The Reprocessed HARMONIC ACE®+7, 5 mm Diameter 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

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an ergonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. Each instrument is shipped with one sterile, single-use, disposable torque wrench.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, specifically "Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis". This document details the comparison to a predicate device and various tests conducted to demonstrate substantial equivalence, rather than a clinical study evaluating a diagnostic or AI-driven device's performance against specific acceptance criteria like accuracy, sensitivity, or specificity.

Therefore, the requested information regarding acceptance criteria, reported device performance in those terms, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth for a diagnostic AI device is not applicable to this document.

The document focuses on demonstrating that the reprocessed surgical shears are as safe and effective as the original, legally marketed predicate device through a series of engineering and performance tests.

Here's what can be extracted regarding the device's performance demonstration:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines functional performance tests and other validations, rather than specific diagnostic accuracy metrics. The "acceptance criteria" are implied to be achieving performance comparable to the predicate device and meeting safety standards.

Acceptance Criteria Category	Specific Test/Validation	Reported Device Performance
Safety & Biocompatibility	Biocompatibility	Conducted
	Validation of Reprocessing	Conducted
	Sterilization Validation	Conducted (Sterile by Ethylene Oxide)
	Pyrogen Free	No (Same as Predicate)
	Electromagnetic Compatibility & Electrical Safety Testing	Conducted (in accordance with IEC 60601-1-2)
Functional Performance	Blade to Clamp Arm Angle	Conducted
	Actuating Trigger Force	Conducted
	MIN/MAX Button Activation Force	Conducted
	Advanced Hemostasis (AH) Button Activation Force	Conducted
	Rotation Knob Force – Actuating Trigger Disengaged	Conducted
	Rotation Knob Force Actuating Trigger Engaged	Conducted
	Jaw Clamp Force	Conducted
	Tissue Retention Force	Conducted
	Shaft Straightness	Conducted
	ATT Functionality and Transection Time	Conducted. Evaluation of device's performance and ability to seal and divide vessels up to 7mm, including transection time.
	Burst Pressure	Conducted. Evaluation of device's performance and ability to seal and divide vessels up to 7mm, including burst pressure.
	Maximum Jaw and Shaft Temperature	Conducted. Evaluation of device's performance and ability to seal and divide vessels up to 7mm, including thermal spread.
	Reliability Testing	Conducted
Packaging & Labeling	Packaging Validation	Conducted
Clinical Equivalence	Pre-Clinical Testing (Acute Animal Study, Chronic Animal Study)	Conducted. "The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate devices and operate as originally intended."

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

This document does not specify exact sample sizes for each test. It generally states that "Bench and laboratory testing was conducted" and includes "verification/comparative testing (to the predicate device)."
Data provenance: Not explicitly stated, but assumed to be internal laboratory testing by Stryker Sustainability Solutions. It is not clinical data from specific countries or indicated as retrospective/prospective in a diagnostic sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not a diagnostic device relying on expert interpretation for ground truth.

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

Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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:

Not applicable. This is a reprocessed surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This is a reprocessed surgical instrument, not an algorithm.

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

For the performance tests, the "ground truth" would be established by engineering specifications, validated test methods, and comparison against the performance of the original, new predicate device. For animal studies, the "ground truth" would be physiological outcomes observed by veterinarians or pathologists.

8. The sample size for the training set:

Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2021

Stryker Sustainability Solutions Aphrodeja Crutch Sr. Regulatory Affairs Specialist 1810 W. Drake Dr. Tempe, Arizona 85283

Re: K202554

Trade/Device Name: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis Regulatory Class: Unclassified Product Code: NLO Dated: February 16, 2021 Received: February 19, 2021

Dear Aphrodeja Crutch:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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OM	ModelNumber	Device Name/Description	ShaftDiameter	ShaftLength
Ethicon	HARH23	Harmonic ACE +7 Shears with AdvancedHemostasis	5mm	23cm
Ethicon	HARH36	Harmonic ACE +7 Shears with AdvancedHemostasis	5mm	36cm
Ethicon	HARH45	Harmonic ACE +7 Shears with AdvancedHemostasis	5mm	45cm

Reprocessed Single-Use Device Models Subject to Clearance :

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Page 1 of 1

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K202554

Device Name

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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SECTION 5: 510(k) SUMMARY

Submitter:

Stryker Sustainability Solutions (SSS) 1810 W. Drake Drive Tempe, Arizona 85283

Contact:

Aphrodeja Crutch, B.A., Pre-law/Legal Studies Sr. Regulatory Affairs Specialist 404.993.1981 (c) 480-763-5310 (f) aphrodeja.crutch@stryker.com

Date of Preparation: September 1, 2020

Name of Device:

Trade/Proprietary Name:	Reprocessed Harmonic ACE® +7, 5mm Diameter Shears withAdvanced Hemostasis (HARH23, HARH36, HARH45)
Common Name:	Scalpel, Ultrasonic, Reprocessed
Classification Information:	Class: UnclassifiedUnclassified Reason: Pre-AmendmentProduct Code: NLQ
Model Numbers:	HARH23, HARH36, HARH45

Predicate Devices:

ModelNumber	510(k)Number	510(k) Title	OriginalManufacturer
HARH23HARH36HARH45	K132612	HARMONIC ACE+ Shears with AdvancedHemostasis	Ethicon Endo-Surgery, LLC

Device Description:

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Each instrument is shipped with one sterile, single-use, disposable torque wrench.

Model Number	Description	Original Manufacturer
HARH23	HARMONIC ACE+7 Shears with Advanced Hemostasis 5mm Diameter, 23cm Length	Ethicon Endo-Surgery, LLC
HARH36	HARMONIC ACE+7 Shears with Advanced Hemostasis 5mm Diameter, 36cm Length	Ethicon Endo-Surgery, LLC
HARH45	HARMONIC ACE+7 Shears with Advanced Hemostasis 5mm Diameter, 45cm Length	Ethicon Endo-Surgery, LLC

Intended Use:

The Reprocessed HARMONIC ACE®+7, 5 mm Diameter 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, pediatric, 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.

Summary of Technological Characteristics in Comparison to the Predicate Devices:

The design, materials, and intended use of Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are equivalent to the predicate devices. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, SSS' reprocessing of HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations.

Substantial Equivalence Table Ethicon Endo-Surqery HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis and Stryker Sustainability Solutions Reprocessed (SSS) HARMONIC ACE@+7, 5 mm Diameter Shears with Advanced Hemostasis:

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Characteristic	Ethicon Endo-SurgeryHARMONIC ACE®+7, 5 mmDiameter Shears withAdvanced Hemostasis	Stryker SustainabilitySolutions (SSS)Reprocessed HARMONICACE®+7, 5 mm DiameterShears with AdvancedHemostasis
Indications for Use	The HARMONIC ACE®+7, 5mm Diameter Shears withAdvanced Hemostasis areindicated for soft tissueincisions when bleedingcontrol and minimal thermalinjury are desired. Theinstruments can be used asan adjunct to or substitutefor electrosurgery, lasersand steel scalpels ingeneral, plastic, pediatric,gynecologic, urologic,thoracic, exposure toorthopedic structures (suchas spine and joint space),sealing and transection oflymphatic vessels, and otheropen and endoscopicprocedures. The instrumentsallow for the coagulation ofvessels up to and including7 mm in diameter, using theAdvanced Hemostasis handcontrol button.	The ReprocessedHARMONIC ACE®+7, 5 mmDiameter Shears withAdvanced Hemostasis areindicated for soft tissueincisions when bleedingcontrol and minimal thermalinjury are desired. Theinstruments can be used asan adjunct to or substitutefor electrosurgery, lasersand steel scalpels ingeneral, plastic, pediatric,gynecologic, urologic,thoracic, exposure toorthopedic structures (suchas spine and joint space),sealing and transection oflymphatic vessels, and otheropen and endoscopicprocedures. Theinstruments allow for thecoagulation of vessels up toand including 7 mm indiameter, using theAdvanced Hemostasis handcontrol button.
Contraindications forUse	• The instruments are notindicated for incising bone.• The instruments are notintended for contraceptivetubal occlusion.	• The instruments are notindicated for incising bone.• The instruments are notintended for contraceptivetubal occlusion.
Sterility	Sterile by Ethylene Oxide	Sterile by Ethylene Oxide
Pyrogen Free	No	No
Expiration Date	The expiration date isprovided on the devicepackage labels. The date ofmanufacture is not providedon the device packagelabels, thus, the shelf life isunknown.	The expiration date isprovided on the devicepackage labels. Theexpiration date is labeled asthree (3) years from thedate of manufacture.
Uses	Single Patient Use	Single Patient Use
Characteristic	Ethicon Endo-SurgeryHARMONIC ACE®+7, 5 mmDiameter Shears withAdvanced Hemostasis	Stryker SustainabilitySolutions (SSS)Reprocessed HARMONICACE®+7, 5 mm DiameterShears with AdvancedHemostasis
Generator	Generator G11 (GEN11) software version 2013_I or later	Generator G11 (GEN11) software version 2013_I or later
Device Materials	Refer to Table 10-2 for a list of patient-contacting materials.	Refer to Table 10-2 for a list of patient-contacting materials.
Device Packaging	Primary Packaging is comprised of a PETG sealed thermoformed tray. One (1) device is secured in the tray. An adhesive-coated DuPont 1073B Tyvek Lid is sealed to the tray to create a sterile barrier system.	Primary Packaging is comprised of a PETG sealed thermoformed tray. One (1) device is secured in the tray. An adhesive-coated DuPont 1073B Tyvek Lid is sealed to the tray to create a sterile barrier system.
	Secondary Packaging is comprised of solid bleached sulfate folding shelf carton. Six (6) Primary Packages are inserted into the Secondary Package.Tertiary Packaging is comprised of a corrugate shipping carton. One (1) Secondary Package is placed in a corrugate shipping carton.	Secondary Packaging is comprised of solid bleached sulfate folding shelf carton. Six (6) Primary Packages are inserted into the Secondary Package.Tertiary Packaging is comprised of a corrugate shipping and sterilization carton. One (1) Secondary Package is placed in a corrugate shipping carton.
Substitute Components	Refer to Table 10-9 for list of substitute components.	Refer to Table 10-9 for list of substitute components.

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Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis. This included the following tests:

Biocompatibility ●
Validation of Reprocessing
Sterilization Validation ●
Functional Performance Tests
- Blade to Clamp Arm Angle o
- o Actuating Trigger Force

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MIN/MAX Button Activation Force o
Advanced Hemostasis (AH) Button Activation Force O
o Rotation Knob Force – Actuating Trigger Disengaged
Rotation Knob Force Actuating Trigger Engaged O
Jaw Clamp Force o
O Tissue Retention Force
Shaft Straightness o
ATT Functionality and Transection Time O
O Burst Pressure
Maximum Jaw and Shaft Temperature o
Reliability Testing o
Electromagnetic Compatibility & Electrical Safety Testing ●
Packaging Validation ●
Pre-Clinical Testing ●
- o Acute Animal Study
- o Chronic Animal Study

The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1-2 and verification/comparative testing (to the predicate device). The bench testing involved evaluation of the device's performance and ability to seal and divide vessels up to 7mm, including thermal spread, transection time, burst pressure, device functionality, and device reliability.

The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate devices and operate as originally intended.

The Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are reprocessed no more than two (2) times. Each reprocessed device is tracked with a Stryker pad print on the device indicating the device has been reprocessed. On the second turn a line will be added on top of the original pad print indicating two reprocessing cycles. Once the device reaches the maximum number of reprocessing cycles, it is rejected and taken out of service. Reprocessing is conducted only by Stryker Sustainability Solutions. Stryker Sustainability Solutions restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Conclusion:

Stryker Sustainability Solutions (SSS) concludes that the Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis is at least as safe and effective as the predicate device as described herein.

Regulation Number and Section

N/A