(27 days)
No
The document describes a microprocessor-controlled surgical stapler with powered maneuverability and firing. While it mentions a "Smart Charger" with enhanced features and a data management interface, there is no mention of AI or ML being used for any function of the device itself, such as tissue analysis, firing optimization, or surgical guidance. The performance studies listed are standard medical device testing (software, electrical safety, EMC, usability) and do not indicate AI/ML model validation.
No.
This device is described as a surgical stapler used for cutting and stapling tissues during various surgical procedures, not for treating or rehabilitating a medical condition.
No
The Signia™ Stapler is described as a surgical device for stapling and cutting tissues, used for resection, transection, and creation of anastomosis, which are therapeutic actions, not diagnostic.
No
The device description explicitly states it is a "battery powered microprocessor controlled surgical stapler" and lists several hardware components and accessories, including a power handle, power shell, and chargers. This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided text, the Signia™ Stapler is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical stapler used for procedures like resection, anastomosis, and transection of tissues within the body during surgery. This is an in vivo application (within a living organism), not an in vitro application (outside the body, typically on biological samples).
- Device Description: The description details a battery-powered surgical stapler and its accessories, all designed for use in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, or tissue) to diagnose diseases or conditions.
Therefore, the Signia™ Stapler is a surgical device, not 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, and creation of anastomosis. It may be used for transection 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 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 of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.
Product codes
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 compatible with Endo GJA™ 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™ Otape - roomnology, 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, preparation, cleaning, sterilization, and use of surgical devices. All of which stay unchanged when compared to the predicate device.
The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ The Signia - System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray, and this submission introduces a new accessory, Signia™ Four-Bay Smart Charger. The Smart Charger's primary purpose introduces a new as the Signia Single-Bay Charger in K160176, but the difference is that Smart Charger offers enhanced features such as four charging stations, a touch-screen LCD display, and data management interface in order to improve user convenience.
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, biliary structures, pancreas.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals qualified in the transportation, preparation, 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)
Non-clinical performance data – Tests performed to demonstrate continued conformance with the FDA recognized standards includes:
-
- Software Verification & Validation per IEC 62304
-
- Electrical Safety Testing per ANSI/AAMI ES 60601-1 & IEC 60601-1
-
- EMC Testing per IEC 60601-1-2
-
- Usability Evaluation per IEC 60601-1-6 & IEC 62366-1
Clinical performance data -- No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
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
§ 878.4750 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Covidien Ms. Katherine Choi Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K170348
Trade/Device Name: Signia Four-Bay Smart Charger (to Be Used With Signia Stapler) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: February 2, 2017 Received: February 3, 2017
Dear Ms. Choi:
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 device
1
related 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.
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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170348
Device Name
Signia™ Four-Bay Smart Charger
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, and creation of anastomosis. It may be used for transection 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 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 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) |
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3
510(k) Summary of Safety and Effectiveness
DATE PREPARED:
February 2, 2017
SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
CONTACT PERSON:
Katherine Y. Choi, RAC Principal Regulatory Affairs Specialist Telephone: (203) 492-8412 Fax: (203) 492-5029
IDENTIFICATION OF DEVICE:
Signia™ Four-Bay Smart Charger (to be used with Signia™ Stapler) Proprietary/Trade Name: Staples, Implantable Classification Name: 21 CFR 878.4750 Requiation Number: Product Code: GDW Class II Device Class: General and Plastic Surgery Review Panel: Surgical Stapler Common Name:
PREDICATE DEVICE:
Proprietary/Trade Name: Signia™ Stapler K160176 (April 26, 2016) 510(k) Number: Classification Name: Staples, Implantable 21 CFR 878.4750 Requlation Number: Product Code: GDW Device Class: Class II General and Plastic Surgery Review Panel: Surgical Stapler Common Name:
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 compatible with Endo GJA™ 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™ Otape - roomnology, 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, preparation, cleaning, sterilization, and use of surgical devices. All of which stay unchanged when compared to the predicate device.
The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ The Signia - System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray, and this submission introduces a new accessory, Signia™ Four-Bay Smart Charger. The Smart Charger's primary purpose introduces a new as the Signia Single-Bay Charger in K160176, but the difference is that Smart
4
Charger offers enhanced features such as four charging stations, a touch-screen LCD display, and data management interface in order to improve user convenience.
INTENDED USE/INDICATIONS FOR USE:
The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads Trie Signia - Olapic, When assumments 2.0 single-use reloads and Signia™ loading units with Tri-Willi Theolape - " Connology, " The Suplications in abdominal, gynecological, pediatric, and thoracic Otapic - 2.0 Single doo carthagoo, had creation of anastomosis. It may be used for transection and Surgery for research, transculative, 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 The Sightia - Stapler, when asou with Endo One - Carrou appearate target tissue from other certain tissue.
The Signia™ Stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ The Olgina - Oldpler, whon acount minimally invasive general abdominal, gynecologic, pediatric recimology, nua upplication of tissue and creation of tissue and creation of anastomosis, as well as and thorable surgery for roosenen and atterior resection. It may be used for transection and resection applivation deep in the porner, for 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™ The olgha - Oldplar, 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 romoroco "proloado" proloaded" in d therecic surgery for resection, transection of tissue and creation abounting, gynoongly pound for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Signia™ Four-Bay Smart Charger is designed for use as an accessory with the Signia™ stapler, The Signia - Tour Day offical Jana Jana touch-screen LCD display screen. Its purpose who houded four power handle. The touchscreen LCD is used to indicate the power handle's is to onalye the organia - power hanigdia™ Single Bay Charger in K160176, the Signia™ Four-Bay Smart Charger employs the smart charging mechanism that provides necessary voltage and current regulation for the given battery chemistry.
SUBSTANTIAL EQUIVALENCE:
The Signia™ Stapler used with the Signia™ Four-Bay Smart Charger is substantially equivalent to the TTIe Signia - Olapics asou with the Signia - the Signia " Single-Bay Charger (K160176) since adding a new charger does not affect the stapling technologies employed. Also, when compared to the Signia™ new onarger, the key difference is the Smart Charger offers enhanced features such as four charging stations, touch-screen LCD display and data ports. Other product specifications are very similar.
SUMMARY OF STUDIES:
Non-clinical performance data – Tests performed to demonstrate continued conformance with the FDA recognized standards includes:
-
- Software Verification & Validation per IEC 62304
-
- Electrical Safety Testing per ANSI/AAMI ES 60601-1 & IEC 60601-1
-
- EMC Testing per IEC 60601-1-2
-
- Usability Evaluation per IEC 60601-1-6 & IEC 62366-1
5
Clinical performance data -- No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
CONCLUSION:
Based upon the supporting data summarized above, we concluded that Signia" with the new Based upon the Supporting add Summanized as safe and effective as the legally marketed device accessory, Sigma - Tour-Day Omart Online of safety and effectiveness than the predicate device.