(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization efficacy of a rigid sterilization container, with no mention of AI or ML technologies.
No
The device is a container for sterilizing other medical devices, not a therapeutic device itself. Its function is to facilitate sterilization and maintain sterility, not to treat a medical condition or ailment.
No
Explanation: The Turbett Surgical Container is described as a device for sterilizing other medical devices and maintaining their sterility. It does not perform any diagnostic function.
No
The device description clearly describes a physical, rigid sterilization container made of stainless steel and aluminum, which is a hardware device. There is no mention of any software component.
Based on the provided information, the Turbett Surgical Container is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to enclose other medical devices for sterilization and maintain their sterility. This is a process related to preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The description details a container for holding surgical instruments during sterilization. It focuses on the physical aspects of the container and its function in the sterilization process.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for the purpose of providing information about a patient's health status.
The device falls under the category of a reusable medical device accessory used in the sterilization process.
N/A
Intended Use / Indications for Use
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 sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray.
Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs.
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.
Product codes
FRG
Device Description
The Turbett Surgical Container 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 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. Actual expected loads in hospital settings are likely to be less. Sterilized instruments can be stored for up to 30 days within the closed container.
The Turbett Surgical Container 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
Pre-vacuum thermal profile
Steam pre-vacuum sterilization efficacy
Pre-vacuum dry time
Microbial aerosol challenge
30 day shelf-life study
Protein analysis and Total Organic Carbon Manual cleaning methods
Human factors usability study
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Turbett Surgical LLC % David Furr Principal Consultant FDC Services 8708 Capehart Cove Austin, Texas 78733
Re: K153025
Trade/Device Name: Turbett Surgical Container Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: December 14, 2015 Received: December 17, 2015
Dear Mr. 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153025
Device Name Turbett Surgical Container
Indications for Use (Describe)
The Turbett Surgical Container is indicated for enclosing other medical devices that are to be sterilized by a healtheare 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 sterilizers with a prevacuum cycle of 2709 (132℃) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per trav.
Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs.
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.
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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3
510(k) Summary Pursuant to 21 CFR 807.92
Date: December 14, 2015
K153025
-
- Submitted By: Turbett Surgical LLC. 125 Tech Park Drive Suite 2108 Rochester, NY 14623 585-755-0133
-
- Contact: David C. Furr FDC Services, LLC 8708 Capehart Cove Austin, Texas 78733 512-906-9654 3. Turbett Surgical Container Product:
- Product code: FRG Class II (21 CFR 880.6850)
-
- Common/Trade Name: Sterilization wrap/container
Description:
The Turbett Surgical Container 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 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. Actual expected loads in hospital settings are likely to be less. Sterilized instruments can be stored for up to 30 days within the closed container.
The Turbett Surgical Container 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 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 sterilizers with a prevacuum cycle of 270°F (132°C) and exposure time of 4 minutes. The container may be loaded with up to 15 trays and up to 25 lbs. per tray.
Validation was done using three trays per level and a maximum instrument load of 25 lbs. per tray. The validation load included six 1mm x 500mm lumens and six 3mm x 400mm lumens. The total weight of instruments and trays validated is 375 lbs.
Use only uncovered, perforated or wire mesh general delivery trays within the Turbett Surgical Container.
Technological Characteristics:
The Turbett Surgical Container has been validated to sterilize 375 Ibs. of instruments along with the dividers. The validation was conducted with 15 instrument trays at 25 lbs. each to represent the most challenging case. The validations included thermal profile, sterilization efficacy, and drying in a prevacuum steam sterilizer. Sterilized instruments can be stored for up to 30 days within the closed container.
The container is constructed of 304 stainless steel sheet metal on a rigid stainless steel frame. The container opens from the side for easy placement and retrieval of surgical trays. A filter comprised of 2 layers of filter paper and a compressible gasket is placed in the outer door. After use, the filter/gasket is discarded.
The following testing was conducted to establish substantial equivalence and efficacy:
ANSI/AAMI ST77: Containment Devices for Reusable Medical Device Sterilization testing:
- Pre-vacuum thermal profile
- Steam pre-vacuum sterilization efficacy ●
- Pre-vacuum drv time ●
- Microbial aerosol challenge
- 30 day shelf-life study o
5
510(k) Premarket Notification Turbett Surgical Container
AAMI TIR 30: A Compendium of Processes, Materials, Test Methods and Acceptance Criteria for Cleaning Reusable Medical Devices testing:
-
Protein analysis and Total Organic Carbon Manual cleaning methods .
ANSI/AAMI HE75: Human Factors Engineering- Design of Medical Devices testing: -
Human factors usability study .
Substantial Equivalence:
The Turbett Surgical Container is substantially equivalent to the SCORES Unit Sterilization Container (K110898). Both products have the same indications for use and perform in a similar manner.
6
| Element of
Comparison | 510(k) Device:
Turbett Surgical Container
K153025 | Predicate Device:
SCORES Unit
K110898 | Explanation of Differences |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation and
Product
Classification Code | 21 CFR 880.6850
FRG | 21 CFR 880.6850
FRG | None |
| Indications for Use | 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 sterilizers with a
prevacuum cycle of 270°F
(132°C) and exposure time
of 4 minutes. The container
may be loaded with up to
15 trays and up to 25 lbs.
per tray. Validation was
done using three trays per
level and a maximum
instrument load of 25 lbs.
per tray. The validation load
included six 1mm x 500mm
lumens and six 3mm x
400mm lumens. The total
weight of instruments and
trays validated is 375 lbs.
Use only uncovered,
perforated or wire mesh
general delivery trays
within the Turbett Surgical
Container. | The SCORES Sterilization 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 must be used with the
SCORES transfer cart, SCORES
filters and integrity locks.
The unit is intended to be used in
prevacuum steam sterilizers with a
prevacuum cycle of 270 degrees and
exposure time of 4 minutes. Use no
more than 3 trays per shelf or 25 lbs.
per tray.
The SCORES Unit was tested and
validated with rigid instruments
containing lumens with an inner
diameter of 3.8mm and an overall
length of 370mm. Do not use with
instruments containing lumens with an
inner diameter smaller than 3.8mm
and an overall length longer than
370mm.
Use only uncovered, perforated or
wire mesh general delivery trays
within the SCORES Sterilization
Container. | No significant differences
other than lumen limitation on
SCORES unit.
Turbett Surgical Container has
been validated with smaller
diameter/longer length lumens. |
| Principal Material
of Construction | Stainless Steel and
aluminum | Stainless Steel | Aluminum is used for
dividers and filter panels for
lighter weight |
| Overall Size | 34"x24"x22" | 33"x36"x21" | Turbett device is more
compact. Validated at this
size. |
| Weight of Empty
Container | 136 lbs. | 150 lbs. (approximated) | The Turbett device is not as
heavy as the comparison. |
| Presentation of
Device | Very Large Container with
transfer cart | Very Large Container with transfer
cart | None |
| Sterilization Method | Steam autoclave | Steam autoclave | None |
| Sterilization Cycle | Prevacuum Steam 4
minute cycle | Prevacuum Steam 4 minute cycle | None |
| Temperature of
Sterilization Cycle | 270°F (132°C) | 270°F (132°C) | None |
| Load | Up to 15 trays at 25 lb
each | Up to 12 trays at 25 lb each | Turbett container holds
slightly more trays. System
has been validated at this
load. |
| Number of
Perforations | 905 holes 0.74 inches
diameter (398.2 square
inches) | 144 holes 1 inch diameter (113.76
square inches) | The vent to volume ratio for
the Turbett device allows for
better steam penetration. |
| Storage | Up to 30 days | Up to 30- days | None |
Predicate Device Comparison Table
7
510(k) Premarket Notification Turbett Surgical Container
Conclusion:
The performance testing data for the subject device (Turbett Surgical Container) demonstrates it is substantially equivalent to the predicate device (K110898). Testing and performance evaluations demonstrate that the product meets specifications and validation requirements.