(17 days)
The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, 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 Flex Powered Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
The instruments are packaged with a battery pack that must be installed prior to use.
The instruments are shipped without a staple cartridge and must be loaded prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.
The provided text describes a 510(k) Premarket Notification for the "Echelon Flex Powered Articulating Endoscopic Linear Cutters." However, the document does not contain specific acceptance criteria or a detailed study that proves the device meets those criteria in the format typically used for AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Echelon Flex Powered Articulating Endoscopic Linear Cutters cleared under K110385). Substantial equivalence is the pathway for many medical devices to market in the US, where a new device is shown to be as safe and effective as a legally marketed device.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The text states:
"Ex-vivo tests (bench) were 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, design verification and design validation."
This indicates that internal design specifications and requirements served as the acceptance criteria. However, the specific metrics, thresholds, and the actual performance results in relation to these criteria are not detailed in this summary. For example, it doesn't specify tensile strength of staple lines, leak rates, or time to complete a staple line.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The text mentions "Ex-vivo tests (bench)" but does not specify the number of samples or the origin of the tissue/materials used for these tests. It also doesn't clarify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not provided for this type of device submission. The Echelon Flex is a mechanical surgical stapler, not an AI/ML diagnostic or prognostic device that relies on expert interpretation to establish ground truth for image or data analysis. Its performance is assessed through objective engineering and biological tests (e.g., staple line integrity, cutting ability).
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As explained above, this is a mechanical device, and its performance evaluation involves objective physical and biological testing, not subjective expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where the AI assists human readers (e.g., radiologists interpreting images). The Echelon Flex is a surgical instrument.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a mechanical surgical tool, not an algorithm. Its operation inherently involves a human surgeon. The "standalone performance" of the device would refer to its function in a benchtop testing environment where a machine operates it, which is implied by the "ex-vivo tests" mentioned.
7. The Type of Ground Truth Used
The "ground truth" for this device would be established through objective measures of mechanical and biological function. For example:
- Mechanical Integrity: Measuring staple line strength, staple formation, cutting completeness, articulation range, firing force, etc., against predefined engineering specifications.
- Biological Performance (Ex-vivo): Testing on animal tissue or cadaveric tissue to evaluate staple line hemostasis, tissue compression, and the ability to cut and staple effectively without leakage or tissue damage.
The document implicitly refers to meeting "design requirements" and "design specifications" established through "process verification, design verification and design validation" as the basis for proving performance.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a mechanical instrument, not an AI/ML algorithm that requires a training set. The "training" for such a device would involve engineering design and iterative testing, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
Summary of Information from the Provided Text:
The document explains that the new Echelon Flex Powered Articulating Endoscopic Linear Cutters are substantially equivalent to a previously cleared predicate device (K110385). This substantial equivalence is based on:
- Intended Use: The device shares the same intended use for transection, resection, and anastomoses in various surgical procedures.
- Technological Characteristics: The device utilizes similar technology (insulated tubular shaft, ergonomic handle with an integrated motor, battery power, articulation system) for cutting and stapling. The stated modification "does not affect the intended use of the device or alter the fundamental scientific technology."
- Performance Testing: "Ex-vivo tests (bench) were 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, design verification and design validation."
- Biocompatibility: Testing was in accordance with AAMI/ANSI/ISO 10993-1:2009 for biological evaluation of medical devices.
Conclusion:
The provided text describes a medical device submission based on substantial equivalence, which primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate. It does not provide the detailed acceptance criteria and study results typical for an AI/ML device where performance is often quantified by metrics like sensitivity, specificity, or AUC against a ground truth established by experts.
For the Echelon Flex Powered Articulating Endoscopic Linear Cutters, "acceptance criteria" are implied by "design specifications and requirements," and "performance" is demonstrated through "ex-vivo (bench) tests," rather than clinical studies with human subjects or AI-specific validation studies.
{0}------------------------------------------------
Ethicon Endo-Surgery, LLC
510(k) Premarket Notification (Special) for Echelon Flex Powered Articulating Endoscopic Linear Cutters
510(k) Summary
Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Carol Hubbard Contact Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. (513) 337-3792 Telephone: (513) 337-2792 Fax: Email: chubbard@its.jnj.com
Date Prepared March 8, 2013
Trade Name: Echelon Flex Powered Articulating Endoscopic Linear Cutters Device Name Common or Usual Name: Cutter/Stapler Classification Name: Staple, Implantable; Stapler, Surgical
Predicate Device Echelon Flex Powered Articulating Endoscopic Linear Cutters (cleared under K110385)
Device Description The Echelon Flex Powered Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
The instruments are packaged with a battery pack that must be installed prior to use.
The instruments are shipped without a staple cartridge and must be loaded prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.
Indications for Use The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Technological Characteristics The instrument utilizes an insulated tubular shaft, an ergonomic handle with an integrated motor, and battery power to simultaneously transect (cut) and staple tissue. The instrument also features an articulation system that can adjust the end effector in increments of 15° to a maximum of 45°.
The modification described in this submission does not affect the intended use of the device or alter the fundamental scientific technology of the device, and 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.
{1}------------------------------------------------
Performance Data Ex-vivo tests (bench) were 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, design verification and design validation.
Testing for all materials is in accordance with the standards AAMI/ANSI/ISO 10993-1:2009 and on FDA General Program Memorandum #G95-1 : Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing."
The Ethicon Endo-Surgery Echelon Flex Powered Articulating Endoscopic Linear Conclusion Cutters are substantially equivalent to the legally marketed Predicate device based upon intended use, technological characteristics, and performance testing.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
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
Letter dated: March 29, 2013
Ethicon Endo-Surgery, LLC % Ethicon End-Surgery, Incorporated Ms. Carol Hubbard Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242
Re: K130653
Trade/Device Name: Echelon Flex™ Powered Articulating Endoscopic Linear Cutters Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 08, 2013 Received: March 12, 2013
Dear Ms. Hubbard:
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.
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
{3}------------------------------------------------
Page 2 - Ms. Carol Hubbard
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Ethicon Endo-Surgery, LLC 510(k) Premarket Notification (Special) for Echelon Flex Powered Articulating Endoscopic Linear Cutters
Indications for Use Form
Indications for Use
510(k) Number (if known): K130653
Device Name: Echelon Flex™ Powered Articulating Endoscopic Linear Cutters
INDICATION FOR USE
The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, 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 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kraūše
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130653
§ 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.