(20 days)
No
The document describes a mechanical surgical stapler reload and its intended use, with no mention of AI or ML capabilities.
No.
This device is a surgical stapler reload used for tissue resection and anastomosis, which are surgical procedures, not therapeutic treatments in themselves.
No
The device is a surgical stapler used for resecting and transecting tissue and creating anastomoses, not for diagnosing medical conditions.
No
The device description clearly describes a physical medical device (stapler reload) that places staples and divides tissue. There is no mention of software as the primary or sole component.
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 stapling device used for resection and transection of tissue and creation of anastomosis during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device description details a surgical stapler reload that places staples and divides tissue. This is a mechanical surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical instrument used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application 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.
Product codes
GDW
Device Description
The single use Endo GIA™ radial reload with Tri-Staple™ technology places three radial (curved) staple rows 60mm in length on each side of a cut line and simultaneously divides the tissue between the third and fourth lines, creating a 60mm curved transection. The medium/thick radial reload places height progressive titanium staple rows. The reloads may be inserted through an access device such as a hand access device or comparable access port. The Endo GIA™ radial reloads with Tri-Staple™ Technology may be used with the Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler handles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecologic, pediatric, thoracic, pelvis, liver, hepatic vasculature, biliary structures, pancreas
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)
Design verification and pre-clinical validation studies were conducted to demonstrate that the subject device Endo GIA™ Radial Reload are safe and effective and perform as intended. In vitro and in vivo testing to support the intended use of this device includes:
- In Vitro
- Firina Force 0
- Retraction Force O
- Staple Formation 0
- In Vivo
- Free Bleed Evaluation o
- Air Leak Test O
- Burst Evaluation 0
- Tissue Grasping and Trauma 0
Biocompatibility .
The result of these tests demonstrates that the subject device Endo GIA™ Radial Reload with Tri-Staple Technology is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Endo GIA™ Radial Reload with Tri-Staple™ Technology (K102291), Endo GIA™ Stapler, DST Series™ GIA™ Stapler and DST Series™ TA™ Stapler (K111825)
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
510(k) Summary
K131705
page 1/2
| SUBMITTER: | Covidien
60 Middletown Avenue
North Haven, CT 06473
(203) 492-5299 (T) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JUL 0 1 2013 |
| CONTACT PERSON: | Katherine Robertson
Senior Specialist, Regulatory Affairs |
| DATE PREPARED: | June 10, 2013 |
| TRADE/PROPRIETRY NAME: | Endo GIA™ Radial Reload with Tri-Staple™ Technology |
| COMMON/USUAL NAME: | Surgical Stapler with Implantable Staples |
| CLASSIFICATION NAME: | Staples, Implantable |
| FDA PANEL NUMBER: | 79 |
| PRODUCT CODE: | GDW |
| CLASS CODE: | Pursuant to 21 CFR 878.4750, an implantable staple is a Class II device. |
| PREDICATE DEVICE(S): | Endo GIA™ Radial Reload with Tri-Staple™ Technology (K102291);
Endo GIA™ Stapler, DST Series™ GIA™ Stapler and DST Series™
TA™ Stapler (K111825) |
| DEVICE DESCRIPTION: | The single use Endo GIA™ radial reload with Tri-Staple™ technology
places three radial (curved) staple rows 60mm in length on each side of
a cut line and simultaneously divides the tissue between the third and
fourth lines, creating a 60mm curved transection. The medium/thick
radial reload places height progressive titanium staple rows. The reloads
may be inserted through an access device such as a hand access device
or comparable access port. The Endo GIA™ radial reloads with Tri-
Staple™ Technology may be used with the Endo GIA™ Ultra Universal,
Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler
handles. |
| INTENDED USE: | The Endo GIA™ Radial Reload with Tri-Staple™ Technology has
application 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.
1
TECHNICAL CHARACTERISTICS:
PERFORMANCE DATA:
MATERIALS:
The Endo GIA™ Radial Reload with Tri-Staple™ Technology is substantially equivalent and has not altered the fundamental scientific technology to the predicate devices with regards to stapling technologies.
All components of the Endo GIA™ Radial Reload with Tri-Staple™ Technology are identical to the predicate Endo GIA™ Radial Reload with Tri-Staple™ Technology. All materials are similar and are in accordance with ISO Standard 10993-1.
Design verification and pre-clinical validation studies were conducted to demonstrate that the subject device Endo GIA™ Radial Reload are safe and effective and perform as intended. In vitro and in vivo testing to support the intended use of this device includes:
- In Vitro .
- Firina Force 0
- Retraction Force O
- Staple Formation 0
- In Vivo ●
- Free Bleed Evaluation o
- Air Leak Test O
- Burst Evaluation 0
- Tissue Grasping and Trauma 0
Biocompatibility .
The result of these tests demonstrates that the subject device Endo GIA™ Radial Reload with Tri-Staple Technology is substantially equivalent to the predicate device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. 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 Center - WO66-G609 Silver Spring, MD 20993-002
July 1, 2013
Covidien % Ms. Katherine Robertson Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K131705
Trade/Device Name: Endo GIA™ Radial Reload with Tri-Staple™ Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: June 10, 2013 Received: June 11, 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.
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 - Ms. Katherine Robertson
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 (2) 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 n ﺭﺑﻂ ﻳﻌﻮﺍ ﺑﺎﻟﻘﺎﺭ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘ 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/defiault.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,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Endo GIA™ Radial Reload with Tri-Staple™ Technology
Indications for Use:
The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131705