The Sterilmed Reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis 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), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

Device Description

The Sterilmed Reprocessed HARMONIC ACE+7 Shears with Advanced Hemostasis 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 a 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 two models are identical to each other in materials, form, fit and function except for the length of the shafts which are 23cm and 36 cm.

AI/ML Overview

This document describes the validation of reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis, demonstrating their substantial equivalence to the original equipment manufacturer (OEM) predicate device. Given that the provided text is a 510(k) summary for a reprocessed medical device (surgical shears), the acceptance criteria and study design are focused on demonstrating that the reprocessed device performs as safely and effectively as the original device. This is a non-clinical submission, thus the information regarding AI/human reader studies, expert consensus on images, etc., is not applicable here.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a reprocessed device are fundamentally centered on demonstrating that it performs equivalently to the new, original device in terms of safety and functional effectiveness. The performance of the reprocessed device is compared against the OEM predicate device. Specific quantitative acceptance criteria or threshold values are not explicitly listed in this summary, but the general principle is that the reprocessed device "performs as originally intended" and is "substantially equivalent" to the predicate.

Test Parameter / Acceptance Criteria	Reported Device Performance (Reprocessed Device)
Functional PerformanceSimulated use, visual inspection, fatigue testing. Must perform as originally intended.	"Performance testing shows the Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis performs as originally intended."
Cleaning ValidationValidation of cleaning efficacy.	"Process validation testing was performed to validate cleaning..."
Sterilization VerificationValidation of sterilization efficacy.	"...and sterilization..."
Ethylene Oxide Residual Testing(ISO 10993-7 compliant for residuals)	"...ethylene oxide residual testing (ISO 10993-7)..."
Packaging Validation(ASTM D4169, ASTM F88, ASTM F2096 compliant)	"...packaging validation (ASTM D4169, ASTM F88, ASTM F2096)..."
Shelf-Life Validation(ASTM 1980-07 compliant)	"...and shelf-life validation (ASTM 1980-07)."
Electrical SafetyMust meet safety standards.	"Testing performed: Electrical Safety"
Vein Seal Burst (1-7mm) & Tissue AdhesionEquivalent sealing performance to predicate.	"Vein Seal Burst (1-7mm) and Tissue Adhesion" (Implied equivalent to predicate)
Artery Seal Burst (1-7mm) & Tissue AdhesionEquivalent sealing performance to predicate.	"Artery Seal Burst (1-7mm) and Tissue Adhesion" (Implied equivalent to predicate)
Lymphatics Seal PerformanceEquivalent sealing performance to predicate.	"Lymphatics Seal Performance" (Implied equivalent to predicate)
Vessel Seal Thermal SpreadMinimize thermal injury, equivalent to predicate.	"Vessel Seal Thermal Spread" (Implied equivalent to predicate)
Drop Fluid IngressMaintain integrity against fluid ingress.	"Drop Fluid Ingress" (Implied satisfactory)
Pad Retention, Pad Life, Grasping ForceMaintain mechanical integrity and function.	"Pad Retention, Pad Life, Grasping Force" (Implied satisfactory)
Biocompatibility(ISO 10993-1 compliant: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity)	"Biocompatibility testing included: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity" (Implied compliant)
Overall Comparison to Predicate DeviceSubstantially equivalent with respect to safety and effectiveness.	"Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size: The document states that "representative samples of reprocessed devices were tested," and for functional testing, "all products produced" undergo visual and validated functional testing. However, specific numerical sample sizes for each test (e.g., how many devices were tested for vein seal burst, or fatigue testing) are not provided in this summary.
Data Provenance: The testing was conducted by Sterilmed, Inc., a reprocessor based in Plymouth, MN, and Maple Grove, MN, USA. The data is from prospective bench testing and validation studies of their reprocessed devices. It is not human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as this is a submission for reprocessed surgical shears based on non-clinical, bench testing, and engineering validation, not an AI or imaging-based device. No "experts" in the sense of medical professionals interpreting images were used to establish ground truth for the device's functional performance. Ground truth was established through validated engineering and laboratory test methods, often comparing performance against the OEM predicate.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving multiple human readers interpreting data, typically in diagnostic imaging. For a reprocessed surgical device, the "adjudication" is inherent in the robust, validated test methods and comparison to established predicate performance. If a test failed, it would need to be investigated and resolved, but there isn't a "reader-based" adjudication process.

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:

This is not applicable. MRMC studies are specific to diagnostic imaging devices, often involving AI, where human readers evaluate cases. This submission is for reprocessed surgical shears, which do not involve human readers for diagnostic interpretation.

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

This is not applicable. This device is a mechanical/ultrasonic surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established by:

Engineering specifications and performance characteristics of the OEM predicate device (Ethicon HARMONIC ACE®+7 Shears with Advanced Hemostasis, K132612).
Validated industry standards and test methods (e.g., ISO 10993, ASTM standards for packaging, electrical safety).
Successful functional performance benchmarks (e.g., vein/artery seal burst pressure, thermal spread, grasping force), which show the device "performs as originally intended."
In essence, the ground truth is that the reprocessed device must meet or exceed the safety and functional performance of the new, original device.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device; there is no "training set" in the computational sense. The "training" for the manufacturing process involves process validation and quality control measures to ensure consistent reprocessing.

9. How the ground truth for the training set was established:

This is not applicable for the same reason as point 8. The "ground truth" for the overall manufacturing and reprocessing process is established through rigorous validation of cleaning, sterilization, packaging, and functional testing protocols to ensure the device is consistently reprocessed to meet its intended performance specifications.

Summary

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Indications for Use

510(k) Number (if known)

K182272

Device Name

Sterilmed Reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis (Models HARH23R and HARH36R)

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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Ethicon OEMModel #	SterilmedModel #	Description
HARH23	HARH23R	Reprocessed HARMONIC ACE+ 7 Shears withAdvanced Hemostasis, 23 cm Length
HARH36	HARH36R	Reprocessed HARMONIC ACE+ 7 Shears withAdvanced Hemostasis, 36 cm Length

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Image /page/2/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Below the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 15, 2019

Sterilmed. Inc. Ms. Jan Flegeau, B.A. Associate Director, Regulatory Affairs 5010 Cheshire Parkway N. Suite 2 Plymouth, Minnesota 55446

Re: K182272

Trade/Device Name: Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (Models HARH23R and HARH36R) Regulatory Class: Unclassified Product Code: NLQ

Dated: March 14, 2019 Received: March 15, 2019

Dear Ms. Flegeau:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

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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510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Date Prepared:	April 11, 2019
Submitter andManufacturer:	Sterilmed, Inc.5010 Cheshire Parkway N, Suite 2Plymouth, MN 55446www.sterilmed.com
ManufacturingFacility Address:	11400 73rd AvenueNorth Maple GroveMN 55369
OfficialCorrespondent:	Ms. Jan Flegeau, B.A.Associate Director, Regulatory AffairsSterilmed, Inc.Tel: 786-575-5903Email: jflegeau@its.jnj.com
Trade Name:	Reprocessed HARMONIC ACE®+ 7 Shears with AdvancedHemostasis (Models HARH23R and HARH36R)
Regulation Name:	Scalpel, Ultrasonic, Reprocessed
Device Classification:	Unclassified
Product Code	NLQ
Predicate Device:	HARMONIC ACE®+7 Shears with Advanced Hemostasis(Ethicon K132612 - Models HARH23 and HARH36)
Device Description:	The Sterilmed Reprocessed HARMONIC ACE+7 Shears withAdvanced Hemostasis are used for coagulation and mechanicaltransection of soft tissue during laparoscopic and openprocedures. The devices allow the surgeon to grasp, coagulate,and transect soft tissue with a single instrument. The devicesare hand-actuated with a shaft and tissue effector that can berotated. The energy delivery can be activated with handactivation or with an optional generator foot switch.The two models are identical to each other in materials, form,fit and function except for the length of the shafts which are23cm and 36 cm.
Model Numbers	HARH23R (shaft length 23 cm)HARH36R (shaft length 36 cm)
Indications For Use:	The Sterilmed Reprocessed HARMONIC ACE+ 7 Shears withAdvanced Hemostasis are indicated for soft tissue incisionswhen bleeding control and minimal thermal injury are desired.
	electrosurgery, lasers and steel scalpels in general, plastic,pediatric, gynecologic, urologic, thoracic, exposure toorthopedic structures (such as spine and joint space), sealingand transection of lymphatic vessels, and other open andendoscopic procedures. The instruments allow for thecoagulation of vessels up to and including 7 mm in diameterusing the Advanced Hemostasis hand control button.
TechnologicalCharacteristics:	The Reprocessed HARMONIC ACE+ 7 Shears with AdvancedHemostasis has the same technological and performancecharacteristics as the predicate device HARMONIC ACE+ 7Shears with Advanced Hemostasis (K132612). The subjectdevices use an EEPROM memory chip that stores deviceidentification, usage tracking, and operating parameters for useby the Generator G11 that provides power for the ReprocessedHARMONIC ACE+ 7 Shears with Advanced Hemostasis. Thedevices have an ergonomic grip housing assembly with handcontrol buttons (MIN for minimum power level, MAX formaximum power level, and Advanced Hemostasis for largevessel [up to 7 mm] sealing).Adaptive Tissue Technology refers to the power outputalgorithm that is utilized by the devices. During use, theAdaptive Tissue Technology algorithm parameters stored onthe device EEPROM are read by the generator and used toreduce the power (current) to the instrument and provide asecondary, higher pitched generator activation tone asAdaptive Tissue Technology regulates the delivery of energy.To do this the generator monitors the thermal condition of theblade during device activation. The Advanced Hemostasismode utilizes a unique algorithm within Adaptive TissueTechnology that modulates the power delivery from theGenerator G11 to the blade of the device maximizinghemostasis.
Functional and SafetyTesting:	Representative samples of reprocessed devices were tested todemonstrate appropriate functional characteristics. Processvalidation testing was performed to validate cleaning andsterilization as well as device packaging. In addition, themanufacturing process includes visual and validated functionaltesting of all products produced. Where appropriate, priorvalidation testing of previously cleared ReprocessedHARMONIC Shears: ACE- (K132566) or ReprocessedHARMONIC Shears: ACE + (K161086) was utilized as thedevices are substantially equivalent. The ReprocessedHARMONIC Shears with Advanced Hemostasis: ACE + 7, arereprocessed no more than one (1) time. The torque wrenchaccessories are reprocessed no more than five (5) times. Eachdevice and accessory are marked and tracked through the
	reprocessing cycle. After the device or torque wrench hasreached the maximum number of reprocessing cycles, one andfive, respectively, it is rejected from further reprocessing.
Summary ofNon-Clinical TestsConducted:	Specific non-clinical tests performed included: cleaningvalidation, sterilization verification, ethylene oxide residualtesting (ISO 10993-7), packaging validation (ASTM D4169,ASTM F88, ASTM F2096), and shelf-life validation (ASTM1980-07). In addition, validation of functional performance(bench testing) was performed through simulated use, visualinspection, and fatigue testing. Testing performed:Electrical Safety Vein Seal Burst (1-7mm) and Tissue Adhesion Artery Seal Burst (1-7mm) and Tissue Adhesion Lymphatics Seal Performance Vessel Seal Thermal Spread Drop Fluid Ingress Pad Retention Pad Life Grasping Force Performance testing shows the ReprocessedHARMONIC ACE+ 7 Shears with AdvancedHemostasis performs as originally intended.In addition, the device was tested for biocompatibilityper ISO 10993-1 for external communicating device,short duration contact with circulating blood (<24 hours).Biocompatibility testing included:Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity
Conclusion:	Sterilmed conducted performance testing for the ReprocessedHARMONIC ACE+ 7 Shears with Advanced Hemostasisagainst the OEM predicate device, HARMONIC ACE+ 7Shears with Advanced Hemostasis (K132612). Resultsdemonstrated substantial equivalence to the predicate deviceswith respect to safety and effectiveness.Sterilmed therefore concludes that the ReprocessedHARMONIC ACE+ 7 Shears with Advanced Hemostasis issafe, effective, and substantially equivalent to the predicatedevice, HARMONIC ACE+ 7 Shears with AdvancedHemostasis.

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Regulation Number and Section

N/A