(114 days)
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 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.
The document describes the Signia™ Sterilization Tray, a device intended to provide storage for specific medical accessories during sterilization, storage, and transportation within a hospital environment. It also facilitates steam sterilization of these enclosed medical devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What the device should achieve) | Reported Device Performance (What the studies showed) |
|---|---|
| Cleaning Efficacy: Device must be adequately cleaned. | Cleaning validation simulated worst-case scenarios, conforming to AAMI TIR30:2011 and FDA's 2015 reprocessing guidance. Cleanliness was assessed by carbohydrate, protein, and hemoglobin residuals. All residuals met predefined acceptance criteria, demonstrating adequate cleanliness. |
| Sterilization Efficacy: Achieve a minimum sterility assurance level (SAL) of 10⁻⁶ when following IFU. | Sterilization validation (based on AAMI/ANSI ST77:2013) demonstrated that a minimum SAL of 10⁻⁶ can be achieved if the sterilization instructions in the IFU are followed for the specified steam sterilization cycles (132 °C for 4 minutes and 134 °C for 3 minutes, both with 20-40 minutes vacuum dry time). |
| Biocompatibility/Safety (Cytotoxicity): Materials contacting enclosed accessories should be non-cytotoxic. | Materials that contact the enclosed Signia™ accessories during sterilization were evaluated for cytotoxicity. The testing results confirmed 'non-cytotoxic', indicating no release of toxic material constituents or leachable chemicals. |
| Material Durability/Reliability: Withstand repeated cleaning and sterilization processes without degradation. | Reliability evaluation concluded that the materials (primarily stainless steel) have been shown through use in other devices to withstand the cleaning and sterilization process without adverse reactions, and the tray will not undergo degradation due to environmental stresses during reprocessing. Repeated processing at listed temperatures has minimal effect. |
| Functional Use (Storage/Transportation): Provide storage for specified Signia™ accessories and allow steam sterilization. | The device description and intended use state it provides storage for one Signia™ adapter, one Signia™ reusable insertion guide, and one Signia™ manual retraction tool, and allows steam sterilization. This functional aspect is implicitly demonstrated by the successful cleaning and sterilization validations involving the loaded tray, and the device description itself. The tray is only intended to maintain sterility if used with an FDA cleared sterilization wrap and in a non-stacked configuration. No explicit "performance" for storage/transport is detailed beyond its structural integrity. |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated for each test. For example, the number of sterilization cycles or cleaning repetitions used in the validation studies is not provided in detail. "Worst-case scenario" is mentioned for cleaning validation, implying a robust test design, but specifics are absent.
- Data Provenance: The studies were non-clinical performance data conducted by the manufacturer (Covidien). The country of origin for the data is not specified, but the submission is to the US FDA, so the studies would adhere to relevant US regulatory standards (e.g., AAMI). The data is prospective in the sense that these were specific validation tests conducted for the purpose of this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. This device is a sterilization tray, which is a physical medical device, not an AI/software device that generates diagnostic outputs or predictions requiring expert review for ground truth establishment. The ground truth for its performance is based on established engineering and microbiological standards for sterilization and cleaning (e.g., AAMI/ANSI ST77:2013, AAMI TIR30:2011, FDA reprocessing guidance).
4. Adjudication Method for Test Set:
- Not applicable. As this is a non-clinical device involving physical and microbiological performance metrics, not an interpretative AI tool, there is no need for expert adjudication of results in the way it would apply to image interpretation or diagnostic performance. The results are based on objective measurements against predefined criteria (e.g., residual levels, SAL).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is relevant for AI systems that aid human readers in diagnosis or interpretation. The Signia™ Sterilization Tray is a physical medical device and does not involve human readers for diagnostic interpretation; therefore, an MRMC comparative effectiveness study is not applicable.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a physical sterilization tray, not an algorithm or software. Therefore, standalone algorithm performance is not a relevant concept for this product.
7. Type of Ground Truth Used:
- The ground truth for the performance of the sterilization tray is based on:
- Established industry standards and regulatory guidance: Such as AAMI/ANSI ST77:2013 (for sterilization), AAMI TIR30:2011, and FDA's 2015 reprocessing guidance (for cleaning).
- Objective scientific measurements: Such as sterility assurance levels (SAL), residual levels of carbohydrates, protein, and hemoglobin, and material properties.
8. Sample Size for Training Set:
- Not applicable. This device is a physical product and does not utilize machine learning or AI algorithms, thus there is no "training set."
9. How Ground Truth for Training Set Was Established:
- Not applicable. As there is no training set for an algorithm, the concept of establishing ground truth for it does not apply.
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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
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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
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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 wrappedor in sterilization container system | 132 °C Pre-vacuum (HiVac) SteamCycles | 134 °C Pre-vacuum (HiVac) SteamCycles |
|---|---|---|
| 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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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
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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 componentswrapped or in sterilizationcontainer 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.
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The comparison between the Signia™ sterilization tray and the predicate tray K130532 is highlighted in the table below.
| Subject DeviceSignia™ sterilization tray | Predicate Device K130532iDrive™ Ultra sterilization tray | |
|---|---|---|
| Encloseddevices forsterilization | The tray can contain at a maximum:one (1) Signia™ adapter,one (1) Signia™ reusable insertion guideandone (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 andone (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 |
| Sterilizationmethods | Prevacuum steam | Prevacuum steam |
| SteamSterilizationparameters | 132 °C Pre-vacuum (Hi Vac) Steam CycleExposure temperature: 270 °F (132 °C)Exposure time: 4 minutesVacuum dry time: 20 - 40 minutes134 °C Pre-vacuum (Hi Vac) Steam CycleExposure temperature: 273 °F (134 °C)Exposure time: 3 minutesVacuum dry time: 20 - 40 minutes | Prevacuum Steam Cycles132°C for 4 minutes134°C for 3 minutesVacuum Dry: 20 minutes |
| Base & LidMaterials | Stainless steel | Aluminum |
| Stacking | Do not stack cases and trays in thesterilization chamber. | Do not stack cases and trays in theautoclave chamber. |
| Max. LoadCapacity | 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.
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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.
§ 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).