(49 days)
Not Found
No
The device description and performance studies focus on mechanical function and safety features, with no mention of AI or ML.
No.
The device is used for transection, and/or creation of anastomoses, delivering staples to divide tissue. This is a surgical instrument for cutting and stapling tissue, not for providing therapy or treatment.
No
Explanation: The device description clearly states its purpose is for transection and/or creation of anastomoses by delivering staples, not for diagnosing medical conditions.
No
The device description clearly describes a physical surgical instrument (linear cutter and reloads) that delivers staples and divides tissue. It mentions hardware components like a safety lock-out feature and a staple retaining cap. The performance studies also focus on bench and simulated use testing of the physical device's function and durability.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for cutting and stapling tissue within the body during surgical procedures. This is an in vivo application.
- Device Description: The description details a mechanical device that delivers staples and cuts tissue. It does not mention any components or processes related to analyzing samples outside the body (which is the definition of in vitro).
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient's tissues during surgery.
N/A
Intended Use / Indications for Use
ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads have application in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads deliver triple staggered rows of staples while simultaneously dividing the tissue between the rows. The instrument's safety lock-out feature is designed to prevent a spent reload from being refired. The instruments deliver a staple line that is approximately 35mm 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)
Bench and simulated use testing, including testing, force to fire and force to failure testing, functional testing, and fragility testing confirm that the subject device performs as intended and is substantially equivalent to the predicate devices.
Clinical testing was not performed in support of this submission.
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.
K961390 35mm ENDOPATH® ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter, K020779 35mm ENDOPATH® ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter, K070887 ENDOPATH® and Echelon Linear Cutters, Staplers and Reloads
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.
0
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JUN - 8 2011
ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads 510k Premarket Application
A Remarkable Application
Section 5: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
- Ethicon Endo-Surgery, LLC Sponsor: 475 Calle C Guaynabo, PR 00969
Contact: Linda Hill Portfolio Leader, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Ph: 513-337-7623 Fax: 513-337-2623 E-mail: LHill3@its.jnj.com
Date of Submission: April 18, 2011
Proprietary Name: ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads
Common Name: Staple, Implantable
Regulatory Class: 21 CFR 878.4750
Product Code: GDW
Predicate Device(s): K961390 35mm ENDOPATH® ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter, K020779 35mm ENDOPATH® ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter, K070887 ENDOPATH® and Echelon Linear Cutters, Staplers and Reloads
Device Description: The ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads deliver triple staggered rows of staples while simultaneously dividing the tissue between the rows. The instrument's safety lock-out feature is designed to prevent a spent reload from being refired. The instruments deliver
1
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ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads,
and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads 510k Premarket Application
a staple line that is approximately 35mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation.
Intended Use: ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads have application in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Technological Characteristics: Both the subject and the predicate instruments have a staple line that is approximately 35 mm long and a cut line that is approximately 32 mm long. The instruments are loaded with either a standard, blue reload or a vascular/thin, white reload. ETS 35mm reloads are interchangeable across all 35mm ETS and ETS-Flex instrument codes. The replacement of the plastic sled with the proposed metal sled does not change the mechanical functions or principles of operations of the ENDOPATH ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter and Reloads. The new metal sled increases the force to bypass, reducing the likelihood of wedge band bypass failure. The metal sled is stiffer than the plastic part that it replaces and has a higher yield and ultimate strength, thereby reducing the potential for shearing or bypass during firing.
Performance Testing: Bench and simulated use testing, including testing, force to fire and force to failure testing, functional testing, and fragility testing confirm that the subject device performs as intended and is substantially equivalent to the predicate devices.
Clinical Testing: Clinical testing was not performed in support of this submission.
Conclusion: The purpose of this 510(k) is to describe proposed changes in the ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads product line. The devices are modified from the plastic cartridge sled to a metal cartridge sled with minor dimensional changes. There are no changes to the indications or intended use of the devices. Bench testing confirms that the subject device performs as intended and that the safety or effectiveness of the ENDOPATH ETS 35mm Endoscopic Linear
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ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads,
510k Premarket Application and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads
Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads is substantially equivalent to that of the predicates.
.
Ethicon Endo-Surgery April 18, 2011
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc Ms. Linda Hill 4545 Creek Road Cincinnati, Ohio 45242
- 8 2011 .IUN
Re: K111111
Trade/Device Name: ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: April 18, 2011 Received: April 20, 2011
Dear Ms. Hill:
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. Ilsting 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
4
Page 2 - Ms. Linda Hill
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 device-related 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/CentersQffices/CDRH/CDRHOffices/ucm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Jon N. Mallinson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111111
Device Name: ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads
Indications For Use
Indications for Use: ENDOPATH ETS 35mm Endoscopic Linear Cutter and Reloads, and ETS-Flex 35mm Endoscopic Articulating Linear Cutter and Reloads have application in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses. The instruments may also be used for transection 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dainl Kune de MKU
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K111111