(24 days)
Not Found
No
The description focuses on mechanical aspects of a surgical stapler and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
This device is a surgical stapler used for creating anastomoses and resecting excess tissue, which is a surgical tool, not a therapeutic device.
No
The device is a surgical stapler used for creating anastomoses in the alimentary tract, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical surgical stapler with various hardware components (staples, shaft lengths, anvil, trocar accessory). The modification mentioned is related to labeling and contraindications, not a change to 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 clearly states the device is used for creating anastomoses (surgical connections) within the alimentary tract during open and laparoscopic surgeries. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical stapler that physically places staples and resects tissue. This is a surgical instrument, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are specifically designed to perform tests on specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EEA™ circular stapler with Tri-Staple™ technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Product codes (comma separated list FDA assigned to the subject device)
GAG, GDW
Device Description
The EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an end-to-end, end-to-side or side-to-side anastomosis in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go. The diameter of the is determined by the selection of the 33 mm, 31 mm, 25 mm stapler. The EEA™ circular stapler with Tri-Staple™ technology is available in 2 shaft lengths; a standard 22 cm shaft and an XL 35 cm shaft. The staplers are offered in 2 staple sizes, medium/thick and extra thick. Staplers with medium/thick staple size (purple) deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers with extra thick staple size (black) deploy three heightprogressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The low profile Tilt-Top™ anvil is available on all staplers. A blunt and a sharp (only applicable to 25mm stapler) tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
The design modification is to add one contraindication per special control 21 CFR 878.4740(b)(2)(ix)(A), and revises IFUs and labels per new regulation requirements.
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)
Non-clinical performance data - Usability assessment was performed for the proposed labeling changes to demonstrate substantial equivalence to the predicate device.
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 29, 2022
Covidien Katherine Choi Senior Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K221005
Trade/Device Name: EEA Circular Stapler with Tri-Staple Technology Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG, GDW Dated: March 30, 2022 Received: April 5, 2022
Dear Katherine Choi:
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
1
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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,
Mark Trumbore Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221005
Device Name
EEATM Circular Stapler with Tri-Staple™ Technology
Indications for Use (Describe)
The EEA™ circular stapler with Tri-Staple™ technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
| 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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3
510(k) Summary
Date Prepared:
Apr 21, 2022
Submitter:
Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 Building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China
US Contact:
Katherine Y. Choi Covidien 60 Middletown Avenue North Haven, CT 06473, USA Senior Principal Regulatory Affairs Specialist Email: katherine.y.choi@medtronic.com
Name of Device:
| Proprietary/Trade Name: | EEA™ Circular Stapler with Tri-Staple™ Technology |
|---|---|
| Model Numbers: | TRIEEA25MT, TRIEEA25XT, TRIEEAXL25MT, |
| TRIEEAXL25XT, TRIEEA28MT, TRIEEA28XT, | |
| TRIEEAXL28MT, TRIEEAXL28XT, TRIEEA31MT, | |
| TRIEEA31XT, TRIEEAXL31MT, TRIEEAXL31XT, | |
| TRIEEA33MT, TRIEEA33XT, TRIEEAXL33MT, | |
| TRIEEAXL33XT | |
| Classification Name: | Staple, Implantable; Stapler, Surgical |
| Regulations Number: | 21 CFR 878.4750, 21CFR 878.4740 |
| Product Codes: | GDW, GAG |
| FDA Panel Number: | 79 |
| Device Class: | Class II |
| Review Panel: | General and Plastic Surgery |
| Common Name: | Surgical stapler with implantable staples |
Predicate Device:
| Proprietary/Trade Name: | EEA™ Circular Stapler with Tri-Staple™ Technology |
|---|---|
| Model Numbers: | TRIEEA25MT, TRIEEA25XT, TRIEEAXL25MT, |
| TRIEEAXL25XT, TRIEEA28MT, TRIEEA28XT, | |
| TRIEEAXL28MT, TRIEEAXL28XT, TRIEEA31MT, | |
| TRIEEA31XT, TRIEEAXL31MT, TRIEEAXL31XT, | |
| TRIEEA33MT, TRIEEA33XT, TRIEEAXL33MT, | |
| TRIEEAXL33XT | |
| 510(k) Number: | K202507 (Primary Predicate Device) |
| K192330, K172361 | |
| Classification Name: | Staple, Implantable |
| Regulations Number: | 21 CFR 878.4750 |
| Product Codes: | GDW / GDW / GDW, GAG |
4
| FDA Panel Number: | 79 |
|---|---|
| Device Class: | Class II |
| Review Panel: | General and Plastic Surgery |
| Common Name: | Surgical stapler with implantable staples |
Device Description:
The EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an end-to-end, end-to-side or side-to-side anastomosis in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go. The diameter of the is determined by the selection of the 33 mm, 31 mm, 25 mm stapler. The EEA™ circular stapler with Tri-Staple™ technology is available in 2 shaft lengths; a standard 22 cm shaft and an XL 35 cm shaft. The staplers are offered in 2 staple sizes, medium/thick and extra thick. Staplers with medium/thick staple size (purple) deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers with extra thick staple size (black) deploy three heightprogressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The low profile Tilt-Top™ anvil is available on all staplers. A blunt and a sharp (only applicable to 25mm stapler) tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
The design modification is to add one contraindication per special control 21 CFR 878.4740(b)(2)(ix)(A), and revises IFUs and labels per new regulation requirements.
Indications for Use:
The EEA™ Circular Stapler with Tri-Staple™ Technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
Technological and Performance Characteristics:
The subject EEA™ Circular Stapler with Tri-Staple™ Technology with a new contraindication does not change the fundamental operating principle and mechanism of action when compared to the predicate device. This Special 510(k) submission is triggered by the addition of a contraindication called for in the Labeling Guidance: a statement noting that the device "should not be used to staple tissues that are necrotic, friable, or have altered integrity, e.g., ischemic or edematous tissues." This contraindication is consistent with surgical training and practice. All EEA™ circular staplers with Tri-Staple™ technology are single-use manual circular staplers.
Substantial Equivalent:
The subject device with a new contraindication is substantially equivalent to the legally marketed EEA™ Circular Stapler with Tri-Staple™ Technology (K202507, K192330, K172361). The intended use, or indications of the subject device is not altered with the introduction of new contraindication.
They are same in fundamental scientific technology in that they are all sterile, single use, handheld, manual surgical instruments equipped with titanium staples intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. The subject and predicate devices are same in design, materials and are sterilized via ethylene oxide.
Summary of Studies:
Non-clinical performance data - Usability assessment was performed for the proposed labeling changes to demonstrate substantial equivalence to the predicate device.
5
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies.
Conclusion:
Based upon the supporting data summarized above, we concluded that the subject device EEA™ Circular Stapler with Tri-Staple™ Technology with a new contraindication is substantially equivalent to the legally-marketed device K202507, K172361 and does not raise different questions or additional risks of safety and effectiveness than the predicate device.