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 until used. 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 (132C) and exposure time of 4 minutes.

. The TS1500 Container may be loaded to a maximum weight of 375 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. in any tray. Minimum drving 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. .

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 transported and 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 text describes the non-clinical testing performed for the Turbett Instrument Pod, a rigid sterilization container. The study aims to demonstrate that the device meets acceptance criteria for sterilization efficacy, thermal profile, and transportation shelf life.

Here's the breakdown of the requested information:

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

Type of Testing	Purpose	Acceptance Criteria	Reported Device Performance
Pre-vacuum sterilization efficacy (AAMI ST77, ISO 17665-1)	Demonstrate Sterilization Capabilities	10-6 SAL (Sterility Assurance Level)	PASSED
Thermal Profile (AAMI ST77)	Demonstrate Heat Penetration in Load	Minimum temperature of 270°F (132°C) achieved within 2 minutes and maintained.	PASSED
Transportation Shelf life Study (AAMI ST77, Modified ASTM D4169-14)	Simulate transportation followed by a shelf life study.	No growth 30 days following sterilization, loading, unloading, and transport.	PASSED

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

The document does not specify the sample size used for the test sets for any of the studies (pre-vacuum sterilization efficacy, thermal profile, or transportation shelf life).
The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Implicitly, since these are design validation tests, they would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for this device. The testing described is hardware-centric (sterilization, heat penetration, biological growth), and ground truth is based on physical and microbiological measurements against predefined scientific/engineering criteria (e.g., SAL, temperature, presence of growth).

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

The concept of adjudication methods (like 2+1, 3+1) is typically relevant for studies involving human interpretation of data, such as medical image analysis. Since this study involves testing of a physical sterilization container against engineering and microbiological standards, adjudication methods are not applicable and are not mentioned.

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

This is not an AI/software device. Therefore, no MRMC comparative effectiveness study was done, and this question is not applicable.

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

This is not an algorithm or AI device. Therefore, no standalone performance study in the context of an algorithm was done. The studies listed (sterilization efficacy, thermal profile, transportation shelf life) are inherently standalone in the sense that they evaluate the device's performance against objective criteria, not in conjunction with human interpretation.

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

The ground truth for these tests is based on:

Sterility Assurance Level (SAL): A predefined microbiological standard of 10^-6, meaning a 1 in a million chance of a non-sterile unit.
Physical Measurements: Specific temperature and time parameters (270°F (132°C) minimum temperature achieved within 2 minutes and maintained).
Microbiological Culture Results: Absence of microbial growth after specified conditions and timeframes.

Essentially, the "ground truth" is defined by established scientific and engineering standards for sterilization and material handling, as outlined by AAMI ST77, ISO 17665-1, and ASTM D4169-14.

8. The sample size for the training set

This device does not involve machine learning or AI, so there is no training set in the typical sense.

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

As there is no training set, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 19, 2021

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

Re: K202593

Trade/Device Name: Turbett Instrument Pod Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: April 13, 2021 Received: April 22, 2021

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Clarence W. Murray, III, 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) K202593

Device Name Turbett Instrument Pod

Indications for Use (Describe)

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

. The TS1500 Container may be loaded to a maximum weight of 375 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. in any tray. Minimum drving 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. .

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)

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510(k) Summary K202593

Date: May 16, 2021

1.	Submitted By:	Turbett Surgical, Inc.125 Tech Park DriveRochester, NY 14625585-755-0133
2.	Contact:	David C. FurrFDC Services, LLC8708 Capehart 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;Predicate device - Turbett Surgical Container K200240

Description:

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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Intended Use:

The unit is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270F (132C) 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.

Technological Characteristics Table:

Shown below is the technological characteristics comparison table for the subject device with the predicate device.

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Element ofComparison	510(k) Device:Turbett Instrument PodK202593	Predicate Device:Turbett Instrument PodK200240	Explanation ofDifferences
Regulation andProductClassificationCode	21 CFR 880.6850FRG	21 CFR 880.6850FRG	None
Indications forUse	The Turbett Instrument Pod isindicated for enclosing other medicaldevices that are to be sterilized by ahealthcare provider. It is intended toallow sterilization of the enclosedmaterials and maintain sterility for upto 30 days until used. The unit isintended to be used in pre-vacuumsteam sterilizers. The unit must beused with the Turbett Surgical filters.The unit is intended to be used inprevacuum steam sterilizers with aprevacuum cycle of 270F (132C) andexposure time of 4 minutes.The TS1500 Container may beloaded to a maximum weight of 375lbs., not to exceed 25 lbs. in any tray.Minimum drying time for loads up to140 lbs. is 10 minutes, for loads up to375 lbs. 30 minutes. The TS1200 Container may beloaded to a maximum weight of 120lbs., not to exceed 25 lbs. in any tray.Minimum drying time is 10 minutes. The TS1000 Container may beloaded to a maximum weight of 100lbs., not to exceed 25 lbs. in any tray.Minimum drying time is 10 minutes. The system was validated with1mm x 500mm lumens. Do not usewith instruments containing lumenswith an inner diameter of smaller than0.5mm and an overall length longerthat 500mm. Use only uncovered, perforated orwire mesh general delivery trayswithin the Turbett Instrument Pod.	The Turbett Instrument Pod is indicatedfor enclosing other medical devices thatare to be sterilized by a healthcareprovider. It is intended to allowsterilization of the enclosed materials andmaintain sterility for up to 30 days untilused. The unit is intended to be used inpre-vacuum steam sterilizers. The unitmust be used with the Turbett Surgicalfilters.The unit is intended to be used inprevacuum steam sterilizers with aprevacuum cycle of 270F (132C) andexposure time of 4 minutes.The TS1500 Container may be loadedto a maximum weight of 375 lbs., not toexceed 25 lbs. in any tray. Minimumdrying time for loads up to 140 lbs. is 10minutes, for loads up to 375 lbs. 30minutes. The TS1200 Container may be loadedto a maximum weight of 120 lbs., not toexceed 25 lbs. in any tray. Minimumdrying time is 10 minutes. The TS1000 Container may be loadedto a maximum weight of 100 lbs., not toexceed 25 lbs. in any tray. Minimumdrying time is 10 minutes. The system was validated with 1mm x500mm lumens. Do not use withinstruments containing lumens with aninner diameter of smaller than 1mm andan overall length longer that 500mm. Use only uncovered, perforated or wiremesh general delivery trays within theTurbett Instrument Pod.	Indications areidentical
PrincipalMaterial ofConstruction	Stainless Steel and aluminum	Stainless Steel and aluminum	Same
Overall Size	Approximate sizeTS1500 34"x24"x22"TS1200 34" x17" x22"TS1000 23" x17" x 22"	Approximate sizeTS1500 34"x24"x22"TS1200 34" x17" x22"TS1000 23" x17" x 22"	All pods areidentical
Presentation of Device	Very Large Container with transfer cart, 3 sizes.	Very Large Container with transfer cart, 3 sizes.	All pods are identical
Sterilization Cycle	Prevacuum Steam 4 minute cycle 132°C	Prevacuum Steam 4 minute cycle 132°C	None
Load	TS1500 up to 375 lbs.TS1200 up to 120 lbs.TS1000 up to 100 lbs.	TS1500 up to 375 lbs.TS1200 up to 120 lbs.TS1000 up to 100 lbs.	All pods are identical
Storage	Up to 30 days	Up to 30 days	None
Transportation	TS1500 may be transported	None	Transport added

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Summary of Non-Clinical Testing:

Provided below is the non-clinical testing performed with the subject device to demonstrate that the device met the acceptance criteria with the standard listed below.

Type of Testing	Purpose	Acceptance Criteria	Result
Pre-vacuum sterilizationefficacyAAMI ST77Containment Devicesfor Reusable MedicalDevice SterilizationISO 17665-1 Sterilizationof Health Care Products –Moist Heat – Part 1Requirements for theDevelopment, Validation,and Routine Control of aSterilization Process forMedical Devices	Demonstrate SterilizationCapabilities	10-6 SAL	PASSED
Thermal ProfileAAMI ST77 ContainmentDevices for ReusableMedical DeviceSterilization	Demonstrate HeatPenetration in Load	Minimum temperature of 270° Fachieved within 2 minutes andmaintained.	PASSED

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Transportation Shelf lifeStudyAAMI ST77 ContainmentDevices for ReusableMedical DeviceSterilizationModified ASTM D4169-14- Standard Practice forperformance testing ofshipping containers andsystems	The purpose was to simulatetransportation of the subjectdevice followed by a shelf lifestudy.	No growth 30 days followingsterilization loading, unloadingand transport.	PASSED
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Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performed as well as or better than the legally marketed predicate devices.

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).