(75 days)
The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application In open or minimally invasive general abdominal, gynecologic, pediatre and thorado surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the perior, it e. low antentiment which and may be used for transection and resection of liver substance, hepatic vasculature and billiary stuctures and for transection and resection of pancreas.
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 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 Reload with Tri- Stable™ Technology may be used with the Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler handles.
The provided text is a 510(k) summary for a medical device, the "Endo GIA™ Radial Reload with Tri-Staple™ Technology". This document describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance data.
However, the provided text does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device. The document pertains to a mechanical surgical stapling device, not an AI/ML system. Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: The document mentions performance data, including "In Vitro (Firing Force, Retraction Force, Staple Formation)" and "In Vivo (Free Bleed Evaluation, Air Leak Test, Burst Evaluation, Tissue Grasping and Trauma, Biocompatibility)". However, it does not provide specific acceptance criteria or quantitative performance results in a table format. It only states that the results "demonstrate that the proposed devices... are substantially equivalent to the predicate devices."
- Sample size used for the test set and the data provenance: Not applicable as there is no AI/ML test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no AI/ML ground truth.
- Adjudication method: Not applicable as there is no AI/ML ground truth.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is a mechanical device, not an AI system assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a mechanical device, not an AI algorithm.
- The type of ground truth used: Not applicable as this is a mechanical device.
- The sample size for the training set: Not applicable as there is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable as there is no AI/ML training set.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, materials, and generic performance testing for a surgical stapler. It does not describe an AI/ML system or its validation process.
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510(k) Summary
| SUBMITTER: | Covidien60 Middletown AvenueNorth Haven, CT 06473(203) 492-5299 (T)(203) 492-5029 (F) |
|---|---|
| CONTACT PERSON: | Katherine KassimSenior Specialist, Regulatory Affairs |
| DATE PREPARED: | August 19, 2013 |
| TRADE/PROPRIETRY NAME: | Endo GIA™ Radial Reload with Tri-Staple™ Technology |
| COMMON/USUAL NAME: | |
| 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 (K131705);Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology(K093410); Endo GIA™ Single Use Tan Reload with Tri-Staple™Technology (K101444) |
| DEVICE DESCRIPTION: | The single use Endo GIA™ Radial Reload with Tri-Staple™ Technologyplaces three radial (curved) staple rows 60mm in length on each side ofa cut line and simultaneously divides the tissue between the third andfourth lines, creating a 60mm curved transection. The radial reloadplaces height progressive titanium staple rows. The reloads may beinserted through an access device such as a hand access device orcomparable access port. The Endo GIA™ Radial Reload with Tri-Stable™ Technology may be used with the Endo GIA™ Ultra Universal,Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra staplerhandles. |
| INTENDED USE: | The Endo GIA™ Radial Reload with Tri-Staple™ Technology hasapplication in open or minimally invasive general abdominal,gynecologic, pediatric and thoracic surgery for resection and transectionof tissue and creation of anastomosis, as well as application deep in thepelvis, i.e. low anterior resection. It may be used for transection andresection of liver substance, hepatic vasculature and biliary structuresand for transection and resection of pancreas. |
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TECHNICAL CHARACTERISTICS:
The Endo GIA™ Radial Reload with Tri-Staple™ Technology black reload and tan reload are substantially equivalent and have not altered the fundamental scientific technology to the predicate devices with regards to stapling technologies. The following summary tables show the similarities and differences between the subject device and the predicate devices.
| Substantial | Endo GIA™ Radial | Endo GIA™ Radial | Endo GIA™ Single |
|---|---|---|---|
| Equivalence Chart | Reload with Tri- | Reload with | Use Black Reload with |
| Black Reload | Staple™ Technology | Tri-Staple™ | Tri-Staple Technology |
| Black Reload | Technology Purple | (predicate - K093410) | |
| (subject devices) | Reload | ||
| (predicate - K131705 ) | |||
| Intended Use | The Endo GIA™ RadialReload with Tri-Staple™Technology hasapplication in open andminimally invasivegeneral abdominal,gynecologic, pediatricand thoracic surgery forresection andtransection of tissue andcreation of anastomosis,as well as applicationdeep in the pelvis, i.e.low anterior resection. Itmay be used fortransection andresection of liversubstances, hepaticvasculature and biliarystructures and fortransection and | Same | The AutoSuture™ EndoGIA™ Staplers haveapplication inabdominal, gynecologic,pediatric and thoracicsurgery for resection,transection and creationof anastomosis. Theymay be used fortransection andresection of liversubstance, hepaticvasculature and biliarystructures. |
| resection of pancreas. | |||
| Staple Line Length | 60mm | 60mm | 45mm or 60mm |
| Cartridge Color | Black | Purple | Same |
| Staple Sizes | 4.0mm, 4.5mm, 5.0mm | 3.0mm, 3.5mm, 4.0mm | Same |
| Cartridge Geometry | Curved | Same | Straight |
| Staple Rows | 3 rows | Same | Same |
| Staple Material | Titanium | Same | Same |
| Single Use | Yes | Same | Same |
| Disposable | Yes | Same | Same |
| Sterilization | The subject devicesshall be sterilized via avalidated ethylene oxide(ETO) cycle to a SAL of106 | Same | Same |
| Packaging | The subject devicesshall be packaged in asterile tray with Tyvek®lid. Each tray ispackaged in a display | Same | Same |
| SubstantialEquivalence Chart forTan Reload | Endo GIA™ RadialReload with Tri-Staple™ TechnologyTan Reload(subject device) | Endo GIA™ RadialReload with Tri-Staple™ TechnologyPurple Reload(predicate K131705) | Endo GIA™ SingleUse Tan Reload withTri-Staple Technology(predicate-K101444) |
| Intended Use | The Endo GIA™ RadialReload with Tri-Staple™Technology hasapplication in open andminimally invasivegeneral abdominal,gynecologic, pediatricand thoracic surgery forresection andtransection of tissue andcreation of anastomosis,as well as applicationdeep in the pelvis, i.e.low anterior resection. Itmay be used fortransection andresection of liversubstances, hepaticvasculature and biliarystructures and fortransection andresection of pancreas. | Same | The AutoSuture™ EndoGIA™ Staplers haveapplication inabdominal, gynecologic,pediatric and thoracicsurgery for resection,transection and creationof anastomoses. Theymay be used fortransection andresection of liversubstance, hepticvasculature and biliarystructures. |
| Staple Line Length | 60mm | 60mm | 45mm or 60mm |
| Cartridge Color | Tan | Purple | Same |
| Staple Sizes | 2.0mm, 2.5mm, 3.0mm | 3.0mm, 3.5mm, 4.0mm | Same |
| Cartridge Geometry | Curved | Same | Straight |
| Staple Rows | 3 rows | Same | Same |
| Staple Material | Titanium | Same | Same |
| Single Use | Yes | Same | Same |
| Disposable | Yes | Same | Same |
| Sterilization | The subject devicesshall be sterilized via avalidated ethylene oxide(ETO) cycle to a SAL of10-6 | Same | Same |
| Packaging | The subject devicesshall be packaged in asterile tray with Tyvek®lid. Each tray ispackaged in a displaybox. | Same | Same |
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All components of the Endo GIA™ Radial Reload with Tri-Staple™ MATERIALS: Technology are similar 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 PERFORMANCE DATA: demonstrate that the proposed devices Endo GIA™ Radial Reload with Tri-Staple™ Technology black reload and tan 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
- Firing Force o
- Retraction Force o
- Staple Formation O
- In Vivo .
・
- Free Bleed Evaluation o
- o Air Leak Test
- o Burst Evaluation
- Tissue Grasping and Trauma o
- . Biocompatibility
The result of these tests demonstrates that the proposed devices Endo GIA™ Radial Reload with Tri-Staple™ Technology black reload and tan reload are substantially equivalent to the predicate devices.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2013
Covidien, LLC Ms. Katherine Kassim Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K132493
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: September 23, 2013 Received: September 24, 2013
Dear Ms. Kassim:
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. Ilisting 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
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Page 2 - Ms. Katherine Kassim
forth in the quality systems (OS) 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Endo GIA™ Radial Reload with Tri-Staple™ Technology
Indications for Use
K132493 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, pediatre and thorado surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the perior, it e. low antentiment which and may be used for transection and resection of liver substance, hepatic vasculature and billiary stuctures and for transection and resection of pancreas.
Prescription Use × (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: K132493
Covidien Supplamental Information Радв 18
§ 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.