K Number
K202593
Device Name
Turbett Instrument Pod
Date Cleared
2021-05-19

(253 days)

Product Code
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

Turbett Surgical Container K200240

Not Found

No
The device description and intended use focus on a physical sterilization container and its performance in steam sterilization cycles. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.

No.
The device is a rigid sterilization container intended for enclosing other medical devices for sterilization and maintaining their sterility, not for directly treating or diagnosing patients.

No

The device is a rigid sterilization container intended for sterilizing and storing other medical devices, not for diagnosing medical conditions.

No

The device description clearly describes a physical, rigid sterilization container made of stainless steel and aluminum, not a software-only product.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

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." It's a container for sterilization and maintaining sterility of surgical instruments.
  • Device Description: The description details a rigid sterilization container used in a steam autoclave to hold surgical instruments.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment. It does not perform any tests or analyses on biological samples.

The device is a sterilization container, which falls under a different regulatory category than IVD devices.

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 until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turgical filters.

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.

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 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.

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)

Type of Testing: Pre-vacuum sterilization efficacy
Purpose: Demonstrate Sterilization Capabilities
Acceptance Criteria: 10-6 SAL
Result: PASSED

Type of Testing: Thermal Profile
Purpose: Demonstrate Heat Penetration in Load
Acceptance Criteria: Minimum temperature of 270° F achieved within 2 minutes and maintained.
Result: PASSED

Type of Testing: Transportation Shelf life Study
Purpose: The purpose was to simulate transportation of the subject device followed by a shelf life study.
Acceptance Criteria: No growth 30 days following sterilization loading, unloading and transport.
Result: PASSED

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

Turbett Surgical Container K200240

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 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

1

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

2

Indications for Use

510(k) Number (if known) K202593

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 until used. The unit is intended to be used in pre-vacuum steam sterilizers. The unit must be used with the Turgical filters.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

510(k) Summary K202593

Date: May 16, 2021

| 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;
Predicate device - Turbett Surgical Container K200240 |

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.

4

Intended 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 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., 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 of
Comparison | 510(k) Device:
Turbett Instrument Pod
K202593 | Predicate Device:
Turbett Instrument Pod
K200240 | Explanation of
Differences |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Regulation and
Product
Classification
Code | 21 CFR 880.6850
FRG | 21 CFR 880.6850
FRG | None |
| 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 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., 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
0.5mm and an overall length longer
that 500mm. Use only uncovered, perforated or
wire mesh general delivery trays
within the Turbett Instrument Pod. | 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., 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. | Indications are
identical |
| Principal
Material of
Construction | Stainless Steel and aluminum | Stainless Steel and aluminum | Same |
| Overall Size | Approximate size
TS1500 34"x24"x22"
TS1200 34" x17" x22"
TS1000 23" x17" x 22" | Approximate size
TS1500 34"x24"x22"
TS1200 34" x17" x22"
TS1000 23" x17" x 22" | All pods are
identical |
| 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 |

6

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 TestingPurposeAcceptance CriteriaResult
Pre-vacuum sterilization
efficacy
AAMI ST77
Containment Devices
for Reusable Medical
Device Sterilization
ISO 17665-1 Sterilization
of Health Care Products –
Moist Heat – Part 1
Requirements for the
Development, Validation,
and Routine Control of a
Sterilization Process for
Medical DevicesDemonstrate Sterilization
Capabilities10-6 SALPASSED
Thermal Profile
AAMI ST77 Containment
Devices for Reusable
Medical Device
SterilizationDemonstrate Heat
Penetration in LoadMinimum temperature of 270° F
achieved within 2 minutes and
maintained.PASSED

7

| Transportation Shelf life
Study

AAMI ST77 Containment
Devices for Reusable
Medical Device
Sterilization

Modified ASTM D4169-14

  • Standard Practice for
    performance testing of
    shipping containers and
    systems | The purpose was to simulate
    transportation of the subject
    device followed by a shelf life
    study. | No growth 30 days following
    sterilization loading, unloading
    and transport. | PASSED |
    |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------|
    |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------|

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.