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

Device Description

The Signia™ Small Diameter Reload is an 8mm diameter reload that will be utilized for open and minimally invasive surgical procedures for transection and resection of tissue and specifically, vascular and thin tissue structures.

The reload is the distal shaft and jaws of the stapler system; comprised of a single-use knife, fixed curve tip anvil and stapler cartridge with two (2) rows of staples on either side of the knife blade.

The Signia™ Small Diameter Reload features a narrow shaft diameter, narrow end-effector, curved-tip anvil, multi-articulation angles, and delivers two staggered rows of titanium staples on either side of the cut line. These features facilitate device access during surgery in smaller/fighter intercostal spaces, smaller surgical spaces and difficult to reach vessels/vasculature.

The Signia™ Small Diameter Reload places staggered rows of titanium staples and simultaneously divides the tissue so that two staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the selection of the single use reload.

The Signia™ small diameter reload is available in multiple configurations with the following features:

. Open Staple Height: 2.0 mm (gray cartridge) and 2.5 mm (white cartridge)
. Cartridge Length: 30 mm and 45 mm
Anvil Tip: Curved .
Reload Shaft Length: Short (15 cm) and Long (24 cm) .
Reload Diameter (mid-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 and placement of staples. The working length of the Signia™ small diameter reload will fit through an 8mm trocar sleeve or larger and is compatible with existing Endo GIA™ handles and Signia™ adapters. The short shaft lengths (15cm) are recommended for use in open or thoracic procedures and are compatible with thoracic trocar sleeves. The long shaft lengths (24 cm) are recommended for use in laparoscopic procedures with 8 mm diameter trocar sleeves. Signia™ small diameter reloads are recommended for use with Covidien compatible short Stapler handles and adapters. Signia™ small diameter reloads contain an intelligence chip. The intelligence chip has the ability to communicate with Covidien powered stapler handles that have a compatible communications interface.

AI/ML Overview

The provided text describes the regulatory clearance of the Signia™ Small Diameter Reloads, a surgical stapler with implantable staples. It outlines the device's indications for use, technological and performance characteristics, and a comparison to predicate devices. The document also lists the various tests performed to demonstrate substantial equivalence, but it does not provide detailed acceptance criteria or the study results for those criteria. Instead, it states that "The design differences were found to not affect the substantial equivalence through applicable design verification activities and risk analysis that showed continued conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing."

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set sample size and ground truth establishment. This information is typically found in detailed study reports or design verification documents, which are not part of this 510(k) summary.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This indicates that a clinical study with human patients to assess performance against specific acceptance criteria (as you've described) was not performed or was not the primary basis for demonstrating substantial equivalence for this particular 510(k) submission.

The tests listed (Functional performance, Chronic survival testing in animal, Usability, Biocompatibility, Electrical Safety, EMC/EMI, Sterilization, Stability/Shelf-life) are primarily non-clinical assessments used for design verification and comparison to predicate devices to demonstrate that the new device performs similarly and is as safe and effective.

To answer your request, if this were a hypothetical scenario where such data was available and analogous to an AI/ML device, the table would look like this:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Functional Performance (Bench)	(Not specified in document)	(Not specified in document)
Functional Performance (Acute Animal)	(Not specified in document)	(Not specified in document)
Chronic Survival (Animal)	(Not specified in document)	(Not specified in document)
Usability (IEC 62366)	(Not specified in document)	(Not specified in document)
Biocompatibility (ISO 10993-1)	(Not specified in document)	(Not specified in document)
Electrical Safety (IEC 60601-1)	(Not specified in document)	(Not specified in document)
EMC/EMI (IEC 60601-1-2)	(Not specified in document)	(Not specified in document)
Sterilization (ISO 11135)	(Not specified in document)	(Not specified in document)
Stability/Shelf-life	(Not specified in document)	(Not specified in document)

Given the information provided:

Sample size used for the test set and the data provenance: Not specified. The document mentions "Bench and Animal (Acute)" tests and "Chronic survival testing in animal" but does not give specific sample sizes for these tests or the provenance of the animal data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this submission did not rely on clinical performance data and thus did not describe a scenario where expert ground truth would be established in the context of human data interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical performance study with human readers/interpreters is described.
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 MRMC study was done, as this is a surgical stapler, not an AI-assisted diagnostic device, and the submission explicitly states no reliance on clinical performance data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (surgical stapler), not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests described, the "ground truth" would be established by physical measurements, engineering standards, animal physiological responses, and laboratory assays, rather than expert consensus, pathology, or outcomes data in humans. The document does not detail specific metrics or 'ground truths' for each test beyond listing the test types.
The sample size for the training set: Not applicable, as this is a physical medical device and not an AI/ML algorithm that would undergo a "training set" process.
How the ground truth for the training set was established: Not applicable, as there is no "training set" for this type of device.

Summary

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September 4, 2019

Covidien Frank Gianelli Regulatory Affairs Senior Product Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K191070

Trade/Device Name: Signia Small Diameter Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: April 19, 2019 Received: April 22, 2019

Dear Mr. Gianelli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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

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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,

for Cindy Chowdhury Acting Assistant Director DHT4B: Division of Infection Control and Plastic 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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Indications for Use

510(k) Number (if known) K191070

Device Name Signia™ Small Diameter Reloads

Indications for Use (Describe)

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

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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510(K) Summary

Date Prepared:

August 28, 2019

Submitter:

Covidien 60 Middletown Avenue North Haven, CT 06473

Contact:

Frank Gianelli Regulatory Affairs Senior Product Specialist Telephone: (203) 492-5352 Fax: (203) 492-5029 frank.j.qianelli@medtronic.com Email:

Name of Device:

Trade/Proprietary Name: Signia™ Small Diameter Reloads Surgical Stapler with Implantable Staples Common Name: Classification Name: Staples, Implantable a. Panel no and product code: 79 GDW

b. Requlation no: 21 CFR 878.4750

Predicate Devices:

Primary:

Trade/Proprietary Name:	Endo GIA™ Auto Suture™ Universal Articulating Loading Unit(Gray and White)
Common Name:	Surgical Stapler with Implantable Staples
Classification Name:	Staples, Implantable, (79 GDW, 21 CFR 878.4750)
510(k) Number:	K111825
Manufacturer:	Covidien

Reference:

Trade/Proprietary Name:	Echelon Flex™ Powered Vascular Stapler with AdvancedPlacement Tip and Endopath Echelon™ Vascular White Reloadfor Advanced Placement Tip
Common Name:	Surgical Stapler with Implantable Staples
Classification Name:	Staples, Implantable, (79 GDW, 21 CFR 878.4750)
510(k) Number:	K141952
Manufacturer:	Ethicon Endo-Surgery Inc.

Device Description:

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The Signia™ small diameter reload is available in multiple configurations with the following features:

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

Indications for Use:

Technological and Performance Characteristics:

The subject Signia™ Small Diameter Reloads are substantially equivalent to primary predicate Endo GIA™ Auto Suture™ Universal Articulating Loading Units (Gray and White) and to reference predicate Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and Endopath Echelon™ Vascular White Reload for Advanced Placement Tip in regard to the stapling technologies employed, intended use and similar indications for use.

Specifically, the subject Signia™ Small Diameter Reloads when used with compatible Covidien stapler handles is similar to reference predicate Endo GIA™ Auto Suture™ Universal Articulating Loading Units (Gray and White) also when used with compatible Covidien stapler handles with respect to features such as staple line length, staple size, reload color (Gray, White), multi-articulation angles, and intended tissue type of thin/vascular. The main difference between the subject Signia™ Small Diameter Reloads and primary predicate Endo GIAT™ Auto Suture™ Universal Articulating Loading Units (Grav and White) is the Signia™ Small Diameter Reloads deliver two-staggered rows of titanium staples on either side of the rather than three-staggered rows of titanium staples on either side of the as with the primary predicate.

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Specifically, the subject Signia™ Small Diameter Reloads when used with compatible Covidien stapler handles is similar to reference predicate Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and Endopath Echelon™ Vascular White Reload for Advanced Placement Tip with respect to features such as narrow shaft diameter, narrow end-effector, curved-tip anvil, multi-articulation angles, and delivering two staggered rows of titanium staples on either side of the cut line. Also, the intended tissue type of thin/vascular is the same for both.

	Proposed Device	Primary Predicate Device(K111825)	Reference Predicate Device(K141952)
Feature	Signia™ Small Diameter Reload(Gray and White)	Endo GIA™ Auto Suture™Universal Articulating LoadingUnits (Gray and White)	Echelon PVS with EchelonVascular Reload
Same basic functionfor reloads - rotation,articulation, clamp,unclamp, firing,retraction, grasping	Yes	Yes	Yes
Indications for use	The Signia™ small diameter grayand white reloads haveapplications in abdominal,gynecologic, pediatric and thoracicsurgery for resection andtransection of vasculature usinggray reloads and thin tissue andvasculature using white reloads.	The Endo GIA™ universal staplershave applications in abdominal,gynecology, pediatric, andthoracic, surgery for resectiontransection and creation ofanastomosis.	The Echelon Flex™ PoweredVascular Stapler with AdvancedPlacement Tip and its reload areintended for transection andresection of tissue andvasculature. The instruments haveapplication in multiple open orminimally invasive general,gynecologic, urologic, thoracic,and pediatric surgical procedures.
Same intended use	Yes	Yes	Yes
Staple line length	30 mm45 mm	30 mm45 mm60 mm	35 mm
Anvil tipconfiguration	Curved tip anvil	Round tip anvil	Curved-tip anvil
Shaft length (fromproximalattachment)	Short (20 cm) and Long (29 cm)	11.25 cm	32 cm
Shaft diameter	12 mm to 8 mmVariable shaft diameter:constructed with shaft diameter of12 mm approximate at proximalend and 8 mm approximate fromnarrowed mid-section of shaft todistal working end at end-effector.	12 mmUniform shaft diameter:constructed with a shaft diameterof 12 mm approximate at proximalend to distal working end at end-effector	9 mm to 12 mmVariable shaft diameter:constructed with a shaft diameterof 9 mm approximate at narrowedproximal end and mid-section ofshaft to 12 mm approximate atdistal working end at end-effector
Staple Sizes:open leg height(cartridge color)	2.0mm (Gray)2.5mm (White)	2.0mm (Gray)2.5mm (White)	2.5 mm (White)
Rows of StaplesStaples per Reload	4 (2 rows on either side of cut line)4 rows x 8 staples/row = 32 total(30mm)4 rows x 11 staples/row = 44 total(45mm)	6 (3 rows on either side of cut line)6 rows x 8 staples/row = 48 total(30mm)6 rows x 11 staples/row = 66 total(45mm)	4 (2 rows on either side of cut line)4 rows x 9 staples/row = 36 total(35mm)
Articulation	Yes (max 45°)	Yes (max 45°)	Yes (max 50°)
Single Patient Use	Yes	Yes	Yes
DisposableIdentification ofmaterials of implant(staple) and tissuecutting component(knife)	YesStaple- TitaniumKnife- Stainless Steel	YesStaple- TitaniumKnife- Stainless Steel	YesStaple - TitaniumKnife - Stainless steel

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Via the below listed tests, qualitative and quantitative data were obtained and used to compare the Signia™ Small Diameter Reloads to primary predicate Endo GIA™ Auto Suture™ Universal Articulating Loading Units and reference predicate Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and Endopath Echelon™ White Reload for Advanced Placement Tip.

The design differences were found to not affect the substantial equivalence through applicable design verification activities and risk analysis that showed continued conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing.

Tests performed to evaluate and compare technological and performance characteristics:

1. Functional performance test Bench and Animal (Acute)
- a. Bench tests
  - i. Visual inspection
    - ii. Force to load, rotate, and lock reload
  - iii. Stapler handle compatibility
  - iv. Knife cut
  - v. Staple formation in test media
  - vi. Firing and retraction forces
  - vii. Communications test with Signia™ Powered Handle
  - 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 Reload vs. Control (primary and reference predicates) staplers for Lobectomy in the Thorax of a Canine
- b. Chronic study of Signia™ Small Diameter Reload vs. Control (primary and reference predicates) staplers for Nephrectomy, Splenectomy, and Ovariohysterectomy in the Abdomen of a Porcine.
1. Usability Tests per IEC 62366
1. Biocompatibility tests per ISO 10993-1
1. Electrical Safety tests per IEC 60601-1
1. EMC/EMI tests per IEC 60601-1-2
1. Sterilization assessment per ISO 11135
1. Stability/Shelf-life studies

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.

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.