(133 days)
The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The Echelon Endoscopic Linear Cutter Reload, Black, is a thick tissue reload for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Powered Flex) in a 60mm configuration. It is part of the current Echelon reload family and provides a closed staple height of 2.3 mm for use in thick tissue such as gastric, lung, and solid organ.
The Echelon Endoscopic Linear Cutter Reload, Black is loaded into an Echelon Endoscopic Linear Cutter and delivers staples into the tissue when the instrument is fired.
Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Echelon Endoscopic Linear Cutter Reload, Black:
It is important to note that the provided text is a 510(k) submission document, which primarily focuses on demonstrating substantial equivalence to a predicate device. As such, the level of detail regarding specific performance studies and their statistical analysis might be different from a peer-reviewed research paper.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Device performs as intended. | "Ex-vivo (bench) testing was performed to ensure that the devices perform as intended and meet design specifications." |
| Design Specifications | Meets established design specifications. | "Device performance was assessed against the design requirements and included process verification and design verification." |
| Substantial Equivalence | Equivalent to predicate device in terms of intended use, technological characteristics, and performance testing. | "The Subject device... is substantially equivalent to the legally marketed Predicate device based on intended use, technological characteristics, and performance testing." |
| Staple Line Integrity | Delivers staples with a closed height of 2.3 mm for thick tissue. | "provides a closed staple height of 2.3 mm for use in thick tissue such as gastric, lung, and solid organ." (This is a design feature, implicitly an acceptance criterion for performance.) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Ex-vivo (bench) testing was performed..." and "Device performance was assessed against the design requirements and included process verification and design verification."
- Sample Size for Test Set: Not explicitly stated in the provided text. The term "ex-vivo (bench) testing" implies a laboratory setting, but the number of devices or tests performed is not quantified.
- Data Provenance: The testing was "ex-vivo (bench) testing." This implies a laboratory, non-clinical setting, likely at the company's facilities. It is prospective testing designed to evaluate the new device. The country of origin of the data is not specified, but the company is based in the U.S. (Guaynabo, PR and Cincinnati, OH).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a bench test of a mechanical device like a stapler reload, "experts" in the traditional sense of medical image interpretation or clinical diagnosis would not be establishing ground truth. The "ground truth" would be objective measurements of mechanical performance (e.g., staple height, staple formation, burst pressure if applicable to the design specification, etc.) against pre-defined engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable/provided in the context of this type of "ex-vivo (bench) testing" for a mechanical device. Adjudication typically refers to resolving discrepancies between multiple human evaluators, which is not relevant here. The evaluation of bench test results would be against pre-defined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted (or at least not reported in this document). An MRMC study is typically used for diagnostic devices (e.g., imaging AI) where multiple human readers interpret cases with and without AI assistance. This document describes a mechanical surgical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A / No explicit algorithm involved. This device is a mechanical surgical stapler reload, not an AI or algorithmic device. Its performance is evaluated mechanically, not by an algorithm.
7. The Type of Ground Truth Used
The ground truth for the "ex-vivo (bench) testing" would be:
- Engineering Design Specifications: Pre-defined quantitative and qualitative requirements for the device's mechanical performance (e.g., staple height of 2.3mm, proper staple formation, firing mechanism integrity, tissue transection capabilities within specified limits).
- Predicate Device Performance Baseline: The performance of the legally marketed predicate device (K112056) would serve as a benchmark for comparison to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided as there is no "training set" for this type of mechanical device.
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| Company | Ethicon Endo-Surgery, LLC475 Calle CGuaynabo, PR 00969 |
|---|---|
| --------- | ---------------------------------------------------------------- |
Contact Christina Canter, RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery. Inc. Telephone: (513) 337-7321 Fax: (513) 337-1122 Email: ccanter2@its.ini.com
OCT 1 8 2013
Date Prepared June 6, 2013
Device Name
| Trade Name: | Echelon Endoscopic Linear Cutter Reload, Black |
|---|---|
| Common or Usual Name: | Endoscopic and Accessory |
| Classification Name: | Staple, Implantable |
Predicate Devices
Echelon Endoscopic Linear Cutter Reload, Black (cleared under K112056)
Device Description
The Echelon Endoscopic Linear Cutter Reload, Black, is a thick tissue reload for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Powered Flex) in a 60mm configuration. It is part of the current Echelon reload family and provides a closed staple height of 2.3 mm for use in thick tissue such as gastric, lung, and solid organ.
The Echelon Endoscopic Linear Cutter Reload, Black is loaded into an Echelon Endoscopic Linear Cutter and delivers staples into the tissue when the instrument is fired.
Indications for Use
The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Technological Characteristics
The design and performance of the Subject device is based on the currently marketed Echelon, Black reload. The modifications described in this submission do not affect the
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intended use of the device or alter the fundamental scientific technology of the device. The summary information that results from the design control process serve as the basis for this submission along with the required elements of a 510(k) found in 21 CFR 807.87.
Performance Data
Ex-vivo (bench) testing was performed to ensure that the devices perform as intended and meet design specifications. Device performance was assessed against the design requirements and included process verification and design verification.
Conclusion
The Subject device, Echelon Endoscopic Linear Cutter Reload, Black, is substantially equivalent to the legally marketed Predicate device based on intended use, technological characteristics, and performance testing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is composed of three stylized, curved lines that resemble a person embracing another person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC Ethicon Endo-Surgery, Inc. Christina Canter 4545 Creek Road Cincinnati, Ohio 45242
October 18, 2013
Re: K131663
Trade/Device Name: Echelon Endoscopic Linear Cutter Reload, Black Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: September 13, 2013 Received: September 16, 2013
Dear Ms. Canter:
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
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Page 2 - Christina Canter
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/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.
fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
Mark Nielkerson -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 Form
Indications for Use
510(k) Number (if known): K131663
Device Name: Echelon Endoscopic Linear Cutter Reload, Black
INDICATION FOR USE
The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause -S
Page 1 of 1
.
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131663
§ 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.