(90 days)
No
The device description and intended use clearly define the device as a sterilization tray for surgical instruments, with no mention of any computational or analytical functions that would involve AI or ML.
No.
The device is a sterilization tray intended to provide storage for other medical devices during sterilization, storage, and transportation; it does not directly provide therapy.
No
The device is a sterilization tray used for storage and sterilization of surgical stapling system components, not for diagnosing medical conditions.
No
The device description clearly states it is an aluminum tray, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing storage for a powered stapling system and its accessories during sterilization, storage, and transportation within a hospital environment. This is a function related to the handling and preparation of surgical instruments, not the diagnosis of disease or other conditions.
- Device Description: The description details a perforated aluminum tray designed for steam sterilization and storage of surgical tools. This aligns with the intended use and does not involve any diagnostic processes.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (blood, tissue, etc.) or to provide information for the diagnosis, treatment, or prevention of disease.
- Performance Studies: The performance studies mentioned relate to sterilization standards (ANSI/AAMI ST77, AAMI TIR30), which are relevant to the reprocessing of medical devices, not diagnostic performance.
- Predicate Devices: The predicate devices listed are also sterilization trays, further supporting that this device falls under the category of surgical instrument handling and sterilization, not IVDs.
In summary, the iDrive™ Ultra sterilization tray is a medical device used for the storage and sterilization of surgical instruments. It does not perform any diagnostic function, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
KCT
Device Description
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.
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
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)
Testing has been performed and includes testing to the following standards:
- ANSI/AAMI ST77:2006
- AAMI TIR30:2003
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
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)
1
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™ Ultra
sterilization tray
(subject device) | PolyVac Surgical
Instrument delivery
system (K012105)
(predicate device) | MetaPak Multi-Purpose
Sterilization Tray
(K993535) (predicate
device) |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The iDrive™ Ultra
sterilization tray
(IDRVTRAY) 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)
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 | Symmetry PolyVac delivery
systems are intended for the
protection, organization and
the delivery to the surgical
field of surgical instruments
and/or other medical devices.
Symmetry PolyVac are not
designed to maintain sterility
by themselves. They are
designed to facilitate the
sterilization process when
used in conjunction with a
wrapping material (FDA
cleared sterilization wrap) or
a specified filtered
sterilization container
system. Wrapping materials
and sterilization containers
are designed to allow air
removal, steam
penetration/evacuation
(drying) and maintain the
sterility of the internal | The MetaPak Instrument
Tray is used for loading
surgical instruments in
order to conveniently
organize, sterilize,
transport and store the
instruments between uses.
The MetaPak Instrument
Tray can be used in pre-
vacuum steam and
ethylene oxide sterilization
cycles. |
TECHNOLOGICAL CHARACTERISTICS:
MATERIALS:
2
| | 134°C for 3 minutes
Vacuum Dry Time: 20
minutes | components. | |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Sterilization | Prevacuum steam | Prevacuum steam | Prevacuum steam |
| Material | Base — Aluminum
Lid - Aluminum
Base Inserts (Grommets)
- Silicone Medical Grade
Class 6 | Base - Aluminum
Lid - Aluminum
Base Inserts (Grommets) -
Silicone Medical Grade Class
6 | Aluminum, Stainless Steel
or aluminum/Radel
combination. |
| Stacking | Do not stack cases and
trays in the autoclave
chamber. Stacking of
cases and trays will
adversely affect
sterilization and drying
effectiveness. | Stacking of delivery systems
and overloading of the units
will adversely effect
sterilization and drying
effectiveness. DO NOT
STACK cases and trays in
autoclave 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.
3
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.
4
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
5
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