The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre- vacum) steam sterilization methods. The system tray is not intended to maintain sterlity; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container.

Device Description

The OsteoMed ExtremiFix Mini & Small System Tray is composed of anodized and non-anodized aluminum, stainless steel, silicone, polyethylene terephthalate (Mylar), polyphenylsulfone (Radel), polyamide 11 (nylon), and ZEUS Perfluoroalkoxy (PFA), which are common tray materials, and is used to enclose, protect, and organize OsteoMed ExtremiFix Mini & Small System implants and surgical instruments. This is a product specific sterilization storage system tray (only for use with the OsteoMed ExtremiFix Mini & Small System) that is intended to provide storage for the OsteoMed ExtremiFix screws and accessories during sterilization, storage, and transportation within the hospital environment.

The OsteoMed ExtremiFix Mini & Small System Tray is a single sterilization storage system that is comprised of one outer case (base + lid), two screw modules (any two of the four sizes), and two trays (handle tray + instrument tray). The trays are perforated to allow for steam sterilization. An FDA-cleared wrap or FDAcleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed ExtremiFix Mini & Small SystemTray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed ExtremiFix Mini & Small System Tray is effective for containing the system devices during sterilization and have been designed to withstand repeated steam sterilization cycles.

AI/ML Overview

The provided text is an FDA 510(k) summary for a medical device: the OsteoMed ExtremiFix Mini & Small System Tray. This document details the device's characteristics, intended use, and the non-clinical testing performed to establish its substantial equivalence to a predicate device.

However, the request asks for information relevant to the study of an AI-powered diagnostic device. The provided text does not describe an AI or diagnostic device. Instead, it pertains to a sterilization tray, which is a physical container used to hold medical instruments for sterilization.

Therefore, many of the requested categories (such as acceptance criteria for AI performance, sample size for test sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, training set details, etc.) are not applicable to this type of device and are not present in the provided document.

I will provide the information that is available in the document, acknowledging where the requested information is not applicable due to the nature of the device.

Here's an analysis of the provided text based on your request:

The device in question is the OsteoMed ExtremiFix Mini & Small System Tray, a sterilization tray for medical implants and instruments. It is not an AI-powered diagnostic device. As such, many of the requested criteria, which are typical for studies validating AI diagnostics, are not applicable.

1. A table of acceptance criteria and the reported device performance

The document presents acceptance criteria and results primarily for non-clinical (bench) testing, focusing on the physical performance and safety of the sterilization tray.

Test Description	Purpose	Acceptance Criteria	Summary of Test Results
Design Validation	To validate the design and performance of the ExtremiFix Mini & Small System.	Surgeons evaluated the functionality of the tray.	Pass; met all requirements
Ship Testing	To establish that the ExtremiFix Mini & Small System, and associated packaging, protects and retains the implants and instruments during normal shipping and handling.	Ship packaged plate per ASTM D-4169 and evaluate package contents for damage upon return.	Pass
Cleaning Validation (reusable instruments)	To validate the prescribed manual cleaning process for the ExtremiFix Mini & Small System.	Use the T7 cannulated long driver as worst-case device to verify that re-useable instruments can be cleaned per instructions to achieve standard requirements for reusable devices per AAMI TIR 12 and AAMI TIR 30.	Pass
Sterilization Validation	To validate the steam sterilization parameters for the ExtremiFix Mini & Small System to ensure that the fully-populated system can be sterilized.	Validate sterilization parameters with 3 consecutive tests. Conducted test for both systems wrapped in polypropylene sterile wrap and system enclosed in rigid container.	Passed for both sterile wrap and rigid container configurations
Reliability Verification (Sterilization Cycles Validation)	To assess the reliability, via repeated use and sterilization, of the ExtremiFix Mini & Small System.	Verify functionality and graphics legibility after the system tray is steam sterilized for 100 cycles with the sterilization parameters described in the IFU.	Passed functional and visual criteria after 100 cycles
Cytotoxicity	The Minimal Essential Media (MEM) Elution test was designed to determine the cytotoxicity of extractable substances.	The ANSI/AAMI/ISO 10993-5 standard states that the achievement of a greater than 2 is considered cytotoxic effect, or a failing score.	Pass
Sensitization	To determine the potential sensitization effects of subject device indirect contact materials.	The test is considered negative for signs of sensitization if the positive response observed is in less than 10% of the test animals.	Pass
Irritation	To determine the potential irritation effects of subject device indirect contact materials.	The requirements of the test will be met if the difference between the test article mean score and control mean score is 1.0 or less.	Pass
Pyrogen testing	The Bacterial Endotoxins Test, or Limulus Amebocyte Lysate (LAL) test, is an in vitro assay to detect and quantify bacterial endotoxin.	For medical devices, the endotoxin limit is not more than 20.0 EU/device.	Pass

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

Sample Size: The document does not specify a quantitative "sample size" in the context of typical AI/diagnostic studies (e.g., number of images or patients). Instead, it refers to:
- "3 consecutive tests" for Sterilization Validation.
- "100 cycles" for Reliability Verification (Sterilization Cycles Validation).
- Testing with "worst-case device" (T7 cannulated long driver) for Cleaning Validation.
- These are engineering and biological validations, not clinical data sets in the AI sense.
Data Provenance: Not applicable. The tests are benchtop, laboratory-based validations of the physical device, not data collected from patients or clinical settings. It's a manufacturing/performance validation, not a data-driven model validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For "Design Validation," "Surgeons evaluated the functionality of the tray." The number and specific qualifications of these surgeons are not specified.
For other tests (e.g., sterilization, biocompatibility, reliability), the "ground truth" is established by adherence to recognized standards (e.g., AAMI TIR, ISO 10993) and measured physical/biological parameters, not human expert consensus on medical images or diagnoses.

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

Not applicable. There is no human interpretation or diagnostic "reading" involved that would require an adjudication method. The tests are objective measurements against pre-defined performance criteria.

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 sterilization tray, not an AI-powered diagnostic tool. No MRMC studies were performed or are relevant.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device's performance validation is based on engineering performance specifications (e.g., maintaining integrity after shipping, ability to withstand sterilization cycles, effective cleaning), and biocompatibility standards (e.g., absence of cytotoxicity, sensitization, irritation, pyrogenicity). These are determined through standardized testing methods, not clinical outcomes or expert medical consensus.

8. The sample size for the training set

Not applicable. This is not an AI model, and therefore, there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

October 29, 2020

OsteoMed LLC Andrew Johnson Senior Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001

Re: K202105

Trade/Device Name: OsteoMed ExtremiFix Mini & Small System Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 28, 2020 Received: July 31, 2020

Dear Andrew Johnson:

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 mediation-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,

For Kapil Panguluri, PhD 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) K202105

Device Name

OsteoMed ExtremiFix Mini & Small System Tray

Indications for Use (Describe)

Sterilization was performed utilizing the ExtremlFix Mini & Small Cannulated Screw System implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 14.1 lbs. in the sterilization system tray.

Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a wrapped configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 50 minutes

Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a rigid container configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes

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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Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue stripe at the top and a gray stripe at the bottom. The word "OSTEOMED" is written in blue and gray in the center of the oval. The logo is simple and modern.

K202105 510(k) SUMMARY

I. SUBMITTER

OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA Phone: 972-677-4795 Fax: 972-677-4601 Email: djohnson@osteomed.com Contact Person: Drew Johnson Date Prepared: 7/28/2020

II. DEVICE

Name of the Device: OsteoMed ExtremiFix Mini & Small System Tray Common or Usual Name: Sterilization Tray Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Regulation: 880.6850 Regulatory Class: II Product Code: KCT

III. PREDICATE DEVICE

Predicate Device: OsteoMed MMF Sterilization Tray (K173391)

Reference Device: NuVasive Sterilization Tray (K143579)

IV. DEVICE DESCRIPTION

The OsteoMed ExtremiFix Mini & Small System Tray is a single sterilization storage system that is comprised of one outer case (base + lid), two screw modules

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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue stripe on the top and a gray stripe on the bottom. The word "OSTEOMED" is written in blue letters in the center of the oval. The logo is simple and modern.

(any two of the four sizes), and two trays (handle tray + instrument tray). The trays are perforated to allow for steam sterilization. An FDA-cleared wrap or FDAcleared rigid sterilization container must be used for sterilization and to maintain the sterility of the contents. The OsteoMed ExtremiFix Mini & Small SystemTray is designed to be used with standard autoclaves used in hospitals and healthcare facilities. As such, the OsteoMed ExtremiFix Mini & Small System Tray is effective for containing the system devices during sterilization and have been designed to withstand repeated steam sterilization cycles.

V. INDICATIONS FOR USE

The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (prevacuum) steam sterilization methods. The system tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices. The System Tray may also be used in conjunction with a legally marketed rigid container.

Sterilization validation was performed utilizing the ExtremiFix Mini & Small Cannulated Screw System implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 14.1 lbs. in the sterilization system tray.

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Image /page/5/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue top and a gray bottom. The word "OSTEOMED" is written in bold, sans-serif font across the center of the oval, with "OSTEO" in blue and "MED" in gray. There is a registered trademark symbol in the upper right corner of the oval.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Provided in the table below is the OsteoMed ExtremiFix Mini & Small System Tray and the comparison with the predicate.

Characteristics	Subject Device:OsteoMed ExtremiFixMini & Small SystemTray	Predicate Device:OsteoMed QuickFixHybrid MMFSterilization Tray(K173391)	Comparison
Product Code	KCT	KCT	Same
21 CFR	888.685	888.685	Same
System Components	Base, lid, screwmodules, instrumenttrays	Base, lid, lockinglatch	Similar
Material Composition	Aluminum, stainlesssteel, silicone,polyethyleneterephthalate, nylon,polyphenylsulfone,ZEUS Perfluoroalkoxy	Aluminum	Similar
Physical Properties	Evenly distributedperforated hole pattern	Evenly distributedperforated hole pattern	Same
Configurations/Dimensions(L x W x H) in.	Outer case: 17.6 x 9.5 x4.1Screw modules: 8.1 x6.1 x 3.3Instrument trays: 9.2 x3.3 x 1.6	Rectangle base withlid: 9.5 x 5.0 x 1.5	Similar
Sterilant Penetration	Sterilant (steam)penetration throughperforations in tray	Sterilant (steam)penetration throughperforations in tray	Same
Sterilization method	Steam	Steam	Same
Sterilization cycle	Pre-vacuum	Pre-vacuum	Same
Exposure temperature	270°F (132°C)	270°F (132°C)	Same
Exposure time	4 minutes	4 minutes	Same
Dry time	30 minutes (rigidcontainer)50 minutes (wrapped)	30 minutes	Similar
Reusable	Yes	Yes	Same
Vent to Volume Ratio	Outer case: 0.231 in2/in3Module: 0.260 in2/in3	Base/lid: 0.050 in2/in3	Similar
Worse Case Lumen	T7 driver long:Ø0.038, L = 0.371" (1ea.)T10 driver long:Ø0.050, length 5" (1ea.)2.0mm module screwhole: Ø0.092, length0.325" (126 ea.)	Base steam hole:Ø0.094, length1.075" (1 ea.)Driver sleeve:Ø0.115, length0.680''Driver handle: blindhole Ø0.111, depth1.173"	Similar
Indications for Use	2.4mm module screwhole: Ø0.105, length0.325" (150 ea.)	The OsteoMed QuickFixHybrid MMFSterilizationTray is intended tocontainOsteoMed QuickFixHybrid MMF implantsandsurgical instruments forsterilization, storage andhandling. The OsteoMedQuickFix Hybrid MMFSterilization Tray issuitable for dynamic airremoval (pre-vacuum)steam sterilizationmethods. The tray is notintended to maintainsterility; they areintendedto be used in conjunctionwith a validated,FDAclearedsterilization wrapin order to maintainsterility of the encloseddevices. The sterilizationtrays may also be used inconjunction with alegally marketed rigidcontainer. Sterilizationvalidation was done forthe OsteoMed QuickFixHybrid MMF device andaccessories. Do notexceed a maximum loadof 2.3 lbs. in thesterilization tray.Validated sterilizationparameters for OsteoMedQuickFix Hybrid MMFSterilization Tray:Method: Steam CyclePre-VacuumTemperature:270°F (132°C)	Similar
	3.0mm module screwhole: Ø0.130, length0.325" (96 ea.)
	4.0mm module screwhole: Ø0.165, length0.325" (108 ea.)
	The OsteoMed Mini &Small System Tray isintended to contain Miniand Small implants andsurgical instruments forsterilization, storage andhandling. The OsteoMedMini & Small SystemTray is suitable fordynamic air removal(prevacuum) steamsterilization methods.The system tray is notintended to maintainsterility; it is intended tobe used in conjunctionwith a validated, FDA-cleared sterilization wrapin order to maintainsterility of the encloseddevices. The SystemTray may also be used inconjunction with alegally marketed rigidcontainer.
	Sterilization validationwas performed utilizingthe ExtremiFix Mini &Small Cannulated ScrewSystem implants andaccessories suchas surgicalinstrumentation.Do not exceed amaximum load of 14.1lbs. in the sterilizationsystem tray.
	Validated sterilizationparameters for OsteoMedExtremiFix Mini &Small System Tray in awrapped configuration:
ExtremiFix Mini &Small System Tray in awrapped configuration:Method: Steam CyclePre-VacuumTemperature: 270°F(132°C)Exposure Time: 4minutesMinimum Dry Time: 50minutesValidated sterilizationparameters for OsteoMedExtremiFix Mini &Small System Tray in arigid containerconfiguration:Method: Steam CyclePre-VacuumTemperature:270°F (132°C)Minimum Dry Time: 30minutes	Exposure Time: 4minutesMinimum Dry Time: 30minutes

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Image /page/6/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The logo is surrounded by a gray and blue oval shape. The word "OSTEOMED" is in blue, and the oval shape is gray on the bottom and blue on the top.

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Image /page/7/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The word "OSTEO" is in blue, and the word "MED" is in gray. The logo is surrounded by a blue and gray oval shape. The logo is clean and professional, and it is likely used to represent a medical company.

SUMMARY OF NON-CLINICAL TESTING

The testing provided below was performed to demonstrate whether the subject device met the performance acceptance criteria of the respective standard listed below:

Biocompatibility Testing

A biocompatibility evaluation was conducted according to FDA guidance document "Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process,"" Guidance for Industry and Food and Drug Administration Staff, dated June 16, 2016. The subject device does not have direct contact with patients. The implants and instruments to be sterilized in the subject device will have contact with the subject device's surfaces; therefore, the subject device's case, trays, and modules have indirect contact with the patient. The subject device indirect patient contact materials are similar materials that were previous cleared with the predicate device, K173391, and the reference device, K143579.

The subject device met testing requirements for:

Cytotoxicity
Sensitization
Irritation
Pyrogen testing ●

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Image /page/8/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue top and a gray bottom. The word "OsteoMed" is written in blue and gray inside the oval. There is a registered trademark symbol in the upper right corner of the logo.

Bench Testing

The following table provides a summary of the bench testing conducted.

TestDescription	Purpose	AcceptanceCriteria	Summary of TestResults
DesignValidation	To validatethe designandperformanceof theExtremiFixMini &SmallSystem	Surgeonsevaluatedthefunctionality of thetray.	Pass; met allrequirements
TestDescription	Purpose	AcceptanceCriteria	Summaryof TestResults
Ship Testing	To establish that theExtremiFix Mini & SmallSystem, and associatedpackaging, protects andretains the implants andinstruments duringnormal shipping andhandling.	Ship packagedplate perASTM D-4169and evaluatepackagecontents fordamage uponreturn.	Pass
CleaningValidation(reusableinstruments)	To validate the prescribedmanual cleaning process forthe ExtremiFix Mini &Small System.	Use the T7cannulated longdriver as worst-case device toverify that re-useableinstruments canbe cleaned perinstructions toachieve standardrequirements forreusable devicesper AAMI TIR 12and AAMI TIR30.	Pass
SterilizationValidation	To validate the steamsterilization parameters forthe ExtremiFix Mini &Small System to ensure thatthe fully-populated systemcan be sterilized.	Validatesterilizationparameters with 3consecutive tests.Conducted test forboth systemswrapped inpolypropylenesterile wrap andsystem enclosed inrigid container.	Passed forbothsterilewrap andrigidcontainerconfigurations
ReliabilityVerification(SterilizationCyclesValidation)	To assess the reliability, viarepeated use andsterilization, of theExtremiFix Mini & SmallSystem.	Verifyfunctionality andgraphics legibilityafter the systemtray is steamsterilized for 100cycles with thesterilizationparametersdescribed in theIFU.	Passedfunctionaland visualcriteriaafter 100cycles
Cytotoxicity	The Minimal EssentialMedia (MEM) Elution testwas designed to determinethe cytotoxicity ofextractable substances.	TheANSI/AAMI/ISO10993-5 standardstates that theachievement of a	Pass

		greater than 2 isconsideredcytotoxic effect, ora failing score.
Sensitization	To determine the potentialsensitization effects ofsubject device indirectcontact materials.	The test isconsidered negativefor signs ofsensitization if thepositive responseobserved is in lessthan 10% of the testanimals.	Pass
Irritation	To determine the potentialirritation effects of subjectdevice indirect contactmaterials.	The requirementsof the test will bemet if thedifference betweenthe test articlemean score andcontrol mean scoreis 1.0 or less.	Pass
Pyrogentesting	The Bacterial EndotoxinsTest, or Limulus AmebocyteLysate (LAL) test, is an invitro assay to detect andquantify bacterial endotoxin,a component of the cell wallof Gram negative bacteria.	For medicaldevices, theendotoxin limit isnot more than 20.0EU/device.	Pass

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Image /page/9/Picture/0 description: The image shows the logo for OsteoMed. The logo is in an oval shape with a blue top and a gray bottom. The word "OSTEOMED" is written in blue and gray letters across the center of the oval. The logo is simple and modern.

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Image /page/10/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in blue, bold letters. The logo is surrounded by a gray and blue oval. The blue part of the oval is on top, and the gray part is on the bottom.

The results on the non-clinical testing demonstrated that the subject device met the acceptance criteria of the standard.

Animal Study

No animal studies were performed to demonstrate safety and efficacy.

Clinical Studies

No clinical studies were performed to demonstrate safety and efficacy.

CONCLUSIONS VII.

The conclusions drawn from the nonclinical tests demonstrate that the OsteoMed ExtremiFix Mini & Small System Tray is as safe, as effective, and performs as well as or better than the legally marketed device OsteoMed MMF Sterilization Tray (K173391) under regulation 21 CFR 880.6850, product code KCT.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).