(25 days)
None
No
The description focuses on mechanical features and staple technology, with no mention of AI or ML.
No
The device is used for surgical procedures like transection, resection, and creating anastomoses, which are interventions rather than treatments or therapies.
No
Explanation: The device is a surgical instrument used for transection, resection, and anastomoses, which are therapeutic actions rather than diagnostic.
No
The device description clearly describes a physical surgical instrument (Linear Cutter) and cartridges containing staples and a knife, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical instrument used for transection, resection, and creating anastomoses in various surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device description details a surgical stapler and cartridges used to deliver staples and cut tissue during surgery. This is a physical tool used in a surgical setting.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges has application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses and can be used with staple line or tissue buttressing materials.
Product codes
GDW, GAG
Device Description
The Ethicon Endo-Surgery Linear Cutter is a sterile, single patient use instrument used in open surgical procedures. The instrument delivers six staggered rows of staples, three on either side of the cut line. The instrument is shipped without a cartridge loaded into the instrument. The cartridge must be loaded as a separate step prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.
Each Ethicon Endo-Surgery Selectable Cartridge contains six staggered rows of staples and an integrated knife located in the safety housing. The selectable staple height feature provides the ability to use one cartridge for compressed tissue with thicknesses of 1.5mm, 1.8mm or 2.0mm. The staple retaining cap on the cartridge protects the staples during shipping and transportation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal, gynecologic, thoracic, and pediatric
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
Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the new devices will perform as intended.
Key Metrics
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.
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SEP 1 6 2009
K092577 Page 1/2
510(k) Summary
Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact Abhilasha Mukherjee, RAC Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3623 Fax: AMukher5@its.jnj.com Email:
Date Prepared August 19, 2009
Device Name Trade Name: Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges Common or Usual Name: Cutter/Stapler and Cartridges Classification Name: Staple, Implantable
Predicate Device Proximate Linear Cutter with Safety Lock-Out and Cartridges (cleared under K020779) .
Device Description The Ethicon Endo-Surgery Linear Cutter is a sterile, single patient use instrument used in open surgical procedures. The instrument delivers six staggered rows of staples, three on either side of the cut line. The instrument is shipped without a cartridge loaded into the instrument. The cartridge must be loaded as a separate step prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.
Each Ethicon Endo-Surgery Selectable Cartridge contains six staggered rows of staples and an integrated knife located in the safety housing. The selectable staple height feature provides the ability to use one cartridge for compressed tissue with thicknesses of 1.5mm, 1.8mm or 2.0mm. The staple retaining cap on the cartridge protects the staples during shipping and transportation: -------------------------------------------------------------------------------------------------------------------
Indications for Use The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges has application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses and can be used with staple line or tissue buttressing materials.
.. . . . . . . .
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K09577 page 2/2
Technological Characteristics The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridge incorporates a new selectable staple height feature, which enables the surgeon to use one cartridge for compressed tissue with thicknesses of 1.5mm, 1.8mm or 2.0mm. This ability eliminates the need for multiple cartridges (a blue cartridge for compressed tissue with a thickness of 1.5mm, a gold cartridge for compressed tissue with a thickness of 1.8mm and a green cartridge for compressed tissue with a thickness of 2.0mm), which is required when using the predicate device. The cartridge contains six staggered rows of staples with an integrated knife located in the safety housing.
Performance Data Bench testing and preclinical laboratory evaluation in an animal model was performed to demonstrate that the new devices will perform as intended.
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
a semple can balga quat lack firealge for compressed triba. · ... - run lige for .. ampressed tissue with a thickness of
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 18 2009
Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Ms. Abhilasha Mukherjee, RAC 4545 Creek Road Cincinnati. Ohio 45242
Re: K092577
Trade Name: Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Product Code: GDW, GAG Dated: August 19, 2009 Received: August 21, 2009
Dear Ms. Mukherjee:
This letter corrects our substantially equivalent letter dated September 15, 2009
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. Ilisting 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Abhilasha Mukherjee, 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Soubane Buelm
les
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows a handwritten string of characters, "K092577", in blue ink. The characters are written in a simple, legible style. The string appears to be a code or identifier, possibly a serial number or reference number. The handwriting is clear and easy to read.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges
Indications for Use:
The Ethicon Endo-Surgery Linear Cutter and Selectable Cartridges has application in The Ethicon Endo-Surgery Lifeai Cattler and Selectuble Ory for transection, resection, and the creation of anastomoses and can be used with staple for tissue 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)
Harbare AniemD
vision Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092577 Page 1 of 1
(Posted November 13, 2003)