(45 days)
Not Found
No
The summary describes a mechanical surgical stapler and reload, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as an endoscopic linear cutter intended for surgical procedures such as transection, resection, and creating anastomoses, which are surgical tools used during treatment, not devices that provide therapy themselves.
No
The device description clearly states its purpose is for "transection, resection, and/or creation of anastomoses" in surgical procedures, which are interventional, not diagnostic, actions.
No
The device description clearly indicates it is a physical reload for an endoscopic linear cutter, a hardware surgical instrument. 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 describes a surgical instrument used for cutting and stapling tissue within the body during surgical procedures. This is a direct intervention on the patient.
- Device Description: The device is a surgical reload for a linear cutter, designed to physically manipulate and join tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health status. The provided description does not mention any such activity.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
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, 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, GAG
Device Description
The Echelon Endoscopic Linear Cutter Reload, White, is a thin 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 will provide a closed staple height of 1.0 mm for use in thin tissue such as mesentery and pulmonary and renal artery and vessels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mesentery and pulmonary and renal artery and vessels, 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 and Animal testing was performed to demonstrate that the device updates 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)
K081146, K070887, K051002, 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
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510(k) Summary
JUL 16 2012
Ethicon Endo-Surgery, LLC Company 475 Calle C Guaynabo, PR 00969
Asifa Vonhof, RAC Contact Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3118 Fax: (513) 337-2314 Email: avonhof(@its.jnj.com
Date Prepared May 31, 2012
Device Name
Trade Name: Echelon Endoscopic Linear Cutter Reload, White Common or Usual Name: Endoscopic and Accessory Staple, Implantable Classification Name:
Predicate Devices
Echelon Endoscopic Linear Cutter Reload. White (K081146, K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Black (K112056)
Device Description
The Echelon Endoscopic Linear Cutter Reload, White, is a thin 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 will provide a closed staple height of 1.0 mm for use in thin tissue such as mesentery and pulmonary and renal artery and vessels.
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 and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
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K121600 page 2/2
Technological Characteristics
The design and performance of the subject device is based on the currently marketed Echelon white reload. In addition a pocket extension feature has been added to the subject device. This feature was introduced in K112056 for the Echelon Black reload submission. MR compatibility data has been derived from the testing performed for the 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
Bench and Animal testing was performed to demonstrate that the device updates do not affect safety and effectiveness and that the device will perform as intended.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Incorporated Ms. Asifa Vonhof, RAC Regulatory Affairs Associate II 4545 Creek Road Cincinnati. Ohio 45242
JUL 16 2012
Re: K121600
Trade/Device Name: Echelon Endoscopic Linear Cutter Reload, White Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: May 31, 2012 Received: June 01, 2012
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, RAC
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 Of ice rated 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/ucm11.5809.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,
Eric D. 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): _ K121600
Device Name: Echelon Endoscopic Linear Cutter Reload, White
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 opon of millinary invaste goarith staple line or tissue buttressing materials. The proveduces. They our 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kane bu hum
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121600
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