Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.

Device Description

Tiger Reusable Sharps Containers are of injection-molded polypropylene plastic, designed for reusable by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture-resistant, leak-resistant on the sides and bottom, impact-resistant, closable, and stable.

The base is made from a high-strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line.

AI/ML Overview

The device in question is the Tiger Reusable Sharps Container.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Standard	Acceptance Criteria	Reported Device Performance (Results)
Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps	ASTM F 2132 -01 (Reapproved 2008)e1	The force needed to penetrate test specimens shall be a minimum of 20 N or greater.	Pass
DOT Drop Test	49 CFR 178.603	There is no damage to the outer packaging likely to adversely affect safety during transport, there is no leakage of the filling substance from the inner packaging.	Pass
DOT Stacking Test	49 CFR 178.606	No test sample may show any deterioration or distortion, which could adversely affect safety or container strength during transport causing instability in stacks of packages.	Pass
DOT Vibration standard	49 CFR 178.608	A packaging passes the vibration test if there is no rupture or leakage from any of the packages. No test sample should show any deterioration which could adversely affect transportation safety or any distortion liable to reduce packaging strength.	Pass
Container stability	ISO 23907, ISO 23907-2	The container shall not topple over when tested.	Pass
Aperture and closure	ISO 23907, ISO 23907-2	It shall be possible to place sharps into the sharps container without using a second hand to manipulate the aperture. The aperture of containers intended to be placed in public access areas should be designed to restrict hand entry and removal of contents from the container. The aperture should be designed to prevent the risk of overfilling.	Pass
Resistance to penetration	ISO 23907, ISO 23907-2, ASTM F2132-01	The force needed to penetrate test specimens shall be a minimum of 20 N or greater.	Pass
Resistance to damage or leakage after dropping	ISO 23907, ISO 23907-2	There shall be no evidence of leakage and no breach of the sharps containment area. Minimum five minutes after every topple: - There shall be no evidence that the performance or function of the container has been compromised. - The container's temporary closure shall remain intact.	Pass
Resistance to spillage by toppling	ISO 23907, ISO 23907-2	There shall be no evidence of leakage and no breach of the sharps containment area. Minimum five minutes after every topple: - There shall be no evidence that the performance or function of the container has been compromised. - The container's temporary closure shall remain intact.	Pass
Accessory strength test	ISO 23907, ISO 23907-2	The strength of Wall Enclosures and Metal Wall brackets shall be tested by filling their associated sharps container with water. The filled container shall be placed into one of each of the respective wall-mounted accessories. After 48 hours, the containers shall be removed, and the accessories shall be inspected for any loss of integrity. There shall be no evidence of sagging, breakage, liquid leakage, or changes in performance for the locking mechanisms.	Pass
Fill line	ISO 23907, ISO 23907-2	The fill line indicator shall be determined by the design of the container, considering the risk of sharps extending above the fill line. It shall be at a level no greater than 85 % of the total capacity of the container.	Pass
Lifespan simulation testing	ISO 23907 First edition 2012-09-01, ASTM F2132-01 (reapproved 2008), ISO 23907-2 First edition 2019-11	To verify the performance of the devices conforms to the applicable performance standards requirement after Lifespan Simulation Testing.	Pass
Cytotoxicity Tests	ISO10993-5	8.6 Evaluation Criteria (Details not provided in the document, but implies a pass/fail determination based on standard cytotoxicity evaluation).	Based on the conditions of the test, the device was found to be non-cytotoxic.
Skin Sensitization Test	ISO10993-10	9.4 Evaluation of results (Details not provided in the document, but implies a pass/fail determination based on standard skin sensitization evaluation).	Based on the conditions of the test, the device was found to be non-sensitizing.
Skin Irritation Test	ISO10993-10	9.4 Evaluation of results (Details not provided in the document, but implies a pass/fail determination based on standard skin irritation evaluation).	Based on the conditions of the test, the device was found to be non-irritating.
Chemical Residues Test	ISO/DIS 15883-5	5.3 Quantitative Study of Extracts (Details not provided in the document, but implies evaluation of chemical residues).	Pass
Cleaning Validation	FDA Guidance, AAMI TIR 30, ISO/DIS 15883-5	1 Evaluation pass/fail criteria for the residual protein and hemoglobin (blood) by Spectrophotometric method (Method 1) 2 Evaluation pass/fail criteria for residual TOC by total organic carbon analyzer (Method 2)	Pass
Disinfection Validation	FDA Guidance, AAMI TIR 30, ISO/DIS 15883-5	The disinfection process should be deemed effective if all three of the following are met: The concentration of the challenge suspension meets 1.1.2 c) requirements. The positive control 1.2.2 e) shows microbial growth of each challenge organism. After processing, no challenge organism was recovered at any site.	Pass

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes used for each individual test or the data provenance (country of origin, retrospective/prospective). It generally refers to "test specimens" or "test samples" for each performance test. The performance testing was done to demonstrate compliance with recognized international and national standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as the tests performed are physical, chemical, and biological performance tests for a medical device (sharps container), not diagnostic image analysis or clinical studies requiring expert ground truth establishment. The "ground truth" for these tests is defined by the technical specifications and acceptance criteria of the referenced standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable for the type of performance testing conducted. Adjudication methods are typically used in clinical trials or studies involving human assessment or interpretation, not for objective engineering or laboratory tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical sharps container and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.

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

This information is not applicable. The device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these performance tests is based on objective measurements and predefined thresholds established by the relevant national and international standards (e.g., ISO, ASTM, DOT CFR). For biological tests, the ground truth is based on the absence of cytotoxicity, sensitization, irritation, or successful disinfection/cleaning as per the specified methods and criteria. No expert consensus, pathology, or outcomes data were used to establish the ground truth for these device performance tests.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model and therefore does not have a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above; there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 11, 2021

International Marketing Specialists Inc. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K203305

Trade/Device Name: Tiger Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK

Dear Charles Mack:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 8/6/21. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence Murray, OHT4: Office of Surgical and Infection Control Devices, 301-796-0270, Clarence.Murray(@fda.hhs.gov.

Sincerely,

Clarence W. Murray III -S

Clarence W. Murray, III, Ph.D. 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

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

August 6, 2021

International Marketing Specialists, Inc % Charles Mack Correspondent International Marketing Specialists, Inc. Contact Address

Re: K203305

Trade/Device Name: Tiger Reusable Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: July 21, 2021 Received: July 26, 2021

Dear Charles Mack:

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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Clarence W. Murray

Enclosure

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Indications for Use

510(k) Number (if known) K203305

Device Name Tiger Reusable Sharps Container

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

|--|--|

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K203305

510(k) Summary (21 CFR §807.92)

Date of Preparation: August 4,2021

I. Submitter Information:

Submitter Name:	International Marketing Specialists, Inc.
Address:	1278 Highway 461, Somerset, Kentucky 42503
Contact Person:	Mr. Rod Calderon, General Manager

US Agent and Correspondent

Mr. Charles Mack Principal Engineer IRC 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: 931-625-4938 Email: charliemack@jrc-us.com

II. Device

Trade Name:	Tiger Reusable Sharps Container
Common Name:	container, sharps
Regulation Number:	21 CFR§880.5570
Regulation Name:	Hypodermic single lumen needle
Regulatory Class:	II
Product Code:	MMK

III. Predicate Device Information

Manufacturer	Predicate Device	510(k) Number
TriumvirateEnvironmental, Inc.	Red2Green ReusableSharps Container	K153363

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IV. Device Description:

Parts &Accessories	Material	Material Specification	Patient Contact(Direct /Indirect)?
Base	Polypropylene	INEOS PP N02G-00	No
Lid	Polyethylene, HighDensity	ExxonMobil TM HDPE HD6719 Series	No
Colorpower	Hififast ScarletHF4Y	PPR007BTS	No

V. Indications for Use

Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices, and other small quantity waste generators for the safe disposal, storage, and transportation of hazardous sharps.

VI. Intended Use

The containers are 100 times reusable, non-sterile, intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is qualified personnel in healthcare facilities and other facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.

All device models only are used with appropriate mounting accessories.

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Model	Weight(empty)	Capacity(total)	Capacity(fullline)	Dimensions offinished goods(mm)(L x W x H)	Colors	Acceptable sites of use
2 GallonCap	875 g	7.8Quarts	6 Quarts	331.98 x 154.48 x324.2	Red baseand whitelid	The target population isqualified personnel inhealth care facilities andother facilities in whichmedical sharps may beused. All the containersare intended to be usedin areas where there isno unsupervised patientaccess.
2 Gallonmailbox	1042 g	7.8Quarts	6 Quarts	332.09 x 154.78x 398.37	lid
3 GallonCap	1187 g	2.9gallons	2.45gallons	331.98 x 154.48 x475.2
3 Gallonmailbox	1354 g	2.9gallons	2.45gallons	332.09 x 154.78 x549.37
8 Gallon	1400 g	7.8 Gal	6.5 Gal	306.36 x 328.41 x479.1

Model	Lidconfiguration	Dimensionsof lidopening(aperture)	PermanentLockingmechanism	TemporaryLockingmechanism lidtocontainer	Requirements formounting
2-galloncap	Cap/drop	63.54 mm	Hand pressuretight	CatamountStandardCableties on each side.	a. Locking wallbracketb. Wall enclosure
2-gallonmailbox	Mailbox	21.63 mm	Counterbalancedoor/ hingeclosure	CatamountStandardCable ties oneach side	a. Locking wallbracketb. Wall enclosure
3-galloncap	Cap/drop	63.54 mm	Hand pressuretight	CatamountStandardCable ties oneach side	a. Locking wallbracketb. Wall enclosure
3-gallonmailbox	Mailbox	21.63 mm	Counterbalancedoor/ hingeclosure	CatamountStandardCable ties oneach side	a. Locking wallbracketb. Wall enclosure
8-gallon	Cap/drop	63.54 mm	Hand pressuretight	CatamountStandard Cableties on each side	Stainless steel or plasticstabilizer/holder

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Element of comparison	Subject Device	Predicate Device	Comparison
Company	International Marketing Specialists, Inc.	Triumvirate Environmental, Inc.	N/A
FDA510(K) Number	Pending	K153363	N/A
Device Name	Tiger Reusable Sharps Container	Red2Green Reusable Sharps Container	N/A
Model Types	2 Gallon cap2 Gallon mailbox3 Gallon cap3 Gallon mailbox8 Gallon	2 Gallon3 Gallon8 Gallon	Identical
Indications for Use	Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices, and other small quantity waste generators for the safe disposal, storage, and transportation of hazardous sharps.	Red2Green Reusable Sharps Containers and accessories are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices, and other small quantity waste generators for the safe disposal, storage, and transportation of hazardous sharps.	Identical
Product Code	MMK	MMK	Identical
Regulation Number	21CFR880.5570	21CFR880.5570	Identical
Class	2	2	Identical
Prescribed	OTC	OTC	Identical
Material	Polyethylene	Polyethylene	Identical
Dimensions (L x W x H)	2 Gallon cap: 331.98 x 154.48 x 324.2 (mm)2 Gallon mailbox: 332.09 x 154.78 x 398.37 (mm)3 Gallon cap: 331.98 x 154.48 x 475.2 (mm)3 Gallon mailbox: 332.09 x 154.78 x 549.37 (mm)8 Gallon: 306.36 x 328.41 x 479.1 (mm)	2 gallon: 6.3 x 12.8 x 10.4 (inches)3 gallon: 6.3 x 12.8 x 15.3 (inches)8 gallon: 13 x 13 x 17.4 (inches)	The same capacity but dimension difference doesn't raise new safety and effectiveness issues and confirm the design requirement.
Intended Location of Use	Health care facilities	Health care facilities	Identical
Element ofcomparison	Subject Device	Predicate Device	Comparison
Color	Red	Red or yellow	Identical
Needle RemovalMechanism	No	No	Identical
Sharps accessand closure	Gravity-activated	Gravity-activated	Identical
Container Closure	Vertical and horizontal drop, lab lid,transportation lid	Vertical and horizontal drop, lab lid,transportation lid	Identical
Accessories	Wall enclosure, wall brackets	Stabilizing tray, wall enclosure, wall bracket,rolling dolly, foot pedal dolly	Identical
Reusable or Non-reusable Container	Reusable	Reusable	Identical
Non-sterile	Yes	Yes	Identical
Performance testing	Container stabilityStrength of handlesAperture and closureResistance to penetrationResistance to damage or leakage after droppingResistance to spillage by topplingFill lineAccessory strength	Puncture resistanceImpact w/ leakStabilityAccessory strength	The subject device confirms theFDA recently recognizedperformance standards for reusablesharps containers, including ISO23907 First edition 2012-09-01,ISO 23907-2 First edition 2019-11,ASTM F2132-01 (reapproved2008).The test conducted by predictdevice at past now already includedin the FDA recognizedperformance standards.
Element ofcomparison	Subject Device	Predicate Device	Comparison
Lifespan SimulationTesting	Lifespan tumbling simulationLifespan transport simulationsLifespan processing simulation	Repeated openingLife cycle	The subject device confirms to theFDA recently recognizedperformance standards for reusablesharps containers, including ISO23907 First edition 2012-09-01,ISO 23907-2 First edition 2019-11,ASTM F2132-01 (reapproved2008);
Transportation Test	ImpactStackingVibration	ImpactStackingVibration	Identical:Conforms to 49 CFR 178.603Conforms to 49 CFR 178.606Conforms to 49 CFR 178.608
Biological Testing	ISO 0993-5, ISO 10993-10, ISO/DIS 15883-5,In vitro cytotoxicity, skin sensitization, cleaningefficacy.	The predicate is N/A for this testing.	N/A
Disinfection	Microbiological Challenge Test,Decontamination Assurance Level of 10-4	The predicate is N/A for this testing.	N/A

Comparison of Technological Characteristics with the Predicate Device VII.

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IX. Summary of Non-Clinical Testing

Performance Data

Performance testing was provided to demonstrate that the Tiger Reusable Sharps Container met the acceptance criteria or specifications found in the standards and guidance provided below.

Test	Standard	AcceptanceCriteria	Results
Puncture Resistanceof Materials Used inContainers forDiscarded MedicalNeedles and OtherSharps	ASTM F 2132 -01(Reapproved 2008)e1	The force needed topenetrate testspecimens shall bea minimum of 20 Nor greater.	Pass
DOT Drop Test	49 CFR 178.603	There is no damageto the outerpackaging likely toadversely affectsafety duringtransport, there isno leakage of thefilling substancefrom the innerpackaging。	Pass
DOT Stacking Test	49 CFR 178.606	No test sample mayshow anydeterioration ordistortion, which couldadversely affectsafety or containerstrength duringtransport causinginstability in stacksof packages.	Pass
Test	Standard	Acceptance Criteria	Results
DOT Vibrationstandard	49 CFR 178.608	A packaging passesthe vibration test ifthere is norupture or leakagefrom any of thepackages. No testsample shouldshow anydeterioration whichcouldadversely affecttransportationsafety or anydistortionliable to reducepackaging strength.	Pass
Container stability	ISO 23907ISO 23907-2	The container shallnot topple overwhen tested	Pass
Aperture and closure	ISO 23907ISO 23907-2	It shall be possibleto place sharps intothe sharps containerwithout using asecond hand tomanipulate theaperture. Theaperture ofcontainers intendedto be placed inpublic access areasshould be designedto restrict handentry and removalof contents from thecontainer.The aperture shouldbe designed toprevent the risk ofoverfilling.	Pass
Resistance topenetration	ISO 23907ISO 23907-2ASTM F2132-01	The force needed topenetrate testspecimens shall bea minimum of 20 Nor greater.	Pass
Test	Standard	Acceptance Criteria	Results
Resistance todamage or leakageafter dropping	ISO 23907ISO 23907-2	There shall be noevidence ofleakage and nobreach ofthe sharpscontainment area.Minimum fiveminutes after everytopple:- There shall be noevidence that theperformance orfunction of thecontainer has beencompromised.- The container'stemporary closureshall remain intact.	Pass
Resistance tospillage by toppling	ISO 23907ISO 23907-2	There shall be noevidence of leakageand no breach ofthe sharpscontainment area.Minimum fiveminutes after everytopple:- There shall be noevidence that theperformance orfunction of thecontainer has beencompromised.- The container'stemporary closureshall remain intact.	Pass
Test	Standard	Acceptance Criteria	Results
Accessory strength test	ISO 23907ISO 23907-2	The strength of Wall Enclosures and Metal Wall brackets shall be tested by filling their associated sharps container with water. The filled container shall be placed into one of each of the respective wall-mounted accessories. After 48 hours, the containers shall be removed, and the accessories shall be inspected for any loss of integrity. There shall be no evidence of sagging, breakage, liquid leakage, or changes in performance for the locking mechanisms	Pass
Fill line	ISO 23907ISO 23907-2	The fill line indicator shall be determined by the design of the container, considering the risk of sharps extending above the fill line. It shall be at a level no greater than 85 % of the total capacity of the container.	Pass
Test	Standard	Acceptance Criteria	Results
Lifespansimulationtesting	ISO 23907 Firstedition 2012-09-01ASTM F2132-01(reapproved2008)ISO 23907-2First edition2019-11	To verify theperformance of thedevices conforms tothe applicableperformancestandardsrequirement afterLifespanSimulation Testing.	Pass
CytotoxicityTests	ISO10993-5	8.6 EvaluationCriteria	Based on the conditions ofthe test, the device was foundto be non-cytotoxic
SkinSensitizationTest	ISO10993-10	9.4 Evaluation ofresults	Based on the conditions ofthe test, the device was foundto be non-sensitizing
Skin IrritationTest	ISO10993-10	9.4 Evaluation ofresults	Based on the conditions ofthe test, the device was foundto be non-irritating
ChemicalResidues Test	ISO/DIS 15883-5	5.3 QuantitativeStudy of Extracts	Pass
CleaningValidation	FDA GuidanceAAMI TIR 30ISO/DIS 15883-5	1 Evaluationpass/fail criteria forthe residual proteinand hemoglobin(blood) bySpectrophotometricmethod (Method 1)2 Evaluationpass/fail criteria forresidual TOC bytotal organic carbonanalyzer (Method2)	Pass
Test	Standard	AcceptanceCriteria	Results
DisinfectionValidation	FDA GuidanceAAMI TIR 30ISO/DIS 15883-5	The disinfectionprocess should bedeemed effective ifall three of thefollowing are met:The concentrationof the challengesuspension meets1.1.2 c)requirements.The positivecontrol 1.2.2 e)shows microbialgrowth of eachchallengeorganism.After processing,no challengeorganism wasrecovered at anysite.	Pass

Performance Testing

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The test results demonstrate the subject devices comply with the applicable requirements.

Clinical Test:

Not applicable.

X Conclusions:

The non-clinical data demonstrate that the Tiger Reusable Sharps Container is as safe, as effective, and performs as well as or better than the predicate device, Red2Green Reusable Sharps Container (K153363) manufactured by Triumvirate Environmental, Inc.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).