(178 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 (connections) between tissues, which is a surgical tool rather than a device designed to deliver therapy or treat a condition directly.
No
The device is a surgical stapler used for creating anastomoses (connections between anatomical structures) during surgery, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "manual, single-use device that places a circular, double staggered row of titanium staples and resects excess tissue," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description 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 on the patient's body.
- Device Description: The device is described as a manual, single-use stapler that places staples and resects tissue. This is a surgical instrument.
- Lack of IVD characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. There is no mention of this device being used with patient specimens or for diagnostic purposes.
The information provided describes a surgical device used for a therapeutic procedure, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The circular stapler with DST Series™ 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
GAG, GDW
Device Description
The Autosuture™ EEA™ Stapler is a manual, single-use device that places a circular. double staggered row of titanium staples and resects excess tissue. It 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.
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
This submission does not require clinical testing.
Non-clinical testing was performed for:
- Application of usability engineering to medical devices per IEC 62366-1:2015 +AMD1:2020
- Standard Test Method for Measurement of Radio Frequency Induced Heating On . or Near Passive Implants During Magnetic Resonance Imaging per ASTM F2182-19
- Standard Test Method for Measurement of Magnetically Induced Displacement . Force on Medical Devices in the Magnetic Resonance Environment per ASTM F2052-21
- Standard Test Method for Measurement of Magnetically Induced Torque on . Medical Devices in the Magnetic Resonance Environment per ASTM F2213-17
- Standard Test Method for Evaluation of MR Image Artifacts from Passive ● Implants per ASTM F2119-07
- Staple formation
- Firing force
- Staple line strength
- Staple line integrity ●
- In-vivo staple line hemostasis ●
- Biocompatibility per ISO 10993-1 .
- Sterilization per ISO 11135
- Stability/Shelf-life
Testing demonstrated that the subject device, Autosuture™ EEA™ Stapler, is substantially equivalent to the predicate devices, Autosuture™ Circular EEA Surgical Stapler and EEA Circular Stapler with Tri-Staple Technology (K062850 and K221005, respectively).
Key Metrics
Not Found
Predicate Device(s)
K062850, K221005, K202507, K192330, K172361
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 30, 2022
Covidien Sanja Jahr Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K221003
Trade/Device Name: Autosuture EEA Stapler (DST Serie EEA Stapler) Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG, GDW Dated: August 5, 2022 Received: August 8, 2022
Dear Sanja Jahr:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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 Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Autosuture™ EEATM Surgical Stapler
Indications for Use (Describe)
The circular stapler with DST Series™ Technology has application throughout the alimentary tract for the creation of endto-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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Image /page/3/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a lighter blue cross in the center, and the word "COVIDIEN" in blue, sans-serif font to the right of the square. The logo is simple and modern, and the colors are calming and professional.
Section 5: 510(k) Summary
Date Prepared:
August 5, 2022
Submitter:
Sanja Jahr Covidien 60 Middletown Avenue North Haven, CT 06473, USA Principal Regulatory Affairs Specialist 203-492-8415 sanja.jahr@medtronic.com
Alternate contact:
Angela Van Arsdale Covidien 60 Middletown Avenue North Haven, CT 06473, USA Sr. Regulatory Affairs Manager 203-492-5787 angela.vanarsdale@medtronic.com
Subject Device:
Proprietary/Trade Name:
- Classification Name: Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Autosuture™ EEA™ Stapler (DST Series™ EEA™ Stapler) Staple, Implantable and Stapler, Surqical 21 CFR 878.4750 and 21 CFR 878.4740 GDW. GAG 79 Class II General and Plastic Surgery Stapler with implantable staple
Primary Predicate Device:
Proprietary/Trade Name: 510(k) Number: Classification Name: Requlations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Autosuture™ Circular EEA Surgical Stapler K062850 Staple, Implantable 21 CFR 878.4750 GDW, GAG 79 Class II General and Plastic Surgery Stapler with implantable staple
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Image /page/4/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white rectangle inside and a light blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in a bold, sans-serif font, also in blue.
Additional Predicate Device:
| Proprietary/Trade Name: |
|---|
| 510(k) Number: |
| Classification Name: |
| Regulations Number: |
| Product Codes: |
| FDA Panel Number: |
| Device Class: |
| Review Panel: |
| Common Name: |
EEA Circular Stapler with Tri-Staple Technology K221005, K202507, K192330, K172361 Staple, Implantable 21 CFR 878.4750 GDW 79 Class II General and Plastic Surgery Stapler with implantable staple
Device Description:
The Autosuture™ EEA™ Stapler is a manual, single-use device that places a circular. double staggered row of titanium staples and resects excess tissue. It has 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.
Indications for Use:
The circular stapler with DST Series™ 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 Characteristics:
In regards to intended use, material, design, and operational principles, the subject device, Autosuture™ EEA™ Stapler, is identical to the predicate Autosuture™ EEA™ Stapler (K062850).
Non-clinical testing:
The below non-clinical testing was performed.
- . Application of usability engineering to medical devices per IEC 62366-1:2015 +AMD1:2020
- Standard Test Method for Measurement of Radio Frequency Induced Heating On . or Near Passive Implants During Magnetic Resonance Imaging per ASTM F2182-19
- Standard Test Method for Measurement of Magnetically Induced Displacement . Force on Medical Devices in the Magnetic Resonance Environment per ASTM F2052-21
- Standard Test Method for Measurement of Magnetically Induced Torque on . Medical Devices in the Magnetic Resonance Environment per ASTM F2213-17
- Standard Test Method for Evaluation of MR Image Artifacts from Passive ● Implants per ASTM F2119-07
- . Staple formation
- Firing force
- Staple line strength
- Staple line integrity ●
- In-vivo staple line hemostasis ●
5
Image /page/5/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white square inside, and a blue vertical line running through the center. To the right of the square is the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
- Biocompatibility per ISO 10993-1 .
- . Sterilization per ISO 11135
- Stability/Shelf-life
Testing demonstrated that the subject device, Autosuture™ EEA™ Stapler, is substantially equivalent to the predicate devices, Autosuture™ Circular EEA Surgical Stapler and EEA Circular Stapler with Tri-Staple Technology (K062850 and K221005, respectively).
Clinical Testing:
This submission does not require clinical testing.
Conclusion:
Based upon the supporting data summarized above, the subject device, Autosuture™ EEA™ Stapler, is substantially equivalent to the predicate devices, Autosuture™ Circular EEA Surgical Stapler and EEA Circular Stapler with Tri-Staple Technology.