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.
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.
The provided text is a 510(k) Summary for a medical device (Echelon Endoscopic Linear Cutter Reload, White). It describes the device, its intended use, and its technological characteristics. However, it does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a specific study proving device performance. This document is a regulatory submission for substantial equivalence, not a full clinical study report.
Here's what can be extracted from the provided text and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Bench and Animal testing performed to demonstrate that device updates do not affect safety and effectiveness and that the device will perform as intended. |
| Performance as Intended | Bench and Animal testing performed to demonstrate that device updates do not affect safety and effectiveness and that the device will perform as intended. |
| Closed Staple Height for Thin Tissue (Mesentery, Pulmonary & Renal Artery/Vessels) | Provides a closed staple height of 1.0 mm. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document. The document mentions "Bench and Animal testing" but does not give sample sizes for either.
- Data Provenance: Not specified. The document states the testing was performed, but not where or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a mechanical device requiring performance testing, not diagnostic image interpretation. Ground truth for mechanical performance typically comes from calibrated measurements and established engineering standards, not expert consensus in the human interpretation sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, often in diagnostic AI. This device's performance is assessed through bench and animal testing, which relies on objective measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a surgical stapling device, not an AI-powered diagnostic tool. MRMC studies and AI assistance comparisons are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical device, not a software algorithm. Its performance is inherent to its design and mechanical function, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "Bench and Animal testing," the ground truth would typically be established by objective measurements and observations according to pre-defined protocols and engineering specifications. For animal testing, this would include observation of tissue healing, staple line integrity, and adverse events, which could be considered a form of outcomes data and pathological observation if tissue samples were analyzed. However, the document does not specify these details.
8. The sample size for the training set
- Not applicable. This is a medical device, not a machine learning model that uses a "training set." The development process involves engineering design, prototyping, and iterative testing, not AI model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this device.
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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.
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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
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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
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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
Page 1 of 1
§ 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.