IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)

K102325 · Covidien, LLC, Formerly Registered AS Tyco Healthca · GDW · Oct 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102325
• Device Name: IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD)
• Applicant: Covidien, LLC, Formerly Registered AS Tyco Healthca
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Oct 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Covidien iDrive™ Powered Handle, when used with the Covidien™ iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses. The Covidien iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the Covidien™ iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

Device Story

iDrive™ System is a powered surgical stapler consisting of a powered handle and a single-use Right Angle Linear Cutter (RALC) reload. Device delivers two rows of titanium staples on each side of a cutting blade. Operation is initiated by buttons on the powered handle, which provides motorized force for clamping and firing. Used in OR settings by surgeons for tissue resection, transection, and anastomosis in gastrointestinal, gynecological, abdominal, and thoracic procedures. Powered mechanism replaces manual force, potentially improving consistency of staple formation and tissue handling. Healthcare providers use the device to perform surgical cuts and closures; output is the physical placement of staples and tissue transection.

Clinical Evidence

Bench testing only. Performance data includes staple line pull-apart strength, staple formation, burst strength, hemostasis (free bleed time), air leak, tissue trauma, knife cutting performance, product security on tissue, autoclave reliability, egress of material, and shaft peak stall output torque. Electrical safety testing performed per IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-8.

Technological Characteristics

Powered surgical stapler; titanium staples; patient-contacting components evaluated per ISO 10993-1:2003. Features powered handle with button-actuated firing and clamping. Electrical safety compliant with IEC 60601-1, 60601-1-2, and 60601-1-8. Battery-operated.

Indications for Use

Indicated for patients undergoing gastrointestinal, gynecological, general abdominal, or thoracic surgery requiring tissue resection, transection, or anastomosis creation.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Covidien, iDriveC (K073001)
• Covidien, RALC (K012809)
• Ethicon, CONTOUR Curved Cutter Stapler (K091322)
• Covidien, Autosuture TA DST Series Stapler (K013860, K801589)

Submission Summary (Full Text)

{0}------------------------------------------------

Covidien IIc (formerly registered as Tyco Healthcare, LP)

K102325
pg 1 of 2

OCT 1 3 2010

### 510(k) Summary of Safety and Effectiveness

SUBMITTER: Covidien IIc (formerly registered as Tyco Healthcare, LP) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: [phone]

CONTACT PERSON: Nishith Desai Associate Manager, Regulatory Affairs Covidien IIc Phone: [phone] Fax: [phone]

August 16, 2010 DATE PREPARED:

TRADE/PROPRIETARY NAME: iDrive™ System

COMMON/USUAL NAME: Implantable, Staple

Surgical devices - Staple, Implantable CLASSIFICATION NAME:

Covidien, iDriveC (K073001) PREDICATE DEVICE(S): Covidien, RALC (K012809) Ethicon, CONTOUR Curved Cutter Stapler (K091322) Covidien, Autosuture TA DST Series Stapler (K013860, K801589)

#### Surgical stapler with Powered Handle, delivering implantable DEVICE DESCRIPTION: titanium staples.

INTENDED USE:

TECHNOLOGICAL

MATERIALS:

CHARACTERISTICS:

iDrive™ Powered Handle

The Covidien iDrive™ Powered Handle, when used with the Covidien™ iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

#### iDrive™ RALC

The Covidien iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the Covidien™ iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.

All patient-contacting components of the iDrive™ Powered Handle and iDrive™ Right Angle Linear Cutter are comprised of materials that have been evaluated in accordance with ISO

{1}------------------------------------------------

<102325
pg 2 of 2

10993-1: 2003, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing.

### PERFORMANCE DATA:

In-vitro and in-vivo testing to support the intended use of this device includes:

- Staple line pull-apart strength test 0
- Staple formation test o
- Staple line burst strength test 0
- Hemostasis (free bleed time) evaluation 0
- Air leak test 0
- Tissue trauma evaluation O
- Knife Cutting Performance test 0
- ಂ Product security on Tissue test while clamping and firing
- o Autoclave Reliability test
- O Egress of material test
- Fire and clamp Shaft peak stall output torque o measurement
- Battery and Battery charger tests O

Additional bench top testing has been performed and includes testing to the following electrical safety standards:

- IEC 60601-1: 1988 + A1 (1991) + A2 (1995) o
- IEC 60601-1-2: 2007 o
- IEC 60601-1-8: 2006 o

{2}------------------------------------------------

Image /page/2/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" arranged around the circumference. Inside the circle is a stylized graphic of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Covidien, LLC % Nishith Desai Associate Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K102325

Trade/Device Name: iDrive™ System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: August 16, 2010 Received: August 17, 2010

OCT 1 3 2010

Dear Nishith Desai:

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

{3}------------------------------------------------

Page 2 - Nishith Desai

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,

Er
Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

K102325 510(k) Number (if known):

Device Name:

OCT 1 3 2010

## Indications For Use

### iDrive™ Powered Handle

The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

### iDrive™ RALC

The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krone for WXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

510(k) Number K102325