(57 days)
The Echelon Endoscopic Cutters, Staplers and Reloads are intended for transection, resection, and/or anastomoses. The instruments have application in multiplesopen of minimally invasive general, gynecologic, urologic, thoracic, and pediative 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 devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. Thesc devices may be used in either open or Endoscopic procedures, depending upon the design. The device is intended for use in transection and resection of tissue for various open or minimally invasive surgical procedures. They arc intended for use in the creation of anastomoses in these procedures. The instruments are reloadable and, as such, they may be reloaded with various cartridges depending on the thickness of tissue that is to be transected or resected.
The Echclon Gray cartridge is a storage case that contains implantable staples. The cartridge is loaded into an Echelon instrument. When the instrument is deployed, it cuts a surgical wound while simultaneously delivering the staples into the tissuc. As in the predicate ETS Gray cartridge, the Echelon Gray cartridges will be available in 45mm lengths. There are 70 staples in the 45mm length cartridge.
Cartridges deliver the staples in a predetermined staple row configuration or pattern in rclation to the cut line. The staple row configurations of both the predicate and the new device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the predicate device and the new device is straight. That is to say, all 6 staples are of the same height and formation.
The provided text describes a 510(k) summary for the Echelon™ Gray Cartridge-45mm, a medical device. However, it does not contain the specific details about acceptance criteria or a study proving that the device meets such criteria in the format requested. The document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and indications for use.
Here's an analysis of what can be extracted and what is missing from the provided text, structured according to your request:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a table of acceptance criteria or specific reported device performance metrics. It states: "Performance Data. Bench testing was performed to demonstrate that the new device will perform as intended." However, the results of this bench testing and the specific criteria it aimed to meet are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing," which implies physical testing of the device. However, it does not specify the sample size used for this test set, nor does it provide any information on data provenance (e.g., country of origin, retrospective or prospective nature of data, as this pertains more to clinical or observational studies).
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)
This section is not applicable to the type of device and testing described. The device is a surgical stapler cartridge, and the "bench testing" would likely involve mechanical and functional evaluations rather than expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3.
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
This section is not applicable. The device is a surgical stapler cartridge, not an AI or imaging diagnostic tool. Therefore, MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned, the testing described is "bench testing." The "ground truth" for such testing would typically be engineering specifications, material properties, and functional requirements (e.g., staple formation, cutting ability, staple height, tissue thickness range). The document does not explicitly state the type of ground truth used beyond implying it relates to the device performing "as intended."
8. The sample size for the training set
This section is not applicable. The document describes a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
In summary:
The provided 510(k) summary focuses on establishing substantial equivalence for a surgical stapler cartridge by detailing its technological characteristics and intended use in comparison to predicate devices. It states that "bench testing was performed to demonstrate that the new device will perform as intended," but it does not provide any specifics regarding acceptance criteria, the results of this testing, the sample size, or any other details typically found in a clinical or performance study report. The questions posed in your request are largely geared towards evaluating diagnostic or AI-driven medical devices, which are not relevant to this particular submission.
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510(k) Summary
| Company | Ethicon Endo-Surgery, LLC |
|---|---|
| 475 Calle C | |
| Guaynabo, Puerto Rico 00969 |
Contact Ruth Ann Wood, R.N., B.A., M.A., RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-3566 Fax: (513) 337-2468 Email: rwood3(@eesus.jnj.com
Date Prepared March 24, 2008
Device Namc Trade Name: Echelon™ Gray Cartridge-45mm
Common or Usual Names: Endoscopic and Accessory
Classification Names: Implantable Staple [21 CFR 878.4750 (GDW)]
- Predicate Devices ENDOPATH Endocutter Gray Cartridge clear under K033269 on December 10, 2003. ENDOPATH Endocutter 60 Endoscopic Linear Cuttcr, cleared under K051002 on May 17, 2005. ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K070887 on May 25, 2007.
Device Description
The Echelon devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. Thesc devices may be used in either open or Endoscopic procedures, depending upon the design. The device is intended for use in transection and resection of tissue for various open or minimally invasive surgical procedures. They arc intended for use in the creation of anastomoses in these procedures. The instruments are reloadable and, as such, they may be reloaded with various cartridges depending on the thickness of tissue that is to be transected or resected.
The Echclon Gray cartridge is a storage case that contains implantable staples. The cartridge is loaded into an Echelon instrument. When the instrument is deployed, it cuts a surgical wound while simultaneously delivering the staples into the tissuc. As in the predicate ETS Gray cartridge, the Echelon Gray cartridges will be available in 45mm lengths. There are 70 staples in the 45mm length cartridge.
Cartridges deliver the staples in a predetermined staple row configuration or pattern in rclation to the cut line. The staple row configurations of both the predicate and the new
MAXY2:21 1 2008
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device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the predicate device and the new device is straight. That is to say, all 6 staples are of the same height and formation.
Indications for Use - The Echclon Ensoscopic Linear Cutters, Staplers and Reloads are intended for transcction, resection, and/or 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.
Technological Characteristics - The cartridge is for use on thin tissues such as mesentary and has a nominal closed staple height of .75 mm. The purpose of the change is to provide physicians with additional cartridge selection in the Echelon family of products.
Performance Data. Bench testing was performed to demonstrate that the new device will perform as intended.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped by a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 2008
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Ruth Ann Wood, R.N., B.A., M.A., RAC Senior Associate, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242-2839
Re: K080839
Trade/Device Name: Echelon Gray Cartridge Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 24, 2008 Received: March 26, 2008
Dear Ms. Wood:
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 - Ruth Ann Wood, R.N., B.A., M.A., 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 responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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 vours.
Mark M. Millman
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): K080839
Device Name: Echelon Gray Cartridge
Indications for Use;
The Echelon Endoscopic Cutters, Staplers and Reloads are intended for transection, resection, and/or anastomoses. The instruments have application in multiplesopen of minimally invasive general, gynecologic, urologic, thoracic, and pediative 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division S
Steif R.P. Odl for mtm
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
(Posted November 13, 2003)
080839 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.