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 coaqulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an erqonomic 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. The only difference between the three (3) model numbers subject of this submission is the shaft length detailed in the table below.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis. This is crucial as the acceptance criteria and supporting studies are focused on demonstrating that the reprocessed device is substantially equivalent to the original, legally marketed predicate device, and operates as originally intended.

Therefore, the studies and acceptance criteria are not about establishing the primary clinical efficacy of a new device, but rather validating the safety and functionality of a reprocessed version against an established benchmark.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it broadly states that the performance testing "demonstrates that reprocessed devices are as safe and effective as the predicates and operate as originally intended."

The types of tests conducted suggest the implicit acceptance criteria would be that the reprocessed device's performance is comparable or equivalent to the predicate device within acceptable limits for:

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility: Device materials are not cytotoxic, irritating, sensitizing, or otherwise harmful.	Not explicitly stated, but validated by "Biocompatibility" testing.
Validation of Reprocessing: The reprocessing procedure effectively cleans, sterilizes, and restores the device, without compromising material integrity.	Not explicitly stated, but validated by "Validation of Reprocessing" testing.
Sterilization Validation: The sterilization method achieves the required Sterility Assurance Level (SAL).	Not explicitly stated, but validated by "Sterilization Validation" testing.
Functional Performance (General): Device functions as specified, with no degradation in operation.	"Device functionality" and "device reliability" were evaluated. Performance "as originally intended" was concluded.
Electrical Safety: Meets relevant electrical safety standards.	Validated in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
Electromagnetic Compatibility: Does not interfere with, or is not affected by, electromagnetic fields.	Validated in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
Software Validation: Any embedded software functions correctly and reliably.	Validated by "Software Validation" testing.
Packaging Validation: Packaging maintains sterility and device integrity until use.	Validated by "Packaging Validation" testing.
Thermal Spread: Comparable thermal spread to the predicate device.	Evaluated in bench and acute/chronic pre-clinical testing. Concluded as "safe and effective as the predicates."
Transection Time: Comparable transection time to the predicate device.	Evaluated in bench testing. Concluded as "safe and effective as the predicates."
Burst Pressure: Comparable burst pressure to the predicate device for sealed vessels.	Evaluated in bench testing. Concluded as "safe and effective as the predicates."
Ability to Seal and Divide Vessels (up to 7mm): Maintained efficacy in sealing and dividing vessels of specified size.	Evaluated in bench and acute/chronic pre-clinical testing. Concluded as "safe and effective as the predicates."
Hemostasis: Ability to achieve hemostasis is maintained.	Evaluated in acute/chronic pre-clinical testing ("ability to achieve hemostasis of vessels and tissues").

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

Sample Size for Test Set: The document does not specify exact sample sizes for each test. It generally refers to "bench and laboratory testing" and "acute and chronic pre-clinical testing."
Data Provenance: The studies were conducted as part of a 510(k) submission by Stryker Sustainability Solutions. The data would be internally generated through laboratory and pre-clinical animal studies. No information is provided regarding the country of origin of the data beyond the applicant company's location (Tempe, Arizona, USA). These studies are inherently prospective as they are specifically designed and executed to support the regulatory submission for the reprocessed device.

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

This information is not applicable in the context of this 510(k) submission. For reprocessed devices, the "ground truth" for performance is typically established by comparing the reprocessed device's objective physical and functional parameters against those of the original, new predicate device, and ensuring it meets its performance claims. This involves engineering and scientific testing rather than expert-derived ground truth based on cases (e.g., in medical image analysis).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant in studies where human readers are interpreting data (e.g., medical images) and their decisions need to be reconciled to form a consensus ground truth. The studies described here are primarily objective, bench, and pre-clinical tests comparing device performance.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic or screening devices (e.g., AI in radiology) to evaluate the impact of a system on human reader performance. This submission is for a reprocessed surgical instrument.

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

This concept is not directly applicable in the way it's typically understood for AI/software devices. The device is a surgical instrument. However, the "Functional Performance Tests" and "Electrical Safety Testing," "Electromagnetic Compatibility Testing," and "Software Validation" can be considered "standalone" evaluations of the device's inherent physical and functional properties, independent of a human operator, to ensure it meets its specifications.

7. The type of ground truth used

The "ground truth" for the performance evaluations performed for this reprocessed device is established through:

Engineering and Scientific Measurements: Objective laboratory measurements of device characteristics (e.g., thermal spread, transection time, burst pressure, electrical parameters).
Pre-clinical Animal Model Observations: Direct observation of the device's effects in acute and chronic animal studies (e.g., hemostasis, tissue effects).
Comparison to Predicate Device Performance: The underlying ground truth is that the reprocessed device must perform equivalently to the original predicate device (HARMONIC ACE+ Shears with Advanced Hemostasis, K132612) and meet its stated indications.

8. The Sample Size for the Training Set

This information is not applicable. This device is a reprocessed physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.

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

This information is not applicable per the reason stated in point 8.

Summary

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

February 23, 2017

Stryker Sustainability Solutions Mr. Scott English Staff Regulatory Affairs Specialist 1810 W. Drake Dr. Tempe, Arizona 85283

Re: K161693

Trade/Device Name: Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis

Regulatory Class: Unclassified Product Code: NLQ Dated: January 24, 2017 Received: January 25, 2017

Dear Mr. English:

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 devicerelated adverse events) (21 CFR 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 1000-1050.

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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,

Jennifer R. Stevenson -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161693

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)

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K161693

510(k) SUMMARY

Submitter:

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

Contact: Mr. Scott English Staff Requlatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) scott.english@stryker.com

Date of Preparation: January 23, 2017

Name of Device:

	Trade/Proprietary Name: Reprocessed HARMONIC ACE® +7, 5mm Diameter Shears withAdvanced Hemostasis
Common Name:	Scalpel, Ultrasonic, Reprocessed
Classification Information:	Class: UnclassifiedUnclassified Reason: Pre-AmendmentProduct Code: NLQ

Predicate Devices:

ModelNumber	510(k)Number	510(k) Title	Original Manufacturer
HARH23HARH36HARH45	K132612	HARMONIC ACE+ Shears with Advanced Hemostasis	Ethicon Endo-Surgery

Device Description:

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ModelNumber	Description	Size
HARH23	Reprocessed HARMONIC ACE® +7 Shears with Advanced Hemostasis	5mm Diameter,23cm Shaft Length
HARH36	Reprocessed HARMONIC ACE® +7 Shears with Advanced Hemostasis	5mm Diameter,36cm Shaft Length
HARH45	Reprocessed HARMONIC ACE® +7 Shears with Advanced Hemostasis	5mm Diameter,45cm Shaft Length

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

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, 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:

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. The differences between the reprocessed device and predicate device include a substitute tissue pad, new scalpel rod blade coating, and replacement Printed Circuit Board (PCB). There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' 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.

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 .
Electrical Safety Testing
Electromagnetic Compatibility Testing ●
Software Validation
Packaging Validation

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K161693

The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, 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.

Acute and chronic pre-clinical testing was conducted to evaluate thermal spread and the ability to achieve hemostasis of vessels and tissues.

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

Conclusion:

Stryker Sustainability Solutions 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