(131 days)
Not Found
No
The description focuses on mechanical function and does not mention any AI/ML components or capabilities.
No
The device is described as an articulating linear cutter and stapler used for transection and/or creation of anastomoses in surgical procedures. Its function is to cut and staple tissue, not to treat or cure a disease or condition in a therapeutic manner.
No
The device is described as a surgical instrument for transection and creation of anastomoses, delivering staples and/or dividing tissue. Its function is interventional, not diagnostic.
No
The device description clearly states it is a sterile, single patient use instrument that delivers staples and/or divides tissue, indicating it is a physical hardware 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 description clearly states the device is a surgical instrument used for "transection, and/or creation of anastomoses" and "delivers staples while simultaneously dividing tissue" or "delivers staples but does not divide tissue." These are actions performed directly on the patient's tissues during surgery.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples or providing diagnostic information based on such analysis.
The device is a surgical stapler/cutter, which is a surgical instrument used for physical manipulation of tissue during a procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads 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 buttressing material. The instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Product codes
GDW
Device Description
The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use instrument that delivers staples while simultaneously dividing tissue between rows. The instruments provide a staple line that is approximately 45 mm long and a cut line that is approximately 41 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
The Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler is a sterile, single patient use instrument that delivers staples but does not divide tissue. The instruments provide a staple line that is approximately 45 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen
Indicated Patient Age Range
pediatric
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 including staple form quality and staple height, staple line integrity, force to close, compatibility with buttress material, lock out reliability and lockout withstand force were performed to confirm that the subject devices perform as intended and are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070887, K061156, K020079, K002398, K961390
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2015
Ethicon Endo-Surgery, LLC Ms. Christina Canter Senior Associate, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242
Re: K150026
Trade/Device Name: Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: April 16, 2015 Received: April 17, 2015
Dear Ms. Canter:
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. 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 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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
David Krause -S
- for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150026
Device Name
Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler
Indications for Use (Describe)
The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads 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 buttressing material. The instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
| Company: | Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo, PR 00969 |
| ---------- | ---------------------------------------------------------------- |
|---|
- Christina Canter, RAC Contact: Senior Associate, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-7321 Fax: (513) 337-1122 Email: ccanter2@its.jnj.com
Date Prepared: January 06, 2015
Device Name
| Trade Name: | Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and
Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical Stapler |
| Classification Name: | Staple, Implantable |
| Regulation Number: | 21CFR 878.4750 |
| Product Code: | GDW |
Marketed Predicate Device
Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter and Endopath® ETS- Flex45 No-Knife Articulating Linear Stapler (K070887, K061156, K020079, K002398, K961390)
Device Description
The Endopath® ETS-Flex45 Endoscopic Articulating Linear Cutter is a sterile, single patient use instrument that delivers staples while simultaneously dividing tissue between rows. The instruments provide a staple line that is approximately 45 mm long and a cut line that is approximately 41 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
The Endopath® ETS-Flex45 No-Knife Articulating Linear Stapler is a sterile, single patient use instrument that delivers staples but does not divide tissue. The instruments provide a staple line that is approximately 45 mm long. An articulation lever on the device enables bilateral movement of the instrument jaws.
4
Indications for Use
The Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS-Flex45 No-Knife Articulating Linear Stapler and reloads are intended for transection, resection, 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 buttressing material. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Technological Characteristics
The subject devices are modifications of the legally marketed predicate devices. The primary design change is the addition of a reload 'lock-out' feature to prevent the device from being fired when a reload is improperly loaded or if no reload is placed into the device. The changes described in this submission do not affect the intended use of the devices or alter fundamental scientific technology of the devices.
Performance Data
Bench testing including staple form quality and staple height, staple line integrity, force to close, compatibility with buttress material, lock out reliability and lockout withstand force were performed to confirm that the subject devices perform as intended and are substantially equivalent to the predicate devices.