(65 days)
Not Found
No
The summary describes a powered surgical stapler and its intended uses. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device's description or performance studies. The studies focus on mechanical and electrical performance, not algorithmic capabilities.
Yes
The device is described as a surgical stapler used in various surgical procedures for "resection, transection, and creation of anastomosis," which are all therapeutic interventions.
No
Explanation: The device is described as a surgical stapler used for resection, transection, and creation of anastomosis. Its intended uses involve performing surgical procedures rather than diagnosing conditions.
No
The device description explicitly states it is a "Surgical stapler with a powered handle, delivering implantable titanium staples," indicating it is a physical hardware device. The performance studies also focus on hardware-related testing like "Staple Formation Verification" and "Lifecycle Reliability Test."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical stapler used for mechanical actions like resection, transection, and creating anastomoses in various surgical procedures. This is a surgical instrument used on the body, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description confirms it's a surgical stapler that delivers implantable staples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely surgical and mechanical.
N/A
Intended Use / Indications for Use
The iDrive Ultra powered handle and Endo GIA adapter, when used with Endo GIA single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas.
The iDrive Ultra powered handle and Endo GIA adapter, when used with Endo GIA curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The iDrive Ultra powered handle and Endo GIA adapter, when used with the Endo GIA Radial Reload with Tri-Staple Technology, has applications in open or minimally invasive raneral abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Product codes
GDW
Device Description
The iDrive Ultra powered handle and Endo GIA adapter, when used with Endo GIA single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas.
The iDrive Ultra powered handle and Endo GIA adapter, when used with the Endo GIA curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The iDrive Ultra powered handle and Endo GIA adapter, when used with the Endo GIA Radial Reload with Tri-Staple Technology, has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecological, pediatric, and thoracic surgery areas, liver substance, hepatic vasculature, biliary structures, pancreas, pelvis (low anterior resection)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
In-vitro and in-vivo testing to support the intended use of this device includes:
- Articulation and Rotation Verification O
- Staple Formation Verification O
- Visual Indication Intensity O
- Aseptic Battery Transfer Test o
- Grasping Capability o
- Tissue Trauma Evaluation O
- Knife Cutting Performance Verification o
- Lifecycle Reliability Test 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) 0
- IEC 60601-1-2: 2007 0
- IEC 60601-2-18: 1996+ A1 (2000) 0
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
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
K121510
page 1/2
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 .: (203) 492-5000
JUL 25 2012
CONTACT PERSON:
Sarah Rizk Senior Product Specialist, Regulatory Affairs Covidien IIc Phone: (203) 492-5493 Fax: (203) 492- 5029
Surgical Stapler with Implantable Staples
Covidien, iDrive TM system (K102325)
DATE PREPARED:
May 18, 2011
TRADE/PROPRIETARY NAME:
y
iDrive™ Ultra powered handle Endo GIA™ adapter iDrive™ Battery Insertion Guide
COMMON/USUAL NAME:
Staple, Implantable CLASSIFICATION NAME:
PREDICATE DEVICE(S):
DEVICE DESCRIPTION:
INTENDED USE:
Surgical stapler with a powered handle, delivering implantable titanium staples.
Covidien, Endo GIA™ Ultra Universal Stapler (K111825)
The iDrive ™ Ultra powered handle and Endo GIA™ adapter, when used with Endo GIA™ single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas.
The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with Endo GIA™ curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The iDrive™ Ultra powered handle and Endo GIA™ adapter, when used with the Endo GIA™ Radial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Traditional 510(k)
Page 22 of 100
1
Covidien IIc (Formerly registered as Tyco Healthcare, LP)
K121510
page 2/2
TECHNOLOGICAL CHARACTERISTICS:
The iDrive™ Ultra powered handle with the Endo GIA™ adapter and Endo GIA™ reloads delivers two sets of triplestaggered rows of titanium staples and simultaneously divides the tissue between the two rows of staples via the single use reload, initiated by buttons on the powered handle.
MATERIALS:
All patient-contacting components of the iDrive™ Ultra powered handle and Endo GIA™ adapter are comprised of materials that have been evaluated in accordance with ISO 10993-1: 2009, 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:
- Articulation and Rotation Verification O
- Staple Formation Verification O
- Visual Indication Intensity O
- Aseptic Battery Transfer Test o
- Grasping Capability o
- Tissue Trauma Evaluation O
- Knife Cutting Performance Verification o
- Lifecycle Reliability Test 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) 0
- IEC 60601-1-2: 2007 0
- IEC 60601-2-18: 1996+ A1 (2000) 0
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
COVIDIEN. FORMERLY US SURGICAL A DIVISION OF TYCO % Ms. Sarah Rizk Regulatory Affairs Product Specialist 60 Middletown Avenue North Haven, Connecticut 06473
JUL 2 5 2012
Re: K121510
Trade/Device Name: iDrive Ultra Powered Handle and Endo GIA adapter Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: May 18, 2012 Received: May 21, 2012
Dear Ms. Rizk:
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
3
Page 2- Ms. Sarah Rizk
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/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,
Eirnd Keith
~ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
iDrive ™ Ultra powered handle and Endo GIA ™ adapter Device Name:
Indications For Use:
The iDrive ™ Ultra powered handle and En do GIA ™ adapter, when used with En do GIA ™ single use reloads have applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection rof liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas.
The iDrive ™ Ultra powered handle and Endo GIA TM adapter, when used with Endo GIA TM curved tip single use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The iDrive ™ Ultra powered handle and En do GIA TM adapter, when used with the Endo GIA TM Radial Reload with Tri-Staple ™ Technology, has applications in open or minimally invasive raneral abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
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
evice Evaluation (ODE)
David Kine for MM
(Division Sign-Off)
Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K/2/5/0