The Reprocessed Surgical Electric Instrument (hereinafter sealer/divider) is indicated for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the ForceTriad™ energy platform the sealer/divider can also be used to seal pulmonary vasculature. The sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective for sterilization procedures.

Device Description

The sealer/divider is for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. The sealer/divider can be used to seal pulmonary vasculature when used with the ForceTriad™ energy platform. The sealer/divider has an 18 cm shaft with a 13.5 mm diameter and can be rotated 180 degrees. The curved jaw is 36 mm long with a 34 mm cutting length. The sealer/divider is activated by pulling the handle until latched and pressing the button on the device or depressing the foot switch.

AI/ML Overview

This document describes the 510(k) Premarket Notification for a Reprocessed Surgical Electric Instrument (sealer/divider) by SterilMed, Inc. It's a submission to demonstrate substantial equivalence to a predicate device, not to prove novel device performance using clinical studies against acceptance criteria in the traditional sense. Therefore, many of the requested elements for a clinical study on a novel device's performance against acceptance criteria are not directly applicable or available in this document.

However, I can extract information related to the functional and safety testing performed to support the substantial equivalence claim, which serves as a form of acceptance criteria for a reprocessed device.

Summary of Acceptance Criteria and Reported Device Performance for Reprocessed Surgical Electric Instrument

This submission focuses on demonstrating that a reprocessed surgical electric instrument is substantially equivalent to its predicate device. The "acceptance criteria" here are defined by the required functional and safety performance of the reprocessed device to ensure it performs as intended and is as safe and effective as the original, single-use device. The "study" involves various non-clinical tests to validate the reprocessing procedures and the performance of the reprocessed device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance / Outcome (Conclusion)
Cleaning Validation	Validation of cleaning procedures to ensure removal of bioburden and residues.	Cleaning validation performed. Implicitly met, as the overall conclusion states substantial equivalence and safety.
Sterilization Validation	Validation of sterilization procedures (e.g., ISO 11135, USP <71>) to ensure sterility.	Sterilization validation performed (ISO 11135, USP <71>). Implicitly met.
Biocompatibility	Testing according to ISO 10993-1 to ensure the reprocessed materials are biocompatible and do not pose new risks. Compliance with ISO 10993-7 for Ethylene Oxide residual testing.	Biocompatibility testing (ISO 10993-1); Ethylene Oxide residual testing (ISO 10993-7) performed. Implicitly met.
Packaging Validation	Validation of packaging integrity and sterility maintenance (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096).	Packaging validation performed (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096). Implicitly met.
Shelf Life Validation	Validation of the shelf life of the reprocessed and packaged device (ASTM 1980-07).	Shelf life validation performed (ASTM 1980-07). Implicitly met.
Functional Performance	- Bench Testing (Simulated Use): Demonstrated appropriate functional characteristics and performance during simulated use on beef tissue. - Visual Inspection: Part of manufacturing process. - Fatigue Testing: To assess durability and material integrity over its reprocessed lifespan. - Function Testing: Part of manufacturing process.	"Performance testing shows the reprocessed sealer/dividers to perform as intended." "Representative samples of reprocessed sealer/dividers were tested to demonstrate appropriate functional characteristics." "Manufacturing process includes visual and validated functional testing of all products produced." "The reprocessed surgical electric instruments are identical to the predicate devices in design, materials... performance specifications, or method of operation."

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

Sample Size: The document repeatedly mentions "representative samples" for the various non-clinical tests (e.g., for functional performance, cleaning validation, sterilization validation). However, specific numerical sample sizes for each test are not provided in this summary section.
Data Provenance: The tests are described as "non-clinical tests" and "bench testing." The simulated use on "beef tissue" suggests laboratory-based, pre-clinical testing. There is no mention of human or animal subjects for these tests. The country of origin for the data is not explicitly stated, but as the submitter (SterilMed, Inc.) is based in Maple Grove, MN, and the submission is to the FDA, it is highly likely the tests were conducted in the US or by US-affiliated testing facilities. The data generated is prospective in the sense that it was specifically generated for this 510(k) submission to demonstrate the performance of the reprocessed devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable or provided in this 510(k) summary. For non-clinical, bench-testing of a reprocessed medical device, the "ground truth" is typically established by physical measurements, chemical analyses, and direct observation of functional performance against established engineering and regulatory standards (e.g., ISO standards, ASTM standards). Expert consensus in the human interpretation sense (like for radiology image analysis) is not relevant here.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving multiple human readers interpreting data (e.g., medical images) where discrepancies need resolution. The tests described are objective, non-clinical measurements and validations against predefined technical specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. An MRMC study is a clinical study designed to evaluate and compare the diagnostic performance of multiple readers on multiple cases, often with and without aid from a device (like AI). The current submission is for a reprocessed surgical instrument and involves non-clinical validation, not a diagnostic imaging device or an AI human-in-the-loop study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This relates to AI algorithms. The device here is a physical surgical instrument.

7. The Type of Ground Truth Used:

The "ground truth" for these tests is based on a combination of:
- Validated Engineering and Regulatory Standards: e.g., ISO and ASTM standards for sterilization, biocompatibility, packaging, and shelf life; USP <71> for sterility.
- Predicate Device Performance: The reprocessed device's performance is compared to the known and established performance characteristics of the original (new) predicate device (Covidien LigaSure Impact™ Hand Activated Sealer/Divider). The implicit "ground truth" is that the reprocessed device must meet or exceed the performance parameters of the new device.
- Objective Measurements and Bench Testing Results: Data from simulated use on beef tissue, visual inspections, fatigue testing, and direct functional testing against design specifications.

8. The Sample Size for the Training Set:

Not applicable. A "training set" refers to data used to train machine learning models. This submission is for a physical medical device, not an AI algorithm. The manufacturing process and validation activities for a reprocessed device do not involve a "training set" in this context.

9. How the Ground Truth for the Training Set was Established:

Not applicable. (See point 8).

In summary, the document provides evidence of rigorous non-clinical testing and validation to demonstrate that the reprocessed surgical electric instrument performs identically to and is as safe as its predicate device. This evidence forms the basis for the FDA's "substantial equivalence" determination, rather than a clinical study against specific disease-detection acceptance criteria commonly seen for diagnostic devices.

Summary

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ОСТ

5 2012

Medical Device Reprocessing
Small Equipment & Instrument Repair

510(K) PREMARKET NOTIFICATION SUBMISSION 04 JANUARY 2012 For Reprocessed Surgical Electric Instruments

II. SUMMARY AND CERTIFICATION

A. 510(k) Summary

Submitter:	SterilMed, Inc.
Contact Person:	Jason Skramsted11400 73rd Avenue NorthMaple Grove, MN 55369Phone: 763-488-3483Fax: 763-488-4491
Date Prepared:	04 January 2012
Trade Name:	Reprocessed Surgical Electric Instrument
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories, Reprocessed

Classification Number: Class II, 21 CFR 878.4400

Product Code: NUJ

PredicateDevices:	The reprocessed sealer/divider is substantially equivalent to the Covidien LigaSure Impact™ Hand ActivatedSealer/Divider (K070162).
DeviceDescription:	The sealer/divider is for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics,and tissue bundles. The sealer/divider can be used to seal pulmonary vasculature when used with theForceTriad™ energy platform.
	The sealer/divider has an 18 cm shaft with a 13.5 mm diameter and can be rotated 180 degrees. The curvedjaw is 36 mm long with a 34 mm cutting length. The sealer/divider is activated by pulling the handle untillatched and pressing the button on the device or depressing the foot switch.
Intended Use:	The Reprocessed Surgical Electric Instrument (hereinafter sealer/divider) is indicated for use in open surgicalprocedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with theForceTriad™ energy platform the sealer/divider can also be used to seal pulmonary vasculature. Thesealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effectivefor sterilization procedures.
TechnologicalCharacteristics:	The reprocessed surgical electric instruments are identical to the predicate devices in design, materials ofconstruction, and intended use. There are no changes to the clinical applications, patient population,performance specifications, or method of operation.
Functional andSafety Testing:	Representative samples of reprocessed sealer/dividers were tested to demonstrate appropriate functionalcharacteristics. Process validation testing was performed to validate the cleaning and sterilization proceduresas well as device packaging. In addition, the manufacturing process includes visual and validated functionaltesting of all products produced.
Summary ofNon-clinicalTestsConducted:	Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packagingvalidation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated useon beef tissue, visual inspection, fatigue testing, and function testing. Performance testing shows thereprocessed sealer/dividers to perform as intended.
Conclusion:	The reprocessed sealer/divider is substantially equivalent to the Covidien LigaSure Impact™ Hand ActivatedSealer/Divider (K070162). This conclusion is based upon the devices' similarities in functional design(principles of operation), materials, indications for use and methods of construction.

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

OCT
5
2012

SterilMed, Incorporated % Mr. Jason Skramsted Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, Minnesota 55369

Re: K120040

Trade Name: Reprocessed Surgical Electric Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: September 28, 2012 Received: October 2, 2012

Dear Mr. Skramsted:

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. 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 801); medical device reporting (reporting of medical

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Page 2 - Mr. Jason Skramsted

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Eric Keith

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

Enclosure

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STERILMED, INC.

Medical Device Reprocessing
Small Equipment & Instrument Repair

. (

Indications for Use

510(k) Number (if known):

Device Name: Reprocessed Surgical Electric Instrument

Indications for Use:

The Reprocessed Surgical Electric Instrument (hereinafter sealer/divider) is indicated for use in open surgical procedures to seal vessels up to and including 7 mm, lymphatics, and tissue bundles. When used with the ForceTriad 101 energy platform the sealer/divider can also be used to seal pulmonary vasculature. The sealer/divider should not be used for tubal sterilization or tubal coagulation as it has not been shown effective for sterilization procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120047

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.