(20 days)
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.
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.
The provided text describes a 510(k) summary for the "Endo GIA™ Radial Reload with Tri-Staple™ Technology," a surgical stapler. However, it does not contain specific acceptance criteria, detailed results from a study, or the information needed to fill out all the requested categories.
The document states that "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." It lists categories of tests conducted: "In Vitro" (Firina Force, Retraction Force, Staple Formation) and "In Vivo" (Free Bleed Evaluation, Air Leak Test, Burst Evaluation, Tissue Grasping and Trauma, Biocompatibility). It concludes that "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."
Based on the provided text, I cannot complete the requested tables and information as many specific details are missing. For instance, it doesn't give precise numerical acceptance criteria, the reported device performance against those criteria, sample sizes, data provenance details, expert qualifications, adjudication methods, or information regarding AI assistance, standalone algorithm performance, or ground truth establishment for training sets.
Therefore, I can only provide a general description of what the document implies about the studies, noting the missing information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Hypothetical numerical criteria are not provided in the document) | Reported Device Performance (Specific numerical data is not provided in the document) |
|---|---|
| In Vitro Tests: | The results demonstrate substantial equivalence to the predicate device. The device performs as intended and is safe and effective. |
| * Firina Force | |
| * Retraction Force | |
| * Staple Formation | |
| In Vivo Tests: | The results demonstrate substantial equivalence to the predicate device. The device performs as intended and is safe and effective. |
| * Free Bleed Evaluation | |
| * Air Leak Test | |
| * Burst Evaluation | |
| * Tissue Grasping and Trauma | |
| Biocompatibility: | In accordance with ISO Standard 10993-1. Substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The studies were "Design verification and pre-clinical validation studies" including "In vitro and in vivo testing." No country of origin is mentioned, nor is it specified if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a medical device (surgical stapler), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" would be related to mechanical performance and biological outcomes, verified through instrumental measurements and observable biological effects in the tests mentioned (e.g., successful staple formation, absence of air leaks, no excessive bleeding, tissue integrity).
4. Adjudication method for the test set:
- Not applicable for this type of device testing. Performance is evaluated against engineering and biological criteria, not expert consensus on interpretations.
5. 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. This device is a surgical stapler, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical stapler, not an AI algorithm.
7. The type of ground truth used:
- The "ground truth" would be objective measurements and observations from the in vitro (e.g., force measurements, visual inspection for staple formation) and in vivo (e.g., observation of bleeding, pressure tests for leaks, histological examination for tissue trauma) tests. It is based on established engineering and biological performance standards for surgical staplers.
8. The sample size for the training set:
- Not applicable. This device is a surgical stapler and does not involve AI training sets.
9. How the ground truth for the training set was established:
- Not applicable. This device is a surgical stapler and does not involve AI training sets or associated ground truth establishment.
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510(k) Summary
K131705
page 1/2
| SUBMITTER: | Covidien60 Middletown AvenueNorth Haven, CT 06473(203) 492-5299 (T) |
|---|---|
| JUL 0 1 2013 | |
| CONTACT PERSON: | Katherine RobertsonSenior 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™ 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 medium/thickradial reload places height progressive titanium staple rows. The reloadsmay be inserted through an access device such as a hand access deviceor 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 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 and |
resection of liver substance, hepatic vasculature and biliary structures
and for transection and resection of pancreas.
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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.
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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
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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
§ 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.