(261 days)
Not Found
No
The document mentions the device is "battery powered microprocessor controlled" but does not include any terms or descriptions related to AI, ML, deep learning, image processing, or data-driven algorithms for decision making. The performance studies focus on traditional device validation methods.
No
The device is a surgical stapler used for creating anastomoses, which is a surgical tool, not a therapeutic device that treats or cures a disease.
No
The device is a surgical stapler used for creating anastomoses in the alimentary tract, not for diagnosing conditions or diseases.
No
The device description explicitly states it is a "battery powered microprocessor controlled surgical stapler" and mentions hardware components like "circular adapters" and "circular single use reloads." It also details hardware-related testing like "Electrical safety testing" and "electromagnetic compatibility (EMC) testing."
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 directly on the patient's body.
- Device Description: The description details a surgical stapler and its components (reloads, adapter, anvil). These are tools used for physical manipulation of tissue during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is a surgical instrument used in vivo (within the living body), not in vitro (in glass, referring to laboratory testing).
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 (comma separated list FDA assigned to the subject device)
GAG, GDW
Device Description
The Tri-Staple™ 2.0 black 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 endto-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for an extra thick tissue thick is identified by the black staple quide. The circular reloads deploy three height-progressive rows of 4.0 mm. 4.5 mm staples. The Tri-Staple™ technology incorporated in the black reload is essentially the same as the legally-marketed K192330 in terms of reload design. The Tri-Staple™ 2.0 black circular reloads are provided sterile for single use, and available in three lumen sizes: 28, 31, and 33 mm. The Tilt-Top™ anvil is available with all circular reloads.
The Tri-Staple™ 2.0 black reloads are for use with the previously-marketed Signia™ Circular Adapter. as part of the Signia™ stapler. 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 surqical 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.
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 studies have been performed to demonstrate substantial equivalence to the predicate devices. When possible, applicable FDA-recognized standards were considered:
- Stability/Shelf-Life study for the single use devices
- Performance testing such as bench top, ex-vivo, and in-vivo pre-clinical testing
- Usability study performed following the FDA's 2016 guidance as well as IEC 62366-1
- Chronic GLP study performed to evaluate the performance in healing metrics and anastomotic index
To address additional design improvements implemented to the previously cleared device. the following supporting data has been included:
- Disinfection validation performed per the FDA 2015 reprocessing guidance
- Reliability data supporting the extended end of life of the reusable devices
- Biocompatibility evaluation conducted in accordance with the FDA's 2020 guidance and ISO 10993-1
- Software verification & validation activities completed following the FDA's guidance documents and IEC 62304
- Cleaning reprocessing validated following the FDA 2015 reprocessing guidance
- Electrical safety testing repeated per ANSI/AAMI ES 60601-1 & IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2
MR safety information has been previously cleared via K182475 and no change has been made to impact MR characteristics, but testing has been repeated per the latest applicable standards.
Previously demonstrated compliance for the following aspects remains unimpacted:
- Sterilization reprocessing validated following the FDA 2015 reprocessing guidance
- Ethylene oxide (EO) sterilization validation for the single use devices with a minimum Sterility Assurance Level (SAL) of 10-6
Clinical performance data – No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.
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
§ 878.4740 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 contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo is in blue and features the agency's acronym next to the words "U.S. FOOD & DRUG ADMINISTRATION". To the left of the FDA logo is the Department of Health & Human Services seal, which includes a stylized human figure. The overall design is clean and professional, reflecting the official nature of the organization.
March 3, 2023
Covidien Katherine Choi Sr. Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K221629
Trade/Device Name: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Adapters) Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical stapler Regulatory Class: Class II Product Code: GAG, GDW
Dear Katherine Choi:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 02/22/2023. Specifically, FDA is updating this SE Letter, the Primary Product Code and the Secondary Product Code were reversed, as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Mark Trumbore, Office of Product Evaluation and Quality, 301-796-5436, Mark.Trumbore@FDA.HHS.Gov.
Sincerely,
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.03.03
09:01:33-05'00'
Mark Trumbore Assistant Director THT4A1: Robotically-Assisted Surgical Device Team DHT4A: Devision of General Surgery Devices OHT4: Division of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services - USA logo. The second logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has a blue square with the letters FDA in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
February 22, 2023
Covidien Katherine Choi Sr. Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K221629
Trade/Device Name: Tri-Staple™ 2.0 Black Circular Reloads (for use with Sigmia™ Circular Adapters) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: January 23, 2023 Received: January 23, 2023
Dear Katherine 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 mav, 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
2
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 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 mediation-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-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
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.02.22
15:15:45 -05'00'
Mark Trumbore Assistant Director THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgerv 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)
Device Name
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
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-toside 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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4
Appendix H
Updated 510(k) Summary
5
510(k) Summary
DATE PREPARED:
January 23, 2023
SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
CONTACT PERSON:
Katherine Y. Choi, RAC Sr. Principal Regulatory Affairs Specialist Telephone: (203) 492-8412
IDENTIFICATION OF DEVICE:
Proprietary/Trade Name: Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) Classification Name: Staples, Implantable Regulation Number: 21 CFR 878.4740 Device Class: Class II Product Code: GAG (Primary), GDW (Secondary) Review Panel: General and Plastic Surgery Common Name: Surgical Stapler
PREDICATE DEVICES:
| Primary Predicate | Secondary Predicate | |
|---|---|---|
| 510(k) Number | K182475 (Mar 14, 2019) | K192330 (Jan 23, 2020) |
| Proprietary/Trade | ||
| Name | Signia Circular Adapters (for use with | |
| Signia Staplers), Tri-Staple 2.0 | ||
| Circular Reloads (for use with Signia | ||
| Circular Adapters) | EEA™ circular stapler with Tri- | |
| Staple™ technology | ||
| Classification Name | Staple, Implantable | Staple, Implantable |
| Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Device Class | Class II | Class II |
| Product Code | GDW, GAG | GDW |
| Review Panel | General and Plastic Surgery | General and Plastic Surgery |
| Common Name | Surgical Stapler | Surgical Stapler |
DEVICE DESCRIPTION:
The Tri-Staple™ 2.0 black 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 endto-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for an extra thick tissue thick is identified by the black staple quide. The circular reloads deploy three height-progressive rows of 4.0 mm. 4.5 mm staples. The Tri-Staple™ technology incorporated in the black reload is essentially the same as the legally-marketed K192330 in terms of reload design. The Tri-Staple™ 2.0 black circular reloads are provided sterile for single use, and available in three lumen sizes: 28, 31, and 33 mm. The Tilt-Top™ anvil is available with all circular reloads.
6
The Tri-Staple™ 2.0 black reloads are for use with the previously-marketed Signia™ Circular Adapter. as part of the Signia™ stapler. 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 surqical 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.
As part of this submission, additional design improvements implemented since K182475 are described.
This submission also addresses the new requirements applicable to the powered circular stapler under FDA's Final Order 2021-22041 and the new FDA's quidance titled "Surgical Staplers and Staples for Internal use - Labeling Recommendations." (issued on October 8, 2021).
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:
All Tri-Staple™ 2.0 circular reloads are, as implied by the product name, designed with Covidien's proprietary Tri-Staple™ technology incorporates the triple staggered rows of titanium staples with different stable height in each staple row. It has a stepped configuration whereby the staples in the outer most row are the tallest and the staples in the inner most row are the smallest. The staple cartridge has a sloping tissue surface which provides for a graduated tissue gap, and provides for each row of staples to effectively have its own tissue qap.
The Tri-Staple™ 2.0 black reloads are for use with Signia™ stapler, which employs the powered stapling technology. The advantages of powered stapling, such as push-button operations, software-controlled tissue compression, stapling, and cutting are included, which resulted in consistent staple lines when compared to the manual instrument where the same actions are achieved through the user's manual force. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.
Above fundamental technologies stay the same as K182475 except for the following design difference: The new reloads will be offered for an extra thick tissue range, which is identified by the black staple guide. The reloads deploy three (3) height-progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The Tri-Staple™ technology incorporated in the new 'black' reloads is identical to the marketed manual circular staplers cleared under K192330.
SUBSTANTIAL EQUIVALENCE:
The below table summarizes the similarities and differences between the subject and predicate devices.
7
| Feature | Subject Device | Primary Predicate K182475 | Secondary Predicate K192330 |
|---|---|---|---|
| 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 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. | |||
| Target Anatomy | Alimentary tract | Alimentary tract | Alimentary tract |
| Surgical | |||
| procedures | Both open and laparoscopic surgeries | Both open and laparoscopic surgeries | Both open and laparoscopic surgeries |
| Operating | |||
| Principle | Software-controlled and powered by a | ||
| built-in battery with push button controls. | |||
| The CTC is now called Adaptive | |||
| Compression Technology (ACT). | 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. | |||
| Stapler Shaft | |||
| Length | Circular Adapter - Standard: 25cm | ||
| Circular Adapter - XL: 30cm | Circular Adapter - Standard: 25cm | ||
| Circular Adapter - XL: 30cm | Standard length: 22cm | ||
| Extra length XL: 35cm | |||
| Audible Feedback | Electronic beeps | Electronic beeps | Manual clicks |
| Firing Force | Pushing the toggle key to fire | Pushing the toggle key to fire | Manual squeezing to fire |
| Safety Features | Error handlings and Recovery modes | Error handlings and Recovery modes | Safety Lever (red color) |
| Intelligent | Yes - provides intelligent interface of | Yes - provides intelligent interface of | No - manual instrument without any ID |
| interface | reloads and adapters with ID-chips | reloads and adapters with ID-chips | chips or electronic parts |
| Biocompatibility | Evaluated per ISO 10993 series and | ||
| FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and | ||
| FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and | ||
| FDA 2016 biocompatibility guidance | |||
| Circular Reloads | |||
| Staple Design | Tri- Staple™ Technology | Tri- Staple™ Technology | Tri-Staple™ Technology |
| Staple Rows | 3 staggered rows of staples with different | ||
| staple height in each staple row | 3 staggered rows of staples with different | ||
| staple height in each staple row | 3 staggered rows of staples with different | ||
| staple height in each staple row | |||
| Staple Material | Titanium per ASTM F67 Grade I | Titanium per ASTM F67 Grade I | Titanium per ASTM F67 Grade I |
| Guide Color | Black | Purple | Black |
| Staple Height | 4.0mm, 4.5mm 5.0mm | 3.0mm, 3.5mm, 4.0mm | 4.0mm, 4.5mm 5.0mm |
| Closed Heights | 1.5mm, 1.75mm, 2.0mm | 1.2mm, 1.5mm, 1.75mm | 1.5mm, 1.75mm, 2.0mm |
| Indicated Tissue | Extra Thick (black) reloads: | Medium/Thick (purple) reloads: | Extra Thick (black) reloads: |
| Thickness Range | 2.25 - 3.0mm (0.090" - 0.120") | 1.5 - 2.25mm (0.060" - 0.090") | 2.25 - 3.0mm (0.090” – 0.120") |
| Shell Diameter/ | |||
| Lumen Sizes | 28mm/31mm/33mm | 21mm/25mm/28mm/31mm/33mm | 28mm/31mm/33mm |
| 25mm added later by K202507 | |||
| Sterilization | Ethylene oxide (EO) | Ethylene oxide (EO) | Ethylene oxide (EO) |
| Biocompatibility | |||
| -Reloads | Evaluated per ISO 10993 series and | ||
| FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and | ||
| FDA 2016 biocompatibility guidance | Evaluated per ISO 10993 series and | ||
| FDA 2016 biocompatibility guidance |
8
SUMMARY OF STUDIES:
Non-clinical performance data - The following studies have been performed to demonstrate substantial equivalence to the predicate devices. When possible, applicable FDA-recognized standards were considered:
- . Stability/Shelf-Life study for the single use devices
- Performance testing such as bench top, ex-vivo, and in-vivo pre-clinical testing ●
- Usability study performed following the FDA's 2016 guidance as well as IEC ● 62366-1
- . Chronic GLP study performed to evaluate the performance in healing metrics and anastomotic index
To address additional design improvements implemented to the previously cleared device. the following supporting data has been included:
- Disinfection validation performed per the FDA 2015 reprocessing guidance .
- . Reliability data supporting the extended end of life of the reusable devices
- ' Biocompatibility evaluation conducted in accordance with the FDA's 2020 guidance and ISO 10993-1
- Software verification & validation activities completed following the FDA's ● guidance documents and IEC 62304
- Cleaning reprocessing validated following the FDA 2015 reprocessing guidance ●
- Electrical safety testing repeated per ANSI/AAMI ES 60601-1 & IEC 60601-1 and ● electromagnetic compatibility (EMC) testing per IEC 60601-1-2
MR safety information has been previously cleared via K182475 and no change has been made to impact MR characteristics, but testing has been repeated per the latest applicable standards.
Previously demonstrated compliance for the following aspects remains unimpacted:
- Sterilization reprocessing validated following the FDA 2015 reprocessing ● guidance
- . Ethylene oxide (EO) sterilization validation for the single use devices with a minimum Sterility Assurance Level (SAL) of 10-6
Clinical performance data – No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.
CONCLUSION:
Based upon the supporting data summarized above, we concluded that the new Tri-Staple™ 2.0 black circular reloads, when used with the already-marketed Signia™ stapler, are as safe and effective as the legally marketed predicate devices, and do not raise different questions of safety and effectiveness than the predicate devices.