(68 days)
Not Found
Not Found
No
The device description focuses on mechanical features like stapling, cutting, safety lock-outs, and articulation. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is described as an endoscopic linear cutter/stapler used for transection and/or creation of anastomoses in surgical procedures, which are interventional actions rather than therapeutic in nature.
No
Explanation: The device is described as an "Endoscopic Linear Cutter" and "Staplers" intended for "transection, and/or creation of anastomoses" in various surgical procedures. Its function is to deliver staples and divide tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes physical, sterile, single-patient use instruments that deliver staples and divide tissue. There is no mention of software as the primary component or function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures (transection, creation of anastomoses) on living tissue within the body. This is the definition of a surgical instrument, not an IVD.
- Device Description: The device description details a mechanical instrument that delivers staples and cuts tissue. This is consistent with a surgical stapler/cutter, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) outside of the body to provide information about a patient's health.
The device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Endocutter 60 Endoscopic Linear Cutter: EC60, SC60, LONG60
The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, and/or creation of anastomoses. The instrument has application in minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.
ETS45 Endoscopic Linear Cutter: TSB45, TSG45, 6SB45
ETS-Flex45 Endoscopic Articulating Linear Cutter: ATB45, ATG45, 6TB45, LONG45A ETS Compact Flex45 Articulating Linear Cutters: SCB45, SCG45, 6CB45
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, 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,
ETS-Flex45 No-Knife Endoscopic Articulating Linear Stapler: NAB45, NAG45
ETS Compact-Flex45 No-Knife Articulating Linear Stapler: NSB45, NSG45
The ENDOPATH ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, 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.
EZ45 Endoscopic Linear Cutter: ET45B, ET45G
The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials.
EZ45 No-Knife Endoscopic Linear Stapler: NK45B, NK45G
The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection, and can be used with staple line or tissue buttressing materials.
Thoracic Endoscopic Linear Cutter: EZ45B, EZ45G
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transection, and/or creation of anastomoses and can be used with staple line buttressing materials.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
Endocutter 60 Endoscopic Linear Cutter: EC60, SC60, LONG60
Sterile, single patient use instruments that deliver staples while simultaneously diving tissue between rows. ECHELON' 60instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 60mm long and a cut line that is approximately 57mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
ETS45 Endoscopic Linear Cutter: TSB45, TSG45, 6SB45
ETS-Flex45 Endoscopic Articulating Linear Cutter: ATB45, ATG45, 6TB45, LONG45A ETS Compact Flex45 Articulating Linear Cutters: SCB45, SCG45, 6CB45
Sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. Instruments with blue (standard) reloads deliver two double- or triple-staggered rows of staples; instruments with green (thick) reloads deliver two double-staggered rows of staples only. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during and transportation. An articulation lever on some instruments enables bilateral movement of the instrument jaws.
ETS-Flex45 No-Knife Endoscopic Articulating Linear Stapler: NAB45, NAG45 ETS Compact-Flex45 No-Knife Articulating Linear Stapler: NSB45, NSG45
Sterile, single patient use instruments with blue (standard) reloads deliver two double- or triple-staggered rows of staples; instruments with green (thick) reloads deliver two double-staggered rows of staples only. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. An articulation lever on the instruments enables bilateral movement of the instrument jaws.
EZ45 Endoscopic Linear Cutter: ET45B, ET45G
Sterile, single patient use instrument that delivers two double-staggered rows of staples while simultaneously diving the tissue between rows. The instrument is designed for use in procedures with or without insufflation. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
EZ45 No-Knife Endoscopic Linear Stapler: NK45B, NK45G
Sterile, single patient use instrument that delivers two double-staggered rows of staples. The instrument is designed for use in procedures with or without insufflation. The instrument's safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
Thoracic Endoscopic Linear Cutter: EZ45B, EZ45G
Sterile, single patient use instrument that delivers two double-staggered rows of staples while simultaneously diving the tissue between rows. The instrument is designed for use in procedures without insufflation. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instrument has a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
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)
Ethicon Endo-Surgery conducted animal testing (Section 19) and a clinical literature search (Section 20) to establish the use of the stapling devices (No-Knife ETS and EZ products only) in the open Left Atrial Appendage Exclusion procedure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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06 1156 p. 8 of 2
510(k) Summary
Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242
JUL - 3 2006
-
Contact Tom Morris Quality Systems/Regulatory Affairs Project Manager Telephone: (513) 337-3235 (513) 337-2235 Fax: Email: tmorris@eesus.jnj.com
Date Prepared June 13, 2006 -
Trade Name: ENDOPATH Linear Cutters and Staplers Device Name Common or Usual Name: Staple, Implantable Classification Name: Staple, Implantable [21 CFR 878.4750 (GDW)]
Predicate Device ENDOPATH Linear Cutters and Staplers
Device Description
Endocutter 60 Endoscopic Linear Cutter: EC60, SC60, LONG60
Sterile, single patient use instruments that deliver staples while simultaneously diving tissue between rows. ECHELON' 60instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 60mm long and a cut line that is approximately 57mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
ETS45 Endoscopic Linear Cutter: TSB45, TSG45, 6SB45
ETS-Flex45 Endoscopic Articulating Linear Cutter: ATB45, ATG45, 6TB45, LONG45A ETS Compact Flex45 Articulating Linear Cutters: SCB45, SCG45, 6CB45
Sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. Instruments with blue (standard) reloads deliver two double- or triple-staggered rows of staples; instruments with green (thick) reloads deliver two double-staggered rows of staples only. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during and transportation. An articulation lever on some instruments enables bilateral movement of the instrument jaws.
ETS-Flex45 No-Knife Endoscopic Articulating Linear Stapler: NAB45, NAG45 ETS Compact-Flex45 No-Knife Articulating Linear Stapler: NSB45, NSG45
Sterile, single patient use instruments with blue (standard) reloads deliver two double- or triple-staggered rows of staples; instruments with green (thick) reloads deliver two double-staggered rows of staples only. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. An articulation lever on the instruments enables bilateral movement of the instrument jaws.
EZ45 Endoscopic Linear Cutter: ET45B, ET45G
Sterile, single patient use instrument that delivers two double-staggered rows of staples while simultaneously diving the tissue between rows. The instrument is designed for use in procedures with or without insufflation. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instruments have a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
EZ45 No-Knife Endoscopic Linear Stapler: NK45B, NK45G
Sterile, single patient use instrument that delivers two double-staggered rows of staples. The instrument is designed for use in procedures with or without insufflation. The instrument's safety lock-out feature is designed to prevent a used reload from
1
K061456 p- 2 of 3
being refired. The instruments have a staple line that is approximately 45mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
Thoracic Endoscopic Linear Cutter: EZ45B, EZ45G
Sterile, single patient use instrument that delivers two double-staggered rows of staples while simultaneously diving the tissue between rows. The instrument is designed for use in procedures without insufflation. The instruments' safety lock-out feature is designed to prevent a used reload from being refired. The instrument has a staple line that is approximately 45mm long and a cut line that is approximately 41mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
Indications for Use
Endocutter 60 Endoscopic Linear Cutter: EC60, SC60, LONG60
The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, and/or creation of anastomoses. The instrument has application in minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.
ETS45 Endoscopic Linear Cutter: TSB45, TSG45, 6SB45
ETS-Flex45 Endoscopic Articulating Linear Cutter: ATB45, ATG45, 6TB45, LONG45A ETS Compact Flex45 Articulating Linear Cutters: SCB45, SCG45, 6CB45
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, 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,
ETS-Flex45 No-Knife Endoscopic Articulating Linear Stapler: NAB45, NAG45
ETS Compact-Flex45 No-Knife Articulating Linear Stapler: NSB45, NSG45
The ENDOPATH ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, 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.
EZ45 Endoscopic Linear Cutter: ET45B, ET45G
The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials.
EZ45 No-Knife Endoscopic Linear Stapler: NK45B, NK45G
The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection, and can be used with staple line or tissue buttressing materials.
Thoracic Endoscopic Linear Cutter: EZ45B, EZ45G
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transection, and/or creation of anastomoses and can be used with staple line buttressing materials.
Technological Characteristics The technological characteristics are identical to the predicate devices. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the Directions for Use and Indications Statements.
Performance Data Ethicon Endo-Surgery conducted animal testing (Section 19) and a clinical literature search (Section 20) to establish the use of the stapling devices (No-Knife ETS and EZ products only) in the open Left Atrial Appendage Exclusion procedure.
2
Image /page/2/Picture/1 description: The image shows a stylized drawing of three parallel, wavy lines. The lines are thick and black, and they appear to be moving or flowing in a similar direction. The overall impression is abstract and minimalist.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUL - 3 2006
Ethicon Endo-Surgerv Inc. % Mr. Tom Morris. MBA. CQE Quality Systems/Regulatory Affairs Project Manager 4545 Creek Road Cincinnati. Ohio 45242
Re: K061156
Trade/Device Name: ENDOPATH device family Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: April 25. 2006 Received: April 26, 2006
Dear Mr. Morris:
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. Iisting 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 - Mr. Tom Morris. MBA. CQF.
forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the clectronic 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,
Herbert Lennox
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2061156
Indications for Use
510(k) Number (if known): . K061156
ENDOPATH device family Device Name:
Endocutter 60 Endoscopic Linear Cutter: EC60, SC60, LONG60
The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynccologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials.
ETS45 Endoscopic Linear Cutter: TSB45, TSG45, 6SB45
ETS-Flex45 Endoscopic Articulating Linear Cutter: ATB45, ATG45, 6TB45, LONG45A ETS Compact Flex45 Articulating Linear Cutters: SCB45, SCG45, 6CB45
The ENDOPATH FTS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating Linear Cutters are intended for transection, 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 buttressing materials.
ETS-Flex45 No-Knife Endoscopic Articulating Linear Stapler: NAB45, NAG45 ETS Compact-Flex45 No-Knife Articulating Linear Stapler: NSB45, NSG45
The ENDOPATH ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers are intended for transection, 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.
EZ45 Endoscopic Linear Cutter: ET45B, ET45G
The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, and/or creation of anastomoses and can be used with stable line or tissue buttressing materials.
EZ45 No-Knife Endoscopic Linear Stapler: NK45B, NK45G
The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection, and can be used with staple line or tissue buttressing materials.
Thoracic Endoscopic Linear Cutter: EZ45B, EZ45G
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transccion, resection, and/or creation of anastomoses and can be used with staple line buttressing materials.
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) | |
|---|---|
| Page 1 of 1 | |
| (Posted November 13, 2003) | (Division Sign-Off) |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K061154 |