(90 days)
Not Found
No
The description mentions a "microprocessor controlled surgical stapler" and software that controls motors based on encoder pulses. This indicates automation and control logic, but not the adaptive learning or pattern recognition characteristic of AI/ML. There is no mention of training data, test data, or algorithms typically associated with AI/ML.
No.
The device is a surgical stapler used for cutting and stapling tissues during various surgical procedures, which is an interventional/diagnostic function, not a therapeutic one.
No
Explanation: The device is described as a "surgical stapler" used for "resection, transection, and creation of anastomosis" in various surgeries. Its function is to cut and staple tissues, which falls under therapeutic intervention, not diagnosis.
No
The device description explicitly states it is a "battery powered microprocessor controlled surgical stapler" and lists hardware components like the Power Handle, Power Shell, and Linear Adapter. While it contains software, it is an integral part of a physical medical device.
Based on the provided text, the Signia™ stapler is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device's application in surgical procedures for resection, transection, and creation of anastomosis in various anatomical sites. This involves direct interaction with living tissue within the body.
- Device Description: The device description details a surgical stapler that mechanically cuts and staples tissue. It is a tool used during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Signia™ stapler does not perform any such analysis of specimens.
Therefore, the Signia™ stapler is a surgical device used in vivo (within the body) and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Signia™ stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of the pancreas.
The Signia™ stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The Signia™ stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ Technology, has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e., low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of the pancreas.
The Signia™ stapler. when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloads preloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides push-button powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ Linear Adapter. System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, and Signia™ Single Bay Charger.
The User controls the Signia™ Stapler via button presses on the Handle and receives feedback status and other information from the Handle via its OLED Display, LED indicator and audible annunciator. Pushbutton / Toggle switches on the Handle are provided for:
- Stapling activation: Advancing the Firing Rod / Clamping / Unclamping .
- Left and Right Articulation .
- Clockwise and Counter Clockwise Rotation .
When the appropriate buttons are pressed, the Signia™ Stapler software initiates stapling (firing), articulation or rotation operation by turning on the appropriate motor. The motors have built-in encoders which provide shaft position information. The software controls motor speed and position using encoder pulses. Since it is possible to press multiple keys simultaneously, software must be able to process them and take appropriate actions.
The Signia™ Stapier is compatible with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads, and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges.
The Signia™ Stapler when used with the abovementioned family of Endo GIA™ reloads is a surgical device for stapling and cutting tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecological, pediatric, and thoracic surgery; liver substance, hepatic vasculature, and biliary structures; pancreas; pelvis, i.e., low anterior resection.
Indicated Patient Age Range
pediatric
Intended User / Care Setting
medical professionals qualified in the transportation, cleaning, sterilization, and use of surgical devices.
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)
Qualitative and quantitative data were obtained and used to compare the Signia™ Stapler to the predicate iDrive Ultra™ Powered Handle with Endo GIA™ Adapter.
The design differences were found to not affect safety or performance through applicable design verification activities that showed conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing.
Tests performed to evaluate and compare technological and performance characteristics:
-
- Lifecvcle Reliability Tests
-
- Cleaning Validation Tests
-
- Aseptic Barrier Tests
-
- Functional Performance Test Bench and Animal
-
- Usability Tests
-
- Biocompatibility tests in accordance with ISO Standard 10993-1
-
- Electrical Safety Tests per IEC 60601-1
-
- EMC/EMI Tests per IEC 60601-1-2
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, layered on top of each other. These profiles are connected to three flowing shapes below, resembling fabric or ribbons. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Covidien Mr. Frank Gianelli Sr. Product Specialist Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06471
Re: K160176
Trade/Device Name: Signia Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 22, 2016 Received: January 27, 2016
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||
|---|---|---|
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 | |
| Indications for Use | Expiration Date: January 31, 2017 | |
| See PRA Statement below. | ||
| 510(k) Number (if known) | K160176 | |
| Device Name | Signia™ Stapler | |
| Indications for Use (Describe) | The Signia™ stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ | |
| Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, | ||
| has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of | ||
| anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and | ||
| for transection and resection of the pancreas. | ||
| The Signia™ stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use | ||
| reloads, can be used to blunt dissect or separate target tissue from other certain tissue. | ||
| The Signia™ stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ Technology, has | ||
| applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection | ||
| and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e., low anterior resection. | ||
| It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for | ||
| transection and resection of the pancreas. | ||
| The Signia™ stapler. when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded | ||
| with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloads preloaded with | ||
| polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for | ||
| resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, | ||
| hepatic vasculature and biliary structures, and for transection and resection of the pancreas. | ||
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including the | ||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | ||
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | ||
| of this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human Services | ||
| Food and Drug Administration | ||
| Office of Chief Information Officer | ||
| Paperwork Reduction Act (PRA) Staff | ||
| PRAStaff@fda.hhs.gov | ||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | ||
| information unless it displays a currently valid OMB number." | ||
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 |
| Covidien | ||
| Traditional 510(k) | Signia™ Stapler | January 22, 2016 |
| Page 56 |
址
3
510(k) Summary of Safety and Effectiveness
Date Prepared:
January 22, 2016
Submitter:
Covidien 60 Middletown Avenue North Haven, CT 06473
Contact:
Frank Gianelli Senior Requlatory Affairs Product Specialist Telephone: (203) 492-5352 Fax: (203) 492-5029 frank.j.gianelli@medtronic.com Email:
Name of Device:
| Trade/Proprietary Name: | Signia™ Stapler |
|---|---|
| Common Name: | Surgical Stapler with Implantable Staples |
| Classification Name: | Staples, Implantable |
| a. Panel no and product code: 79 GDW | |
| b. Regulation no: 21 CFR 878.4750 |
Predicate Device:
| Trade/Proprietary Name: | iDrive™ Ultra Powered Handle with Endo GIA™ Adapter |
|---|---|
| Common Name: | Surgical Stapler with Implantable Staples |
| Classification Name: | Staples, Implantable, (79 GDW, 21 CFR 878.4750) |
| 510(k) Number: | K121510 |
| Manufacturer: | Covidien |
Device Description:
The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides push-button powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ Linear Adapter. System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, and Signia™ Single Bay Charger.
The User controls the Signia™ Stapler via button presses on the Handle and receives feedback status and other information from the Handle via its OLED Display, LED indicator and audible annunciator. Pushbutton / Toggle switches on the Handle are provided for:
- Stapling activation: Advancing the Firing Rod / Clamping / Unclamping .
- Left and Right Articulation .
- Clockwise and Counter Clockwise Rotation .
When the appropriate buttons are pressed, the Signia™ Stapler software initiates stapling (firing), articulation or rotation operation by turning on the appropriate motor. The motors have built-in encoders which provide shaft position information. The software controls motor speed and position using encoder pulses. Since it is possible to press multiple keys simultaneously, software must be able to process them and take appropriate actions.
The Signia™ Stapier is compatible with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads, and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges.
4
The Signia™ Stapler when used with the abovementioned family of Endo GIA™ reloads is a surgical device for stapling and cutting tissues. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, cleaning, sterilization, and use of surgical devices.
Intended Use:
The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single-use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of the pancreas.
The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The Signia™ Stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ Technology, has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e., low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of the pancreas.
The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri-Staple™ 2.0 single use reinforced reloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.
- Note: The Signia™ Stapler is intended for use with Endo GIA™ Reloads, Endo GIA™ Reloads with Tri-Staple™ Technology, Signia™ Loading Units with Tri-Staple™ 2.0 cartridges and Tri-Staple™ 2.0 Reloads and does not carry a separate indication from these stapling devices.
Technological and Performance Characteristics:
The Signia™ Stapler is substantially equivalent to the predicate iDrive Ultra™ Powered Handle with Endo GIA™ Adapter in regard to the stapling technologies employed.
Qualitative and quantitative data were obtained and used to compare the Signia™ Stapler to the predicate iDrive Ultra™ Powered Handle with Endo GIA™ Adapter.
The design differences were found to not affect safety or performance through applicable design verification activities that showed conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing.
Tests performed to evaluate and compare technological and performance characteristics:
-
- Lifecvcle Reliability Tests
-
- Cleaning Validation Tests
-
- Aseptic Barrier Tests
-
- Functional Performance Test Bench and Animal
-
- Usability Tests
- Biocompatibility tests in accordance with ISO Standard 10993-1 6.
5
-
- Electrical Safety Tests per IEC 60601-1
-
- EMC/EMI Tests per IEC 60601-1-2
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusion:
Through the comparison of technological and performance characteristics and the results of rinough the Significancer vas found to be substantially equivalent to the predicate device.