The Echelon families of endoscopic linear cutters (articulating and straight) 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 Cutters (Articulating and Straight) Device Description are sterile, single patient use instruments that simultaneously cut and staple tissue. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shafts for both the articulating and straight instruments can rotate freely in either direction. In addition, the Echelon Articulating Endoscopic Linear Cutters incorporate an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are shipped without a cartridge and must be loaded prior to use. The instruments' lock-out feature is designed to prevent a used cartridge from being refired.
The provided text describes the Ethicon Endo-Surgery Echelon Endoscopic Linear Cutters (Articulating and Straight). However, it does not contain acceptance criteria or detailed results from a scientific study proving the device meets specific criteria. The document is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and outcome metrics.
Here's a breakdown of what the document does provide concerning performance, and what it lacks based on your request:
What is provided:
- Performance Data: "Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the devices will perform as intended."
What is NOT provided in the document concerning a study:
- A table of acceptance criteria and the reported device performance: This is absent. The document only generically states "perform as intended" without defining specific quantitative or qualitative criteria for success.
- Sample size used for the test set and the data provenance: Not mentioned for any specific test. The phrase "preclinical laboratory evaluation in an animal model" is too vague to extract this information.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such expert-driven ground truth establishment is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a surgical instrument, not an AI diagnostic tool involving human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. The "preclinical laboratory evaluation in an animal model" implies physiological outcomes or observations, but details are missing.
- The sample size for the training set: Not applicable, as this is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided text:
The document states that "Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the devices will perform as intended." However, it does not specify:
- Acceptance Criteria: No specific numerical or qualitative targets for performance are listed (e.g., staple line integrity, burst pressure, number of misfires, tissue damage thresholds).
- Reported Device Performance: No specific numerical or qualitative results from the tests are reported against any criteria.
- Details of the Study: Missing are details about the methodology, sample sizes, animal model specifics, or the exact endpoints measured in the "preclinical laboratory evaluation" or "bench testing."
Therefore, based solely on the provided 510(k) summary, it's not possible to complete the requested table or answer most of the questions about detailed study design and acceptance criteria. The regulatory filing focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and the broad statement that testing confirmed intended performance, rather than providing a detailed scientific publication of performance metrics against predefined acceptance criteria.
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K081146
pg 1 of 2
510(k) Summary
| Company | Ethicon Endo-Surgery, LLC475 Calle CGuaynabo, PR 00969 |
|---|---|
| Contact | Abhilasha Mukherjee, RACRegulatory Affairs AssociateEthicon Endo-Surgery, Inc.Telephone: (513) 337-3623Fax: (513) 337-2584Email: AMukher5@eesus.jnj.com |
Date Prepared April 21, 2008
Device Name Trade Name: Echelon Endoscopic Linear Cutters (Articulating and Straight) Common or Usual Name: Cutter/Stapler Classification Name: Stapler, Surgical / Staple, Implantable
Regulatory Information
| Regulation Number: | 21 CFR § 878.4800 |
|---|---|
| Regulation Name: | Stapler, Surgical |
| Regulatory Class: | I |
| Product Code: | GAG |
| Regulation Number: | 21 CFR 878.4750 |
| Regulation Name: | Staple, Implantable |
| Regulatory Class: | II |
| Product Code: | GDW |
Predicate Device ENDOPATH Endocutter 60 Endoscopic Linear Cutters (cleared under K051002 and expanded indications cleared under K070887).
The Echelon Endoscopic Linear Cutters (Articulating and Straight) Device Description are sterile, single patient use instruments that simultaneously cut and staple tissue. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shafts for both the articulating and straight instruments can rotate freely in either direction. In addition, the Echelon Articulating Endoscopic Linear Cutters incorporate an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
The instruments are shipped without a cartridge and must be loaded prior to use. The instruments' lock-out feature is designed to prevent a used cartridge from being refired.
JUN 2 6 2008
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Indications for Use The Echelon families of endoscopic linear cutters (articulating and straight) 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 technological characteristics of the Echelon Straight Endoscopic Linear Cutters are similar to the predicate device except for some changes in the ergonomic features. The Echelon Articulating Endoscopic Linear Cutters incorporate a new articulation mechanism as compared to the predicate device. The articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
Performance Data Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the devices will perform as intended.
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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 features a stylized eagle with its wings forming three curved lines. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2008
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Abhilasha Mukherjee, RAC Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242-2839
Re: K081146
Trade/Device Name: Echelon Endoscpic Linear Cutters (Articulating and Straight) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: April 21, 2008 Received: April 22, 2008
Dear Abhilasha Mukherjee:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Abhilasha Mukherjee, RAC
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,
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems . at (240) 276-3464. You may obtain other general information on your responsibilites under the Act from the Division of Small Manufacturers, International and Consumer Assistances e at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 1208 U46
Device Name: Echelon Endoscopic Linear Cutters (Articulating and Straight)
Indications for Use:
The Echelon families of endoscopic linear cutters (articulating and straight) 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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
(Posted November 13, 2003)
510(k) Number
§ 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.