(133 days)
Not Found
No
The document describes a surgical stapler and reload, focusing on mechanical function and tissue thickness. There is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is an endoscopic linear cutter used for transection and/or creation of anastomoses during surgical procedures, which is an instrument used by a surgeon to perform a procedure rather than delivering a therapeutic effect.
No
The device is an endoscopic linear cutter used for surgical procedures such as transection and creating anastomoses, not for diagnosing conditions.
No
The device description clearly describes a physical medical device (Endoscopic Linear Cutter Reload) that delivers staples into tissue. There is no mention of software as the primary or sole component.
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 during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details a surgical reload that delivers staples into tissue. This is consistent with a surgical device, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely surgical.
N/A
Intended Use / 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.
Product codes
GDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric, lung, solid organ, liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Indicated Patient Age Range
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
| Company | Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo, 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
1
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
3
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
4
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