(43 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, 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 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 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 Ethicon Endo-Surgery Echelon Flex Powered Articulating Endoscopic Linear Cutters (K110385) is a surgical device, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML device evaluations (e.g., performance metrics like sensitivity/specificity, sample sizes for AI training/testing sets, expert adjudication, MRMC studies) are not applicable.
This device is primarily evaluated through bench testing to demonstrate its mechanical performance and functional equivalence to a predicate device.
Here's an adaptation of the requested information, focusing on what is relevant for a non-AI surgical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from regulatory requirements for such devices) | Reported Device Performance (Inferred from "bench testing was performed to demonstrate that the new devices will perform as intended") |
|---|---|---|
| Mechanical/Functional Performance | Staple Line Formation: Ensure proper staple formation and security across various tissue thicknesses. | Performed as intended, demonstrating satisfactory staple line formation. |
| Tissue Cutting: Demonstrate effective and clean tissue transection. | Performed as intended, demonstrating effective tissue cutting. | |
| Articulation Mechanism: Verify the articulation mechanism operates correctly (e.g., adjusts in 15° increments up to 45°). | Articulation mechanism operates as intended, achieving specified angles. | |
| Firing Mechanism: Ensure reliable and consistent firing of staples and cutting blade. | Firing mechanism performed reliably and consistently. | |
| Safety Lock-Out Feature: Confirm the safety lock-out prevents firing empty/used cartridges. | Safety lock-out feature functioned correctly. | |
| Battery Power System: Demonstrate proper functioning of the battery-powered system. | Battery power system operated as intended, facilitating device function. | |
| Biocompatibility | Materials in contact with tissue meet biocompatibility standards. | Materials are similar to the predicate device and are presumed to meet biocompatibility standards (often addressed by material information, not explicit performance in this summary). |
| Sterility | Device is sterile. | Device is supplied sterile (stated as "sterile, single patient use instruments"). |
| Packaging Integrity | Packaging maintains sterility and device integrity. | Packaging maintained integrity (not explicitly stated in summary but a standard requirement). |
| Durability/Reliability | Device maintains performance throughout its intended single use. | Demonstrated through bench testing to function for its single-use purpose. |
| Substantial Equivalence | Device performs as safely and effectively as the predicate device. | Achieved, as indicated by the FDA's 510(k) clearance based on the submitted data showing "will perform as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. For bench testing of surgical devices, sample sizes vary depending on the specific test (e.g., number of firings, units tested for articulation). These are typically statistical samples sufficient to demonstrate reliability and consistency.
- Data Provenance: The data is from bench testing presumably conducted by the manufacturer, Ethicon Endo-Surgery, LLC. The text does not specify the country of origin of the data beyond the company's location (Guaynabo, PR and Cincinnati, OH). The studies would be prospective in nature, as new devices are manufactured and tested to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This concept is not applicable for the type of device and study described. Bench testing of a surgical stapler does not rely on human experts to establish "ground truth" in the way AI/ML algorithms do for image interpretation or diagnosis. The "ground truth" for mechanical performance is defined by engineering specifications and objective measurements (e.g., staple height, pull-apart force, cutting efficiency).
4. Adjudication Method for the Test Set
- Not applicable. Adjudication relates to resolving disagreements among human readers or experts, which is not a component of bench testing for a mechanical surgical device. Performance is verified against objective, measurable criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance (e.g., radiologists interpreting images). This device is a surgical instrument and its evaluation does not involve diagnostic interpretation or human readers in an MRMC context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- This is not applicable as the device is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily objective engineering specifications and physical measurements. This includes:
- Mechanical performance metrics (e.g., staple formation, cutting force, articulation angles).
- Material properties.
- Functional reliability tests.
- Comparison to predicate device performance benchmarks.
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment for it. The design specifications and predicate device performance effectively serve as the "ground truth" for the device's development and testing.
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MAR 2 5 2011
510(k) Summary
Ethicon Endo-Surgery, LLC Company 475 Calle C Guaynabo, PR 00969
Contact Asifa Vonhof, RAC Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3118 (513) 337-2314 Fax: Email: avonhof@its.jnj.com
Date Prepared February 09, 2011
Device Name Trade Name: Echelon Flex Powered Articulating Endoscopic Linear Cutters Common or Usual Name: Cutter/Stapler Classification Name: Staple, Implantable ; Stapler, Surgical
Predicate Device Echelon Endoscopic Linear Cutters-Articulating (cleared under K081146)
The Echelon Flex Powered Articulating Endoscopic Linear Cutters Device Description 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 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, 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.
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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°.
Performance Data Bench testing was performed to demonstrate that the new devices will perform as intended.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Asifa Vonhof 4545 Creek Road Cincinnati, Ohio 45242
MAR 2 5 % .. i
Re: K110385
Trade/Device Name: Echelon Flex Powered Articulating Endoscopic Linear Cutters Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: February 9, 2011 Received: February 10, 2011
Dear Asifa Vonhof:
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
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Page 2 - Asifa Vonhof
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Aling B. Rohn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _KII0305
Device Name: Echelon Flex Powered Articulating Endoscopic Linear Cutters
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.
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)
Daind Kucuefer MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K110385
§ 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.