(90 days)
The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Utra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra 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) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:
Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes
Vacuum Dry: 20 minutes
The iDrive™ Ultra sterilization tray is an optional, over-the counter, accessory to aid in storage and sterilization of the iDrive™ Ultra powered handle, Endo GIA™ adapter, iDrive™ battery insertion guide and iDrive™ Ultra manual adapter tool. It can simultaneously accommodate the following components:
One (1) iDrive™ Ultra powered handle
Two (2) Endo GIA™ adapters
Two (2) iDrive™ battery insertion guides
One (1) iDrive™ Ultra manual adapter tool
The iDrive™ Ultra sterilization tray is an aluminum tray which is perforated to allow penetration of steam during steam sterilization. The tray can be processed through a minimum autoclave cycle of either 134°C for 3 minutes or 132°C for 4 minutes while being wrapped with a CSR wrap or within a sterilization container system.
Here's an analysis of the provided text regarding the iDrive™ Ultra sterilization tray, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed report of a new clinical study. As such, information regarding AI performance metrics (like sensitivity, specificity, F1 score), sample sizes for AI training/testing, expert qualifications, and MRMC studies will not be present as this device is a physical sterilization tray, not an AI diagnostic or assistive tool.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization Effectiveness: | The tray can be processed through a minimum autoclave cycle of either 134°C for 3 minutes or 132°C for 4 minutes with a 20-minute vacuum dry time. |
| - Ability to allow steam penetration/evacuation (drying) when used with appropriate wrap/container system for specific cycles. | The tray is perforated to allow penetration of steam during steam sterilization. It is intended to be sterilized by "Prevacuum Steam Cycles: 132°C for 4 minutes" and "134°C for 3 minutes" with a "Vacuum Dry Time: 20 minutes." The document states it facilitates the sterilization process when used with a wrapping material (FDA cleared sterilization wrap) or a specified filtered sterilization container system. |
| - Maintenance of sterility of internal components. | The tray is intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap. |
| Biocompatibility: Device materials are safe for use in a medical environment (no patient contact, but handled). | The iDrive™ Ultra sterilization tray is comprised of materials that are in accordance with ISO 10993-1. (This standard addresses biological evaluation of medical devices). |
| Physical Integrity/Durability: Ability to withstand processing and daily use. | Implied through general performance testing to standards like ANSI/AAMI ST77:2006 and AAMI TIR30:2003, which include aspects of material compatibility and performance under sterilization conditions. The trays are described as reusable. |
| Storage/Organization: Ability to securely hold specified components. | Can simultaneously accommodate: One (1) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides, one (1) iDrive™ Ultra manual adapter tool. |
| Load Capacity: Maximum weight it can hold. | 15 pounds. |
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of the device (a physical sterilization tray) and the document (510(k) Summary), this information is not applicable in the context of an AI/algorithm test set. The "test set" here refers to the actual physical trays and associated sterilization equipment used for physical, performance-based testing.
- Sample Size: Not explicitly stated as a number of "samples" in the way an AI study would define it. The testing involved multiple sterilization cycles and evaluations on the physical device. Typically, for such devices, a statistically significant number of cycles or tests are performed (e.g., n=3 for replicates, or stress testing until failure for durability), but the exact numbers are not detailed in this summary.
- Data Provenance: Not explicitly stated. The testing would have been conducted by Covidien, LLC, likely in their own laboratories or through contract labs. It's prospective testing for the purpose of this submission.
- Country of Origin: Not specified for the testing itself, but the submitter is Covidien LLC from North Haven, CT, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a physical sterilization tray, not an AI system requiring expert-derived ground truth. The "ground truth" for sterilization effectiveness would be determined by objective measures (e.g., biological indicators, chemical integrators, sterility assays, temperature/pressure monitoring) according to validated protocols, not expert consensus on images or interpretations.
4. Adjudication Method for the Test Set
Not applicable for a physical device. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert ratings are resolved for diagnostic classifications, which is irrelevant for a sterilization tray.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of a sterilization tray involves objective, verifiable outcomes related to sterilization efficacy and device integrity:
- Sterilization Efficacy: Achieved by passing established sterilization cycle parameters (temperature, pressure, time, vacuum dry time) and demonstrated sterility through biological indicators (killing of spore-forming bacteria), chemical indicators (color change), and physical monitoring of the autoclave cycle.
- Material Compatibility: Demonstrated by conformity to ISO 10993-1.
- Durability/Reusability: Demonstrated by the tray's physical integrity and functional performance after repeated sterilization cycles.
- Containment/Organization: Demonstrated by the physical fit of the specified components within the tray.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/machine learning device.
Summary of the Study Proving Device Meets Acceptance Criteria (from the 510(k) Summary):
The document states: "PERFORMANCE DATA: Testing has been performed and includes testing to the following standards: - ANSI/AAMI ST77:2006 - AAMI TIR30:2003 ."
These standards are critical for sterilization practices and medical device material compatibility, respectively:
- ANSI/AAMI ST77:2006 (or its current version): This standard typically covers "Containment devices for reusable medical device sterilization." It would detail requirements and test methods for instrument trays, wrappers, and containers regarding their ability to facilitate sterilization, prevent recontamination, and withstand reprocessing.
- AAMI TIR30:2003 (or its current version): This Technical Information Report (TIR) from AAMI focuses on "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices." While the tray itself isn't a "reusable medical device" in the same sense as an instrument, this TIR often provides guidance on material compatibility and resistance to reprocessing methods, including sterilization.
Implicit Study Design:
The "study" would involve:
- Preparation: Loading the iDrive™ Ultra sterilization tray with the specified maximum configuration of instruments/components.
- Sterilization Cycles: Running the loaded tray through the specified prevacuum steam cycles (132°C for 4 minutes and 134°C for 3 minutes, both with a 20-minute vacuum dry time) in a validated autoclave, likely using an FDA-cleared sterilization wrap.
- Sterility Assurance: Monitoring the sterilization cycle parameters, and using biological and chemical indicators to confirm that sterility was achieved within the tray.
- Material Compatibility/Integrity: Visual and functional inspection of the tray and its components after multiple sterilization cycles to ensure no degradation, melting, warping, or other adverse effects that would compromise its function or the sterility of the contents.
- Biocompatibility: Evidence of compliance with ISO 10993-1, likely through material certificates and prior evaluations of the silicone and aluminum materials.
- Load Capacity Testing: Demonstrating that the tray can safely support 15 pounds without structural failure.
The "acceptance criteria" are implied by the successful completion of these tests in accordance with the cited standards and the stated operational parameters for the device. The conclusion of the 510(k) is that, based on this testing and comparison to predicate devices, the iDrive™ Ultra sterilization tray is substantially equivalent and safe and effective for its intended use.
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MAY 3 0 2013
510(k) Summary of Safety and Effectiveness
SUBMITTER:
Covidien IIc 60 Middletown Avenue North Haven, CT 06473 USA 203.492.5299 (T)
Katherine Robertson Senior Requlatory Affairs Specialist
DATE PREPARED:
CONTACT PERSON:
TRADE/PROPRIETARY NAME:
PRODUCT CODE:
REGULATION NUMBER:
COMMON/USUAL NAME:
CLASSIFICATION NAME:
PREDICATE DEVICES:
DEVICE DESCRIPTION:
INTENDED USE:
May 3, 2013
iDrive™ Ultra sterilization tray
KCT
21 CFR 880.6850
sterilization tray
sterilization wrap
PolyVac Surgical Instrument Delivery System (K012105) MetaPak Multi-Purpose Instrument Tray (K993535)
The iDrive™ Ultra sterilization tray is an optional, over-the counter, accessory to aid in storage and sterilization of the iDrive™ Ultra powered handle, Endo GIA™ adapter, iDrive™ battery insertion guide and iDrive™ Ultra manual adapter tool. It can simultaneously accommodate the following components:
One (1) iDrive™ Ultra powered handle
Two (2) Endo GIA™ adapters
Two (2) iDrive™ battery insertion guides
One (1) iDrive™ Ultra manual adapter tool
The iDrive™ Ultra sterilization tray is an aluminum tray which is perforated to allow penetration of steam during steam sterilization. The tray can be processed through a minimum autoclave cycle of either 134°C for 3 minutes or 132°C for 4 minutes while being wrapped with a CSR wrap or within a sterilization container system.
The iDrive™ Ultra sterilization tray, an over-the-counter accessory, is intended to provide storage for the iDrive™ Ultra powered stapling system during sterilization, storage and transportation within the hospital environment. The tray can contain at a maximum: one (1) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2)
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iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:
Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes Vacuum Dry Time: 20
The iDrive™ Ultra sterilization tray is an optional accessory to aid in storage and sterilization of the iDrive™ Ultra powered handle, Endo GIA™ adapter, iDrive™ battery insertion guide and iDrive™ Ultra manual adapter tool.
The iDrive™ Ultra sterilization tray is not intended for patient contact. The iDrive™ Ultra sterilization tray is comprised of materials that are in accordance with ISO 10993-1.
PERFORMANCE DATA:
Testing has been performed and includes testing to the following standards:
- ANSI/AAMI ST77:2006 .
- AAMI TIR30:2003 .
SUBJECT AND PREDICATE COMPARISON:
| iDrive™ Ultrasterilization tray(subject device) | PolyVac SurgicalInstrument deliverysystem (K012105)(predicate device) | MetaPak Multi-PurposeSterilization Tray(K993535) (predicatedevice) | |
|---|---|---|---|
| Indications | The iDrive™ Ultrasterilization tray(IDRVTRAY) is intendedto provide storage for theiDrive™ Ultra poweredstapling system duringsterilization, storage, andtransportation within thehospital environment. Thetray can contain at amaximum: one (1)iDrive™ Ultra poweredhandle, two (2) EndoGIA™ adapters, two (2)iDrive™ battery insertionguides, and one (1)iDrive™ Ultra manualadapter tool. The tray isintended to be sterilizedby the following cycles:Prevacuum SteamCycles:132°C for 4 minutes | Symmetry PolyVac deliverysystems are intended for theprotection, organization andthe delivery to the surgicalfield of surgical instrumentsand/or other medical devices.Symmetry PolyVac are notdesigned to maintain sterilityby themselves. They aredesigned to facilitate thesterilization process whenused in conjunction with awrapping material (FDAcleared sterilization wrap) ora specified filteredsterilization containersystem. Wrapping materialsand sterilization containersare designed to allow airremoval, steampenetration/evacuation(drying) and maintain thesterility of the internal | The MetaPak InstrumentTray is used for loadingsurgical instruments inorder to convenientlyorganize, sterilize,transport and store theinstruments between uses.The MetaPak InstrumentTray can be used in pre-vacuum steam andethylene oxide sterilizationcycles. |
TECHNOLOGICAL CHARACTERISTICS:
MATERIALS:
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| 134°C for 3 minutesVacuum Dry Time: 20minutes | components. | ||
|---|---|---|---|
| Sterilization | Prevacuum steam | Prevacuum steam | Prevacuum steam |
| Material | Base — AluminumLid - AluminumBase Inserts (Grommets)- Silicone Medical GradeClass 6 | Base - AluminumLid - AluminumBase Inserts (Grommets) -Silicone Medical Grade Class6 | Aluminum, Stainless Steelor aluminum/Radelcombination. |
| Stacking | Do not stack cases andtrays in the autoclavechamber. Stacking ofcases and trays willadversely affectsterilization and dryingeffectiveness. | Stacking of delivery systemsand overloading of the unitswill adversely effectsterilization and dryingeffectiveness. DO NOTSTACK cases and trays inautoclave chamber. | Yes |
| Maximum | 15 pounds | Full size case (~9x19x4) — 22 | Unknown |
| Load Capacity | pounds |
The subject device and predicate devices are manufactured from identical metals, autoclavable, reusable and relative in dimensions, the subject device differs slightly from the predicate devices as the iDrive™ Ultra Sterilization Tray can only be sterilized via a prevacuum steam cycle while the PolyVac Surgical Instrument delivery system can be sterilized by prevacuum steam or gravity steam and the MetaPak Multi-Purpose Instrument Tray is sterilized by prevacuum steam or ethylene oxide. Additionally, the PolyVac Surgical Instrument delivery system and the iDrive™ Ultra Sterilization Tray cannot be stacked while the MetaPak Multi-Purpose Instrument Tray can be stacked.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the text "Public Health Service" in a simple, sans-serif font. The text is black and appears to be against a white background. The words are stacked on a single line and are evenly spaced.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2013
Ms. Katherine Robertson Senior Regulatory Affairs Specialist Covidien, Limited Liability Company 60 Middletown Avenue NORTH HAVEN CT 06473
Re: K130532
Trade/Device Name: iDrive™ Ultra Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: May 3, 2013 Received: May 6, 2013
Dear Ms. Robertson:
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.
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Page 2 - Ms. Robertson
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 the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
DN: C=US; O=U.S. Government, ou=HHS,_
ou=FDA; ou=People, cn=Mary S. Runner
-Susan Runner, DDS, MA
0.9.2342.19200300.100.1:1=1300087950-
Date: 2013.05.30 15:47:49-04'00'
Kwame Ulmer, M.S. 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):
Device Name: iDrive™ Ultra Sterilization Tray
Indications for Use:
The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Utra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra 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) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles:
Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes
Vacuum Dry: 20 minutes
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use > (21 CRF Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANTOHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shani J. Smith
2013.05.30 14:54:05 -04'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 3
§ 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).