The Reprocessed Harmonic Shears with Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Device Description

The Reprocessed Harmonic Shears with Adaptive Tissue Technology are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate and transect soft tissue with a single instrument. The devices are hand-actuated with shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The device includes a torque wrench as an accessory piece (the torque wrench is designed to ensure that the hand piece is properly secured to the device.

AI/ML Overview

The provided text describes the 510(k) summary for Sterilmed's Reprocessed Harmonic Shears with Adaptive Tissue Technology. It details various tests conducted to demonstrate substantial equivalence to the predicate device.

Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "Performance testing shows the reprocessed Harmonic Shears with Adaptive Tissue Technology to perform as originally intended" and "Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."

The types of tests performed, which imply the areas where performance was assessed, are listed under "Summary of Non-Clinical Tests Conducted" and "Functional and Safety Testing." These tests aimed to demonstrate that the reprocessed devices perform as well as the original predicate devices.

Acceptance Criteria (Implied from Tests)	Reported Device Performance
Cleaning validation success	Validated to meet cleaning requirements.
Sterilization verification success	Validated to meet sterilization requirements.
Ethylene oxide residual levels (meeting ISO 10993-7)	Met ISO 10993-7 requirements.
Packaging integrity (meeting ASTM D4169, ASTM F88, ASTM F2096)	Validated to maintain packaging integrity.
Shelf-life validation success (meeting ASTM 1980-07)	Validated to maintain shelf-life.
Functional performance (bench testing) equivalent to predicate device	Performed "as originally intended" and demonstrated "substantial equivalence" to predicate devices for: - Electrical Safety - Device Functionality - Vessel Seal Burst (Static and Burst Pressure) - Vessel Seal Thermal Spread - Drop - Fluid Ingress - Pad Retention - Pad Failure - Clamp Force
Biocompatibility (meeting ISO 10993-1 for short duration contact with blood)	Passed tests for: - Cytotoxicity - Sensitization - Irritation/Intracutaneous Reactivity - Acute Systemic Toxicity - Hemocompatability - Chemical Pyrogens - Hemolysis - Immune Response

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

The document mentions "Representative samples of reprocessed devices were tested" for functional characteristics. However, specific sample sizes for each test are not provided in this summary.

The data provenance is from non-clinical tests conducted by Sterilmed, Inc., a reprocessing company. This is an in-house prospective testing of their reprocessed devices. The country of origin is implicitly the USA where Sterilmed is located and where the FDA regulatory submission was made.

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

This type of information is not applicable to this document. The "ground truth" for this device (a reprocessed surgical instrument) is established by objective engineering and safety standards (e.g., sterilization parameters, mechanical performance, biocompatibility) rather than expert interpretation of data like images or patient outcomes. The performance is compared against the original (predicate) device.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective measurements against engineering standards and comparison to a predicate device, not on subjective assessments requiring adjudication among experts.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic or assistive technology that would involve human readers or AI.

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

This question is not applicable as the device is a reprocessed surgical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on defined engineering specifications, performance standards, regulatory requirements (e.g., ISO for biocompatibility and residuals), and the performance characteristics of the legally marketed predicate device. The goal is to demonstrate that the reprocessed device performs identically or equivalently to the new/original device.

8. The Sample Size for the Training Set

This question is not applicable. This is a reprocessed medical device, not an AI or machine learning algorithm that requires a "training set."

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

This question is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple-line design representing the bodies.

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

September 20, 2016

Sterilmed, Inc. Ms. Neelu Gibson Senior Director, Regulatory Affairs 5010 Cheshire Parkway, Suite 2 Plymouth, Minnesota 55446

Re: K161086

Trade/Device Name: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: August 19, 2016 Received: August 22, 2016

Dear Ms. Gibson:

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 device

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related adverse events) (21 CFR Part 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 Parts 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K161086

Device Name

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23 cm)

Indications for Use (Describe)

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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K161086 Device Name and Model Numbers

Device Name	Model Number
Reprocessed Harmonic ACE®+ Shears, 5 mm Diameter, 23cm Length, With Adaptive Tissue Technology	HAR23R
Reprocessed Harmonic ACE®+ Shears, 5 mm Diameter, 36cm Length, With Adaptive Tissue Technology	HAR36R

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Image /page/4/Picture/0 description: The image shows the logo for STERILMED. The logo consists of a stylized green and blue circular arrow on the left, followed by the word "STERILMED" in black and light blue lettering. The first part of the word, "STERIL", is in black, while the "MED" is in a lighter blue color.

K161086

510(k) SUMMARY

Submitter andManufacturer:	Sterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446www.sterilmed.com
OfficialCorrespondent:	Neelu GibsonSr. Director, Regulatory Affairs (RAC)Sterilmed, Inc.Tel: 908-705-3160Fax: 763-488-4576Email: ngibson9@its.jnj.com
Date ofSubmission:	15 March 2016
Trade Name:	Reprocessed Harmonic Shears with Adaptive Tissue Technology (23 cm),Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm)
Common Name:	Reprocessed Harmonic Shears with Adaptive Tissue Technology
510(k) Number:	K161086
DeviceClassification:	Name: Electrosurgical cutting and coagulation device and accessories.Regulation: 21CFR 878-4400Pro Code: NUJClass: Class II
Predicate Device:	Harmonic ACE Shears + Adaptive Tissue Technology (K121550).
DeviceDescription:	The Reprocessed Harmonic Shears with Adaptive Tissue Technology areused for coagulation and mechanical transection of soft tissue duringlaparoscopic and open procedures. The devices allow the surgeon tograsp, coagulate and transect soft tissue with a single instrument. Thedevices are hand-actuated with shaft and tissue effector that can be rotated.The energy delivery can be activated with hand activation or with anoptional generator foot switch.The device includes a torque wrench as an accessory piece (the torquewrench is designed to ensure that the hand piece is properly secured to thedevice.
Indicationsfor Use:	The Reprocessed Harmonic Shears with Adaptive Tissue Technology areindicated for soft tissue incisions when bleeding control and minimalthermal injury are desired. The instruments can be used as an adjunct toor substitute for electrosurgery, lasers and steel scalpels in general, plastic,pediatric, gynecologic, urologic, thoracic, exposure to orthopedicstructures (such as spine and joint space) and other open and endoscopicprocedures.
TechnologicalCharacteristics:	The reprocessed Harmonic Shears with Adaptive Tissue Technology havethe same technological and performance characteristics as the predicatedevices, K121550. The reprocessed Harmonic Shears with AdaptiveTissue Technology incorporate an ergonomic handle and tapered bladegeometry. Similar to the predicate models, each of these reprocesseddevices includes an EEPROM memory chip that stores deviceidentification, usage tracking, and operating parameters for use by theEthicon Endo-Surgery, Inc. Generator 11 generator that provides powerfor the devices.
	Adaptive Tissue Technology refers to the power output algorithm that isutilized by the devices. During use, the Adaptive Tissue Technologyalgorithm parameters stored on the device EEPROM are read by thegenerator and used to reduce the power (current) to the instrument andprovide a secondary, higher pitched generator activation tone when thereis little or no tissue between the instrument blade and tissue pads. To dothis the generator monitors the thermal condition of the blade duringdevice activation.
Functionaland SafetyTesting:	Representative samples of reprocessed devices were tested todemonstrate appropriate functional characteristics. Process validationtesting was performed to validate the cleaning and sterilizationprocedures as well as device packaging. In addition, the manufacturingprocess includes visual and validated functional testing of all productsproduced. Where appropriate prior validation testing of previouslycleared Reprocessed Harmonic Shears (K132566) was utilized for thesame reprocessing procedures, equipment, and sterilization processing.The Reprocessed Harmonic Shears with Adaptive Tissue Technology arereprocessed no more than one (1) time. The torque wrench accessoriesare reprocessed no more than five (5) times. Each device and accessoryis marked and tracked through the reprocessing cycle. After the deviceor torque wrench has reached the maximum number of reprocessingcycles, one and five, respectively, it is rejected from further reprocessing.
Summary ofNon-ClinicalTests Conducted:	Specific non-clinical tests performed included: cleaning validation,sterilization verification, ethylene oxide residual testing (ISO 10993-7),packaging validation (ASTM D4169, ASTM F88, ASTM F2096), andshelf-life validation (ASTM 1980-07). In addition, validation offunctional performance (bench testing) was performed through simulated Electrical Safety Device Functionality Vessel Seal Burst (Static and Burst Pressure) Vessel Seal Thermal Spread Drop Fluid Ingress Pad Retention Pad Failure Clamp Force
	Performance testing shows the reprocessed Harmonic Shears withAdaptive Tissue Technology to perform as originally intended.In addition, the device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (<24 hours). Biocompatibilitytesting included:Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Hemocompatability Chemical Pyrogens Hemolysis Immune Response
Conclusion:	Sterilmed conducted performance testing (described above) for theReprocessed Harmonic Shears with Adaptive Tissue Technology (23 cmand 36 cm) against the OEM predicate devices, Harmonic ACE Shears +Adaptive Tissue Technology, Models HAR23 and HAR36 (K121550).Results demonstrated substantial equivalence to the predicate deviceswith respect to safety and effectiveness.Sterilmed therefore concludes that the Reprocessed Harmonic Shears withAdaptive Tissue Technology (23 cm, 36 cm) are safe, effective, andsubstantially equivalent to the predicate devices, Harmonic ACE Shears +Adaptive Tissue Technology, Models HAR23 and HAR36 (K121550)

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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.