontechniques.	The WTF Secura Syringe (with Similarneedle) is used for aspiration of (Indication for usefluids from vials and ampoules of subject deviceanda variety of fluid injectionsbelow the surface of the skin.The WTF Secura Syringe (withneedle) has a manuallyattached WTF SecuraRetracting Needle. The WTFSecura Syringe (with needle)contains an inner passive safetymechanism used to allow theWTF Secura Retracting Needletobe retracted inside theplunger rod of the syringewhen operator's thumb forcereleased. After activation theneedle is fully contained insidethe syringe guarding againstaccidental needlesticks duringnormal handling and disposalof the used needle/ syringecombination.	falls within theindication for useof predicatedevice)
DeviceConfigurationand Materials	Barrel: PolypropylenePlunger: PolypropylenePlunger stopper: LubricatedIsoprene rubberSafety mechanism spring:Stainless SteelNeedle hub and screw connector:PolypropyleneNeedle: stainless steelSyringe and Needle Lubricant:Silicone Medical	Barrel: PolypropylenePlunger: PolypropylenePlunger seal: LubricatedIsoprene rubberSafety mechanism spring:Stainless SteelNeedle hub: PolypropyleneNeedle: stainless steelSyringe and Needle Lubricant:Silicone Medical	Same
SyringeVolume	SafeR Syringe and SafeR Sting1/2/2.25/3/5 ml	Syringe volume: 1/2.5/3/5/10ml	Similar (theproposed devicehas syringevolumes1/2/2.25/3/5 mlthat fall within thevolume range ofthe predicatedevice(1/2.5/3/5/10 ml)
Syringe Design	Piston Syringe (Syringe Antistick)with hypodermic single lumenneedle	Syringe Design: Piston Syringe(Syringe Antistick) withhypodermic single lumenneedle	Same
Needle Design	Tip Type: Tri-Beveled TipNeedle tip configuration: Regularpoint	Needle Design: Tri-BeveledTip	Same
Connection	Needle hub luer lock connector.Needle & syringe separable	Needle hub luer lockconnector.Needle & syringe separable	Same
Safety features	Passive safety feature, manuallyactivated by user	Passive safety feature,manually activated by user	Same
Needle lengthtolerances	Conform to ISO 7864	Conform to ISO 7864	Same
Needle systemcolour coding	Conform to ISO 6009	Conform to ISO 6009	Same
SyringeDimensioncharacteristics	Barrel flanges sizes are adequateto enable the syringe to be heldsecurely according to ISO 7886-1	Conform to ISO 7886-1	Same
BarrelTransparency	Clear as required by ISO 7886-1	Clear as required by ISO 7886-1	Same
Gradationlegibility	Legible as per ISO 7886-1requirements	Conform to ISO 7886-1	Same
Toleranceongraduatedcapacity	Conform to ISO 7886-1	Conform to ISO 7886-1	Same
Graduatedscalecharacteristics	Conform to ISO 7886-1requirements	Conform to ISO 7886-1	Same
Deliveraccuracy/capacity	Conform to ISO 7886-1	Conform to ISO 7886-1	Same
Barrelperformances	Dead space lower than upperspecification given in ISO 7886-1;Safer Syringes are free from airand liquid leakage and there is noplunger stopper detachment as perISO 7886-1 requirements	Conformity to ISO 7886-1claimed	Same
Syringe limitsfor acidity oralkalinity andfor extractablesmetals	When tested according to themethod described in ISO 7886-1The pH value of distilled waterexposed to the finish syringeproduct does not change morethan 1 unit and the overall contentof metals (lead, tin, zinc and iron)does not exceed 5mg/kg	Conformity to ISO 7886-1 isclaimed	Same
Syringelubricantamount	< 0.25mg/cm2 as per ISO 7886-1requirements	Conformity to ISO 7886-1 isclaimed	Same
RetractableNeedles gaugeand length	20 G – 1" 1 ¼" and 1 ½"21 G – 1" 1 ¼" and 1 ½"22 G – 1" 1 ¼" and 1 ½"23 G – 1" 1 ¼" and 1 ½"25 G – 5/8" and 1"26 G – 5/8" and 1"27 G – ½"	21 G – 1 1/8" and 1 ¼"22 G – 1 ¼" and 1"23 G – 1"25 G – 1"30 G 1"	Similar (Theproposed devicehas a higherchoice of needlelengths andgaugesrespect to thepredicate device.)
Dosing needlegauge andlength	18G - 1 ¼"	18G - 1"	Similar
Needleperformances	In accordance with ISO 7864requirements, needle point issharp and free from defects,needle surface is smooth and freefrom defects and needle-hubbonding strengths are higher thanthe specification given in thestandard	Conformity to ISO 7864 isclaimed	Same
Sharp Injuryprotectionfeature andreusepreventionfeatureperformances	Conform to ISO 7886-4 and ISO23908	Conform to ISO 7886-4(alleged compliance to ISO23908 given the claimedcompliance to 7886-1 in whichit is stated "Syringes withintegrated or add-on sharpsprotection shall comply withISO 23908")	Same
PrimaryPackagingbarrier	Sterile barrier of primarypackaging according to ISO11607 1/2	Sterile barrier of primarypackaging according to ISO11607 1/2	Same
Biocompatibility	Conform to ISO 10993	Conform to ISO 10993	Same
Sterilization	SAL 10-6 EO sterilizationaccording to ISO 11135	SAL 10-6 EO sterilizationaccording to ISO 11135	Same
Ethylene Oxideresiduals	Conform to ISO 10993-7	Conform to ISO 10993-7	Same

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7. Non-Clinical Performance Testing

Table below summarizes the purpose of each test performed and the reference standard requirements.

Test	Ref. Standard requirements
Syringe Visual Inspection	ISO 7886-1:2017ISO 7864:2016ISO 9626:2016
Dimensional Verification	ISO 7886-1:2017ISO 7864:2016
Syringe pH verification	ISO 7886-1:2017
Needle pH verification	ISO 7864:2016
Corrosion resistance	ISO 9626:2016
Extractables Metals	ISO 7886-1:2017
Lubricant amount	ISO 7886-1:2017ISO 7864:2016ISO 9626:2016
Needle point	ISO 7864:2016
Needle outer surface
Needle bonding strength	ISO 7864:2016
Needle Penetration and Drag Force
Volume Verification and Dead Space
Air Leakage	ISO 7886-1:2017
Piston operating force
Liquid Leakage
Sharp Injury protection feature activation	ISO 23908:2011ISO 7886-4:2018
Access the device in the safe mode	ISO 23908:2011
Positive pressure Liquid leakage
Sub-atmospheric pressure air leakage	ISO 80369-7:2021
Resistance to separation from axial load	ISO 80369-20:2015
Resistance to separation from unscrewing
Usability Test	EN 62366-1:2020

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Health Care Workers SafeR Usability Evaluation
Visual Inspection for Packaging	ASTM F1886/F1886M-16
Bubble leak test	UNI EN ISO 11607-1:2021,ASTM F2096-11 (2019)
Peeling strength seal bond	ASTM F88-F88M -15
Biological evaluation	ISO10993-1, ISO10993-5,ISO10993-10, ISO10993-11

Performance tests (bench) were conducted to verify that SafeR Syringe and SafeR Sting meet all design specifications as is substantially equivalent (SE) to the predicate device. The test results and the comparison with predicate performances show that the subject product is substantially equivalent to the predicate device in performance.

Sterile barrier packaging testing were performed on the proposed device. The test results showed that the device package can maintain its integrity.

Sterilization testing per ISO 11135 and shelf-life testing were performed on the proposed device. EO residue and Endotoxin did not exceed the limits of relevant Standards. Shelflife test results showed that the device can maintain its performance during the claimed shelf life.

Biological evaluation for SafeR Syringe and SafeR Sting has been performed per ISO 10993-1 and all biological endpoints relevant for the biological safety assessment have been evaluated. The results of the biocompatibility testing confirm that SafeR Syringe and SafeR Sting are biocompatible in compliance for indirect blood path with limited contact duration <24hrs. Cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, and particulate testing per USP <788> were provided for both components.

8. Substantial Equivalence Conclusion

SafeR Syringe and SafeR Sting were compared to the predicate device WTF SECURA SYRINGE AND NEEDLE. Based on the evidence collected, the substantial equivalence between SafeR Syringe and SafeR Sting and predicate device has been verified. Through functional performance testing the subject device has demonstrated substantial equivalence to the predicate device.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).