The Turbett Surgical Container is indicated for enclosing other medical devices that are to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical filters.

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray.

Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.

Device Description

The Turbett Surgical Container is a rigid sterilization container with a fenestrated door holding a single-use filter. The container is designed to be used in a steam autoclave and hold multiple open trays containing surgical instruments. Trays within the container are separated by dividers to ensure separation and maximum steam exposure. The container has been validated to sterilize 375 lbs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. Actual expected loads in hospital settings are likely to be less. Sterilized instruments can be stored for up to 30 days within the closed container.

The Turbett Surgical Container is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door.

The use of a single-use disposable filter cartridge installed in the fenestrated door eliminates the need for a sealed gasket found on other rigid containers. The omission of a reusable gasket eliminates contamination risks due to failed reusable gaskets.

AI/ML Overview

The provided text describes the Turbett Surgical Container and its approval through the 510(k) pathway, which means it demonstrated "substantial equivalence" to a predicate device. This process typically focuses on comparing the new device's characteristics and performance to a legally marketed predicate, rather than establishing strict acceptance criteria and proving the device meets them through a deeply detailed study in the same way a novel high-risk device might.

However, based on the provided text, we can extract the validation parameters and the evidence used to support the substantial equivalence claim.

Here's an analysis of the "acceptance criteria" and "study" information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, specific rigid "acceptance criteria" for performance are not explicitly stated with numerical targets in the same way a clinical trial might, but rather the performance is demonstrated to be equivalent or better than the predicate device across various tests. The "reported device performance" is the outcome of these validation tests.

Acceptance Criteria Category (Implied)	Turbett Surgical Container Reported Performance
Sterilization Efficacy (Pre-vacuum thermal profile)	Validated (Testing conducted)
Sterilization Efficacy (Steam pre-vacuum sterilization efficacy)	Validated (Testing conducted)
Drying Time (Pre-vacuum dry time)	Validated (Testing conducted)
Microbial Containment (Microbial aerosol challenge)	Validated (Testing conducted)
Sterility Maintenance (30 day shelf-life study)	Demonstrated ability to maintain sterility for up to 30 days.
Cleaning Efficacy (Protein analysis and Total Organic Carbon Manual cleaning methods)	Validated (Testing conducted)
Usability (Human factors usability study)	Validated (Testing conducted)
Load Capacity	Up to 15 trays at 25 lb each (Total: 375 lbs). Validated with six 1mm x 500mm lumens and six 3mm x 400mm lumens.
Sterilization Cycle Temperature	270°F (132°C)
Sterilization Cycle Exposure Time	4 minutes
Instrument Lumens (Critical characteristic for sterilization)	Validated with 1mm x 500mm lumens and 3mm x 400mm lumens (Predicate was limited to 3.8mm inner diameter and 370mm length).

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

Sample Size: The document does not specify a numerical "sample size" in terms of how many units of the container were tested, or how many sterilization cycles were performed for each test. It mentions "Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens." This describes the configuration of the test load, not a statistical sample size for the test itself.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a medical device in the US, the testing would typically be conducted by the manufacturer or contracted labs under their direction, likely in a prospective manner according to established standards.

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

This information is not provided in the document. For device validation testing as described (thermal profiles, sterilization efficacy, microbial challenges, etc.), "experts" in the sense of medical professionals establishing a ground truth (like radiologists reviewing images) are generally not involved. Instead, the "ground truth" is established by adherence to recognized consensus standards (like ANSI/AAMI ST77 and AAMI TIR 30) and the scientific principles behind sterilization and cleaning. The "experts" would be the personnel conducting and interpreting these standardized tests, whose qualifications are typically laboratory scientists or engineers specialized in sterilization validation.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are common in studies involving human interpretation (e.g., image analysis by multiple radiologists) to resolve discrepancies and establish a robust ground truth. For device validation tests like those listed, the results are typically quantitative measurements or pass/fail criteria against a standard, not subject to human interpretation discrepancies that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Turbett Surgical Container is a physical medical device (sterilization container), not an AI algorithm, so this type of study is irrelevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone study was not done. This question is also typically relevant for AI/software as a medical device. The Turbett Surgical Container is a physical device; its "performance" is its ability to facilitate sterilization and maintain sterility, which is tested independently of human intervention during the sterilization process itself (though human operators load and unload the device).

7. The Type of Ground Truth Used

The ground truth for the validation of the Turbett Surgical Container was established through adherence to recognized industry standards and scientific principles related to sterilization, cleaning, and human factors. Specifically, the document references:

ANSI/AAMI ST77: Containment Devices for Reusable Medical Device Sterilization testing (which includes pre-vacuum thermal profile, steam pre-vacuum sterilization efficacy, pre-vacuum dry time, microbial aerosol challenge, and 30-day shelf-life study).
AAMI TIR 30: A Compendium of Processes, Materials, Test Methods and Acceptance Criteria for Cleaning Reusable Medical Devices testing (protein analysis and Total Organic Carbon Manual cleaning methods).
ANSI/AAMI HE75: Human Factors Engineering- Design of Medical Devices testing (human factors usability study).

The "ground truth" is that if the device performs successfully under these standardized testing protocols, it meets the requirements for a sterilization container.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning or AI algorithms where data is used to train a model. For a physical medical device like the Turbett Surgical Container, there is no AI model or training set in this context. The manufacturing process and design are based on engineering principles and materials science, not data-driven model training.

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

This information is not applicable because, as explained above, there is no "training set" for this physical medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 14, 2016

Turbett Surgical LLC % David Furr Principal Consultant FDC Services 8708 Capehart Cove Austin, Texas 78733

Re: K153025

Trade/Device Name: Turbett Surgical Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 14, 2015 Received: December 17, 2015

Dear Mr. Furr:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153025

Device Name Turbett Surgical Container

Indications for Use (Describe)

The Turbett Surgical Container is indicated for enclosing other medical devices that are to be sterilized by a healtheare provider. It is intended to allow sterilization of the enclosed materials and maintain sterility for up to 30 days until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with Turbett Surgical filters.

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 2709 (132℃) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per trav.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary Pursuant to 21 CFR 807.92

Date: December 14, 2015

K153025

1. Submitted By: Turbett Surgical LLC. 125 Tech Park Drive Suite 2108 Rochester, NY 14623 585-755-0133
1. Contact: David C. Furr FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733 512-906-9654 3. Turbett Surgical Container Product:
- Product code: FRG Class II (21 CFR 880.6850)
1. Common/Trade Name: Sterilization wrap/container

Description:

The Turbett Surgical Container is loaded into the autoclave with a dedicated transfer carriage. The container is constructed of 304 stainless steel with an anodized aluminum filter housing/door.

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Intended Use:.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.

Technological Characteristics:

The Turbett Surgical Container has been validated to sterilize 375 Ibs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. The validations included thermal profile, sterilization efficacy, and drying in a prevacuum steam sterilizer. Sterilized instruments can be stored for up to 30 days within the closed container.

The container is constructed of 304 stainless steel sheet metal on a rigid stainless steel frame. The container opens from the side for easy placement and retrieval of surgical trays. A filter comprised of 2 layers of filter paper and a compressible gasket is placed in the outer door. After use, the filter/gasket is discarded.

The following testing was conducted to establish substantial equivalence and efficacy:

ANSI/AAMI ST77: Containment Devices for Reusable Medical Device Sterilization testing:

Pre-vacuum thermal profile
Steam pre-vacuum sterilization efficacy ●
Pre-vacuum drv time ●
Microbial aerosol challenge
30 day shelf-life study o

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510(k) Premarket Notification Turbett Surgical Container

AAMI TIR 30: A Compendium of Processes, Materials, Test Methods and Acceptance Criteria for Cleaning Reusable Medical Devices testing:

Protein analysis and Total Organic Carbon Manual cleaning methods .
ANSI/AAMI HE75: Human Factors Engineering- Design of Medical Devices testing:
Human factors usability study .

Substantial Equivalence:

The Turbett Surgical Container is substantially equivalent to the SCORES Unit Sterilization Container (K110898). Both products have the same indications for use and perform in a similar manner.

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Element ofComparison	510(k) Device:Turbett Surgical ContainerK153025	Predicate Device:SCORES UnitK110898	Explanation of Differences
Regulation andProductClassification Code	21 CFR 880.6850FRG	21 CFR 880.6850FRG	None
Indications for Use	The Turbett SurgicalContainer is indicated forenclosing other medicaldevices that are to besterilized by a healthcareprovider. It is intended toallow sterilization of theenclosed materials andmaintain sterility for up to30 days until used. The unitis intended to be used inpre-vacuum steamsterilizers. The unit must beused with Turbett Surgicalfilters. The unit is intendedto be used in prevacuumsteam sterilizers with aprevacuum cycle of 270°F(132°C) and exposure timeof 4 minutes. The containermay be loaded with up to15 trays and up to 25 lbs.per tray. Validation wasdone using three trays perlevel and a maximuminstrument load of 25 lbs.per tray. The validation loadincluded six 1mm x 500mmlumens and six 3mm x400mm lumens. The totalweight of instruments andtrays validated is 375 lbs.Use only uncovered,perforated or wire meshgeneral delivery trayswithin the Turbett SurgicalContainer.	The SCORES Sterilization Containeris indicated for enclosing othermedical devices that are to besterilized by a healthcare provider. Itis intended to allow sterilization of theenclosed materials and maintainsterility for up to 30 days until used.The unit must be used with theSCORES transfer cart, SCORESfilters and integrity locks.The unit is intended to be used inprevacuum steam sterilizers with aprevacuum cycle of 270 degrees andexposure time of 4 minutes. Use nomore than 3 trays per shelf or 25 lbs.per tray.The SCORES Unit was tested andvalidated with rigid instrumentscontaining lumens with an innerdiameter of 3.8mm and an overalllength of 370mm. Do not use withinstruments containing lumens with aninner diameter smaller than 3.8mmand an overall length longer than370mm.Use only uncovered, perforated orwire mesh general delivery trayswithin the SCORES SterilizationContainer.	No significant differencesother than lumen limitation onSCORES unit.Turbett Surgical Container hasbeen validated with smallerdiameter/longer length lumens.
Principal Materialof Construction	Stainless Steel andaluminum	Stainless Steel	Aluminum is used fordividers and filter panels forlighter weight
Overall Size	34"x24"x22"	33"x36"x21"	Turbett device is morecompact. Validated at thissize.
Weight of EmptyContainer	136 lbs.	150 lbs. (approximated)	The Turbett device is not asheavy as the comparison.
Presentation ofDevice	Very Large Container withtransfer cart	Very Large Container with transfercart	None
Sterilization Method	Steam autoclave	Steam autoclave	None
Sterilization Cycle	Prevacuum Steam 4minute cycle	Prevacuum Steam 4 minute cycle	None
Temperature ofSterilization Cycle	270°F (132°C)	270°F (132°C)	None
Load	Up to 15 trays at 25 lbeach	Up to 12 trays at 25 lb each	Turbett container holdsslightly more trays. Systemhas been validated at thisload.
Number ofPerforations	905 holes 0.74 inchesdiameter (398.2 squareinches)	144 holes 1 inch diameter (113.76square inches)	The vent to volume ratio forthe Turbett device allows forbetter steam penetration.
Storage	Up to 30 days	Up to 30- days	None

Predicate Device Comparison Table

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510(k) Premarket Notification Turbett Surgical Container

Conclusion:

The performance testing data for the subject device (Turbett Surgical Container) demonstrates it is substantially equivalent to the predicate device (K110898). Testing and performance evaluations demonstrate that the product meets specifications and validation requirements.

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).