(57 days)
Not Found
No
The device description and performance studies focus on the physical components and sterilization efficacy, with no mention of AI or ML technologies.
No.
The device is a sterilization system for other medical devices, not a direct therapeutic device for patients.
No
Explanation: The SteriCUBE System is a sterilization containment device, not a diagnostic device. It is used to enclose other medical devices for sterilization and maintain their sterility, as explicitly stated in the "Intended Use / Indications for Use" section.
No
The device description explicitly details physical components such as a stainless steel sterilization cabinet, adjustable transfer cart, filters, and integrity locks, indicating it is a hardware device.
Based on the provided text, the SteriCUBE Multiple Tray Sterilization System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Intended Use of SteriCUBE: The SteriCUBE System is intended for sterilizing other medical devices used by healthcare providers. It encloses these devices during the sterilization process and maintains their sterility.
- No Specimen Analysis: The description of the SteriCUBE System and its intended use does not involve the analysis of any human specimens. Its function is purely related to the sterilization of medical instruments.
Therefore, the SteriCUBE Multiple Tray Sterilization System falls under the category of a medical device used for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SteriCUBE Multiple Tray Sterilization System) 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 SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks.
The SteriCUBE System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The SteriCUBE System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the SteriCUBE System.
Product codes
KCT
Device Description
The SteriCUBE® Multiple Tray Sterilization Systems are also referred to as the “SteriCUBE Systems” and include the SteriCUBE MTS225 System and the SteriCUBE MTS300 System. The SteriCUBE System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. An optional reusable ceramic drain filter and single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. The optional ceramic drain filter should be replaced every 6 months or after 160 uses, whichever comes first. An optional STEAMPlus™ tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. Adjustable shelves within the cabinet can hold up to three trays (uncovered, perforated or wire mesh) of devices and/or surgical instruments intended for a single patient surgery. No more than 25 pounds can be loaded per tray for a maximum of 75 pounds per shelf. The MTS300 Cabinet (with four shelves) can hold up to 300 pounds per load and the MTS225 Cabinet (with three shelves) can hold up to 225 pounds per load. The loaded cabinet is deployed from the adjustable transfer cart and processed in pre-vacuum steam sterilizers. Processing includes the standard conditioning phase of the autoclave followed by a sterilization cycle time of 4 minutes and a dry cycle of a minimum of 5 minutes. Sterility is maintained for up to 30 days.
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)
Nonclinical data was generated to ensure the SteriCUBE System continues to meet the intended use. Sterilization efficacy verification studies were performed in accordance with the appropriate requirements of ANSI/AAMI ST77:2013 Containment devices for reusable medical device sterilization.
The SteriCUBE Systems (both the SteriCUBE MTS225 and MTS300 Systems) have demonstrated the ability to: achieve a 10-6 SAL when sterilizing longer and smaller lumen sized instruments (rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm), meet the shorter minimum dry time of 5 minutes, and maintain sterility for 30 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a recognizable symbol of the agency's role in regulating and overseeing food and drug products in the United States.
September 28, 2022
SteriCUBE, LLC % Annette Hillring President Hillring & Associates, Inc. 3012 St. Charles Drive Tampa, Florida 33618
Re: K222328
Trade/Device Name: SteriCUBE® Multiple Tray Sterilization Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: July 29, 2022 Received: August 2, 2022
Dear Annette Hillring:
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,
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222328
Device Name SteriCUBE(R) Multiple Tray Sterilization Systems
Indications for Use (Describe)
The SteriCUBE Multiple Tray Sterilization System) 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 SteriCUBE System Transfer Cart, SteriCUBE System Filters and SteriCUBE System Integrity Locks.
The SteriCUBE System is intended to be used in prevacuum steam sterilizers with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs. per tray.
The SteriCUBE System was tested and validated with rigid instruments containing lumens with an inner diameter of 0.7mm and an overall length of 500mm as well as lumens with an inner diameter of 1.0mm and an overall length of 850mm. Do not use with instruments containing lumens with an inner diameter smaller than 0.7mm and an overall length longer than 500mm or lumens with an inner diameter smaller than 1.0mm and an overall length longer than 850mm.
Use only uncovered, perforated or wire mesh general delivery trays within the SteriCUBE System.
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
K222328 510(k) Summary
| Submitter | SteriCUBE, LLC
2701 Beach Boulevard South
Gulfport, FL 33707
Contact person: Michele E. Mauzerall, CEO
Phone: 908-300-7093
Email: mem.pmbs@gmail.com
Date prepared: September 27, 2022 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | SteriCUBE® Multiple Tray Sterilization Systems |
| Predicate Device | MTS225 and MTS300 Multiple Tray Sterilization Systems (“MTS Systems”) cleared most recently November 5, 2019, via K190541 |
| Device Description | The SteriCUBE® Multiple Tray Sterilization Systems are also referred to as the “SteriCUBE Systems” and include the SteriCUBE MTS225 System and the SteriCUBE MTS300 System. The SteriCUBE System is comprised of the stainless steel sterilization cabinet and adjustable transfer cart. An optional reusable ceramic drain filter and single use filters and integrity locks with sterilization indicator dots are used with the system for each sterilization cycle. The optional ceramic drain filter should be replaced every 6 months or after 160 uses, whichever comes first. An optional STEAMPlus™ tray record card with STEAMPlus sterilization integrator (SPS Medical) may be utilized by the healthcare provider. Adjustable shelves within the cabinet can hold up to three trays (uncovered, perforated or wire mesh) of devices and/or surgical instruments intended for a single patient surgery. No more than 25 pounds can be loaded per tray for a maximum of 75 pounds per shelf. The MTS300 Cabinet (with four shelves) can hold up to 300 pounds per load and the MTS225 Cabinet (with three shelves) can hold up to 225 pounds per load. The loaded cabinet is deployed from the adjustable transfer cart and processed in pre-vacuum steam sterilizers. Processing includes the standard conditioning phase of the autoclave followed by a sterilization cycle time of 4 minutes and a dry cycle of a minimum of 5 minutes. Sterility is maintained for up to 30 days. |
Continued on next page
4
Section 5: 510(k) Summary, continued
| Indications for
Use | The SteriCUBE Multiple Tray Sterilization System (SteriCUBE® System) 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 SteriCUBE System Transfer Cart, SteriCUBE System Filters
and SteriCUBE System Integrity Locks. | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The SteriCUBE System is intended to be used in prevacuum steam sterilizers
with a prevacuum cycle of 270°F and exposure time of 4 minutes. Use no
more than 3 trays per shelf or 25 lbs. per tray. | |
| | The SteriCUBE System was tested and validated with rigid instruments
containing lumens with an inner diameter of 0.7mm and an overall length of
500mm as well as lumens with an inner diameter of 1.0mm and an overall
length of 850mm. Do not use with instruments containing lumens with an
inner diameter smaller than 0.7mm and an overall length longer than 500mm
or lumens with an inner diameter smaller than 1.0mm and an overall length
longer than 850mm. | |
| | Use only uncovered, perforated or wire mesh general delivery trays within the
SteriCUBE System. | |
| Comparison of
Technological
Characteristics
with the
Predicate
Device | There are no new technological characteristics associated with the modified
SteriCUBE System. A comparison of the technological characteristics of the
subject device, the SteriCUBE System (SteriCUBE MTS225 and SteriCUBE
MTS300 Systems) to the predicate, the currently marketed MTS225 and
MTS300 Systems, is provided in the table on the following pages. | |
| | Continued on next page | |
| Characteristic | Subject Device: | Predicate Device: |
| | SteriCUBE® Systems (SteriCUBE MTS225 and | MTS225 and MTS300 Systems |
| | SteriCUBE MTS300 Systems) | (K190541) |
| Indications for Use | The SteriCUBE Multiple Tray Sterilization System 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 SteriCUBE System Transfer
Cart, SteriCUBE System Filters and SteriCUBE System Integrity
Locks. | The MTS System (Multiple Tray Sterilization System) 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 MTS System Transfer Cart,
MTS System Filters and MTS System Integrity Locks. |
| | The SteriCUBE System is intended to be used in prevacuum
steam sterilizers with a prevacuum cycle of 270°F and exposure
time of 4 minutes. Use no more than 3 trays per shelf or 25 lbs.
per tray. | The MTS System is intended to be used in prevacuum steam
sterilizers with a prevacuum cycle of 270°F and exposure time of 4
minutes. Use no more than 3 trays per shelf or 25 lbs. per tray. |
| | The SteriCUBE System was tested and validated with rigid
instruments containing lumens with an inner diameter of 0.7mm
and an overall length of 500mm as well as lumens with an inner
diameter of 1.0mm and an overall length of 850mm. Do not use
with instruments containing lumens with an inner diameter
smaller than 0.7mm and an overall length longer than 500mm or
lumens with an inner diameter smaller than 1.0mm and an overall
length longer than 850mm. | The MTS System was tested and validated with rigid instruments
containing lumens with an inner diameter of 0.7mm and an overall
length of 500mm as well as lumens with an inner diameter of
1.0mm and an overall length of 850mm. Do not use with
|
| | Use only uncovered, perforated or wire mesh general delivery
trays within the SteriCUBE System. | Use only uncovered, perforated or wire mesh general delivery trays
within the MTS System. |
| | Sterilization | Prevacuum cycle of 270°F and exposure time of 4 |
| Parameters | minutes | minutes |
| Minimum Drying | 5 minutes | 10 minutes |
| Time | | |
| Characteristic | Subject Device:
SteriCUBE Systems (SteriCUBE MTS225 and
SteriCUBE MTS300 Systems) | Predicate Device:
MTS225 and MTS300 Systems
(K190541) |
| Sterility
Maintenance | 30 days | 30 days |
| Cabinet Material | 16 gauge stainless steel | 16 gauge stainless steel |
| Weight w/ Shelves | 212 lbs (MTS300) and 185 lbs (MTS225) | 212 lbs (MTS300) and 185 lbs (MTS225) |
| Filter Material | Heavy duty sterilization wrap by SPS Medical
Optional ceramic drain filter
Optional sterilization wrap filter separators | Heavy duty sterilization wrap by SPS Medical |
| Volume-to-Vent
Ratio | 129.131 (MTS300) and 94.725 (MTS225) | 129.131 (MTS300) and 94.725 (MTS225) |
| Deployment into
Sterilization
Chamber | Adjustable transfer cart | Adjustable transfer cart |
| Recommended
Sterilization Trays | All manufacturers' trays – uncovered, perforated or
wire mesh general delivery trays | All manufacturers' trays – uncovered, perforated or wire
mesh general delivery trays |
| Recommended
Sterilizers | All makes and models with dimensions compatible
with the SteriCUBE System | All makes and models with dimensions compatible with
the MTS System |
5
Section 5: 510(k) Summary, continued
Comparison of Technological Characteristics with the Predicate Device, continued
6
Continued on next page
Section 5: 510(k) Summary, continued
Comparison of Technological Characteristics with the Predicate Device, continued
Continued on next page
7
Section 5: 510(k) Summary, continued
| Comparison of
Technological
Characteristics
with the
Predicate
Device,
continued | Modifications introduced into the SteriCUBE® Multiple Tray Sterilization
Systems do not affect the technological characteristics. The cabinet material
remains stainless steel and a filtration system utilizing disposable paper filters
of the same material from the same supplier is the method by which
sterilization is achieved and maintained. The optional reusable drain ceramic
filter and paper filter separators are available for user convenience and
performance data confirms their effectiveness. The cabinet continues to be
deployed into the sterilization chamber with an adjustable transfer cart. The
sterilization parameters and sterility maintenance specifications are identical
to the predicate device. | |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The SteriCUBE Systems (both the SteriCUBE MTS225 and MTS300
Systems) have demonstrated the ability to:
achieve a 10-6 SAL when sterilizing longer and smaller lumen sized
instruments (rigid instruments containing lumens with an inner
diameter of 0.7mm and an overall length of 500mm as well as lumens
with an inner diameter of 1.0mm and an overall length of 850mm), meet the shorter minimum dry time of 5 minutes, and maintain sterility for 30 days. | |
| Performance
Data | Nonclinical data was generated to ensure the SteriCUBE System continues to
meet the intended use. Sterilization efficacy verification studies were
performed in accordance with the appropriate requirements of ANSI/AAMI
ST77:2013 Containment devices for reusable medical device sterilization. | |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR
807, and based upon the information and scientifically valid data provided in
this premarket notification, SteriCUBE, LLC, concludes that the subject
device, the SteriCUBE Systems (SteriCUBE MTS225 and MTS300 Systems)
is as safe, as effective and perform as well as the predicate device, the
MTS225 and MTS300 Multiple Tray Sterilization Systems (K190541). | |