(114 days)
Not Found
No
The device is a sterilization tray, a passive accessory for holding other medical devices during sterilization. The description focuses on materials, design for steam penetration, and cleaning/sterilization validation, with no mention of computational or analytical functions.
No
The device is a sterilization tray used for storing and sterilizing other medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
The device is a sterilization tray intended to hold other medical devices for sterilization, storage, and transportation. It does not perform any diagnostic function.
No
The device description clearly states the Signia™ sterilization tray is composed of physical materials (stainless steel, inserts, strips, protective covers) and is a reusable accessory for storing and sterilizing other physical medical devices. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage, sterilization, and transportation of surgical tools (insertion guide and retraction tool) within a hospital environment. This is a function related to the preparation and handling of surgical instruments, not the analysis of biological samples for diagnostic purposes.
- Device Description: The device is a sterilization tray made of stainless steel with features designed to facilitate steam sterilization and hold surgical accessories. This aligns with the description of a medical device used in the surgical workflow, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body, nor is there any indication of it being used to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Therefore, the Signia™ sterilization tray falls under the category of a medical device used in the surgical setting, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Signia™ sterilization tray is intended to provide storage for the Signia™ reusable insertion guide and Signia™ manual retraction tool during sterilization, storage and transportation within the hospital environment. The Signia™ sterilization tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) Signia™ adapter, one (1) Signia™ reusable insertion guide and one (1) Signia™ manual retraction tool. The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
STEAM STERILIZATION
Pre-vacuum (HiVac) Steam Cycles
Item: Tray with components wrapped or in sterilization container system: 132 °C Pre-vacuum (HiVac) Steam Cycles, 134 °C Pre-vacuum (HiVac) Steam Cycles
Exposure temperature: 270 °F (132 °C), 273 °F (134 °C)
Exposure time: 4 minutes, 3 minutes
Vacuum dry time: 20 - 40 minutes, 20 - 40 minutes
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Signia™ sterilization tray is an optional reusable accessory to the Signia™ stapling system, and is intended to provide storage of the Signia™ accessories during sterilization, as well as, storage and transportation within the hospital environment. The Signia™ sterilization tray can simultaneously accommodate at a maximum the following Signia™ accessories:
One (1) Signia™ adapter
One (1) Signia™ reusable insertion guide
One (1) Signia™ manual retraction tool
The Signia™ sterilization tray is composed of a lid and base made of stainless steel. Both the lid and base are perforated to allow penetration of steam during sterilization. There are two latches on the side to secure the lid to the base, and handles for holding or transporting the tray. Inside of the base, inserts and strips are placed to hold the respective Signia™ accessories along with the pre-printed layout of the accessory as a visual aid. Each corner has a protective cover for protection.
The Signia™ sterilization tray is designed to facilitate the sterilization process when used in conjunction within the Central Supply Room (CSR) wrapping material (an FDA cleared sterilization wrap). The tray is intended to be reprocessed, which is first to be cleaned either manually or by an automatio washerdisinfector, and then sterilization. The tray is to be handled by medical personnel qualified in the transportation, cleaning, sterilization and use of surgical devices.
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
hospital environment. The tray is to be handled by medical personnel qualified in the transportation, cleaning, sterilization and use of surgical devices.
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)
Non-clinical performance data - Although the Signia™ sterilization tray is not intended for patient contact, all the materials that contact the enclosed Signia™ accessories during sterilization have been evaluated for cytotoxicity as an additional validation of safety to determine if there was any release of the material constituents or leachable chemicals produced from the cleaning and sterilization process that might be potentially toxic, and the testing results confirmed 'non-cytotoxic'.
The cleaning validation was designed to simulate the worst case scenario conforming to several industry standards including AAMI TIR30:2011 and the FDA's 2015 reprocessing quidance document. The cleanliness of the tray was assessed by carbohydrate, protein and hemoglobin residuals, and all residuals met predefined acceptance criteria demonstrating the adequate cleanliness of the tray using the cleaning instructions.
The sterilization validation, designed based on the FDA-recognized standard AAMI/ANSI ST77:2013, demonstrated the minimum sterility assurance level (SAL) of 10-6 can be achieved if the sterilization instructions in the instructions for use (IFU) were followed.
The reliability evaluation concluded the materials used in the Signia™ sterilization tray have been shown, through use in other devices, to withstand the cleaning and sterilization process without any adverse reactions and the tray will not undergo degradation due to the environmental stresses it is exposed to during reprocessing.
Clinical performance data - No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
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.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that resembles an abstract caduceus, with three stylized human profiles forming the staff and a serpent-like shape winding around them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
Covidien Katherine Choi, RAC Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K161347
Trade/Device Name: Signia™ Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: August 5, 2016 Received: August 8, 2016
Dear Katherine Choi:
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,
Michael D. Ryan -S
for Tina Kiang, Ph.D. Acting 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) K161347
Device Name Signia™ Sterilization Tray
Indications for Use (Describe)
The Signia™ sterilization tray is intended to provide storage for the Signia™ reusable insertion guide and Signia™ manual retraction tool during sterilization, storage and transportation within the hospital environment. The Signia™ sterilization tray is only intended to maintain sterility of the enclosed if it is used in coniunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) Signia™ adapter, one (1) Signia™ reusable insertion guide and one (1) Signia™ manual retraction tool. The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
STEAM STERILIZATION
Pre-vacuum (HiVac) Steam Cycles
| Item: Tray with components wrapped
or in sterilization container system | 132 °C Pre-vacuum (HiVac) Steam
Cycles | 134 °C Pre-vacuum (HiVac) Steam
Cycles |
|----------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| Exposure temperature | 270 °F (132 °C) | 273 °F (134 °C) |
| Exposure time | 4 minutes | 3 minutes |
| Vacuum dry time | 20 - 40 minutes | 20 - 40 minutes |
Type of Use (Select one or both, as applicable)
| Depurative Use (Part 111, 21 CFR 331, Subpart D) | |
|---|---|
| Over-The-Counter Use (Part 111, 21 CFR 331, Subpart C) |
| | Prescription Use {Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K161347 510(k) Summary
DATE PREPARED:
September 2, 2016
SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
CONTACT PERSON:
Katherine Y. Choi, RAC Principal Requlatory Affairs Specialist Telephone: (203) 492-8412 Fax: (203) 492-5029
IDENTIFICATION OF DEVICE:
| Proprietary/Trade Name: | Signia™ sterilization tray |
|---|---|
| Classification Name: | Sterilization wrap |
| Regulation Number: | 21 CFR 880.6850 |
| Product Code: | KCT |
| Device Class: | Class II |
| Review Panel: | General Hospital |
| Common Name: | Sterilization tray |
PREDICATE DEVICE:
| Proprietary/Trade Name: | iDrive™ Ultra sterilization tray |
|---|---|
| 510(k) Number: | K130532 (Clearance date: May 20, 2013) |
| Classification Name: | Sterilization wrap |
| Regulation Number: | 21 CFR 880.6850 |
| Product Code: | KCT |
| Device Class: | Class II |
| Review Panel: | General Hospital |
| Common Name: | Sterilization tray |
DEVICE DESCRIPTION:
The Signia™ sterilization tray is an optional reusable accessory to the Signia™ stapling system, and is intended to provide storage of the Signia™ accessories during sterilization, as well as, storage and transportation within the hospital environment. The Signia™ sterilization tray can simultaneously accommodate at a maximum the following Signia™ accessories:
One (1) Signia™ adapter One (1) Signia™ reusable insertion guide One (1) Signia™ manual retraction tool
The Signia™ sterilization tray is composed of a lid and base made of stainless steel. Both the lid and base are perforated to allow penetration of steam during sterilization. There are two latches on the side to secure the lid to the base, and handles for holding or transporting the tray. Inside of the base, inserts
4
and strips are placed to hold the respective Signia™ accessories along with the pre-printed layout of the accessory as a visual aid. Each corner has a protective cover for protection.
The Signia™ sterilization tray is designed to facilitate the sterilization process when used in conjunction within the Central Supply Room (CSR) wrapping material (an FDA cleared sterilization wrap). The tray is intended to be reprocessed, which is first to be cleaned either manually or by an automatio washerdisinfector, and then sterilization. The tray is to be handled by medical personnel qualified in the transportation, cleaning, sterilization and use of surgical devices.
INTENDED USE/INDICATIONS FOR USE:
The Signia™ sterilization tray is intended to provide storage for the Signia™ reusable insertion guide and Signia™ manual retraction tool during sterilization, storage and transportation within the hospital environment. The Signia™ sterilization tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) Signia™ adapter, one (1) Signia™ reusable insertion guide and one (1) Signia™ manual retraction tool. The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
STEAM STERILIZATION
Pre-vacuum (HiVac) Steam Cycles
| Item: Tray with components
wrapped or in sterilization
container system | 132 °C Pre-vacuum (HiVac)
Steam Cycles | 134 °C Pre-vacuum (HiVac)
Steam Cycles |
|-------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| Exposure temperature | 270 °F (132 °C) | 273 °F (134 °C) |
| Exposure time | 4 minutes | 3 minutes |
| Vacuum dry time | 20 - 40 minutes | 20 - 40 minutes |
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Signia™ sterilization tray is designed to withstand the indicated cleaning and sterilization conditions to aid in storage and sterilization of the Signia™ accessories. The tray itself is largely made of stainless steel, and does not require any special storage conditions. Repeated processing at the listed temperatures has minimal effect on the sterilization tray.
SUBSTANTIAL EQUIVALENCE:
The Signia™ sterilization tray has the same intended use as the legally-marketed iDrive™ Ultra sterilization tray cleared via K130532 (May 20, 2013) since both are metal sterilization trays. Also the predicate device and new Signia™ sterilization tray can undergo autoclave sterilization. However, the enclosed devices are different.
5
The comparison between the Signia™ sterilization tray and the predicate tray K130532 is highlighted in the table below.
| | Subject Device
Signia™ sterilization tray | Predicate Device K130532
iDrive™ Ultra sterilization tray |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Enclosed
devices for
sterilization | The tray can contain at a maximum:
one (1) Signia™ adapter,
one (1) Signia™ reusable insertion guide
and
one (1) Signia™ manual retraction tool. | The tray can contain at a maximum:
one (1) iDrive™ Ultra powered handle,
two (2) Endo GIA™ adapters,
two (2) iDrive™ battery insertion guides and
one (1) iDrive™ Ultra manual adapter tool. |
| Dimensions | Approx. 10.0 x 21.4 x 3.0 (H) inches | Approx. 10 x 21 x 3 (H) inches |
| Sterilization
methods | Prevacuum steam | Prevacuum steam |
| Steam
Sterilization
parameters | 132 °C Pre-vacuum (Hi Vac) Steam Cycle
Exposure temperature: 270 °F (132 °C)
Exposure time: 4 minutes
Vacuum dry time: 20 - 40 minutes
134 °C Pre-vacuum (Hi Vac) Steam Cycle
Exposure temperature: 273 °F (134 °C)
Exposure time: 3 minutes
Vacuum dry time: 20 - 40 minutes | Prevacuum Steam Cycles
132°C for 4 minutes
134°C for 3 minutes
Vacuum Dry: 20 minutes |
| Base & Lid
Materials | Stainless steel | Aluminum |
| Stacking | Do not stack cases and trays in the
sterilization chamber. | Do not stack cases and trays in the
autoclave chamber. |
| Max. Load
Capacity | 10 pounds | 15 pounds |
SUMMARY OF STUDIES:
Non-clinical performance data - Although the Signia™ sterilization tray is not intended for patient contact, all the materials that contact the enclosed Signia™ accessories during sterilization have been evaluated for cytotoxicity as an additional validation of safety to determine if there was any release of the material constituents or leachable chemicals produced from the cleaning and sterilization process that might be potentially toxic, and the testing results confirmed 'non-cytotoxic'.
The cleaning validation was designed to simulate the worst case scenario conforming to several industry standards including AAMI TIR30:2011 and the FDA's 2015 reprocessing quidance document. The cleanliness of the tray was assessed by carbohydrate, protein and hemoglobin residuals, and all residuals met predefined acceptance criteria demonstrating the adequate cleanliness of the tray using the cleaning instructions.
The sterilization validation, designed based on the FDA-recognized standard AAMI/ANSI ST77:2013, demonstrated the minimum sterility assurance level (SAL) of 10° can be achieved if the sterilization instructions in the instructions for use (IFU) were followed.
The reliability evaluation concluded the materials used in the Signia™ sterilization tray have been shown, through use in other devices, to withstand the cleaning and sterilization process without any adverse reactions and the tray will not undergo degradation due to the environmental stresses it is exposed to during reprocessing.
6
Clinical performance data - No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
CONCLUSION:
Based upon the supporting data summarized above, we concluded that Signia™ sterlization tray is as safe and as effective as the legally marketed device K130532, and does not raise different questions of safety and effectiveness than the predicate device.