(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a rigid sterilization container. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
Explanation: The device is a sterilization container intended to enclose other medical devices for sterilization and maintain their sterility. It does not directly provide therapy to a patient.
No
The device is a rigid sterilization container used to enclose other medical devices for sterilization and maintain their sterility, not to diagnose a condition or disease.
No
The device description clearly describes a physical, rigid sterilization container made of stainless steel and aluminum, not software.
Based on the provided information, the Turbett Instrument Pod is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "enclosing other medical devices that are to be sterilized by a healthcare provider." This is a sterilization and storage function for medical instruments, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a rigid sterilization container designed for use in a steam autoclave to hold surgical instruments. This aligns with a sterilization device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on sterilization efficacy, drying capability, microbial barrier properties, and cleaning effectiveness – all relevant to a sterilization container, not an IVD.
In summary, the Turbett Instrument Pod is a medical device used for the sterilization and storage of other medical devices, not for performing diagnostic tests.
N/A
Intended Use / 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℃) 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.
Product codes (comma separated list FDA assigned to the subject device)
FRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-Vacuum thermal profile (TS1000, TS1500) - To demonstrate steady state thermal conditions throughout the containers during processing. Results: Pass - All locations at or above exposure temperature.
Pre-Vacuum sterilization efficacy (TS1500) - To validate sterilization efficacy in a 4 minute steam pre-vacuum cycle. Results: Pass - 10-6 SAL demonstrated.
Pre-Vacuum sterilization efficacy (TS1000, TS1500) - To demonstrate drying capability after a 4 minute steam pre-vacuum cycle. Results: Pass - Units were within weight specifications and visibly dry.
Microbial Aerosol Challenge (TS1500) - To determine microbial barrier properties in maintaining sterility integrity. Results: Pass.
Protein analysis and Total Organic Carbon Manual and Mechanical Cleaning Methods - To demonstrate effectiveness of manual and mechanical cleaning of the device. Results: Pass.
30 Day Event Related Shelf Life Study (TS1500) - To demonstrate container contents can be maintained in a sterile state for up to 30 days. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Achieve a 10-6 SAL
Pre/Post weight difference less than 0.2% and no visible moisture
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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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).