REPROCESSED HARMONIC SCALPEL by STERILMED, INC.

The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Device Description

SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator, torque wrench and grip assist and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when closing the distal mechanism. The instrument has a working length of 9 cm, an active blade of 16 mm and utilizes a curved blade and clamp arm. This device allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.

AI/ML Overview

Device Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The device under review is the "Reprocessed Harmonic Scalpel," and its acceptance criteria are established through a demonstration of substantial equivalence to its predicate device, the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192). The study focuses on demonstrating that the reprocessed device performs functionally and safely as intended, aligning with the predicate device.

The acceptance criteria are not explicitly numerical thresholds for performance metrics (e.g., a specific force or cutting speed). Instead, they are defined by successful completion of a battery of non-clinical tests and functional performance evaluations, which collectively attest to the device's ability to maintain the inherent functional design, materials, indications for use, and methods of construction of the original device.

Acceptance Criteria Category	Reported Device Performance
Cleaning Validation	Performed through process validation testing to validate cleaning procedures.
Sterilization Validation	Performed through process validation testing to validate sterilization procedures, in accordance with ISO 11135 and USP <71>.
Biocompatibility Testing	Conducted in accordance with ISO 10993-1.
Ethylene Oxide Residual Testing	Performed in accordance with ISO 10993-7.
Packaging Validation	Performed in accordance with ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096.
Shelf Life Validation	Performed in accordance with ASTM 1980-07.
Functional Performance (Bench Testing)	Performed through simulated use on beef tissue, visual inspection, fatigue testing (including repeated cycling and maximum power testing), and function testing (including system checks). Performance testing shows the Reprocessed Harmonic Scalpels to perform as intended.
Manufacturing Process Quality Controls	The manufacturing process includes visual and validated functional testing of all products produced, ensuring appropriate functional characteristics for representative samples.
Substantial Equivalence to Predicate Device	Concluded based upon similarities in functional design (principles of operation), materials, indications for use, and methods of construction with the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192). The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears.

2. Sample Size and Data Provenance (Test Set)

Sample Size: The document states that "Representative samples of reprocessed harmonic scalpels were tested." However, the exact numerical sample size for each specific test or for the overall test set is not provided in the summary.
Data Provenance: The study appears to be entirely retrospective in the sense that it relies on bench testing and comparisons to existing standards and predicate devices. The data provenance can be considered manufacturer-generated data (SterilMed, Inc.) as it describes internal testing and validation processes. No mention of geographical origin for the data is made, implying it was conducted in the manufacturer's testing facilities (likely in the US, given the submission to the FDA).

3. Number of Experts and Qualifications (Test Set Ground Truth)

This study does not involve human expert interpretation of medical images or diagnoses, so the concept of "experts establishing ground truth for the test set" in the context of medical image analysis is not applicable. The "ground truth" for this device is established by adherence to engineering specifications, validated test methods, and comparison to the predicate device's known performance and manufacturing standards. The validation involves certified testing against industry standards (e.g., ISO, ASTM, USP) which are developed by expert committees in their respective fields.

4. Adjudication Method (Test Set)

No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as this is not a study involving human readers making subjective assessments that require reconciliation. The assessment of performance relies on objective, quantifiable tests and adherence to established standards and specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of medical data (like imaging), comparing human reader performance with and without AI assistance. This submission pertains to a reprocessed surgical instrument, not a diagnostic AI device. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant here.

6. Standalone Performance (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This device is a physical surgical instrument, not a software algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

The ground truth used for this study is a combination of:

Established Industry Standards: Compliance with recognized international and national standards for sterilization (ISO 11135, USP <71>), biocompatibility (ISO 10993-1), ethylene oxide residuals (ISO 10993-7), packaging (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life (ASTM 1980-07).
Predicate Device Performance: The functional design, materials, indications for use, and methods of construction of the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192) serve as the benchmark for substantial equivalence.
Objective Functional Testing: Verified performance "as intended" through simulated use on beef tissue, visual inspection, fatigue testing, and function testing with system checks.

In essence, the ground truth is defined by the demonstrated ability of the reprocessed device to meet the safety and performance specifications of the original device and comply with relevant regulatory and technical standards.

8. Sample Size for the Training Set

This submission describes the testing and re-processing of a physical medical device. It does not involve machine learning algorithms or AI, and therefore, the concept of a "training set" is not applicable. The 'training' for this device is the established reprocessing protocol itself, and its validation.

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

Since there is no "training set" in the context of machine learning for this device, this question is not applicable. The "ground truth" for the reprocessing protocol itself is established through extensive engineering and scientific validation to ensure that the reprocessed device is safe, sterile, and performs identically to its new counterpart. This includes developing and validating cleaning, sterilization, and inspection methods based on scientific principles and regulatory requirements.

Summary

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II. SUMMARY AND CERTIFICATION

SUMMARY AND CERTIFICATION
A.	510(k) Summary	K111794
	Submitter:	SterilMed, Inc.
	Contact Person:	Onya Dendinger11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 763-488-3410Fax: 763-488-2051
	Date Prepared:	June 24, 2011
	Trade Name:	Reprocessed Harmonic Scalpel
	Classification Name:	Scalpel, Ultrasonic, Reprocessed
	Classification Number:	Unclassified
	Product Code:	NLO

PredicateDevices:	The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears(510(k) K063192).
DeviceDescription:	SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator, torque wrenchand grip assist and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation ofvessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN andMAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied whenclosing the distal mechanism. The instrument has a working length of 9 cm, an active blade of 16 mm andutilizes a curved blade and clamp arm. This device allows for the cutting and coagulation of vessels up to andincluding 5 mm in diameter.Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.
IntendedUse:	The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cuttingsoft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired.The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels inabdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and otheropen procedures.
Functionaland SafetyTesting:	Representative samples of reprocessed harmonic scalpels were tested to demonstrate appropriate functionalcharacteristics. Process validation testing was performed to validate the cleaning and sterilization procedures aswell as device packaging. In addition, the manufacturing process includes visual and validated functional testingof 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 use onbeef tissue, visual inspection, fatigue testing (including repeated cycling and maximum power testing), andfunction testing (including system checks). Performance testing shows the Reprocessed Harmonic Scalpels toperform as intended.
Conclusion:	The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears.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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

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

JAN 1 1 2012

SterilMed, Inc. % Ms. Onya Dendinger 11400 73td Avenue North Maple Grove, Minnesota 55369

Re: K111794

Trade/Device Name: Reprocessed Harmonic Scalpel Regulatory Class: Unclassified Product Code: NLQ Dated: December 29, 2011 Received: December 30, 2011

Dear Ms. Dendinger:

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 – Ms. Onya Dendinger

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

E. 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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Image /page/3/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."

Indications for Use

KIII 794 510(k) Number (if known):

Device Name: Reprocessed Harmonic Scalpel

Indications for Use:

The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open 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)

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(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111794

Regulation Number and Section

N/A