The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set.

The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.

Sterilization Cycle Parameters

Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes

Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes

Device Description

The POGO Screw Instrumentation Tray is a custom autoclavable, compartmentalized, and perforated tray with a locking lid. It is intended to enclose and protect medicel device instrumentation, and to facilitate the sterilization process by allowing sterilant peneration and air removal. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap.

AI/ML Overview

The POGO Screw Instrumentation Tray is a device designed to enclose and protect medical device instrumentation, facilitate the sterilization process by allowing sterilant penetration and air removal, and maintain the sterility of the internal components when used with an FDA-cleared sterilization wrap. The device's performance was validated through sterilization validation testing, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use:	The POGO Screw Instrumentation Tray is intended to enclose medical devices during steam sterilization.
Technological Characteristics (Design, Materials):	The design and materials (perforated plastic tray from thermoplastic RADEL, stainless steel latch, silicone containment brackets) allow free steam passage. Substantially equivalent to the predicate device in size and volume.
Sterilization Efficacy (Pre-vacuum Steam):	Capable of effective sterilization at 132°C for 4 minutes exposure with 30 minutes drying time, when used with an FDA-cleared sterilization wrap.
Sterilization Efficacy (Gravity Steam):	Capable of effective sterilization at 132°C for 15 minutes exposure with 80 minutes drying time, when used with an FDA-cleared sterilization wrap.
Equivalence to Predicate Device (PolyVac Tray K040223):	Demonstrated substantial equivalence in design, materials, construction, and intended use to the predicate device.
Compliance with Performance Standards:	Met the requirements of ISO 11134.

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

The document does not explicitly state the specific sample size for the test set used in the sterilization validation. However, it indicates Sterilization Validation was conducted. The data provenance is not specified, but it would typically be prospective testing performed by the manufacturer, FxDEVICES, in a controlled lab environment to assess the device's ability to withstand and facilitate sterilization effectively.

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

This information is not provided in the document. For sterilization validation, the "ground truth" is typically established through recognized industry standards (e.g., ISO 11134) and validated laboratory protocols, rather than expert consensus on individual cases. The expertise lies in the validation engineers and microbiologists conducting the testing and interpreting the results against established sterilization efficacy parameters.

4. Adjudication Method for the Test Set:

Not applicable in this context. Sterilization validation involves objective measurements of sterility assurance levels (SAL) based on challenge tests (e.g., biological indicators) and physical parameters, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is an instrumentation tray for sterilization, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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 assessed through its physical properties and its ability to facilitate a sterilization process.

7. The Type of Ground Truth Used:

The ground truth for sterilization validation is based on:

Sterility Assurance Level (SAL): Objective, quantifiable evidence that the sterilization process has achieved a predefined probability of a single viable microorganism being present on an item after sterilization (typically 10^-6 for critical devices).
Compliance with Industry Standards: Adherence to recognized standards like ISO 11134 for steam sterilization, which outlines the requirements for the development, validation, and routine control of a sterilization process for medical devices. This involves using biological indicators and physical parameter monitoring.
Predicate Device Equivalence: The performance of the new device is compared to a legally marketed predicate device (PolyVac Tray K040223) that has already demonstrated safety and effectiveness for the same intended use.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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K091806

FEB 2 2 2010

510(k) Summaries of Safety and Effectiveness FxDEVICES POGO Screw Instrumentation Tray January 11, 2010

1. Sponsor Name FxDEVICES One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
Device Name: 2. Panel: Classification Name: CFR Number: Product Code:

POGO Screw Instrumentation Tray General Hospital Sterilization Wrap Class II (per 21 CFR 880.6850) KCT

Identification of Predicate or Legally Marketed Device 3. The POGO Screw Instrumentation Tray is substantially equivalent to the PolyVac Tray cleared under K040223.

4. Device Description:

1. Intended Use
  The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set. It is indicated for over-the-counter use.

Sterilization Cycle Parameters

Method: Steam Cycle: Pre-vacuum Temperature: 1320C Exposure: 4 minutes Drying Time: 30 minutes
Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes

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Q. Comparison of Technological Characteristics
The 510(k) "Substantial equivalence decision making process (detailed) decision tree" (from CDRH 510(k) manual 92-4158) was utilized to make the following determination of substantial equivalence.

Does the new device have the same intended use?

Yes, the new device has the same intended use as the predicate. Both are used to enclose medical devices during steam sterilization.

Does the new device have the same technological characteristics, e.g. design, materials etc.?

Yes, the design and materials are equivalent. The design and materials used in the POGO Screw Instrumentation Tray, a perforated plastic tray manufactured from thermoplastic RADEL with a stainless steel latch and silicone containment brackets, allows free steam passage and is substantially equivalent to the predicate device. All trays have various dimensions such that the proposed trays and the predicate devices are substantially equivalent in size and volume. The sterilization of all trays has met the requirements of the same performance standard, ISO 11134. The associated procedures for the use of the devices, i.e. the manufacturer's recommended sterilization cycles are similar.

Are descriptive characteristics precise enough to ensure equivalence?

Yes, labeling, intended use, and device descriptions ensure equivalence. In addition, sterilization validation is available to ensure equivalency of the devices.

7. Performance Testing

Sterilization Validation was conducted to support equivalency

8. Statement of Equivalency

The POGO Screw Instrumentation Tray is substantially equivalent in design, materials, construction and intended use as those of the predicate. Since the POGO Screw Instrumentation Tray is the same in intended use and technological characteristics as the predicate devices, the POGO Screw Instrumentation Tray does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.

The test results demonstrate that the POGO Screw Instrumentation Tray is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

FEB 2 2 2010

Mr. Rich Lipschutz President Fxdevices One South Ocean Boulevard Boca Raton, Florida 33432

Re: K091806

Trade/Device Name: POGO Screw Instrumentation Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 12, 2010 Received: January 21, 2010

Dear Mr. Lipschutz

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. 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.

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Page- 2 Mr. Lipschutz

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Runey

Anthony Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K091806

Device Name: POGO Screw Instrumentation Tray

Indications For Use:

The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set.

Sterilization Cycle Parameters

Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes

Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes

Prescription Use

AND/OR

Over-The-Counter Use X

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

itt D.Claveris- W.ll

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tuvision of Anesthesiology, General Hospital Intection Control, Dental Devices

(Division Sign-f

510(k) Number: K0911806

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).