(149 days)
Not Found
No
The description explicitly states it is a "manual device" and there is no mention of AI, ML, image processing, or data sets for training/testing.
No
The device is a surgical stapler used to create anastomoses, which involves joining tissues together, primarily for structural reconstruction rather than for treating or curing a disease in itself.
No
The device description clearly states its function is to place staples and resect tissue for creating anastomoses during surgery. This is a surgical tool, not a diagnostic one.
No
The device description clearly details a physical, mechanical surgical stapler made of materials like stainless steel and titanium, which is manually operated and used in surgical procedures. It is 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 clearly states the device is for creating anastomoses (surgical connections) within the alimentary tract during open and laparoscopic surgeries. This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a mechanical stapling device used to physically join tissues. It does not mention any components or processes related to testing samples of human origin in vitro (outside the body).
- Performance Studies: The performance studies focus on the mechanical function of the stapler, tissue healing, and biocompatibility, all of which are relevant to a surgical device used on a patient. There are no studies related to analyzing biological samples for diagnostic purposes.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The EEATM 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-sicle anastomoses in both open and laparoscopic surgeries.
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) has application throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.
Product codes
GDW, GAG
Device Description
The EEA™ circular stapler with Tri-Staple™ technology (Black) places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an endto-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go. The subject circular stapler will be offered for an extra thickness range, which is identified by the black staple guide. Staplers with extra thick staple size deploy three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The subject circular staplers are available in 3 lumen sizes 28, 31. 33mm and 2 shaft lengths a standard 22 cm shaft and an XL 35 cm shaft. The Tilt-Top™ anvil is available on all staplers. A blunt tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is manufactured with patient contact materials (stainless steel, titanium) that are utilized within the predicate devices (K172361 and K062850).
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is a manual device which is utilized by approximating tissue, instrumentation activation by squeezing the handle firmly as far as it will go, audible and tactile firing indicator upon completion of the staple firing and removal of the device from the surgical field in the same manner as the predicate devices (K172361 and K062850).
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) 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 devices (K172361 and K062850).
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
Non-clinical performance data was presented, including:
- Performance Test In-Vitro: Visual inspection, safety lock release force, staple formation on test media, anvil attach force, anvil detach force, clamping force, unclamping force, and firing force. All acceptance criteria were satisfied.
- Performance Test Ex-Vivo: Ex-Vivo Firings, Knife cut evaluation, Leak / Burst test. All units evaluated yielded comparable or better results to the acceptance criteria, demonstrating substantial equivalence.
- Performance Test In-Vivo Study: Atraumatic tissue test, Hemostasis test, Staple formation on tissues, Chronic survival study. All units evaluated yielded comparable or better results to the acceptance criteria for In-Vivo acute test, demonstrating substantial equivalence. A chronic animal study showed no differences in healing metrics or anastomotic index between the subject and predicate devices.
- Performance Test Human Factors/Usability: Human factors evaluation was conducted on the subject and predicate devices. Usability testing validated performance, mitigated potential use errors, and validated training and instruction. The results demonstrate substantial equivalence.
- Biocompatibility tests: Cytotoxicity, Sensitization, Intracutaneous irritation, Acute system toxicity, Pyrogenicity. Test results support the devices are biocompatible.
- Sterilization assessment per ISO 11135: Overkill method used for validation, ETO residual test. Validation demonstrates a minimum Sterility Assurance Level (SAL) of 10-6.
- Stability/Shelf-life studies: Aging test for 5 years shelf life, Product and packaging functional test. Results support a 5-year shelf life.
No clinical study was deemed necessary.
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/0 description: The image contains the logo of the U.S. Food & 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.
January 23, 2020
Covidien Frank Gianelli Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K192330
Trade/Device Name: EEA Circular Stapler with Tri-Staple Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 16, 2019 Received: December 19, 2019
Dear Mr. Gianelli:
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 medical devices and radiation-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,
Cindy Chowdhury, Ph.D., M.B.A. Acting 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Dnug Administration
Indications for Use
510(k) Number (if known)
Device Name
EEATM Circular Stapler with Tri-Staple™ Technology
Indications for Use (Describe)
The EEATM 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-sicle 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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See PRA Statement below.
3
510(k) Summary
Date Prepared:
January 20, 2020
Submitter:
Sarah Tang Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China
Contact:
Frank Gianelli (U.S. Agent) on behalf of Sarah Tanq Covidien 60 Middletown Avenue North Haven, CT 06473, USA Senior Regulatory Affairs Specialist Telephone: (203) 492-5352 Fax: (203) 492-5029 frank.j.gianelli@medtronic.com Email:
Name of Device:
Proprietary/Trade Name: EEATM Circular Stapler with Tri-Staple™ Technology (Black) Model Numbers: TRIEEA28XT, TRIEEA31XT, TRIEEA33XT, TRIEEAXL28XT, TRIEEAXL31XT, TRIEEAXL33XT Classification Name: Staple, Implantable Requlations Number: 21 CFR 878.4750 Product Codes: GDW, GAG FDA Panel Number: 79 Device Class: Class II Review Panel: General and Plastic Surgery Common Name: Surgical Stapler
Predicate Devices:
Primary Predicate Device: Proprietary/Trade Name: 510(k) Number: Classification Name: Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Additional Predicate Device: Proprietary/Trade Name: 510(k) Number: Classification Name:
EEA™ Circular Stapler with Tri-Staple™ Technology (Purple) K172361 Staple, Implantable 21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery Surgical Stapler
EEA™ Circular Stapler with DST Series™ Technology K062850 Staple, Implantable
4
Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery Surgical Stapler
Device Description:
The EEA™ circular stapler with Tri-Staple™ technology (Black) places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an endto-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go. The subject circular stapler will be offered for an extra thickness range, which is identified by the black staple guide. Staplers with extra thick staple size deploy three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The subject circular staplers are available in 3 lumen sizes 28, 31. 33mm and 2 shaft lengths a standard 22 cm shaft and an XL 35 cm shaft. The Tilt-Top™ anvil is available on all staplers. A blunt tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is manufactured with patient contact materials (stainless steel, titanium) that are utilized within the predicate devices (K172361 and K062850).
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is a manual device which is utilized by approximating tissue, instrumentation activation by squeezing the handle firmly as far as it will go, audible and tactile firing indicator upon completion of the staple firing and removal of the device from the surgical field in the same manner as the predicate devices (K172361 and K062850).
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) 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 devices (K172361 and K062850).
Indications for Use:
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) has application throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.
Technoloqical Characteristics:
The subject new devices EEA™ circular stapler with Tri-Staple™ technology (Black) are substantially equivalent to primary predicate device K172361 EEA™ Circular Stapler with Tri-Staple™ Technology (Purple) and the additional predicate device K062850 EEA™ circular stapler with DST Series™ technology regarding the fundamental stapling technologies employed, intended use and indications for use. All of them are single-use manual circular staplers that have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-toside anastomoses in both open and laparoscopic surgeries.
The Tri-Staple™ technology used in the subject devices are fundamentally the same as the primary predicate device K172361 with the exception that the subject devices deploy 3 height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples for use in extra thick tissue applications and is identified by the black staple quide. Conversely, the primary predicate devices
5
deploy 3 height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples for use in medium/thick tissue applications and is identified by the purple staple quide. That's why an additional predicate offering for an extra thick tissue thickness is introduced as control device in performance testing.
The additional predicate device K062850 EEA™ circular stapler with DST Series™ technology deploy 2 staggered rows of 4.8mm staples, for use in extra thickness range similar to the subject device. A series of comparison testing has been conducted between the subject new devices and the additional predicate devices and is provided in this submission.
Substantial Equivalent:
The subject devices have the same intended use and indications for use as the predicate devices.
They are similar in fundamental scientific technology in that they are all sterile, single used, 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 similar in design, materials and are sterilized via ethylene oxide.
The below table further summarizes the similarities and differences between the subject and predicate devices.
| | Subject Device | Primary Predicate Device
(K172361) | Additional Predicate Device (K062850) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | EEATM Circular Stapler with
Tri-StapleTM Technology
(Black) | EEATM Circular Stapler with
Tri-StapleTM Technology
(Purple) | EEATM Circular Stapler with
DST SeriesTM Technology |
| Manufacturer | Covidien | Covidien | Covidien |
| Constructional | Image: EEA Circular Stapler with Tri-Staple Technology (Black) | Image: EEA Circular Stapler with Tri-Staple Technology (Purple) | Image: EEA Circular Stapler with DST Series Technology |
| Indications for Use | 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 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 | Manual | Manual | Manual |
| Anatomical Site | Alimentary tract | Alimentary tract | Alimentary tract |
| Surgical Approach | Open and laparoscopic | Open and laparoscopic | Open and laparoscopic |
| Staple Rows | 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 |
6
| | Subject Device | Primary Predicate Device
(K172361) | Secondary Predicate
Device (K062850) |
|----------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------|
| Features | EEATM Circular Stapler with
Tri-StapleTM Technology
(Black) | EEATM Circular Stapler with
Tri-StapleTM Technology
(Purple) | EEATM Circular Stapler with
DST SeriesTM Technology |
| Staple Guide
Color | Black | Purple | Green |
| Staple Size
(open leg height) | 4.0mm, 4.5mm 5.0mm | 3.0mm, 3.5mm, 4.0mm | 4.8mm, 4.8mm |
| Staple Material | Titanium per ASTM F67
Grade I | Titanium per ASTM F67
Grade I | Titanium per ASTM F67
Grade I |
| Lumen Sizes | 28mm/31mm/33mm | 28mm/31mm/33mm | 28mm/31mm/33mm |
| Stapler Length | Standard length: 22cm
Extra length XL: 35cm | Standard length: 22cm
Extra length XL: 35cm | Standard length: 22cm
Extra length XL: 35cm |
| Audible Feedback | Yes | Yes | Yes |
| Anvil Head | 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 | Red color | Red color | White color |
| Key Parts | Knife: Stainless Steel | Knife: Stainless Steel | Knife: Stainless Steel |
| Materials | Anvil: Stainless Steel | Anvil: Stainless Steel | Anvil: Stainless Steel |
| | Tube: Aluminum | Tube: Aluminum | Tube: Aluminum |
| Biocompatibility | Evaluated per ISO 10993-1
series and FDA 2016
biocompatibility guidance | Evaluated per ISO 10993-1
series and FDA 2016
biocompatibility guidance | Evaluated per ISO 10993-1
series |
| Single Use | Yes | Yes | Yes |
| Disposable | Yes | Yes | Yes |
| Sterile | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| Shelf Life | 5 years | 5 years | 5 years |
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 devices.
-
- Performance Test _ In-Vitro
- . Visual inspection on product, packaging and instruction for use
- . Safety lock release force test
- Staple formation on test media .
- Anvil attach force test
- . Anvil detach force test
- . Clamping force test
- . Unclamping force test
- Firing force test ●
The acceptance criteria of each test within the In-Vitro section has been satisfied and results deemed acceptable.
-
- Performance Test _ Ex-Vivo
- EX-Vivo Firings .
- Knife cut evaluation .
- . Leak / Burst test
7
All units evaluated vielded comparable or better results in accordance with the acceptance criteria for Ex-Vivo test, which demonstrate the substantial equivalence of the subject devices as compared to the predicate device.
-
- Performance Test _ In-Vivo Study
- Atraumatic tissue test ●
- Hemostasis test ●
- Staple formation on tissues
- . Chronic survival study
All units evaluated yielded comparable or better results in accordance with the acceptance criteria for In-Vivo acute test, which demonstrate the substantial equivalence of the subject devices as compared to the predicate device.
The chronic animal study performed to evaluate the performance of the subject device and predicate device shows no differences in healing metrics or anastomotic index.
-
- Performance Test Human Factors/Usability per IEC 62366 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
- Human factors evaluation was conducted on the subject device and the predicate . devices. This testing report has been included in the predicate submission (K172361).
- . The usability testing validated the performance of the device meets identified user needs and intended use; validated potential use errors identified which have been mitigated through the product design or instruction; validate training and instruction via the proposed device Instruction for Use on device operation.
- The results of the testing demonstrate the substantial equivalence of the subject ● devices as compared to the predicate device.
-
- Biocompatibility tests per ISO 10993-1 and FDA guidance "Use of international Standard ISO 10993-1" issued June 16, 2016
- Cytotoxicity test o
- Sensitization .
- Intracutaneous irritation
- . Acute system toxicity
- . Pyrogenicity
The biocompatibility test results support the subject devices are biocompatible.
-
- Sterilization assessment per ISO 11135
- Overkill method used for validation ●
- ETO residual test
The sterilization validation demonstrates the sterilization cycle used for the single use devices can effectively achieve a minimum Sterility Assurance Level (SAL)of 10-6.
-
- Stability/Shelf-life studies
- Aging test for 5 years shelf life ●
- . Product and packaging functional test
The stability study results support a 5-year shelf life of the single use devices.
8
-
- 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 intended use, technological characteristics and supporting performance data summarized above, we concluded that the new subject devices EEA™ Circular Stapler with Tri-Staple™ Technology are substantially equivalent to the legally-marketed predicate devices K172361 and K062850.