(90 days)
No
The summary describes a mechanical surgical stapler and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is a surgical stapler intended for transection, resection, and/or anastomoses of tissue, which are surgical procedures, not therapeutic treatments.
No
The device is described as a surgical instrument for cutting and stapling tissue, not for diagnosis. Its intended use involves "transaction, resection, and/or anastomoses," which are surgical procedures, not diagnostic ones.
No
The device description clearly outlines a physical, sterile, single-use instrument that delivers staples and cuts tissue. It also describes a physical cartridge containing implantable staples. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Echelon Endoscopic Linear Cutters and Cartridges are surgical instruments used for cutting and stapling tissue during surgical procedures. They are used directly on the patient's body, not on samples taken from the body.
- Intended Use: The intended use clearly describes surgical procedures (transaction, resection, anastomoses) on various organs and tissue types.
- Device Description: The description focuses on the mechanical function of cutting and stapling tissue with implantable staples.
The device is a surgical instrument, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The Echelon Endoscopic Linear Cutters and Cartridges are intended for transaction, resection, and/or 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 devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. These 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 during multiple open or minimally invasive surgical procedures. They are 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 Echelon Zebra 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 tissue. As in the predicate Echclon cartridge, the Zebra cartridges are available in 60 mm lengths. Zebra cartridges will also be available in a 45 mm length for use with the 45mm instruments. There are 70 staples in the 45mm length cartridge and 88 staplers in the 60 mm length cartridge.
Cartridges deliver the staples in a predetermined staple row configuration or pattern in relation 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 prodicate device is straight. That is to say, all 6 staples are of the same height and formation. The Zebra cartridge staple row configuration is step-wise. This means that of the 6 staples, the two outer most staples are of a taller height and formation than the 4 inner staples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 testing was performed to demonstrate that the new 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
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
080972 1/2
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 April 3, 2008
Trade Name: Echelon™ Zebra Cartridges Device Name
Common or Usual Names: Endoscopic and Accessory
Classification Names:
Implantable Staple [21 CFR 878.4750 (GDW)]
Predicate Devices ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K051002 on May 17, 2005. ENDOPATH Endocutter 60 Endoscopic Linear Cutter, cleared under K.070887 on May 25, 2007.
Device Description
The Echelon devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. These 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 during multiple open or minimally invasive surgical procedures. They are 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 Echelon Zebra 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 tissue. As in the predicate Echclon cartridge, the Zebra cartridges are available in 60 mm lengths. Zebra cartridges will also be available in a 45 mm length for use with the 45mm instruments. There are 70 staples in the 45mm length cartridge and 88 staplers in the 60 mm length cartridge.
Cartridges deliver the staples in a predetermined staple row configuration or pattern in relation to the cut line. The staple row configurations of both the predicate and the new
JUL - 3 2008
1
device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the prodicate device is straight. That is to say, all 6 staples are of the same height and formation. The Zebra cartridge staple row configuration is step-wise. This means that of the 6 staples, the two outer most staples are of a taller height and formation than the 4 inner staples.
Indications for Use The Echelon Endoscopic Linear Cutters and Cartridges are intendcd for transaction, rescction, and/or anastomoscs. 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 with the 2 inner white rows and 1 outcr blue row is used on thin tissues such as mesentary and has a nominal closed staple height of 1.0 mm on the 2 inner rows of staples and a nominal closed staple height of 1.5mm on the outer row. The cartridge with the 2 inner blue rows and the 1 outer green row is used on regular tissue and has a nominal closed staple height of 1.5 mm on the 2 inner rows of staples and a nominal closed staple height of 2.0 mm on the outer row. The cartridge with the 2 inner green rows and the 1 outer purple row is used on thick tissue and has a nominal closed staple height of 2.0 mm on the 2 inner rows of staples and a nominal closed staple height of 2.5mm in the outer row. 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Ms. Ruth Ann Wood, R.N., B.A., M.A., RAC Senior Associate, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242-2839
JUL - 3 2008
Re: K080972
Trade/Device Name: Echelon Zebra Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 3, 2008 Received: April 4, 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
3
Page 2 - Ms. 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 H. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ICO 972 1/1
Indications for Use
510(k) Number (if known):
Device Name: Echelon Zebra Cartridges
Indications for Use:
The Echelon Endoscopic Linear Cutters and Cartridges are intended for transaction, resection, and/or 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number /2060572