(214 days)
Not Found
No
The summary mentions a "microprocessor controlled surgical stapler" and "software version installed," but there is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No.
This device is a surgical stapler used for creating anastomoses, which is a surgical tool rather than a therapeutic device designed to treat a disease or improve health outcomes directly.
No
The device is a surgical stapler used for creating anastomoses during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components like reusable instruments, motor-mating connectors, sensor gauges, and a battery-powered microprocessor-controlled surgical stapler. While software is mentioned as controlling the stapler's application (linear or circular), the device is fundamentally a hardware-based surgical stapler system.
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 "creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries" within the alimentary tract. This describes a surgical procedure performed on the patient's body.
- Device Description: The description details a "surgical stapler" used for "surgical stapling." This is a surgical instrument used during a procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform such tests.
The device is a surgical instrument used during a surgical procedure, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
Product codes
GAG, GDW
Device Description
The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).
The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.
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
medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. ... in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
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 testing was performed including: Reprocessing per ISO 17664, Sterilization per ISO 11135, Stability/Shelf Life, Biocompatibility per ISO 10993-1, Software verification & validation activities completed per IEC 62304, Cybersecurity Assessment following FDA's Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued September 27, 2023, Electrical safety report per ANSI/AAMI ES 60601-1 and electromagnetic compatibility (EMC) report per IEC 60601-1-2, Performance testing such as bench top, in-vivo and ex-vivo animal testing, Chronic animal study, Usability evaluation performed per IEC 62366-1, and Reliability testing. Previously demonstrated compliance for MR safety information (K221629) and Ethylene oxide (EO) sterilization were unimpacted. This submission does not require clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4740 Surgical stapler.
(a) Surgical stapler for external use.
(1)
Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.(b) Surgical stapler for internal use.
(1)
Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
4 ) Avoidance of use of the stapler on the aorta;(
5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
6 ) Ensuring stapler compatibility with staples; and(
7 ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.
0
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 & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 01, 2024
Covidien (Part of Medtronic) Carolina Cabezas Sr. Regulatory Affairs Specialist 60 Middletown Ave. North Haven, Connecticut 06473
Re: K240881
Trade/Device Name: Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL) (For use with Signia™ Stapler) Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical stapler Regulatory Class: Class II Product Code: GAG. GDW Dated: March 29, 2024 Received: April 1, 2024
Dear Carolina Cabezas:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is by Tek N. Lamichhane -S. The date of the signature is 2024.11.01 11:29:48 -04'00'.
Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240881
Device Name
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)
Indications for Use (Describe)
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of 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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K240881
Image /page/4/Picture/1 description: The image shows the logo for Covidien, a healthcare products company. The logo consists of a blue square with a white rectangle in the center and a light blue vertical line running through the middle. To the right of the square is the word "COVIDIEN" in blue, sans-serif font. Below the logo is the text "Page 1 of 2" in black.
510(k) Summary
DATE PREPARED:
November 1, 2024
SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
CONTACT PERSON:
Carolina Cabezas Sr. Requlatory Affairs Specialist Telephone: (203) 492-6054 carolina.m.cabezas@medtronic.com
IDENTIFICATION OF DEVICE:
Proprietary/Trade Name:
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia ™ Circular Adapter XL Length (SIGCIRXL) Classification Name: Surgical Stapler 21 CFR 878.4740 Regulation Number: Device Class: Class II GAG (Primary), GDW (Secondary) Product Code: General and Plastic Surgery Review Panel: Common Name: Surgical Stapler
PREDICATE DEVICE:
| 510(k) Number | K221629 (Feb 22, 2023) |
|---|---|
| Proprietary/Trade | |
| Name | Tri-Staple 2.0 Black Circular |
| Reloads (for use with Signia | |
| Circular Adapters) | |
| Classification Name | Surgical Stapler |
| Regulation Number | 21 CFR 878.4740 |
| Device Class | Class II |
| Product Code | GAG, GDW |
| Review Panel | General and Plastic Surgery |
| Common Name | Surgical Stapler |
DEVICE DESCRIPTION:
The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).
The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is
5
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K240881
indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.
INDICATIONS FOR USE:
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
TECHNOLOGICAL CHARACTERISTICS:
The modified Signia™ circular adapters have the same intended use, material, and operational principles as the predicate Signia™ circular adapters (K221629). The design of the modified Signia™ circular adapters remains similar to the predicate Signia™ circular adapters (K221629). The main difference between the subject Signia™ circular adapters and the predicate Signia™ circular adapters is that the subject adapters have a fixed trocar rather than a removable trocar design. The function and use of the circular adapters remain the same as the predicate K221629.
NON-CLINICAL TESTING:
The below non-clinical testing was performed:
- Reprocessing per ISO 17664
- . Sterilization per ISO 11135
- . Stabilitv/Shelf Life
- . Biocompatibility per ISO 10993-1
- . Software verification & validation activities completed per IEC 62304
- . Cybersecurity Assessment following FDA's Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued September 27, 2023.
- . Electrical safety report per ANSI/AAMI ES 60601-1 and electromagnetic compatibility (EMC) report per IEC 60601-1-2
- Performance testing such as bench top, in-vivo and ex-vivo animal testing
- Chronic animal study
- Usability evaluation performed per IEC 62366-1
- Reliability testing
Previously demonstrated compliance for the following aspects remains unimpacted:
- MR safety information has been previously cleared via K221629 and no change has been made to ● impact MR characteristics.
- . Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility Assurance Level (SAL) of 10-6
CLINICAL TESTING:
This submission does not require clinical testing.
CONCLUSION:
Based upon the supporting data summarized above, the modified Signia™ circular adapters, when used with the existing Signia™ stapler, are substantially equivalent to the legally marketed predicate devices.