(57 days)
Not Found
No
The summary describes a mechanical surgical stapler and reload system with features like articulation, different staple heights, and a lock-out mechanism. There is no mention of AI, ML, image processing, or data-driven decision-making.
No.
The device cuts and staples tissue during surgical procedures, which is a surgical tool function, not a therapeutic intervention to treat a disease or medical condition.
No
Explanation: The device is described as an endoscopic linear cutter and stapler used for surgical procedures, not for diagnosing medical conditions.
No
The device description clearly describes a physical instrument (endoscopic linear cutter) with mechanical components (staples, cutting line, articulation mechanism) and a battery pack. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures involving cutting and stapling tissue for transection and anastomosis. This is a direct surgical intervention on the body.
- Device Description: The device description details a surgical instrument that physically interacts with tissue (cutting and stapling).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of Endoscopic Linear Cutters and Reloads are intended for transection, 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.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site.
The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads come in five colors corresponding to different closed staple heights, with the intention of being used in different tissue thickness.
The instruments are packaged with a primary lithium battery pack that must be installed prior to use.
The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being used in different tissue thickness.
The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) are designed for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Flex Powered and Echelon Flex Powered Plus) in a 60mm configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen
Indicated Patient Age Range
pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to demonstrate that the changes introduced in the updated devices support substantial equivalence to the predicate device.
Four outputs from the staple-line testing were evaluated for equality with the primary goal of improving the cartridge pan retention at the proximal end of the reload to predicates. In all cases, the subject reloads demonstrated equivalent performance relative to the predicates. The overall results from the bench testing are therefore acceptable since the subject reloads demonstrated substantial equivalency to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
February 6, 2019
Ethicon Endo-Surgery, LLC % Brian Ruble Associate Director, Regulatory Affairs Ethicon Endo-Surgery, Inc 4545 Creek Road Cincinnati, Ohio 45245
Re: K183435
Trade/Device Name: Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 7, 2018 Received: December 11, 2018
Dear Mr. Ruble:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by David David Krause -S Krause -S Krause -S
Date: 2019.02.06 12:56:59 -05'00'
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183435
Device Name
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of Endoscopic Linear Cutters and Reloads
Indications for Use (Describe)
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of Endoscopic Linear Cutters and Reloads are intended for transection, 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Company | Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo, PR 00969 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Brian Ruble
Associate Director, Regulatory Affairs
Ethicon Endo-Surgery, Inc.
Telephone: (513) 337-1593
Email: BRuble1@its.jnj.com |
| Date Prepared: | December 07, 2018 |
| Common or Usual Name: | Surgical Stapler with Implantable Staples |
| Classification Name: | Staple, implantable (21 CFR 878.4750) |
| Regulatory Class: | Class II |
| Product Code: | GDW |
Subject Device Trade Name
Echelon Endoscopic Linear Cutter Reload, White (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Blue (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Gold (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Green (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Black (+ Gripping Surface Technology)
Predicate Devices Trade Name (K140560)
Echelon Endoscopic Linear Cutter Reload, White (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Blue (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Gold (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Green (+ Gripping Surface Technology) Echelon Endoscopic Linear Cutter Reload, Black (+ Gripping Surface Technology)
Device Description
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site.
4
The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads come in five colors corresponding to different closed staple heights, with the intention of being used in different tissue thickness.
The instruments are packaged with a primary lithium battery pack that must be installed prior to use.
The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being used in different tissue thickness.
The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) are designed for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Flex Powered and Echelon Flex Powered Plus) in a 60mm configuration.
Indications for Use
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of Endoscopic Linear Cutters and Reloads 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.
Technological Characteristics
The design and performance of the subject device is based on the currently marketed Echelon Endoscopic Linear Cutter Reloads. The changes described in the submission do not affect the intended use of the devices or alter fundamental scientific technology of the device. Magnetic Resonance studies are not required because the dimensional changes in the cartridge sub assembly will not impact the shape and form of the staples. Stapling is the technological principle for both the subjects and predicate devices. It is based on the use of endoscopic instrumentation for transection, resection and/or creation of anastomoses.
Performance Data
Bench testing was performed to demonstrate that the changes introduced in the updated devices support substantial equivalence to the predicate device.
5
Labelling
Update to IFU. Tyveks and Cartons to bring them up to date with current global labelling requirements.
Sterilization
The subject devices will be sterilized by Cobalt 60 irradiation. The device will be validated to a minimum sterilization (radiation) dose of 25 kGy to achieve a 10 € sterility assurance level (SAL).
The sterilization process will be validated, and the sterilization dose will be established per the requirements of the following FDA recognized standards:
ISO 11137-1:2006 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (FDA Recognition Number 14-328).
ISO 11137-2:2012 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (FDA Recognition Number 14-364).
The subject devices are intended for single patient use and are not intended to be reused or resterilized.
ISO11737-1:2006, Sterilization of health care product-Microbiological methods- Part 1: Determination of the population of microorganisms on product.
ISO11737-2:2009, Sterilization of Medical Devices-Part 2: Tests of sterility performed in the validation of a sterilization process.
Biocompatibility Testing
Biocompatibility testing was not required for this submission as no new materials were introduced on this device. All materials are already cleared under the predicate device submission (K140560).
Electrical Safety and Electromagnetic Compatibility
Electrical Safety and Electromagnetic Compatibility section does not apply because the Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) do not contain any electronics.
Bench Testing
Force to Close, Staple Form Ouality, Formed Staple Height and Staple Line Integrity were evaluated for Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) to support substantial equivalence to the predicate device.
Clinical Testing
Clinical Testing section is not applicable. No clinical data was collected to demonstrate equivalency.
6
Conclusion
Four outputs from the staple-line testing were evaluated for equality with the primary goal of improving the cartridge pan retention at the proximal end of the reload to predicates. In all cases, the subject reloads demonstrated equivalent performance relative to the predicates. The overall results from the bench testing are therefore acceptable since the subject reloads demonstrated substantial equivalency to the predicate device.