For Stapler: The reusable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

For Reload: The ReliaMax™ single use gastrointestinal anastomosis reload when used with ReliaMax™ reusable gastrointestinal anastomosis stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

Device Description

Reusable surgical stapler with a single use reload

AI/ML Overview

The provided text describes a 510(k) summary for the ReliaMax™ Gastrointestinal Anastomosis Stapler and Reload. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study with specific performance metrics against those criteria for the ReliaMax device itself.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

There is no explicit table of acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity) against which the ReliaMax™ device's performance is reported. Instead, the document states: "The results of this testing demonstrates that the ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are substantially equivalent to the predicate device."

The performance evaluations conducted are listed as:

Performance Evaluation	Reported Device Performance
Firing and Retraction Force	Results demonstrate substantial equivalence to the predicate device.
Clamping and Unclamping Force	Results demonstrate substantial equivalence to the predicate device.
Staple Formation Verification	Results demonstrate substantial equivalence to the predicate device.
Hemostasis	Results demonstrate substantial equivalence to the predicate device.
Burst Strength	Results demonstrate substantial equivalence to the predicate device.
Lung Air Leak	Results demonstrate substantial equivalence to the predicate device.
Lifecycle Reliability Test	Results demonstrate substantial equivalence to the predicate device.

Note: The document does not provide the specific numerical results of these tests for either the ReliaMax™ device or the predicate device, nor does it define explicit "acceptance criteria" they were compared against, beyond the general goal of demonstrating substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "in vitro and in vivo performance evaluations" were conducted. However, no specific sample sizes for these test sets are provided, nor is the data provenance (e.g., country of origin, retrospective/prospective nature) detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the provided text describes a medical device study (stapler for surgical procedures) which typically relies on objective physical or biological measurements rather than expert consensus on image interpretation or similar diagnostic tasks. Ground truth for a surgical stapler would involve measuring physical properties and biological outcomes in tested tissues/animals.

4. Adjudication Method

This information is not applicable for the type of device study described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not applicable as this is a surgical stapling device, not an imaging or diagnostic device requiring human reader interpretation. No human-in-the-loop performance is described.

6. Standalone Performance Study

Yes, a standalone performance study was done for the ReliaMax™ device. The "Performance Data" section explicitly states: "In vitro and in vivo performance evaluations were conducted to demonstrate that ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are safe and effective and that they perform as intended." This indicates algorithmic (device-only) performance testing. However, the exact methodology and detailed results for these evaluations are not provided beyond the general summary.

7. Type of Ground Truth Used

The ground truth for the "in vitro and in vivo performance evaluations" would have likely been based on objective measurements of physical and biological properties. For example:

Staple Formation Verification: Visual inspection or microscopic analysis of staple formation.
Hemostasis: Measurement of blood leakage.
Burst Strength: Measurement of pressure at which the stapled anastomosis fails.
Lung Air Leak: Measurement of air leakage from stapled lung tissue.
Forces and Reliability: Physical measurements using load cells and endurance testing.

8. Sample Size for the Training Set

There is no mention of a "training set" in the context of this device study. Surgical staplers are typically evaluated through engineering tests and non-clinical (e.g., animal, cadaver) studies, not through AI/machine learning models that require training data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as no training set for an AI/ML model is mentioned.

Summary

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Ki22781 Page 1/2

FEB 5 2013

...

510(k) Summary of Safety and Effectiveness

SUBMITTER:	Covidien, Formerly US Surgical A Division of Tyco Healthcare60 Middletown Avenue
	North Haven, CT 06473
	Tel. No.: (203) 492-5284

CONTACT PERSON: Mary Mellows Senior, Requiatory Specialist

DATE PREPARED: September 7, 2012

TRADE/PROPRIETARY NAME: ReliaMax™ Gastrointestinal Anastomosis Stapler and Reload

COMMON/USUAL NAME: Surgical Stapler with Implantable Staples

CLASSIFICATION NAME: Staples, Implantable

DST™ Series GIA™ Staplers (K111825) PREDICATE DEVICE(S): .

DEVICE DESCRIPTION: Reusable surgical stapler with a single use reload

INTENDED USE: For Stapler: The reusable staplers have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. They may be used for transection and resection of the pancreas.

For Reload: The ReliaMax™ single use gastrointestinal anastomosis reload when used with ReliaMax™ reusable gastrointestinal anastomosis stapler have applications in abdominal, gynecological, pediatric and thoracic surgical for resection, transection and creation procedures of anastomosis. They may be used for transection and resection of the pancreas.

TECHNOLOGICAL CHARACTERISTICS:

ReliaMax™ The Gastrointestinal Anastomosis Staplers and Reloads are substantially equivalent to the predicate device (K111825) with regard to the stapling technologies.

The ReliaMax™ Gastrointestinal Anastomosis Staplers will be available in sizes that are encompassed by the predicate (K111825), 60mm and 80mm lengths. ReliaMax™ Reloads will be provided in three staple sizes, similar to the predicate (K111825) to accommodate various tissue thicknesses: 2.5mm, 3.8mm, and 4.8mm.

Identical to the predicate (K111825). ReliaMax™ Reloads will place two double rows of titanium staples and simultaneously cut and divide tissue between the two double rows.

All components of ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are comprised of materials that are in accordance with ISO Standard 10993-1.

Covidien Traditional 510(k) Premarket Nolification

MATERIALS:

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K1227.81 Page 2/2

The materials used in the design of the Reliamax™ are identical to the materials in the DST™ Series GIA™ disposable stapler, with one exception. The Reliamax™ also includes a plastic material, which is not used in the DST series GIA™ disposable stapler. All performance stability and biocompatibility testing was conducted using this material with acceptable results.

PERFORMANCE DATA:

In vitro and in vivo performance evaluations were conducted to demonstrate that ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are safe and effective and that they perform as intended.

In vitro and in vivo testing to support the intended use of this device includes:

Firing and Retraction Force o
Clamping and Unclamping Force 0
O Staple Formation Verification
Hemostasis 0
Burst Strength 0
0 Lung Air Leak
Lifecycle Reliability Test 0

The results of this testing demonstrates that the ReliaMax™ Gastrointestinal Anastomosis Staplers and Reloads are substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the top half of the circle. Inside the circle is an emblem of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Covidien, Formerly US Surgical Division of Tyco Healthcare % Ms. Mary Mellows Senior Regulatory Specialist 60 Middletown Avenue North Haven, Connecticut 06473

March 15, 2013

Re: K122781

Trade/Device Name: Reliamax™ Gastrointestinal Anastomosis and Reload Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: January 10, 2013 Received: January 28, 2013

Dear Ms. Mellows:

This letter corrects our substantially equivalent letter of February 5, 2013.

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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Page 2 - Ms. Mary Mellows

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known): K122781

Device Name: ReliaMax™ Gastrointestinal Anastomosis Stapler and Reload

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K122781

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.