(162 days)
No
The description focuses on the mechanical function of a surgical stapler and does not mention any AI/ML components or capabilities.
No.
This device is a surgical stapler used for creating anastomoses and resecting excess tissue, which is an instrument used during surgery, not a therapeutic device that treats disease or provides therapy.
No
The device is a surgical stapler used for creating anastomoses in the alimentary tract, not for diagnosing conditions.
No
The device description clearly outlines a physical surgical stapler with mechanical components (handle, shaft, staples, anvil, trocar accessory). There is no mention of software being the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the EEA™ circular stapler is a surgical instrument used during surgery to create anastomoses (connections) in the alimentary tract. It physically manipulates tissue within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely mechanical and surgical.
Therefore, the EEA™ circular stapler with Tri-Staple™ technology is a surgical device, not an In Vitro Diagnostic.
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. The instrument is activated by squeezing the handle firmly as far as it will go. The subject circular stapler is available in 21mm lumen size and 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 tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
Both the subject device and the predicate device (K202507 and K221005) are from the same product family Tri-Staple™ EEA™ stapler. The subject device EEA™ Circular Stapler with Tri-Staple™ Technology (lumen size 21mm) provides the surgeons a choice of additional lumen size selection to best suit the target anatomy.
The subject EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K202507 and K221005).
In the same manner as the predicate device (K202507 and K221005), the subject EEA™ Circular Stapler with Tri-Staple™ Technology is a manual surgical stapling device that places a circular, triple staggered row of titanium staples and resects tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. An audible and tactile firing indicator will provide additional feedback of firing completion.
The subject EEA™ Circular Stapler with Tri-Staple™ Technology is a single-use device that is packaged and sterilized via ETO (Ethylene Oxide) with a 5-year shelf life, which is the same as the predicate device (K202507 and K221005).
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 - the following testing has been performed to demonstrate substantial equivalence to the predicate device.
- Performance Test (In-Vitro)
- Visual/Packaging Inspection
- IFU Walkthrough
- Safety Lock Release Force Test
- Staple Formation on Test Medium
- Anvil Retention Force Test
- Anvil Attach Force Test
- Anvil Detach Force Test
- Clamping Force Test
- Unclamping Force Test
- Firing Force Test
- Performance Test (Ex-Vivo)
- Ex-Vivo Firinas
- Knife Cut Evaluation
- Leak / Burst Test
- Performance Test (In-Vivo)
- Atraumatic Tissue Test
- Hemostasis Test
- Staple Formation on Tissues
- Performance Test (Chronic)
Chronic animal study performed to evaluate the performance of the subject device and the reference device shows no differences in healing metrics or anastomotic index, and the results demonstrate that the acceptance criteria were met.
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.
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
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November 30, 2022
Covidien Leo Chen Principal Regulatory Affairs Specialist Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Shanghai. China
Re: K221771
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: October 28, 2022 Received: November 4, 2022
Dear Leo Chen:
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 co mmerce 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
1
requirements, including, but not limited to: registration and listing (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-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/cdrl-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 -S | Digitally signed by
Mark Trumbore -S |
|---------------------|-----------------------------------------|
| | Date: 2022.11.30
15:32:48 -05'00' |
Mark Trumbore, PhD 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221771
Device Name
EEATM Circular Stapler with Tri-StapleTM 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) | |
|---|---|
| ☒ 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 K221771
Date Prepared:
Nov 28, 2022
Submitter:
Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China Principal Regulatory Affairs Specialist Telephone: +86 21 3323 0182 Email: leo.chen@medtronic.com
US Contact:
Angela Van Arsdale Covidien 60 Middletown Avenue North Haven, CT 06473, USA Sr. Regulatory Affairs Manager Email: angela.vanarsdale@medtronic.com
Name of Device:
| Proprietary/Trade Name: | EEA™ Circular Stapler with Tri-Staple™ Technology |
|---|---|
| Model Numbers: | TRIEEA21MT, TRIEEA21XT, TRIEEAXL21MT, TRIEEAXL21XT |
| Classification Name: | Stapler, Surgical; Staple, Implantable |
| Regulations Number: | 21CFR 878.4740, 21 CFR 878.4750 |
| Product Codes: | GAG, GDW |
| FDA Panel Number: | 79 |
| Device Class: | Class II |
| Review Panel: | General and Plastic Surgery |
| Common Name: | Surgical stapler with implantable staples |
Primary Predicate Device:
| Proprietary/Trade Name: | EEATM Circular Stapler with Tri-StapleTM Technology |
|---|---|
| 510(k) Number: | K202507 |
| Classification Name: | Staple, Implantable |
| Regulations Number: | 21 CFR 878.4750 |
| Product Codes: | GDW |
| FDA Panel Number: | 79 |
| Device Class: | Class II |
| Review Panel: | General and Plastic Surgery |
| Common Name: | Surgical stapler with implantable staples |
Secondary Predicate Device:
| Proprietary/Trade Name: | EEATM Circular Stapler with Tri-StapleTM Technology |
|---|---|
| 510(k) Number: | K221005 |
4
Classification Name: Requlations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Reference Device:
- Proprietary/Trade Name: 510(k) Number: Classification Name: Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Stapler, Surgical; Staple, Implantable 21CFR 878.4740, 21 CFR 878.4750 GAG, GDW 79 Class II General and Plastic Surgery Surgical stapler with implantable staples
EEA™ Circular Stapler with DST Series™ Technology K062850 Staple, Implantable 21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery 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. The instrument is activated by squeezing the handle firmly as far as it will go. The subject circular stapler is available in 21mm lumen size and 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 tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
Both the subject device and the predicate device (K202507 and K221005) are from the same product family Tri-Staple™ EEA™ stapler. The subject device EEA™ Circular Stapler with Tri-Staple™ Technology (lumen size 21mm) provides the surgeons a choice of additional lumen size selection to best suit the target anatomy.
The subject EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K202507 and K221005).
In the same manner as the predicate device (K202507 and K221005), the subject EEA™ Circular Stapler with Tri-Staple™ Technology is a manual surgical stapling device that places a circular, triple staggered row of titanium staples and resects tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. An audible and tactile firing indicator will provide additional feedback of firing completion.
The subject EEA™ Circular Stapler with Tri-Staple™ Technology is a single-use device that is packaged and sterilized via ETO (Ethylene Oxide) with a 5-year shelf life, which is the same as the predicate device (K202507 and K221005).
5
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 anastomoses in both open and laparoscopic surgeries.
Technological and Performance Characteristics:
The subject device EEA™ circular stapler with Tri-Staple™ technology (lumen size 21mm) is substantially equivalent to the predicate device K202507 and K221005 (lumen sizes 25mm, 28mm, 31mm and 33mm) regarding the fundamental stapling technologies employed, intended use and indications for use. All EEA™ circular staplers with Tri-Staple™ technology are singleuse manual circular staplers that have 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.
The Tri-Staple™ technology used in the subject device is fundamentally the same as the predicate device K202507 and K221005. The subject circular staplers are available in 21mm lumen size. meanwhile, the predicates are available in 4 lumen sizes 25mm, 31mm and 33mm. That's why a reference device K062850 offering 21mm lumen size is to be introduced as control device in performance testing.
Substantial Equivalent:
The subject new product models have the same intended use and indications for use as the predicate device.
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, but different in lumen size.
The below table further summarizes the similarities and differences between the subject and predicate devices.
| Features | Subject Device
K221771 | Predicate Device | | Reference Device
K062850 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K202507 | K221005 | |
| | | EEATM Circular Stapler with Tri-StapleTM Technology | | EEATM Circular Stapler with
DST SeriesTM Technology |
| Manufacturer | Same as
predicate device. | Covidien | | Covidien |
| Indications for
Use | Same as
predicate device. | The EEATM Circular Stapler with Tri-StapleTM 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. | | The EEATM Circular Stapler
with DST SeriesTM
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. |
| Operation
Method | Same as
predicate device. | Manual | | Manual |
| Features | Subject Device
K221771 | Predicate Device
K202507 | K221005 | Reference Device
K062850 |
| | EEATM Circular Stapler with Tri-StapleTM Technology | | EEATM Circular Stapler with Tri-StapleTM Technology | EEATM Circular Stapler with
DST SeriesTM Technology |
| Anatomical
Site | Same as
predicate device. | Alimentary tract | Alimentary tract | Alimentary tract |
| Surgical
Approach | Same as
predicate device. | Open and laparoscopic | Open and laparoscopic | Open and laparoscopic |
| Staple Rows | Same as
predicate device. | 3 staggered rows of staples with different staple height in
each staple row | 3 staggered rows of staples with different staple height in
each staple row | 2 staggered rows of staples
with same staple height in
each staple row |
| Staple Guide
Color | Same as
predicate device. | Black
Purple | Black
Purple | Aqua (21mm) |
| Staple Size
(open leg
height) | Same as
predicate device. | Black staple guide:
4.0mm,4.5mm,5.0mm
Purple staple guide:
3.0mm,3.5mm,4.0mm | Black staple guide:
4.0mm,4.5mm,5.0mm
Purple staple guide:
3.0mm,3.5mm,4.0mm | Aqua (21mm):
4.8mm, 4.8mm
3.5m, 3.5mm |
| Lumen Sizes | 21mm
Same as
reference device
(21mm), which is
selected to be the
control device in
the performance
testing. | 25mm | 25mm/28mm/31mm/33mm | 21mm |
| Staple Material | Same as
predicate device. | Titanium per ASTM F67 Grade I | Titanium per ASTM F67 Grade I | Titanium per ASTM F67
Grade I |
| Stapler Length | Same as
predicate device. | Standard length: 22cm
Extra length XL: 35cm | Standard length: 22cm
Extra length XL: 35cm | Standard length: 22cm
Extra length XL: 35cm |
| Audible
Feedback | Same as
predicate device. | Yes | Yes | Yes |
| Anvil Head | Same as
predicate device. | 3 staggered rows of anvil bucket, lipless design | 3 staggered rows of anvil bucket, lipless design | 2 staggered rows of anvil
bucket, lipped design |
| Safety Lever | Same as
predicate device. | Red color | Red color | White color |
| Key Parts
Materials | Same as
predicate device. | Knife: Stainless Steel
Anvil: Stainless Steel
Tube: Aluminum | Knife: Stainless Steel
Anvil: Stainless Steel
Tube: Aluminum | Knife: Stainless Steel
Anvil: Stainless Steel
Tube: Aluminum |
| Biocompatibility | Same as
predicate device. | Evaluated per ISO 10993-1 series and FDA
biocompatibility guidance | Evaluated per ISO 10993-1 series and FDA
biocompatibility guidance | Evaluated per ISO 10993-1
series |
| Single Use | Same as
predicate device. | Yes | Yes | Yes |
| Disposable | Same as
predicate device. | Yes | Yes | Yes |
| Sterile | Same as
predicate device. | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| Shelf Life | Same as
predicate device. | 5 years | 5 years | 5 years |
6
7
Tests performed to evaluate and compare technological and performance characteristics:
Non-clinical performance data - the following testing has been performed to demonstrate substantial equivalence to the predicate device.
- Performance Test (In-Vitro) 1.
- Visual/Packaging Inspection
- IFU Walkthrough
- . Safety Lock Release Force Test
- . Staple Formation on Test Medium
- Anvil Retention Force Test
- Anvil Attach Force Test
- Anvil Detach Force Test ●
- Clamping Force Test .
- Unclamping Force Test .
- . Firing Force Test
-
- Performance Test (Ex-Vivo)
- Ex-Vivo Firinas
- Knife Cut Evaluation ●
- . Leak / Burst Test
-
- Performance Test (In-Vivo)
- Atraumatic Tissue Test
- Hemostasis Test ●
- Staple Formation on Tissues
-
- Performance Test (Chronic)
Chronic animal study performed to evaluate the performance of the subject device and the reference device shows no differences in healing metrics or anastomotic index, and the results demonstrate that the acceptance criteria were met.
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 is substantially equivalent to the legally-marketed device (K202507 and K221005) and does not raise different questions or additional risks of safety and effectiveness than the predicate device.