IDRIVE ULTRA STERILIZATION TRAY

K130532 · Covidien, Formerly US Surgical A Divison of Tyco H · KCT · May 30, 2013 · General Hospital

Device Facts

• Record ID: K130532
• Device Name: IDRIVE ULTRA STERILIZATION TRAY
• Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
• Product Code: KCT · General Hospital
• Decision Date: May 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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

Device Story

Aluminum sterilization tray designed for storage, sterilization, and transport of iDrive™ Ultra powered stapling system components; includes powered handle, Endo GIA™ adapters, battery insertion guides, and manual adapter tool. Perforated design allows steam penetration during autoclave cycles (132°C/4 min or 134°C/3 min). Used in hospital environments by clinical staff; requires wrapping with FDA-cleared sterilization wrap. Non-stacked configuration only. Protects instruments during sterilization process; facilitates organized storage and transport.

Clinical Evidence

Bench testing only. Testing performed per ANSI/AAMI ST77:2006 and AAMI TIR30:2003 to validate sterilization efficacy and material compatibility.

Technological Characteristics

Aluminum base and lid; medical grade Class 6 silicone grommets. Perforated for steam penetration. Dimensions: 15 lb load capacity. Sterilization: Prevacuum steam (132°C/4 min or 134°C/3 min). Non-stacked configuration. Compliant with ISO 10993-1.

Indications for Use

Indicated for storage, sterilization, and transport of iDrive™ Ultra powered stapling system components (powered handle, Endo GIA™ adapters, battery insertion guides, manual adapter tool) within hospital environments. Requires use with FDA-cleared sterilization wrap. Not for patient contact.

Regulatory Classification

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.

Predicate Devices

• PolyVac Surgical Instrument Delivery System (K012105)
• MetaPak Multi-Purpose Instrument Tray (K993535)

Submission Summary (Full Text)

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K130532

### 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™ Ultra<br>sterilization tray<br>(subject device) | PolyVac Surgical<br>Instrument delivery<br>system (K012105)<br>(predicate device) | MetaPak Multi-Purpose<br>Sterilization Tray<br>(K993535) (predicate<br>device) |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The iDrive™ Ultra<br>sterilization tray<br>(IDRVTRAY) is intended<br>to provide storage for the<br>iDrive™ Ultra powered<br>stapling system during<br>sterilization, storage, and<br>transportation within the<br>hospital environment. The<br>tray can contain at a<br>maximum: one (1)<br>iDrive™ Ultra powered<br>handle, two (2) Endo<br>GIA™ adapters, two (2)<br>iDrive™ battery insertion<br>guides, and one (1)<br>iDrive™ Ultra manual<br>adapter tool. The tray is<br>intended to be sterilized<br>by the following cycles:<br>Prevacuum Steam<br>Cycles:<br>132°C for 4 minutes | Symmetry PolyVac delivery<br>systems are intended for the<br>protection, organization and<br>the delivery to the surgical<br>field of surgical instruments<br>and/or other medical devices.<br>Symmetry PolyVac are not<br>designed to maintain sterility<br>by themselves. They are<br>designed to facilitate the<br>sterilization process when<br>used in conjunction with a<br>wrapping material (FDA<br>cleared sterilization wrap) or<br>a specified filtered<br>sterilization container<br>system. Wrapping materials<br>and sterilization containers<br>are designed to allow air<br>removal, steam<br>penetration/evacuation<br>(drying) and maintain the<br>sterility of the internal | The MetaPak Instrument<br>Tray is used for loading<br>surgical instruments in<br>order to conveniently<br>organize, sterilize,<br>transport and store the<br>instruments between uses.<br>The MetaPak Instrument<br>Tray can be used in pre-<br>vacuum steam and<br>ethylene oxide sterilization<br>cycles. |

### TECHNOLOGICAL CHARACTERISTICS:

MATERIALS:

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| | 134°C for 3 minutes<br>Vacuum Dry Time: 20<br>minutes | components. | |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Sterilization | Prevacuum steam | Prevacuum steam | Prevacuum steam |
| Material | Base — Aluminum<br>Lid - Aluminum<br>Base Inserts (Grommets)<br>- Silicone Medical Grade<br>Class 6 | Base - Aluminum<br>Lid - Aluminum<br>Base Inserts (Grommets) -<br>Silicone Medical Grade Class<br>6 | Aluminum, Stainless Steel<br>or aluminum/Radel<br>combination. |
| Stacking | Do not stack cases and<br>trays in the autoclave<br>chamber. Stacking of<br>cases and trays will<br>adversely affect<br>sterilization and drying<br>effectiveness. | Stacking of delivery systems<br>and overloading of the units<br>will adversely effect<br>sterilization and drying<br>effectiveness. DO NOT<br>STACK cases and trays in<br>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.

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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