(28 days)
Not Found
No
The document describes a powered surgical stapler and adapter. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is mechanical (converting rotary to linear motion) and its deactivation is based on service life, not intelligent processing.
No.
The device is a surgical stapler and handle used for resection, transection, and creation of anastomosis during various surgeries, which are surgical procedures, not therapeutic treatments.
No
The device is described as a surgical tool used for resection, transection, and creation of anastomosis, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a "powered handle" and "adapter," which are physical hardware components used in surgical procedures. The performance studies also involve physical testing like "Staple formation verification" and "Knife cutting performance verification."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical stapling system used for resection, creation of anastomosis, transection, and blunt dissection of tissues and organs within the body during surgical procedures. This is a direct surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a powered handle and adapter used with stapling reloads. This aligns with surgical instruments, not diagnostic equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
The device is a surgical instrument used for performing procedures on living tissue, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The iDrive™ Ultra powered handle and Endo GIA™ single used with Endo GIA™ single use reloads have applications in abdominal, graecological, pediatric, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection and resection of liver substance, and biliary structures and for transection and resection of pancess.
The iDrive™ Ultra powered handle and Endo GLA™ adapter, when used with Endo GLA™ curved tip single use 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™ Rodial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general stoominal, gynesologic, pediative and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, it.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 Endo GIA™ Extra Long Adapter (EGIAADAPTXL) is a longer version of our currently cleared Endo GIA™ Standard Adapter (EGIAADAPT).
The Endo GIA™ adapter converts the rotary output of the iDrive™ Ultra powered handle to linear motion, enabling compatibility with all Endo GIA™ stapling reloads units.
The iDrive™ Ultra powered handle and Endo GIA™ adapter are multi-patient reusable devices. The devices will deactivate after reaching the end of their service life.
devices are to be used by medical The professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. Endo GIA™ single use loading units and reloads with Tri-Staple™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
The Endo GIA™ Extra Long Adapter is being introduced to enable medical professionals with a choice of adapters for ease of access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, graecological, pediatric, and thoracic surgery, liver substance, hepatic vasculature, biliary structures, pancreas, pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices, sterile operating room 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)
Design verification studies were conducted to demonstrate that the proposed device, the Endo GIA™ Extra Long Adapter substantially equivalent to the predicate device.
In-vitro Testing:
- Articulation and rotation verification.
- Staple formation verification.
- Knife cutting performance verification.
- Lifecycle reliability test
Electrical safety testing
Biocompatibility testing
The results of testing demonstrate that the modified Endo GIA™ Extra Long Adapter is substantially equivalent to the legally marketed Endo GIA™ Adapter (K121510).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K121510, K123318 (mentioned in table under predicate)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K133762 Page 1/4
JAN - 8 2014
510(k) Summary
SUBMITTER:
CONTACT PERSON:
Covidien IIc 60 Middletown Avenue North Haven, CT 06473 USA
Debra Peacock Regulatory Affairs Product Manager Covidien IIc (203) 492-6935 Phone: (203) 492-5029 Fax: e-mail: debra.peacock@covidien.com
DATE PREPARED:
PRODUCT CODE:
REGULATION NUMBER:
COMMON/USUAL NAME:
CLASSIFICATION NAME:
DEVICE DESCRIPTION:
TRADE/PROPRIETARY NAME:
Surgical Stapler with Implantable Staples
Endo GIA™ Extra Long Adapter
Staple, Implantable
12/09/13
GDW
iDrive™ Ultra and Endo GIA™ Adapter (K121510) PREDICATE DEVICES:
21 CFR 878.4750
GIA TM The Endo Extra Long Adapter (EGIAADAPTXL) is a longer version of our currently cleared Endo GIA™ Standard Adapter (EGIAADAPT).
The Endo GIA™ adapter converts the rotary output of the iDrive™ Ultra powered handle to linear motion, enabling compatibility with all Endo GIA™ stapling reloads units.
The iDrive™ Ultra powered handle and Endo GIA™ adapter are multi-patient reusable devices. The devices will deactivate after reaching the end of their service life.
devices are to be used by medical The professionals qualified in the transportation, preparation, cleaning, sterilization, and use
203-492-5000 [T]
Covidien
60 Middletown Avenue North Haven, ct 06473
Covidien Special 510(k) Premarket Notification
1
of surgical devices. Endo GIA™ single use loading units and reloads with Tri-Staple™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
The Endo GIA™ Extra Long Adapter is being introduced to enable medical professionals with a choice of adapters for ease of access.
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.
Covidien
. 60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473
203-492-5000 [T]
INTENDED USE
Covidien Special 510(k) Premarket Notification
2
| CHARACTERISTICS: | ||
|---|---|---|
| Characteristic | Proposed | |
| Endo GIA™ Extra Long | ||
| Adapter | Predicate | |
| iDrive™ Ultra and Endo GIA™ | ||
| Adapter | ||
| (K121510/ K123318) | ||
| IFU | Same | Same |
| System Component | Same | Endo GIA™ adapter indicated for |
| use with the iDrive™ Ultra Powered | ||
| Stapling System. | ||
| Materials | Same (No change in | |
| materials from previous | ||
| device). | 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. | ||
| Adapter Dimensional | ||
| Specifications | 14.07" (total length) | |
| 1.52" (max width) | 10.27" (total length) | |
| 1.25" (max width) | ||
| Configuration | Same | Endo GIA™ adapter and Endo |
| GIA™ reloads delivers two sets of | ||
| triple staggered 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 | ||
| Labeling | Unchanged (universal | |
| adapter IFU) | Same |
There are no changes in materials for the Endo MATERIALS: GIA™ Extra Long Adapter (EGIAADAPTXL) from the predicate Endo GIA™ adapter. All materials are in accordance with ISO 10993-1. PERFORMANCE DATA: Design verification studies were conducted to demonstrate that the proposed device, the Endo GIA™ Extra Long Adapter substantially equivalent to the predicate device.
Covidien
60 MIDDLETOWN AVENUE NORTH HAVEN, CT 06473
203-492-5000 [T]
TECHNOLOGICAL
3
In-vitro testing supports the intended use of this device includes:
In-vitro Testing:
- Articulation and rotation verification .
- . Staple formation verification
- . Knife cutting performance verification
- . Lifecycle reliability test
Electrical safety testing Biocompatibility testing
The results of testing demonstrate that the modified Endo GIA™ Extra Long Adapter is substantially equivalent to the legally marketed Endo GIA™ Adapter (K121510).
CONCLUSION:
COVIDIEN
60 Middletown Avenue NORTH HAVEN. CT 06473
203-492-5000 [T]
(
Covidien Special 510(k) Premarket Notification
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2014
Covidien Ms. Debra Peacock Regulatory Affairs Product Manager 60 Middletown Avenue North Haven, Connecticut 06473
Re: K133762
Trade/Device Name: Endo GIA™ Extra Long Adapter Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 9, 2013 Received: December 11, 2013
Dear Ms. Peacock:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Debra Peacock
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Endo GIA Extra Long Adapter
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name Endo GIA™ Extra Long Adapter
Indications for Use (Describe)
The iDrive™ Ultra powered handle and Endo GIA™ single used with Endo GIA™ single use reloads have applications in abdominal, graecological, pediatric, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection and resection of liver substance, and biliary structures and for transection and resection of pancess.
The iDrive™ Ultra powered handle and Endo GLA™ adapter, when used with Endo GLA™ curved tip single use 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™ Rodial Reload with Tri-Staple™ Technology, has applications in open or minimally invasive general stoominal, gynesologic, pediative and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, it.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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Page Lotz
PRC Publishing Services (301) 443-6740
Covidien Special 510(k) Premarket Notification Page 25 of 111