(88 days)
Not Found
No
The device description and performance studies focus on mechanical function and tissue interaction, with no mention of AI or ML.
No
The device is described as a surgical stapler used to cut and staple tissue for anastomosis, which is a procedural tool rather than a therapeutic device that treats or cures a condition.
No
Explanation: The device description states that the Ethicon™ Circular Staplers "simultaneously staple and cut tissue to create an anastomosis," which is a therapeutic surgical function, not a diagnostic one. The performance studies and intended use also focus on the mechanical performance and safety of stapling and cutting, rather than detecting or identifying a medical condition.
No
The device description explicitly states it is a sterile, single-use device that simultaneously staples and cuts tissue, describing physical components like shafts, endeffectors, and an anvil. This indicates a hardware-based medical device, not software-only.
Based on the provided information, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Ethicon™ Circular Staplers are surgical devices used to staple and cut tissue within the alimentary tract to create anastomoses (surgical connections between two structures). This is an in vivo procedure, meaning it is performed directly on a living organism.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test on bodily fluids or tissues outside of the body.
Therefore, the Ethicon™ Circular Staplers are surgical instruments, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Ethicon™ Circular Staplers have applications throughout the alimentary tract for end, end-to-soside anastomoses.
The Ethicon™ Circular Staplers have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses. The predicate device also has the same indications for use.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The Ethicon™ Circular Staplers are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver 2 concentric rows of staples on the outside of the cut line. The Ethicon™ Circular Staplers are available in two device configurations: CDH and ECS and two shaft lengths; a standard 26 cm shaft and an XL 37 cm shaft. Each configuration is available in 4 endeffector sizes: 21 mm, 25 mm, 29 mm, 33 mm. These configurations function in the same manner - to compress tissue and to produce the same closed staple on tissue. They differ primarily in the length of the curved shaft and the shaft's ability to maintain a pneumatic seal specifically for use in laparoscopic surgical procedures. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- formed staple height
- biocompatibility
- acute hemostasis evaluation
- device removal acceptability
- healing of stapled anastomosis.
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 (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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2018
Ethicon Endo-Surgery, LLC % Rubina Dosani, M.S. Sr. Regulatory Affairs Program Lead 4545 Creek Road Cincinnati, Ohio 45242
Re: K181653
Trade/Device Name: Ethicon™ Circular Staplers, Ethicon™ XL Circular Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: June 21, 2018 Received: June 22, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K181653
Device Name
Ethicon™ Circular Staplers, Ethicon™ XL Circular Staplers
Indications for Use (Describe)
The Ethicon™ Circular Staplers have applications throughout the alimentary tract for end, end-to-soside anastomoses.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Submitter Information: | Ethicon Endo-Surgery, LLC |
|---|---|
| 475 Calle Street | |
| Guaynabo, PR 00969 |
Application Correspondent
Rubina Dosani Sr. Regulatory Affairs Program Lead Ethicon Endo-Surgery, LLC. Telephone: (513) 337-3566 (513) 337-2314 Fax: Email: rdosani@its.jnj.com
Date Prepared June 21, 2018
| Device Trade Name: | Ethicon™ Circular Staplers,
Ethicon™ Circular Staplers XL Sealed |
|--------------------------------|------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Circular Stapler |
| Classification Regulation: | 21 CFR 878.4750; Implantable Staple |
| Device Class: | II |
| Panel: | 79, General & Plastic Surgery |
| Classification (Product) Code: | GDW |
| | Legally Marketed Predicate Device: Ethicon Endo-Surgery® Curved Intraluminal
Staplers (cleared under K983536) |
Device Description
The Ethicon™ Circular Staplers are sterile, single use devices that simultaneously staple and cut tissue to create an anastomosis. The devices deliver 2 concentric rows of staples on the outside of the cut line. The Ethicon™ Circular Staplers are available in two device configurations: CDH and ECS and two shaft lengths; a standard 26 cm shaft and an XL 37 cm shaft. Each configuration is available in 4 endeffector sizes: 21 mm, 25 mm, 29 mm, 33 mm. These configurations function in the same manner - to compress tissue and to produce the same closed staple on tissue. They differ primarily in the length of the curved shaft and the shaft's ability to maintain a pneumatic seal specifically for use in laparoscopic surgical procedures. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location.
Indications for Use
The Ethicon™ Circular Staplers have applications throughout the alimentary tract for end-to-end, end-to side, and side-to-side anastomoses. The predicate device also has the same indications for use.
4
Technological Characteristics
The Ethicon™ Circular Stapler is substantially equivalent to the predicate Ethicon Endo-Surgery® Curved Intraluminal Staplers with respect to the device function and design. The subject device has a similar design as the predicate with the addition of shorter staple height range and lower force to fire. 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. The device is manually powered; it is not powered by an outside energy source. 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
- formed staple height
- biocompatibility
- acute hemostasis evaluation
- device removal acceptability
- healing of stapled anastomosis. ●
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.