(119 days)
Endo GIA™ Staplers: The Endo GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Endo GIA™ Radial Reload with Tri-Staple™ Technology: 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.
DST Series™ GIA™ Staplers: The DST Series™ GIA™ Staplers and the DST Series™ SGIA™ Knifeless Stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The SGIA™ Knifeless stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
DST Series™ TA™ Staplers: The Auto Suture™ TA™ Reloadable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in 30, 45 and 60 mm lengths as well as being available with optional Duet TRS™ staple line reinforcement material and optional curved-tip anvil for reloads with Tri-Staple™ Technology.
The Endo GIA™ Single Use Radial Reload with Tri-Staple™ Technology places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in a 60 mm length only.
The DST Series™ GIA™ Stapler place two double staggered rows of titanium staples and simultaneously divides the tissue between the two double rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in 60, 80 and 100 mm lengths.
The DST Series™ SGIA™ Knifeless Stapler places two double staggered rows of titanium staples. The size of the staples is determined by the selection of a 2.5 mm staple size single use reload available in a 60 mm length only.
The DST Series™ TA™ Stapler places a double staggered row of titanium staples. The size of the staples is determined by the selection of the appropriate single use reload that is available in 30, 45, 60 and 90 mm lengths.
This document is a 510(k) Summary of Safety and Effectiveness for the Endo GIA™ Staplers, DST Series™ GIA™ Staplers, and DST Series™ TA™ Staplers. The primary change highlighted is the inclusion of a specific indication for use in the transection and resection of the pancreas.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for functional performance (e.g., staple line integrity, leak rates, burst pressure). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices and the successful clinical literature review.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is substantially equivalent to predicate devices | "The Endo GIA™ Staplers, DST Series™ GIA™ Staplers and TECHNOLOGICAL DST Series™ TA™ Staplers are each identical to their predicate device." and "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..." |
| Materials are in accordance with ISO Standard 10993-1 | "All components of the Endo GIA™ Staplers, DST Series™ MATERIALS: GIA™ Staplers and DST Series™ TA™ Staplers are comprised of materials, which are in accordance with ISO Standard 10993-1." |
| Clinical application for transection and resection of pancreas is supported | "A clinical literature review was performed to demonstrate and PERFORMANCE DATA. support the clinical application of the Endo GIA™ Staplers, DST Series™ GIA™ Staplers and DST Series™ TA™ Staplers for transection and resection of pancreas." (The outcome of this review is implied to be sufficient for regulatory approval, as the device was deemed substantially equivalent.) |
| Intended Use includes transection/resection of pancreas | The "Indications For Use" section details the specific application of the devices for "transection and resection of pancreas" for all listed stapler types (Endo GIA™ Staplers, DST Series™ GIA™ Staplers, and DST Series™ TA™ Staplers). This is the key performance claim being supported by the literature review and forms the basis of the substantial equivalence for the expanded indication. No specific numerical performance metrics are provided for pancreatic resection, but rather the general applicability is deemed supported. |
Study Details
-
Sample size used for the test set and the data provenance:
The document mentions a "clinical literature review." This implies that the 'test set' was not a de novo, prospectively collected dataset for this specific submission, but rather existing published clinical data. The exact sample size (number of patients or cases) of the literature review is not specified. The data provenance (country of origin, retrospective/prospective) is also not specified, as it would depend on the individual studies included in the review. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not describe a process for establishing ground truth with a specific number of experts for a 'test set' in the traditional sense of an AI/diagnostic device study. The "clinical literature review" relies on the reported outcomes and findings of published studies, where the "ground truth" would have been established by the inherent diagnostic and surgical practices of the medical professionals involved in those studies (e.g., surgeons performing the procedures, pathologists examining resected tissue, follow-up clinicians assessing outcomes). The qualifications of these implicit "experts" from the literature are not detailed but would generally be medical professionals specializing in surgery (abdominal, gynecologic, pediatric, thoracic) and pathology. -
Adjudication method for the test set:
Not applicable in this context. The clinical literature review does not describe an adjudication process for a specific test set. The review synthesizes findings from multiple studies, and any form of "adjudication" would be at the discretion of the original study authors or implicitly through the peer-review process of the medical literature itself. -
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 is a surgical device, not a diagnostic AI device. The submission does not describe an MRMC study or any AI assistance. The clinical literature review supports the device's intended use, not the performance of human readers with or without AI. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical surgical stapling device, not a software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical literature review, the "ground truth" would have been derived from the outcomes data (e.g., successful transection, anastomosis integrity, post-operative complications, patient survival) and potentially pathology results from the surgical procedures described in the reviewed literature. It would be based on the established clinical practices and follow-up prevalent in those studies. -
The sample size for the training set:
Not applicable. This is a medical device, and the "clinical literature review" is not a "training set" in the context of machine learning. The device design and manufacturing process would involve extensive engineering testing and simulations, but the literature review serves to expand the intended use based on existing clinical evidence, not to train an algorithm. -
How the ground truth for the training set was established:
Not applicable, as there is no training set in the AI sense for this device submission.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness Surgical Devices, a global business unit SUBMITTER: of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: (203) 492-5352 CONTACT PERSON: Frank Gianelli Senior Associate, Regulatory Affairs October 19, 2011 DATE PREPARED: Endo GIA™ Staplers TRADE/PROPRIETARY NAME: DST Series™ GIA™ Staplers DST Series™ TA™ Staplers Staple, Implantable COMMON/USUAL NAME: Staple, Implantable CLASSIFICATION NAME: a. Panel no and product code: 79-GDW b. Regulation no: 21 CFR 878.4750 Endo GIA™ Staplers (K061095, K083519, K093410, K101444, PREDICATE DEVICE(S): K103263, K102291, K080898) DST Series™ GIA™ Staplers (K032696) DST Series™ TA™ Staplers (K032696) ENDOPATH Linear Cutters and Staplers (K070887) (K070887 Echelon Linear Cutters and Staplers The Endo GIA™ Stapler places two, triple-staggered rows of DEVICE DESCRIPTION: titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in 30, 45 and 60 mm lengths as well as being available with optional Duet TRS™ staple line reinforcement material and optional curved-tip anvil for reloads with Tri-Staple™ Technology: · 2.0 mm staple size single use reload (gray cartridge) · 2.5 mm staple size single use reload (white cartridge · 3.5 mm staple size single use reload (blue cartridge) · 4.8 mm staple size single use reload (green cartridge) · 2.0, 2.5, 3.0 mm staple size single use reload with Tri-Staple™ Technology (tan cartridge) · 3.0, 3.5, 4.0 mm staple size single use reload with Tri-Staple™ Technology (purple cartridge) · 4.0, 4.5, 5.0 mm staple size single use reload with Tri-Staple™ Technology (black cartridge) The Endo GIA™ Single Use Radial Reload with Tri-Staple™ Technology places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate single use reload that is
- available in a 60 mm length only: · 3.0, 3.5, 4.0 mm staple size single use radial reload with Tri-Staple™ Technology (purple cartridge)
OCT 2 5 2011
{1}------------------------------------------------
The DST Series™ GIA™ Stapler place two double staggered rows of titanium staples and simultaneously divides the tissue between the two double rows. The size of the staples is determined by the selection of the appropriate single use reload that is available in 60, 80 and 100 mm lengths:
KIII825 0. 2 of
- · 2.5 mm staple size single use reload (white cartridge) (60, 80, and 100 mm lengths)
- · 3.5 mm staple size single use reload (blue cartridge) (80 and 100 mm lengths only
- · 4.8 mm staple size single use reload (green cartridge) (80 and 100 mm lengths only)
The DST Series™ SGIA™ Knifeless Stapler places two double staggered rows of titanium staples. The size of the staples is determined by the selection of a 2.5 mm staple size single use reload available in a 60 mm length only.
The DST Series™ TA™ Stapler places a double staggered row of titanium staples. The size of the staples is determined by the selection of the appropriate single use reload that is available in 30, 45, 60 and 90 mm lengths:
- · 2.5 mm staple size single use reload (white cartridge) (30, 45, 60 and 90 mm lengths)
- · 3.5 mm staple size single use reload (blue cartridge) (45, 60 and 90 mm lengths only
- · 4.8 mm staple size single use reload (green cartridge) (45, 60 and 90 mm lengths only)
INTENDED USE:
Endo GIA™ Staplers:
The Endo GIA™ Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Endo GIA™ Radial Reload with Tri-Staple™ Technology:
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.
DST Series™ GIA™ Staplers:
The DST Series™ GIA™ Staplers and the DST Series™ SGIA™ Knifeless Stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The SGIA™ Knifeless stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
{2}------------------------------------------------
DST Series TM TATM Staplers:
The Auto Suture™ TA™ Reloadable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Endo GIA™ Staplers, DST Series™ GIA™ Staplers and TECHNOLOGICAL DST Series™ TA™ Staplers are each identical to their CHARACTERISTICS: predicate device. The only change is the inclusion of a specific indication concerning each device's use for the transection and resection of pancreas as a subset of the general indication for each of these devices.
- All components of the Endo GIA™ Staplers, DST Series™ MATERIALS: GIA™ Staplers and DST Series™ TA™ Staplers are comprised of materials, which are in accordance with ISO Standard 10993-1.
A clinical literature review was performed to demonstrate and PERFORMANCE DATA. support the clinical application of the Endo GIA™ Staplers, DST Series™ GIA™ Staplers and DST Series™ TA™ Staplers for transection and resection of pancreas.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 5 2011
Covidien % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K111825
Trade/Device Name: Endo GIA"" Stapler, DST Series™ GIA™ Stapler and
DST Series™ Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: September 29, 2011 Received: September 30, 2011
Dear Mr. Gianelli:
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.
{4}------------------------------------------------
Page 2 - Mr. Frank Gianelli
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 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.
Eric Keith
ForMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
111825
Indications For Use
510(k) Number (if known): 长川贸25
Device Name: Endo GIA™ Stapler, DST Series™ GIA™ Stapler and DST Series™ TA™ Stapler
Indications For Use:
Endo GIA™ Staplers:
The following indications are applicable to the Endo GIA™ Ultra Universal Stapler with Endo GIA™ Reloads with Tri-Staple™ Technology including Curved Tip Reloads:
The Endo GIA™ Ultra Universal Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Endo GIA™ Ultra Universal Staplers when used with the Endo GIA™ Curved-Tip Reloads can be used to blunt dissect or separate target tissue from other certain tissue.
The following indications are applicable to the Endo GIA™ Ultra Universal Stapler with Duet TRS™ Reloads with Tri-Staple™ Technology including Duet TRS™ Curved Tip Reloads:
The Endo GIA™ Ultra Universal Staplers with Duet TRS™ Reloads with Tri-Staple™ Technology have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The Endo GIA™ Ultra Universal Staplers when used with the Duet TRS™ Curved-Tip Reloads can be used to blunt dissect or separate target tissue from other certain tissue.
The following indications are applicable to the Endo GIA™ Ultra Universal Stapler with Radial Reload with Tri-Staple™ Technology:
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 of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The following indications are applicable to the Endo GIA™ Universal Stapler with Endo GIA™ Straight and Roticulator ™ SULUs:
The Endo GIA™ Universal Staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
The following indications are applicable to the Endo GIA™ Universal Stapler with Duet TRS™ Reloads:
The Endo GIA™ Ultra Universal Staplers with Duet TRS™ Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of
{6}------------------------------------------------
anastomosis. They may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
DST Series ™ GIA™:
The Auto Suture™ GIA™ Reloadable Staplers and the SGIA™ Knifeless Stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. The SGIA™ Knifeless stapler may be used for occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
DST Series™ TA™:
The Auto Suture™ TA™ Reloadable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used 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)
Eriel Keith
Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111825
§ 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.