(124 days)
No
The summary describes a mechanical stapling device with a battery-powered firing system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies focus on mechanical and biological outcomes, not algorithmic performance.
No
The device is described as a surgical stapler used to cut and staple tissue during anastomoses, which is a procedural tool rather than a device intended for treating a disease or condition itself.
No
The device is described as a surgical stapler that simultaneously staples and cuts tissue to create an anastomosis. Its function is to perform a surgical procedure (joining tissues), not to diagnose a condition or disease.
No
The device description clearly states it is a physical, sterile, single-patient use device with a battery-powered firing system, shaft, end-effector, and detachable anvil. It is a surgical stapler, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures within the alimentary tract for creating anastomoses (connecting two parts of the tract). This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a surgical stapler that cuts and staples tissue. This is a tool used during surgery, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue samples, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The ECHELON CIRCULAR™ Powered Staplers have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Product codes
GDW
Device Description
The ECHELON CIRCULAR™ Powered Staplers are sterile, single-patient use devices that simultaneously staple and cut tissue with a battery powered firing system to create an anastomosis. The devices deliver 2 rows of staples on the outside of the cut line. The ECHELON CIRCULAR™ Powered Staplers are available in a 24 cm curved shaft length in 4 end-effector sizes: 23mm, 25mm, 29mm and 31mm. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location. The devices are packaged with a battery pack that must be installed prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
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
Performance data demonstrate that the subject device is substantially equivalent to the predicate device and the differences between the devices were found not to affect safety or performance. The following bench and animal tests were performed to demonstrate substantial equivalence to the predicate:
- staple line integrity and staple form quality equivalency ●
- leak onset pressure equivalency
- force to fire
- o formed staple height
- battery output
- o fluid ingress
Animal testing performed included acute hemostasis evaluation, device removal acceptability, device insertion tissue effects, healing of stapled anastomosis and staple line perfusion.
The conclusions of the testing demonstrate that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
This submission does not include data from Clinical Studies.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2017
Ethicon Endo-Surgery, LLC Ms. Rubina Dosani Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati, Ohio 45242
Re: K163523
Trade/Device Name: ECHELON CIRCULAR Powered Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 20, 2017 Received: March 22, 2017
Dear Ms. Dosani:
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 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
1
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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163523
Device Name ECHELON CIRCULAR™ Powered Staplers
Indications for Use (Describe) The ECHELON CIRCULAR™ Powered Staplers have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Submitter Information: | Ethicon, LLC |
|---|---|
| 475 Calle Street | |
| Guaynabo, PR 00969 | |
| Application Correspondent | |
| Rubina Dosani | |
| Sr. Regulatory Affairs Program Lead | |
| Ethicon Endo-Surgery, LLC. | |
| Telephone: | (513) 337-3566 |
| Fax: | (513) 337-2314 |
| Email: | rdosani@its.jnj.com |
Date Prepared December 14, 2016
| Device Trade Name: | ECHELON CIRCULAR™ Powered Staplers |
|---|---|
| Device Common Name: | Circular Stapler |
| Classification Regulation: | 21 CFR 878.4750 |
| Device Class: | II |
| Panel: | General & Plastic Surgery |
| Classification (Product) Code: | GDW |
Legally Marketed Predicate Device: Ethicon Endo-Surgery® Curved Intraluminal Staplers (cleared under K983536)
Device Description
The ECHELON CIRCULAR™ Powered Staplers are sterile, single-patient use devices that simultaneously staple and cut tissue with a battery powered firing system to create an anastomosis. The devices deliver 2 rows of staples on the outside of the cut line. The ECHELON CIRCULAR™ Powered Staplers are available in a 24 cm curved shaft length in 4 end-effector sizes: 23mm, 25mm, 29mm and 31mm. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location. The devices are packaged with a battery pack that must be installed prior to use.
Indications for Use
The ECHELON CIRCULAR™ Powered Staplers have applications throughout the alimentary tract for end-to-end, end-to side, and side-to-side anastomoses.
Technological Characteristics
The subject device utilizes battery power to allow powered staple formation and lumen cutting to create the anastomosis. The subject device has a similar design as the predicate with the addition of tighter staple height range and staple pockets extensions to the end-effector of the device as
4
well as a slightly different shape of the formed staples. Similar to the predicate, a rotatable adjustment knob enables the compression of tissue and selection of a target staple height based on the tissue compression within the green zone. No energy passes through to the patient in the use of the subject or predicate devices. Neither the subject device or predicate device uses software.
Performance Data
Performance data demonstrate that the subject device is substantially equivalent to the predicate device and the differences between the devices were found not to affect safety or performance. The following bench and animal tests were performed to demonstrate substantial equivalence to the predicate:
- staple line integrity and staple form quality equivalency ●
- leak onset pressure equivalency
- force to fire
- o formed staple height
- battery output
- o fluid ingress
Animal testing performed included acute hemostasis evaluation, device removal acceptability, device insertion tissue effects, healing of stapled anastomosis and staple line perfusion.
The conclusions of the testing demonstrate that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
This submission does not include data from Clinical Studies.