← Product Code [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG) · K200240 # Turbett Instrument Pod (K200240) _Turbett Surgical, Inc. · FRG · Apr 30, 2020 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K200240 ## Device Facts - **Applicant:** Turbett Surgical, Inc. - **Product Code:** [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG.md) - **Decision Date:** Apr 30, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6850 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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 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°C) and exposure time of 4 minutes. ## Device Story Rigid sterilization container system; holds multiple open surgical instrument trays; utilizes fenestrated door with single-use disposable filter cartridge; eliminates need for reusable gaskets. Available in three sizes (TS1500, TS1200, TS1000). Loaded into steam autoclave via dedicated transfer carriage. Separates trays with dividers to ensure steam exposure. Used by healthcare providers in sterile processing departments. Provides sterile storage for up to 30 days. Benefits include reduced contamination risk from failed gaskets and high-capacity instrument sterilization. ## Clinical Evidence Bench testing only. Validated per ANSI/AAMI ST77:2013 and AAMI TIR30:2011. Testing included thermal profiling, sterilization efficacy (10^-6 SAL), drying time verification, microbial aerosol challenge, cleaning validation (protein/TOC analysis), and 30-day shelf-life maintenance. All tests passed. ## Technological Characteristics Rigid container constructed of 304 stainless steel and anodized aluminum. Features fenestrated door with single-use disposable filter. Dimensions: TS1500 (34"x24"x22"), TS1200 (34"x17"x22"), TS1000 (23"x17"x22"). Energy source: steam autoclave. Connectivity: none. Sterilization: prevacuum steam (270°F/132°C). ## Regulatory 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. ## Predicate Devices - Turbett Surgical Container ([K153025](/device/K153025.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in bold, blue letters, with the word 'ADMINISTRATION' written in a smaller font size below. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200240 Device Name Turbett Instrument Pod #### Indications for Use (Describe) 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. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary K200240 #### Date: April 28, 2020 | 1. | Submitted By: | Turbett Surgical, Inc.
125 Tech Park
Drive Rochester,
NY 14625
585-755-0133 | |----|--------------------------------|-----------------------------------------------------------------------------------------------------| | 2. | Contact: | David C. Furr
FDC Services,
LLC 8708
Capehart Cove
Austin, Texas 78733
512-906-9654 | | 3. | Product: | Turbett Instrument Pod ">– TS1500, TS1200, TS1000
Product code: FRG - Class II (21 CFR 880.6850) | | 4. | Common/Classification
Name: | Sterilization wrap/container; | | 5. | Predicate Device: | Turbett Surgical Container K153025 | #### 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. {4}------------------------------------------------ #### 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. {5}------------------------------------------------ # Comparison of Technological Characteristics: Shown below is a comparison of the subject device with the predicate device. | Element of
Comparison | 510(k) Device:
Turbett Instrument Pod
K200240 | Predicate Device:
Turbett Surgical Container
K153025 | Comment | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Regulation and
Product
Classification
Code | 21 CFR 880.6850
FRG | 21 CFR 880.6850
FRG | Same | | 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 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°C)
and exposure time of 4 minutes. | 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 | Similar | | | | | | | Principal
Material of
Construction | • 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.
Stainless Steel and aluminum | sterilizers with a prevacuum
cycle of 270°F (132°C) and
exposure time of 4 minutes.
Use no more than 3 trays per
level or 25 lbs. per tray.
The container may be loaded
with up to 15 trays and up to
25 lbs. per tray. Validation
was done using 3 trays per
level and a maximum
instrument load of 25 lbs. per
tray. The validation load
included six 1mm by 500mm
lumens and six 3mm by
400mm lumens. The total
weight of instruments and
trays validated was 375 lbs.
Use only uncovered,
perforated or wire mesh
general delivery trays within
the Turbett Surgical
Container.
Stainless Steel and aluminum | Same | | Overall Size | Approximate size
TS1500 34"x24"x22"
TS1200 34" x17" x22"
TS1000 23" x17" x 22" | 34"x24"x22" | Similar | | Presentation of
Device | Very Large Container with
transfer cart, 3 sizes. | Very Large Container with
transfer cart | Similar | | Sterilization
Cycle | Prevacuum Steam 4 minute cycle
132°C | Prevacuum Steam 4 minute
cycle 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 volume
ratio | TS1500 - 0.270
TS1200 - 0.269
TS1000 - 0.264 | Turbett Surgical Container
0.265 | Different | | Storage | Up to 30 days | Up to 30 days | Same | {6}------------------------------------------------ {7}------------------------------------------------ ## 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 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 | Pass -
10-6 SAL
demonstrated | | Pre-Vacuum sterilization efficacy
(TS1000, TS1500)
ANSI/AAMI ST77:2013 Containment
Devices for Reusable Medical Device
Sterilization | 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 Methods
AAMI 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 | ## 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). --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K200240](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K200240) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com