The Turbett Instrument Pod 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. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turbett Surgical filters.

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132℃) and exposure time of 4 minutes.

o The TS1500 Container may be loaded to a maximum weight of 375 lbs. not to exceed 25 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes.

. The TS1200 Container may be loaded to a maximum weight of 120 lbs. not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.

The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.

The system was validated with 1mm x 500mm lumens. Do not use with instruments containing lumens with an inner diameter of smaller than 1mm and an overall length longer that 500mm.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.

Device Description

The Turbett Instrument Pod 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 is available in three sizes (TS1500 34"x24"x22"; TS1200 34" x17" x22"; TS1000 23" x17" x 22"). The original container (TS1500) 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. Additional containers include the TS1200 and TS1000 sizes which can hold 120 lbs. of instruments.

Sterilized instruments can be stored for up to 30 days within the closed container.

The Turbett Instrument Pod 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 document is a 510(k) summary for the Turbett Instrument Pod, a medical device classified as a sterilization wrap/container. It outlines the device's indications for use, its comparison to a predicate device, and the non-clinical testing performed to demonstrate its safety and effectiveness.

However, this document does NOT describe the acceptance criteria and study proving the device meets those criteria in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled diagnostic or assistive device.

The questions you asked (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are highly relevant to the rigorous evaluation of AI/ML medical devices. The Turbett Instrument Pod is a physical device used for sterilization, and its evaluation process is based on traditional engineering and microbiology testing, not AI/ML performance.

Therefore, I cannot answer the specific questions about AI/ML device acceptance criteria and study details using the provided text. The text does not contain any information about:

AI/ML algorithms
Image analysis or diagnostic tasks
Human reader improvement with AI assistance
Expert radiologists or multi-reader studies
Training or test datasets in the context of machine learning

Instead, I can describe the acceptance criteria and study details related to the physical medical device as presented in the document.

Acceptance Criteria and Study for the Turbett Instrument Pod (Physical Sterilization Device)

The Turbett Instrument Pod is a sterilization container. Its acceptance criteria and proof of meeting them are based on its ability to effectively sterilize and maintain sterility of enclosed instruments, as well as its cleanability and physical characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

Name of Test/Citation	Purpose	Acceptance Criteria	Results (Reported Device Performance)
Pre-Vacuum thermal profile (TS1000, TS1500)ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization	To demonstrate steady-state thermal conditions throughout the containers during processing	Demonstrate various locations within the container can reach and maintain exposure temperature	Pass - All locations at or above exposure temperature
Pre-Vacuum sterilization efficacy (TS1500)ANSI/AAMI ST77:2006 Containment Devices for Reusable Medical Device Sterilization	To validate sterilization efficacy in a 4-minute steam pre-vacuum cycle	Achieve a 10⁻⁶ SAL (Sterility Assurance Level)	Pass - 10⁻⁶ SAL demonstrated
Pre-Vacuum sterilization efficacy (TS1000, TS1500)ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization (likely referring to drying test based on results)	To demonstrate drying capability after a 4-minute steam pre-vacuum cycle	Pre/Post weight difference less than 0.2% and no visible moisture after specified drying time	Pass - Units were within weight specifications and visibly dry
Microbial Aerosol Challenge (TS1500)ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization	To determine microbial barrier properties in maintaining sterility integrity	Demonstrate maintenance of sterility by no growth of internal test coupons following exposure to microbial aerosol	Pass
Protein analysis and Total Organic Carbon Manual and Mechanical Cleaning MethodsAAMI TIR30:2011 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices	To demonstrate effectiveness of manual and mechanical cleaning of the device	Residual protein samples and Total Organic Carbon within test limit	Pass
30-Day Event Related Shelf Life Study (TS1500)ANSI/AAMI ST77:2013 Containment Devices for Reusable Medical Device Sterilization	To demonstrate container contents can be maintained in a sterile state for up to 30 days	Maintain sterility of contents for 30 days	Pass

The documentation specifies that testing of the TS1000 and TS1500 models bracketed the parameters for the TS1200, implying that separate explicit tests were not run for the TS1200 for all mentioned criteria, as its performance was inferred from the other two models.

Regarding the AI/ML specific questions (which are not applicable to this document):

Sample sizes used for the test set and data provenance: Not applicable. For a physical device, "test set" would refer to the number of physical units tested, experimental repetitions, or biological indicators used. The document implies sufficient units were tested to demonstrate the specified criteria, but explicit numbers for each test are not given (e.g., how many cycles or replicate experiments). Data provenance is not mentioned, as it's a physical product test.
Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for sterilization efficacy is established through standardized microbiological and chemical tests using biological and chemical indicators, not by human expert review of images or data.
Adjudication method for the test set: Not applicable. Test results are objective measurements (e.g., 10⁻⁶ SAL, weight change, presence/absence of microbial growth, chemical limits).
MRMC comparative effectiveness study and effect size: Not applicable. This is a physical sterilization container, not an AI-assisted diagnostic tool.
Standalone performance (algorithm only without human-in-the loop performance): Not applicable. There is no algorithm. The device performs its function physically.
The type of ground truth used: For sterilization, the ground truth is established through standard laboratory methods utilizing biological indicators (e.g., Geobacillus stearothermophilus spores for steam sterilization) to quantify sterilization assurance levels, along with physical and chemical indicators to monitor cycle parameters. For drying, it's weight change and visual inspection. For cleaning, it's established by specific chemical tests for residual protein and total organic carbon. For microbial barrier, it's the absence of growth after microbial challenge.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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April 30, 2020

Turbett Surgical Inc. % David Furr Consultant FDC services 8708 Capehart Cove Austin, Texas 78733

Re: K200240

Trade/Device Name: Turbett Instrument Pod Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: January 28, 2020 Received: January 31, 2020

Dear David 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. 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

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

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Christopher K. Dugard, M.S. Assistant Director (acting) 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) K200240

Device Name Turbett Instrument Pod

Indications for Use (Describe)

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132℃) and exposure time of 4 minutes.

. The TS1200 Container may be loaded to a maximum weight of 120 lbs. not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.

The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.

The system was validated with 1mm x 500mm lumens. Do not use with instruments containing lumens with an inner diameter of smaller than 1mm and an overall length longer that 500mm.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.

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)

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

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510(k) Summary K200240

Date: April 28, 2020

1.	Submitted By:	Turbett Surgical, Inc.125 Tech ParkDrive Rochester,NY 14625585-755-0133
2.	Contact:	David C. FurrFDC Services,LLC 8708Capehart CoveAustin, Texas 78733512-906-9654
3.	Product:	Turbett Instrument Pod ">– TS1500, TS1200, TS1000Product code: FRG - Class II (21 CFR 880.6850)
4.	Common/ClassificationName:	Sterilization wrap/container;
5.	Predicate Device:	Turbett Surgical Container K153025

Description:

Sterilized instruments can be stored for up to 30 days within the closed container.

The Turbett Instrument Pod 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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Indications for Use:

The Turbett Instrument Pod 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. The unit is intended to be used in prevacuum steam sterilizers. The unit must be used with the Turbett Surgical filters.

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132°C) and exposure time of 4 minutes.

The TS1500 Container may be loaded to a maximum weight of 375 lbs., not to exceed . 25 lbs. in any tray. Minimum drying time for loads up to 140 lbs. is 10 minutes, for loads up to 375 lbs. 30 minutes.

The TS1200 Container may be loaded to a maximum weight of 120 lbs., not to . exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.

The TS1000 Container may be loaded to a maximum weight of 100 lbs., not to ● exceed 25 lbs. in any tray. Minimum drying time is 10 minutes.

The system was validated with 1mm x 500mm lumens. Do not use with instruments ● containing lumens with an inner diameter of smaller than 1mm and an overall length longer that 500mm.

Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Instrument Pod.

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Comparison of Technological Characteristics:

Shown below is a comparison of the subject device with the predicate device.

Element ofComparison	510(k) Device:Turbett Instrument PodK200240	Predicate Device:Turbett Surgical ContainerK153025	Comment
Regulation andProductClassificationCode	21 CFR 880.6850FRG	21 CFR 880.6850FRG	Same
Indications forUse	The Turbett Instrument Pod isindicated for enclosing othermedical devices that are to besterilized by a healthcare provider.It is intended to allow sterilizationof the enclosed materials andmaintain sterility for up to 30days. The unit is intended to beused in pre-vacuum steamsterilizers. The unit must be usedwith the Turbett Surgical filters.The unit is intended to be used inprevacuum steam sterilizers with aprevacuum cycle of 270F (132°C)and exposure time of 4 minutes.	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 to 30days until used. The unit isintended to be used in pre-vacuum steam sterilizers. Theunit must be used withTurbett Surgical filters.The unit is intended to beused in prevacuum steam	Similar

PrincipalMaterial ofConstruction	• The TS1500 Container may beloaded to a maximum weight of375 lbs., not to exceed 25 lbs. inany tray. Minimum drying time forloads up to 140 lbs. is 10 minutes,for loads up to 375 lbs. 30minutes.• The TS1200 Container may beloaded to a maximum weight of120 lbs., not to exceed 25 lbs. inany tray. Minimum drying time is10 minutes.• The TS1000 Container may beloaded to a maximum weight of100 lbs., not to exceed 25 lbs. inany tray. Minimum drying time is10 minutes.• The system was validated with1mm x 500mm lumens. Do not usewith instruments containinglumens with an inner diameter ofsmaller than 1mm and an overalllength longer that 500mm.Use only uncovered, perforated orwire mesh general delivery trayswithin the Turbett Instrument Pod.Stainless Steel and aluminum	sterilizers with a prevacuumcycle of 270°F (132°C) andexposure time of 4 minutes.Use no more than 3 trays perlevel or 25 lbs. per tray.The container may be loadedwith up to 15 trays and up to25 lbs. per tray. Validationwas done using 3 trays perlevel and a maximuminstrument load of 25 lbs. pertray. The validation loadincluded six 1mm by 500mmlumens and six 3mm by400mm lumens. The totalweight of instruments andtrays validated was 375 lbs.Use only uncovered,perforated or wire meshgeneral delivery trays withinthe Turbett SurgicalContainer.Stainless Steel and aluminum	Same
Overall Size	Approximate sizeTS1500 34"x24"x22"TS1200 34" x17" x22"TS1000 23" x17" x 22"	34"x24"x22"	Similar
Presentation ofDevice	Very Large Container withtransfer cart, 3 sizes.	Very Large Container withtransfer cart	Similar
SterilizationCycle	Prevacuum Steam 4 minute cycle132°C	Prevacuum Steam 4 minutecycle 132°C	Same
Load	TS1500 up to 375 lbs.TS1200 up to 120 lbs.TS1000 up to 100 lbs.	Up to 15 trays at 25 lb each	Similar
Vent to volumeratio	TS1500 - 0.270TS1200 - 0.269TS1000 - 0.264	Turbett Surgical Container0.265	Different
Storage	Up to 30 days	Up to 30 days	Same

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Summary of Non-Clinical Testing:

The following testing was conducted to demonstrate whether the device met the acceptance criteria of the standard. Testing of the TS1000 and TS1500 brackets the parameters for the TS1200:

Name of Test/Citation	Purpose	Acceptance Criteria	Results
Pre-Vacuum thermal profile (TS1000, TS1500)ANSI/AAMI ST77:2013 ContainmentDevices for Reusable Medical DeviceSterilization	To demonstrate steadystate thermal conditionsthroughout the containersduring processing	Demonstrate variouslocations within thecontainer can reach andmaintain exposuretemperature	Pass - Alllocations at oraboveexposuretemperature
Pre-Vacuum sterilization efficacy(TS1500)ANSI/AAMI ST77:2006Containment Devices for ReusableMedical Device Sterilization	To validate sterilizationefficacy in a 4 minutesteam pre-vacuum cycle	Achieve a 10-6 SAL	Pass -10-6 SALdemonstrated
Pre-Vacuum sterilization efficacy(TS1000, TS1500)ANSI/AAMI ST77:2013 ContainmentDevices for Reusable Medical DeviceSterilization	To demonstrate dryingcapability after a 4 minutesteam pre-vacuum cycle	Pre/Post weightdifference less than0.2% and no visiblemoisture after specifieddrying time	Pass - Unitswere withinweightspecificationsand visibly dry
Microbial Aerosol Challenge(TS1500)ANSI/AAMI ST77:2013 ContainmentDevices for Reusable Medical DeviceSterilization	To determine microbialbarrier properties inmaintaining sterilityintegrity	Demonstratemaintenance of sterilityby no growth ofinternal test couponsfollowing exposure tomicrobial aerosol	Pass
Protein analysis and Total OrganicCarbon Manual and MechanicalCleaning MethodsAAMI TIR30:2011 A Compendiumof Processes, Materials, Test Methods,and Acceptance Criteria for CleaningReusable Medical Devices	To demonstrateeffectiveness of manualand mechanical cleaning ofthe device	Residual proteinsamples and TotalOrganic Carbon withintest limit	Pass
30 Day Event Related Shelf LifeStudy (TS1500) ANSI/AAMIST77:2013 Containment Devices forReusable Medical Device Sterilization	To demonstrate containercontents can be maintainedin a sterile state for up to30 days	Maintain sterility ofcontents for 30 days	Pass

Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the Turbett Instrument Pod is as safe, as effective, and performed as well as or better than the legally marketing predicate device (K153025).

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).