Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization tray for surgical instruments and implants. The description focuses on its materials, components, and sterilization parameters, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is a system tray for the sterilization, storage, and handling of implants and surgical instruments, not a therapeutic device itself.

Diagnostic

No

The device is a system tray for the sterilization and storage of implants and instruments, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical system tray made of various materials (aluminum, stainless steel, silicone, etc.) intended for sterilization, storage, and handling of implants and instruments. It is not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the tray is for containing implants and surgical instruments for sterilization, storage, and handling. It is used in conjunction with sterilization methods and wraps/containers to maintain sterility of the enclosed devices.
Device Description: The description reinforces its function as a sterilization storage system for implants and instruments.
Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This is the core definition of an IVD.

The device is a sterilization tray, which is a type of medical device used in the preparation and handling of other medical devices (implants and instruments).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 (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.

Sterilization 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.

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

Product codes (comma separated list FDA assigned to the subject device)

KCT

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 FDA-cleared 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospitals and healthcare facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility Testing

Study type: Biocompatibility evaluation 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.
Key results: The subject device met testing requirements for Cytotoxicity, Sensitization, Irritation, and Pyrogen testing.

Bench Testing

Design Validation
- Study type: Design and performance validation
- Key results: Pass; met all requirements.
Ship Testing
- Study type: Evaluate implant and instrument protection and retention during shipping and handling.
- Key results: Pass.
Cleaning Validation (reusable instruments)
- Study type: Validate prescribed manual cleaning process.
- Key results: Pass.
Sterilization Validation
- Study type: Validate steam sterilization parameters for the fully-populated system.
- Key results: Passed for both sterile wrap and rigid container configurations.
Reliability Verification (Sterilization Cycles Validation)
- Study type: Assess reliability via repeated use and sterilization.
- Key results: Passed functional and visual criteria after 100 cycles.
Cytotoxicity
- Study type: Determine cytotoxicity of extractable substances using Minimal Essential Media (MEM) Elution test.
- Key results: Pass.
Sensitization
- Study type: Determine potential sensitization effects of indirect contact materials.
- Key results: Pass.
Irritation
- Study type: Determine potential irritation effects of indirect contact materials.
- Key results: Pass.
Pyrogen testing
- Study type: Detect and quantify bacterial endotoxin using Limulus Amebocyte Lysate (LAL) test.
- Key results: Pass.

Animal Study

No animal studies were performed to demonstrate safety and efficacy.

Clinical Studies

No clinical studies were performed to demonstrate safety and efficacy.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

OsteoMed MMF Sterilization Tray (K173391)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

NuVasive Sterilization Tray (K143579)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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

2

Indications for Use

510(k) Number (if known) K202105

Device Name

OsteoMed ExtremiFix Mini & Small System Tray

Indications for Use (Describe)

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.

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 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

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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.

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

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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 OsteoMed ExtremiFix
Mini & Small System
Tray OsteoMed QuickFix
Hybrid MMF
Sterilization Tray
(K173391) | Comparison |
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| KCT | KCT | Same |
| 888.685 | 888.685 | Same |
| Base, lid, screw
| Base, lid, locking
| Similar |
| Aluminum, stainless
| Aluminum | Similar |
| Evenly distributed
| Evenly distributed
| Same |
| Outer case: 17.6 x 9.5 x
| Rectangle base with
| Similar |
| Sterilant (steam)
| Sterilant (steam)
| Same |
| Steam | Steam | Same |
| Pre-vacuum | Pre-vacuum | Same |
| 270°F (132°C) | 270°F (132°C) | Same |
| 4 minutes | 4 minutes | Same |
| 30 minutes (rigid
| 30 minutes | Similar |
| Yes | Yes | Same |
| Outer case: 0.231 in2/in3
| Base/lid: 0.050 in2/in3 | Similar |
| T7 driver long:
| Base steam hole:
| Similar |
| 2.4mm module screw
| The OsteoMed QuickFix
| 3.0mm module screw
| | |
| 4.0mm module screw
| | |
| The OsteoMed Mini &
| |
| Sterilization validation
| | |
| Validated sterilization
| | |
| | |

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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.

| 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
functionalit
y of the
tray. | Pass; met all
requirements |
| Test
Description | Purpose | Acceptance
Criteria | Summary
of Test
Results |
| 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
configurati
ons |
| 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 | Pass |
| | | | |
| | | greater than 2 is
considered
cytotoxic effect, or
a failing score. | |
| 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,
a component of the cell wall
of Gram negative bacteria. | For medical
devices, the
endotoxin limit is
not more than 20.0
EU/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.