(75 days)
Not Found
No
The document describes a mechanical surgical stapler and explicitly states that AI, DNN, or ML were not found in the description.
No
The device is a surgical stapler used to cut and join tissue, not to treat a disease or disorder.
No
The device, Ethicon™ Circular Staplers, is described as a surgical tool used to "simultaneously staple and cut tissue to create an anastomosis," which is a treatment or surgical procedure, not a diagnostic one. Its function is to perform a physical action on tissue, not to provide information for diagnosis.
No
The device description clearly 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, the Ethicon™ Circular Staplers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for creating anastomoses (surgical connections) within the alimentary tract. This is a surgical procedure performed directly on the patient's tissue.
- Device Description: The device is a surgical stapler that physically cuts and staples tissue. It is a mechanical device used during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The description of the Ethicon™ Circular Staplers does not involve the analysis of any biological specimens.
Therefore, the Ethicon™ Circular Staplers are a surgical device used for performing a procedure on a patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Ethicon™ Circular Staplers have application throughout the alimentary tract for end, end-to-soside anastomoses.
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, 29 mm, 33 mm. These configurations function in the same manner - to compress tissue and to produce the same closed staple on tissue. 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
Prescription Use
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)
Ex-vivo (bench) testing was performed to ensure that the device performed as intended and met design specifications. Device performance was assessed against the design requirements. Risk analysis and design verification testing were conducted for the changes described in this submission to ensure that the performance of the device was not affected by the device modifications. Verification testing included tissue cutting reliability testing, test skin force-to-fire, and device stapling performance testing. The results of the testing support the conclusion that the performance of the device has not been affected by the changes.
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.
Ethicon™ Circular Staplers, Ethicon™ Circular Staplers XL. (cleared under K181653)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 27, 2020
Ethicon Endo-Surgery LLC % Rubina Dosani Manager, Regulatory Affairs Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati, Ohio 45242
Re: K201280
Trade/Device Name: Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: May 9, 2020 Received: June 29, 2020
Dear Rubina 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 Actinclude 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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201280
Device Name Ethicon™ Circular Stapler
Indications for Use (Describe)
The Ethicon™ Circular Staplers have application throughout the alimentary tract for end, end-to-soside 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 Endo-Surgery, LLC 475 Calle Street Guaynabo, PR 00969
Application Correspondent
Rubina Dosani Manager, Regulatory Affairs Ethicon Endo-Surgery, LLC. Telephone: (513) 236-2841 (513) 337-2314 Fax: Email: rdosani@its.jnj.com
Date Prepared May 9, 2020
| 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™ Circular Staplers, Ethicon™ Circular Staplers |
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, 29 mm, 33 mm. These configurations function in the same manner - to compress tissue and to produce the same closed staple on tissue. Each device has a detachable anvil that allows a surgeon to place the anvil in the desired location.
XL. (cleared under K181653)
Indications for Use
The Ethicon™ Circular Staplers have applications throughout the alimentary tract for end-toend, end-to side, and side-to-side anastomoses. The predicate device also has the same indications for use. There is no change to the indications for use.
Technological Characteristics
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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 except for a change in the knife grind angle and the washer thickness in the end-effector of the device. 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 nor predicate device uses software.
Performance Data
Ex-vivo (bench) testing was performed to ensure that the device performed as intended and met design specifications. Device performance was assessed against the design requirements. Risk analysis and design verification testing were conducted for the changes described in this submission to ensure that the performance of the device was not affected by the device modifications. Verification testing included tissue cutting reliability testing, test skin force-tofire, and device stapling performance testing. The results of the testing support the conclusion that the performance of the device has not been affected by the changes.
This submission does not include data from Clinical Studies.
Conclusion
The modification described in this submission does not affect the intended use of the device or alter the fundamental scientific technology of the device. Summary information from the design control process serves as the basis for this submission. The Ethicon™ Circular Stapler is substantially equivalent to the legally marketed predicate device based upon intended use, technological characteristics and performance testing.