(185 days)
No
The description mentions a "microprocessor controlled stapler" and "software verification & validation activities," but there is no mention of AI, ML, or any learning or adaptive capabilities. The device appears to be a standard electronically controlled surgical stapler.
No
The device is a surgical stapler used for creating anastomoses during surgery, which is a tool for a medical procedure rather than a therapeutic device that directly treats a disease or condition.
No
The Signia™ stapler is a surgical device used to create anastomoses (connections) in the alimentary tract by deploying staples and resecting tissue. It is a tool for performing a surgical procedure, not for diagnosing a condition.
No
The device description explicitly states it is a "battery powered microprocessor controlled stapler" and includes various hardware components like a power handle, power shell, circular adapters, and reloads. It also mentions electrical safety and EMC testing, which are relevant to hardware.
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-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries" within the alimentary tract. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical stapler system used for physically joining tissues. It involves mechanical components, power, and staples.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical tool used for treatment during a procedure.
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
GDW, GAG
Device Description
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 stapler that provides push-button powered maneuverability and firing of compatible reloads. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, 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.
The Signia™ Stapler has been previously cleared through K160176 for use with various Covidien reloads. By introducing new devices such as Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, the Signia™ Stapler can be used for the new indication of creating circular anastomoses throughout the alimentary tract in both open and laparoscopic surgeries.
The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ Power Handle and the Signia™ Power Shell to make up the Signia™ stapler. The circular adapters are composed of motor-mating connectors, sensor qauge, and device communications interfaces to provide functionality and communications between compatible reloads and the Signia™ Power Handle. The user can manually rotate the handle in 0, 90, 180 degrees to position the device if required, and the user can fire within these locked and rotated positions. The circular adapters are available in two shaft lengths, standard and extra-long, and both sizes are compatible with the new Tri-Staple™ 2.0 circular reloads.
The Tri-Staple™ 2.0 circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as end-to-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for a medium/thick tissue thickness range, which is identified by the purple staple qiuide. The circular reloads deploy three height-progressive rows of 3.0 mm. 3.5 mm and 4.0 mm titanium staples. The Tri-Stable™ 2.0 technology incorporated in the reloads is essentially the same as the legally-marketed bredicate K172361 in terms of reload design. The circular reloads are provided sterile for single use, and available in five lumen sizes: 21, 25, 28, 31, and 33 mm. The Tit-Top™ anvil is available with all circular reloads.
To create a circular anastomosis, the Signia™ Stapler consists of the Signia™ Power Handle, Signia™ Power Shell, Signia™ Circular Adapter, and Tri-Staple™ 2.0 circular reload. The existing system accessories such as Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray (optional), and Signia™ Four-Bay Smart Charger (optional) can be also used.
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, cleaning, sterilization, and use of surgical devices. ... sterile operating room environment.
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 - The following testing has been performed to demonstrate substantial equivalence to the predicate device. When possible FDA-recognized standards were considered:
- Stability/Shelf Life study results support a 5-year shelf life of the single use devices.
- Ethylene oxide (EO) sterilization validation demonstrates the sterilization cycle used for the single use devices can effectively achieve a minimum Sterility Assurance Level (SAL) of 10-6.
- Reprocessing validation performed per the FDA 2015 reprocessing quidance demonstrates that, when the reprocessing instructions are followed, the new reusable devices can be properly cleaned and sterilized prior to each use.
- Reliability data supports the end of life of the reusable adapters.
- Biocompatibility evaluation conducted in accordance with the FDA's 2016 quidance and ISO 10993-1 supports that the subject devices are biocompatible.
- Software verification & validation activities completed in accordance with the FDA's 2015 guidance and IEC 62304 demonstrates that, when the subject devices are used with the Signia™ Stapler, they successfully meet the software specifications.
- Electrical safety testing per ANSI/AAMI ES 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2 confirms that the new devices meet safety requirements.
- Performance testing such as bench top, in-vivo and ex-vivo animal testing demonstrates the substantial equivalence of the subject devices as compared to the predicate device and/or meeting the product specifications. Such testing includes, for example, chip communication test, interlock test, linear to EEA back to linear firings, tissue abrasion, hemostasis, staple formation in media and animal tissue, burst test, and across staple line firing.
- Usability evaluation performed following IEC 60601-1-6 and IEC 62366-1 demonstrates that the subject devices meet product design specifications by validating various use cases as well as Instructions for Use (IFU) and training.
- Chronic animal study performed to evaluate the performance of the subject device and predicate device shows no differences in healing metrics or anastomotic index, and the results demonstrate that the acceptance criteria were met.
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 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 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.
March 14, 2019
Covidien Ms. Katherine Choi Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K182475
Trade/Device Name: Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: September 7, 2018 Received: September 10, 2018
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. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by David David Krause -S Krause -S Date: 2019.03.14 08:09:44 -04'00 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) K182475
Device Name
Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads (For use with Signia™ Stapler)
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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3
510(k) Summary
DATE PREPARED:
March 13, 2019
SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
CONTACT PERSON:
Katherine Y. Choi, RAC Principal Requlatory Affairs Specialist Telephone: (203) 492-8412 Fax: (203) 492-5029
IDENTIFICATION OF DEVICE:
Proprietary/Trade Name:
Classification Name: Regulation Number: Product Code: Device Class: Review Panel: Common Name:
Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads (For use with Signia™ Stapler) Staples, Implantable 21 CFR 878.4750 GDW Class II General and Plastic Surgery Surgical Stapler
PREDICATE DEVICE:
Proprietary/Trade Name: 510(k) Number: Classification Name: Requlation Number: Product Code: Device Class: Review Panel: Common Name:
EEA™ circular stapler with Tri-Staple™ technology K172361 (Feb 16, 2018) Staples, Implantable 21 CFR 878.4750 GDW, GAG Class II General and Plastic Surgery Surgical Stapler
DEVICE DESCRIPTION:
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 stapler that provides push-button powered maneuverability and firing of compatible reloads. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, 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.
The Signia™ Stapler has been previously cleared through K160176 for use with various Covidien reloads. By introducing new devices such as Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, the Signia™ Stapler can be used for the new indication of creating circular anastomoses throughout the alimentary tract in both open and laparoscopic surgeries.
4
The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ Power Handle and the Signia™ Power Shell to make up the Signia™ stapler. The circular adapters are composed of motor-mating connectors, sensor qauge, and device communications interfaces to provide functionality and communications between compatible reloads and the Signia™ Power Handle. The user can manually rotate the handle in 0, 90, 180 degrees to position the device if required, and the user can fire within these locked and rotated positions. The circular adapters are available in two shaft lengths, standard and extra-long, and both sizes are compatible with the new Tri-Staple™ 2.0 circular reloads.
The Tri-Staple™ 2.0 circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as end-to-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for a medium/thick tissue thickness range, which is identified by the purple staple quide. The circular reloads deploy three height-progressive rows of 3.0 mm. 3.5 mm and 4.0 mm titanium staples. The Tri-Stable™ 2.0 technology incorporated in the reloads is essentially the same as the legally-marketed bredicate K172361 in terms of reload design. The circular reloads are provided sterile for single use, and available in five lumen sizes: 21, 25, 28, 31, and 33 mm. The Tit-Top™ anvil is available with all circular reloads.
To create a circular anastomosis, the Signia™ Stapler consists of the Signia™ Power Handle, Signia™ Power Shell, Signia™ Circular Adapter, and Tri-Staple™ 2.0 circular reload. The existing system accessories such as Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray (optional), and Signia™ Four-Bay Smart Charger (optional) can be also used.
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.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Tri-Staple™ technology used in the subject devices are fundamentally the same as the predicate device K172361 with an exception that the subject devices employ the powered stapling technology. Covidien is extending the powered feature to the circular stapling application as an evolution of stapling technology to utilize the advantages of powered stapling, such as push-button operations, and controlled compression, stapling, and cutting, which resulted in consistent staple lines when compared to the manual instrument where the same actions are achieved through the user's manual force. This is accomplished by introducing the new devices for the currently-marketed Signia™ Stapler (K160176).
SUBSTANTIAL EQUIVALENCE:
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is the same as the legally-marketed EEA™ Circular Stapler with Tri-Staple™ Technology in K172361 in terms of the intended use and indications for use. Covidien's proprietary Tri-Staple™ technology is fundamentally the same between the subject and predicate devices. The notable difference is the operating principle of powered versus manual. For example, the clamp, staple, and cut strokes are controlled separately in the Signia™ stapler whereas the predicate device performs the staple and cut functions almost simultaneously. Also, the subject devices are equipped with an advanced software algorithm called Controlled Tissue Compression (CTC). The subject devices offer several safety features controlled by software as well as a manual recovery process using the retraction tool. The below table further summarizes the similarities and differences between the subject and predicate devices.
5
| Feature | New/Subject Devices | Predicate Device K172361 |
|---|---|---|
| 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-end, end-to-side, | ||
| and side-to-side anastomoses in both open | ||
| and laparoscopic surgeries. | The EEA™ 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-side anastomoses in | ||
| both open and laparoscopic surgeries. | ||
| Operating | ||
| Principle | Software-controlled and powered by a built-in | |
| battery with push button controls, and | ||
| Controlled Tissue Compression (CTC) feature | Manual - activated by squeezing the handle | |
| firmly as far as it will go. | ||
| Construction | Signia™ Stapler consists of the Signia™ | |
| Power Handle, Signia™ Power Shell, | ||
| Signia™ Circular Adapter (Standard and XL), | ||
| and Tri-Staple™ 2.0 circular single-use | ||
| reload | One integrated piece with handle and reload, | |
| unable to detach | ||
| Stapler Shaft | Circular Adapter Standard: 25cm | Standard length: 22cm |
| Length | Circular Adapter XL: 30cm | Extra length XL: 35cm |
| Audible | ||
| Feedback | Electronic beeps | Manual clicks |
| Firing Force | Pushing the toggle key to fire | Manual squeezing to fire (staple and cut) |
| Safety Features | Various error handlings and recovery modes | Manual Safety Lever |
| Intelligent | ||
| Interface | Yes - Provided intelligent interface of reloads | |
| and adapters with ID-chips | No electronic parts | |
| Reusable | ||
| Device | Signia™ Circular Adapters (including trocar) | |
| and Trocar Tip protector are reusable | The entire device is for single use | |
| Biocompatibility | Evaluated per ISO 10993 series and FDA | |
| 2016 biocompatibility guidance | Evaluated per ISO 10993 series and FDA 2016 | |
| biocompatibility guidance | ||
| Tri-Staple™ 2.0 Circular Reloads | ||
| Staple Design | Same as the predicate | Tri-Staple™ Technology: 3 staggered rows of |
| staples with different staple height in each | ||
| staple row | ||
| Staple Height | Same as the predicate | 3.0mm, 3.5mm, 4.0mm |
| Anvil Design | Same as the predicate | 3 staggered rows of anvil bucket, |
| Lipless design. | ||
| Anvil Center | ||
| Rod | Same as the predicate | Over mold center rod design |
| Indicated Tissue | ||
| Thickness | ||
| Range | Same as the predicate | Medium/Thick (purple) reloads: |
| 1.5 - 2.25 mm (0.060" - 0.090") | ||
| Lumen Sizes | 21mm/25mm/28mm/31mm/33mm | 28mm/31mm/33mm |
| Sterilization | ||
| Method | Same as the predicate | Ethylene oxide (EO) |
| Other Devices | ||
| Packaged with | ||
| the Reloads | Tilt-Top™ anvil Anvil tips (blunt or sharp) Tri-Staple™ 2.0 introducer device (also | |
| known as TAIDs) for 21 and 25 mm Irrigation channel (optional accessory) | Tilt-Top™ anvil Anvil tips (blunt or sharp) |
6
SUMMARY OF STUDIES:
Non-clinical performance data - The following testing has been performed to demonstrate substantial equivalence to the predicate device. When possible FDA-recognized standards were considered:
- . Stability/Shelf Life study results support a 5-year shelf life of the single use devices.
- Ethylene oxide (EO) sterilization validation demonstrates the sterilization cycle used for the ● single use devices can effectively achieve a minimum Sterility Assurance Level (SAL) of 10°.
- . Reprocessing validation performed per the FDA 2015 reprocessing quidance demonstrates that. when the reprocessing instructions are followed, the new reusable devices can be properly cleaned and sterilized prior to each use.
- . Reliability data supports the end of life of the reusable adapters.
- . Biocompatibility evaluation conducted in accordance with the FDA's 2016 quidance and ISO 10993-1 supports that the subject devices are biocompatible.
- . Software verification & validation activities completed in accordance with the FDA's 2015 guidance and IEC 62304 demonstrates that, when the subject devices are used with the Signia™ Stapler, they successfully meet the software specifications.
- Electrical safety testing per ANSI/AAMI ES 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2 confirms that the new devices meet safety requirements.
- Performance testing such as bench top, in-vivo and ex-vivo animal testing demonstrates the . substantial equivalence of the subject devices as compared to the predicate device and/or meeting the product specifications. Such testing includes, for example, chip communication test, interlock test, linear to EEA back to linear firings, tissue abrasion, hemostasis, staple formation in media and animal tissue, burst test, and across staple line firing.
- . Usability evaluation performed following IEC 60601-1-6 and IEC 62366-1 demonstrates that the subject devices meet product design specifications by validating various use cases as well as Instructions for Use (IFU) and training.
- . Chronic animal study performed to evaluate the performance of the subject device and predicate device shows no differences in healing metrics or anastomotic index, and the results demonstrate that the acceptance criteria were met.
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 supporting data summarized above, we concluded that the new devices SigniaTM circular adapters and Tri-Staple™ 2.0 circular single use reloads are, when used with the already-marketed Signia™ stapler, as safe and effective as the legally-marketed predicate device K172361, and does not raise different questions of safety and effectiveness than the predicate device.