(153 days)
Not Found
No
The summary describes a mechanical surgical stapler reload and does not mention any AI or ML components or functionalities.
No
This device is an endoscopic linear cutter and reload used for transection, resection, and/or creation of anastomoses during surgical procedures, not for therapeutic treatment.
No.
The device is a surgical stapler used for transection, resection, and/or creation of anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description clearly indicates it is a physical reload for a surgical stapler, a hardware component, and not a software-only 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 during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a surgical reload for a linear cutter, designed to deliver staples into tissue. This is a mechanical surgical tool, not a diagnostic reagent or instrument used to analyze samples like blood, urine, or tissue in vitro.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information. The device's function is purely mechanical for surgical manipulation of tissue.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
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 both 45mm and 60mm configurations. It is an addition to the current Echelon reload family and will provide 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 Linear Cutter and delivers staples into the tissue when the instrument is fired.
The design and performance of the new device, Echelon Endoscopic Linear Cutter Reload, Black, is based on the predicate, Echelon Endoscopic Linear Cutter Reload, Green.
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)
Bench and Animal testing was performed to demonstrate that the new features do not affect safety and effectiveness and that the device will perform as intended.
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 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
DEC 1 9 2011
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 July 18, 2011
Device Name Trade Name: Echelon Endoscopic Linear Cutter Reload, Black Common or Usual Name: Endoscopic and Accessory Classification Name: Staple, Implantable
| Predicate Device Echelon Endoscopic Linear Cutters Reload, Green |
|---|
| (cleared under K081146, K070887, K051002) |
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 both 45mm and 60mm configurations. It is an addition to the current Echelon reload family and will provide 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 Linear Cutter and delivers staples into the tissue when the instrument is fired.
The design and performance of the new device, Echelon Endoscopic Linear Cutter Reload, Black, is based on the predicate, Echelon Endoscopic Linear Cutter Reload, Green.
1
a/2
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.
Technological Characteristics
The Echelon Endoscopic Linear Cutter Reload, Black has a larger staple size than the predicate device. All design differences between the new and predicate device can be attributed to the need to accommodate the larger size staple in the new device.
Performance Data Bench and Animal testing was performed to demonstrate that the new features do not affect safety and effectiveness and that the device will perform as intended.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle with three wing-like shapes, representing health, humans, and services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 9 2011
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Ms. Asifa Vonhof 4545 Creek Road Cincinnati, Ohio 45242
Re: K112056
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: December 07, 2011 Received: December 08, 2011
Dear 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
3
Page 2 - Ms. Asifa Vonhof
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Euinl Keith
- Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Echelon Endoscopic Linear Cutter Reload, Black
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.
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)
Daniel Keene for MIXM
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K112056