(48 days)
No
The summary describes a mechanical surgical stapler and cutter with a battery-powered firing system. There is no mention of AI, ML, image processing, or data-driven decision making. The performance studies listed are standard tests for mechanical and electrical safety and function.
No
This device is an electro-mechanical surgical cutting and stapling device used for transection, resection, and/or creation of anastomoses, not primarily for therapeutic purposes.
No
The device is described as an endoscopic linear cutter and reloader, intended for surgical procedures like transection, resection, and creation of anastomoses. It is a surgical tool, not a device used to diagnose medical conditions or diseases.
No
The device description clearly outlines a physical, sterile, single-patient use instrument with a battery-powered firing system, staples, and articulation mechanisms. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for cutting and stapling tissue within the body during surgical procedures. IVDs are used to examine specimens from the body (like blood, urine, or tissue samples) outside the body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a surgical instrument with a cutting and stapling mechanism, designed for direct interaction with tissue during surgery. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The ENDOPATH ECHELON™ 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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Product codes
GDW
Device Description
The Echelon Flex Powered Plus 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 two shaft lengths: 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 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)
Performance testing conducted to determine the new devices were substantially equivalent to the predicates, included; Biocompatibility (per ISO 10993-1:2009), Electrical Safety (per AAM / ANSI ES 60601-1:2005/(R) 2012), Electromagnetic Compatibility (per IEC 60601-1-2 edition 3:2007-03) and Bench Testing (Force to Close, Staple Form Quality, Formed Staple Height, Staple Line Integrity and Compatibility with buttress material).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130653, K110385, K121600, K070887, K051002, K131663, K112056
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
| Company | Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo, PR 00969 |
|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Asifa Vonhof, RAC
Regulatory Affairs Associate II
Ethicon Endo-Surgery, Inc.
Telephone: (513) 337-3118
Fax: (513) 337-2314
Email: avonhof@its.jnj.com |
Date Prepared April 15, 2014
Device Name
Trade Name:
Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter 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)
Common or Usual Name: Surgical Stapler with Implantable Staples Classification Name: Staple, Implantable
Predicate Devices
Echelon Flex Powered Articulating Endoscopic Linear Cutters (K130653, K110385) Echelon Endoscopic Linear Cutter Reload, White (K121600, K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Blue (K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Gold (K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Green (K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Black (K131663 K112056)
Device Description
The Echelon Flex Powered Plus 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 two shaft lengths: 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 Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology)
APR 2 2 2014
1
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 ENDOPATH ECHELON™ 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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Technological Characteristics
The design and performance of the subject devices is based on the currently marketed Echelon Flex Powered platform of Linear Cutters and reloads. The changes described in this submission do not affect the intended use of the devices or alter fundamental scientific technology of the devices. Many of the new features added to the reloads were introduced in prior reload submissions (KI12056, KI21600). MR compatibility data has been derived from the testing performed for the currently marketed Echelon Black reload. The data for the Black reload represents the worst case scenario, due to its larger staple design and greater mass.
Performance Data
Performance testing conducted to determine the new devices were substantially equivalent to the predicates, included; Biocompatibility (per ISO 10993-1:2009), Electrical Safety (per AAM / ANSI ES 60601-1:2005/(R) 2012), Electromagnetic Compatibility (per IEC 60601-1-2 edition 3:2007-03) and Bench Testing (Force to Close, Staple Form Quality, Formed Staple Height, Staple Line Integrity and Compatibility with buttress material).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, with its wings spread and its head turned to the right.
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
April 22, 2014
Ethicon Endo-Surgery, LLC Asifa Vonhof Regulatory Affairs Associate II 4545 Creek Road Cincinnati. Ohio 45242
Re: K140560
Trade/Device Name: The ENDOPATH ECHELON" and ECHELON FLEX" families of endoscopic linear cutters and reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 4, 2014 Received: March 5, 2014
Dear Mr./Ms. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Asifa Vonhof
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 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140560
Device Name
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads
Indications for Use (Describe)
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anstoments have application in multiple oven or minimally invasive general, gynecologic, urologic, thoracic, and pediatic surgical procedures. They can be used with staple line or tissue buttessing 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Peter L. Hudson
S
FORM FDA 3881 (9/13)
5
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