The Signia™ small diameter curved tip gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of vasulature using gray reloads and thin tissue and vasculature using white reloads.

The Signia™ small diameter regular (round) tip white reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of thin tissue and the creation of anastomosis.

Device Description

Signia™ Small Diameter Reloads are 8 mm diameter reloads that shall be utilized for open and minimally invasive surgical procedures for the transection of tissue, specifically vascular and thin tissue structures. They shall be offered with both a curved tip (cleared in predicate submission K191070) and a new reqular (round) tip model. The Signia™ small diameter regular (round) tip white reloads shall be indicated for use in the creation of anastomosis.

The reload is the distal shaft and jaws of the stapler system comprised of a single-use knife. fixed anvil, and the fixed stapler cartridge with two (2) rows of titanium staples on either side of the cut line. The reload is single use only and the cartridges cannot be replaced.

Signia™ Small Diameter Reloads feature a narrow shaft, narrow end-effector, narrow anvil with either a curved tip or regular (round) tip, and multiple articulation angles up to 45 degrees. These features facilitate device access to smaller or tighter surgical spaces (e.g. intercostal) as well as difficult-to-reach vasculature. Signia™ Small Diameter Reloads shall be available in multiple configurations with the following features:

Open Staple Height: 2.0 mm (grav cartridge) and 2.5 mm (white cartridge) ●
Cartridge Length: 30 mm and 45 mm .
Anvil Tip: Curved tip (gray and white) and Regular (Round) tip (white) ●
Reload Shaft Length: Short (15 cm) and Long (24 cm) ●
Reload Diameter (upper-shaft to distal end): 8 mm ●

The curved tip on the distal-end of the reload can be used to aid in positioning the reload around target tissue / vessels for subsequent firing. The working length of the Signia™ small diameter reload will fit down an 8mm trocar sleeve or larger, and is compatible with existing Covidien manual and powered stapling handles (see Section 11.10: Compatible Stapling Handles). The short shaft length (15 cm) is recommended for use in open, thoracoscopic or laparoscopic procedures and are compatible with appropriately-sized trocar sleeves, 8 mm or larger. The long shaft length (24 cm) is recommended for use in laparoscopic procedures with appropriately-sized trocar sleeves, 8 mm or larger. The Signia™ Small Diameter Reloads are recommended for use with Covidien compatible short stapler adapters and handles. The reloads contain an intelligence chip, which has the ability to communicate with the Covidien powered Signia™ Stapler handle that has a compatible communications interface.

Through this submission, a new reload model SIGSDL45VT with a regular (round) tip anyil shall be added to the stapling family of Signia™ Small Diameter Reloads as a line extension. Additionally, the indications of Signia™ Small Diameter regular (round) tip white reloads shall be expanded to include creation of anastomosis based on the supporting data provided in this submission.

AI/ML Overview

This document describes the Signia™ Small Diameter Reloads for surgical staplers. The existing curved tip reloads were previously cleared, and this submission (K222641) adds a new regular (round) tip model and expands the indications for the regular (round) tip white reloads to include the creation of anastomosis.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with pass/fail thresholds. Instead, it details a comprehensive suite of performance tests performed to demonstrate substantial equivalence to a predicate device (K191070) and a reference device (K111825) for anastomosis. The fundamental acceptance criterion seems to be that the subject device performs comparably to or better than the predicate/reference devices in relevant performance tests.

Here's a summary of the performance tests conducted, implying "acceptance" if the subject device performs equivalently or acceptably:

Performance Characteristic/Test	Applicable Reloads	Performance/Outcome (Implied Acceptance)
Bench Tests (Acute):	Both Curved & Regular (Round) Tip new model	Demonstrated comparable performance to predicate (K191070).
Visual inspection	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Force to load, rotate, and lock reload	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Stapler handle compatibility	Both Curved & Regular (Round) Tip new model	Compatible with existing Covidien manual and powered stapler handles; presumed acceptable.
Knife cut	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Staple formation in test media	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Firing and retraction forces	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Communications test with Signia™ Powered Handle	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Trocar Insertion/Removal forces	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Pneumo-seal leak rate	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Worst Case Ex vivo Burst Pressure including Veins	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Animal Acute Tests:	Both Curved & Regular (Round) Tip new model	Demonstrated comparable performance to predicate (K191070).
Tissue trauma	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Grasping trauma	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Hemostasis	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Staple formation in intended tissue	Both Curved & Regular (Round) Tip new model	No issues reported; presumed acceptable.
Chronic Survival Testing in Animal:	Curved Tip Reloads (vs. Control)	Demonstrated substantial equivalence to predicate (K191070) and reference in lobectomy, nephrectomy, splenectomy, and ovariohysterectomy. Implied acceptable long-term performance.
Chronic Survival Testing in Animal (Anastomosis):	Regular (Round) Tip Reload (vs. Control)	Demonstrated comparable performance to reference device (K111825) for Jeju-Jejunostomy. Implied acceptable long-term performance.
Human Factors / Usability Tests:	General use, labeling, and anastomosis (new model)	Performed per IEC 62366-1 and FDA guidance. No issues reported; presumed acceptable.
Biocompatibility Tests:	All models	Performed per ISO 10993-1 and FDA guidance. No issues reported; presumed acceptable.
Electrical Safety Tests:	All models	Performed per IEC 60601-1. No issues reported; presumed acceptable.
Electromagnetic Compatibility (EMC):	All models	Performed per IEC 60601-1-2. No issues reported; presumed acceptable.
Sterilization Assessment:	All models	Performed per ISO 11135. No issues reported; presumed acceptable.
Stability / Shelf-life Studies:	All models	No issues reported; presumed acceptable.

2. Sample size used for the test set and the data provenance

The document provides the following details:

Bench Tests: The specific sample sizes for each bench test are not provided.
Animal Acute Tests: The specific sample sizes for these tests are not provided.
Chronic Survival Testing in Animal:
- Lobectomy (Thorax of Canine): Sample size not specified.
- Nephrectomy, Splenectomy, Ovariohysterectomy (Abdomen of Porcine): Sample size not specified.
- Jeju-Jejunostomy (Small Bowel of Canine): Sample size not specified.
Provenance: All animal studies (acute and chronic) were conducted as pre-clinical studies by the manufacturer (Covidien). The country of origin for the animal studies is not explicitly stated but is typically conducted at contract research organizations. These are prospective studies given they are conducted to support a new device feature/indication.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on interpretations by human experts establishing a "ground truth" for a test set in the context of diagnostic AI/imaging.

4. Adjudication method for the test set

This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on adjudicating expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a surgical stapler, which is a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is a surgical stapler, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is established through:

Physical measurements: For bench tests (e.g., staple formation, burst pressure, forces, dimensions).
In-vivo observations and histological/pathological evaluation: For animal acute and chronic studies (e.g., tissue trauma, hemostasis, staple formation in tissue, long-term healing and integrity of staple lines, anastomosis success). This would involve veterinary pathologists and surgeons assessing outcomes.
Usability testing: Direct observation and feedback from users (e.g., surgeons).

8. The sample size for the training set

This section is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable.

Summary

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November 29, 2022

Covidien Robert Zott Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K222641

Trade/Device Name: Signia™ Small Diameter Reloads Including Regular (Round) Tip Version Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: August 30, 2022 Received: September 1, 2022

Dear Robert Zott:

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

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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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2022.11.29
12:57:00 -05'00'

Mark Trumbore Assistant Director, THT4A1: Robotically -Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Indications for Use

510(k) Number (if known)

K222641

Device Name

Signia™ Small Diameter Reloads Including Regular (Round) Tip Version

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)

Page 1 of 1

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510(k) Summary K222641

Date Prepared:

August 30, 2022

Submitter:

Covidien 60 Middletown Avenue North Haven, CT 06473 USA

Contact Person:

Robert Zott Senior Regulatory Affairs Specialist Email: robert.zott@medtronic.com Phone: (917) 421-6878

ldentification of Device:

Trade/Proprietary Name:	Signia™ Small Diameter Reloads
Common Name:	Surgical Stapler with Implantable Staples
Regulation Number:	21 CFR 878.4750 / 21 CFR 878.4740
Regulation Name:	Implantable Staple
Device Class:	Class II
Product Code:	GDW / GAG
Review Panel:	General and Plastic Surgery

Predicate Device:

Trade/Proprietary Name:	Signia™ Small Diameter Reloads
Common Name:	Surgical Stapler with Implantable Staples
Regulation Number:	21 CFR 878.4750
Regulation Name:	Implantable Staple
Device Class:	Class II
Product Code	GDW
Review Panel:	General and Plastic Surgery
510(k) Number:	K191070
Manufacturer:	Covidien

Reference Device:

Trade/Proprietary Name:	Endo GIA™ Staplers
Common Name:	Surgical Stapler with Implantable Staples
Regulation Number:	21 CFR 878.4750
Regulation Name:	Implantable Staple
Device Class:	Class II

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Product Code:	GDW
Review Panel:	General and Plastic Surgery
510(k) Number:	K111825
Manufacturer:	Covidien

Device Description:

Open Staple Height: 2.0 mm (grav cartridge) and 2.5 mm (white cartridge) ●
Cartridge Length: 30 mm and 45 mm .
Anvil Tip: Curved tip (gray and white) and Regular (Round) tip (white) ●
Reload Shaft Length: Short (15 cm) and Long (24 cm) ●
Reload Diameter (upper-shaft to distal end): 8 mm ●

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Indications for Use:

The Signia™ small diameter curved tip gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection of vasculature using gray reloads and thin tissue and vasculature using white reloads.

The Signia™ small diameter regular (round) tip white reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection of thin tissue and vasculature and the creation of anastomosis.

Technological and Performance Characteristics:

The subject curved tip Signia™ Small Diameter Reloads with the revised stapling guidance labeling and the subject reqular (round) tip Signia™ Small Diameter Reload with the anastomosis indication and the revised stapling guidance labeling are substantially equivalent to the predicate devices described in K191070 with regard to the stapling technologies employed and the performance characteristics described in the predicate submission. The fundamental operation of the Signia™ Small Diameter Reloads has not changed: to deliver two-staggered rows of titanium staples to either side of the cut line utilizing a narrow shaft, narrow end-effector, narrow anvil with either a curved tip or regular (round) tip, and multiple articulation angles up to 45 degrees. The curved tip and regular (round) tip designs differ only in the shape of the anvil; the pockets of the anvil that form the staples are identical.

Features	Subject Devices (K222641)Signia™ Small Diameter ReloadIncluding Regular (Round) Tip	Predicate Device (K191070)Signia™ Small Diameter Reload
Indications for use	The Signia™ small diameter curved tip grayand white reloads have applications inabdominal, gynecologic, pediatric and thoracicsurgery for resection and transection ofvasculature using gray reloads and thin tissueand vasculature using white reloads.The Signia™ small diameter regular (round) tipwhite reload has applications in abdominal,gynecologic, pediatric and thoracic surgery forresection and transection of thin tissue andvasculature and the creation of anastomosis.	The Signia™ small diameter gray and whitereloads have applications in abdominal,gynecologic, pediatric and thoracic surgeryfor resection and transection of vasculatureusing gray reloads and thin tissue andvasculature using white reloads.
Models /Tip Configuration	SIGSDS30CTV - Curved TipSIGSDS30CTVT - Curved TipSIGSDL45CTVT - Curved TipSIGSDL45VT - Regular (Round)Tip	SIGSDS30CTV - Curved TipSIGSDS30CTVT - Curved TipSIGSDL45CTVT - Curved TipNote: All reorder codes in the predicatesubmission have curved anvil tip design asdesignated by "CT" in the model name.
Features	Subject Device (K222641)Signia™ Small Diameter ReloadIncluding Regular (Round) Tip	Predicate Device (K191070)Signia™ Small Diameter Reload
Basic Functions:Rotation,Articulation,Clamping,Unclamping,Firing,Retraction,Grasping.	Yes	Yes
Staple Line Length	SIGSDS30CTV (30 mm)SIGSDS30CTVT (30 mm)SIGSDL45CTVT (45 mm)SIGSDL45VT (45 mm)	SIGSDS30CTV (30 mm)SIGSDS30CTVT (30 mm)SIGSDL45CTVT (45 mm)
Shaft Length	SIGSDS30CTV (15 cm)SIGSDS30CTVT (15 cm)SIGSDL45CTVT (24 cm)SIGSDL45VT (24 cm)	SIGSDS30CTV (15 cm)SIGSDS30CTVT (15 cm)SIGSDL45CTVT (24 cm)
Shaft Diameter	Same as Predicate	12 mm (proximal end) to8 mm (distal end)
Staple Sizes:(Open Leg Height /Cartridge Color)	SIGSDS30CTV (2.0 mm / Gray)SIGSDS30CTVT (2.5 mm / White)SIGSDL45CTVT (2.5 mm / White)SIGSDL45VT (2.5 mm / White)	SIGSDS30CTV (2.0 mm / Gray)SIGSDS30CTVT (2.5 mm / White)SIGSDL45CTVT (2.5 mm / White)
Target ThicknessRange	Same as Predicate	1.0 - 1.5 mm (White)0.75 - 1.00 mm (Gray)
Rows of Staples	Same as Predicate	4 Total(2 rows on either side of cut line)
Staples per Reload	Same as Predicate	32 total (30 mm cartridge)44 total (45 mm cartridge)
Articulation	Same as Predicate	Yes (max 45°)
Single Patient Use& Disposable	Same as Predicate	Yes
Materials of Stapleand Knife	Same as Predicate	Staple: TitaniumKnife: Stainless Steel
Features	Subject Device (K222641)Signia™ Small Diameter ReloadIncluding Regular (Round) Tip	Predicate Device (K191070)Signia™ Small Diameter Reload
DeviceCompatibility	Same as Predicate	Compatible with Covidien manual andpowered stapler handles.
1-Wire®communicationcapability withSignia™ PowerHandle	Same as Predicate	Yes
Biocompatibility	Same as Predicate	Materials used were evaluated inaccordance with ISO 10993-1 BiologicalEvaluation of Medical Devices -- Part 1:Evaluation and Testing.

Substantial Equivalence Overview Table

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Summary of Studies:

Performance testing completed for the Signia™ small diameter curved tip reloads was submitted, reviewed and cleared in the predicate submission (K191070). This testing demonstrated both substantial equivalence to legally marketed devices as well as establishing performance specifications for its intended use and indications for use. Additional testing for the reqular (round) tip reload included the chronic testing and usability for anastomosis, supported by clinical literature.

Differing only in the anvil's distal tip geometry, all remaining technological characteristics including aspects of design, dimensional specifications, and manufacturing between the new reqular (round) tip reload model SIGSDL45VT and the predicate curved tip model SIGSDL45CTVT remain the same, including but not limited to the implantable staple design, anvil pocket design, knife design, and cartridge design. The previously-submitted performance data for the predicate curved tip model SIGSDL45CTVT remains applicable to the new reqular (round) tip model. The difference in the anvil tip shape does not impact stapling performance and does not raise different questions of safety and effectiveness when compared with the predicate device. The following is the summary of all the appliable performance testing.

Tests performed to evaluate and compare technological and performance characteristics:

1. Performance test Bench and Animal (Acute)
- a. Bench tests:
  - i. Visual inspection;
  - ii. Force to load, rotate, and lock reload;

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iii. Stapler handle compatibility:
iv. Knife cut;
v. Staple formation in test media;
Firing and retraction forces; vi.
Communications test with Signia™ Powered Handle: vii.
viii. Trocar Insertion/Removal forces;
ix. Pneumo-seal leak rate;
x. Worst Case Ex vivo Burst Pressure including Veins.
b. Animal acute tests:
- i. Tissue trauma;
- ii. Grasping trauma;
- iii. Hemostasis;
- iv. Staple formation in intended tissue.
1. Chronic survival testing in animal:
- a. Chronic study of Signia™ Small Diameter Reloads vs. Control (predicate and reference device) for Lobectomy in the Thorax of a Canine;
- b. Chronic study of Signia™ Small Diameter Reloads vs. Control (predicate and reference device) for Nephrectomy, Splenectomy, and Ovariohysterectomy in the Abdomen of a Porcine.
- c. Chronic study of Signia™ Small Diameter Regular (Round) Tip Reload vs. Control (reference device) for Jeju-Jejunostomy in the Small Bowel of a Canine model.
1. Human Factors / Usability Tests per IEC 62366-1 and Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff Document, issued on February 3, 2016, for general use, labeling, and anastomosis.
1. Biocompatibility tests per ISO 10993-1 and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk manaqement process" Guidance for Industry and Food and Drug Administration Staff Document, issued on September 4, 2020.
1. Electrical Safety tests per IEC 60601-1.
1. Electromagnetic Compatibility (EMC) per IEC 60601-1-2.
1. Sterilization assessment per ISO 11135.

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1. Stability / Shelf-life studies.
1. Published clinical literature.

In addition. labeling was updated in accordance with Surgical Staplers and Staples for Internal Use - Labeling Recommendations, Guidance for Industry and Food and Drug Administration Staff Document, issued on October 8, 2021.

No clinical study was performed and no clinical data is provided, herein. Substantial equivalence has been demonstrated by non-clinical and preclinical studies.

Reference Device:

In addition to the predicate device. Endo GIA™ staplers (K111825) was cited in this submission for additional comparison as it was previously cleared for the creation of anastomosis. Endo GIA™ staplers were used in comparative performance testing as a control device in both the predicate submission K191070 and the chronic study for anastomosis.

Conclusion:

Based upon the data summarized above, Covidien concludes that the subject Signia™ Small Diameter Reloads including both the curved tip and regular (round) tip are as safe and effective as the predicate devices legally marketed under K191070, and do not raise different questions of safety and effectiveness when compared with the predicate device.

Regulation Number and Section

§ 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.