The HARMONIC Hook instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Device Description

The HARMONIC Hook instrument is a sterile, single patient use instrument, consisting of a 5 mm titanium blade. The instrument allows for the cutting of soft tissue and coagulation of vessels up to and including 2 mm in diameter. The working length of the HARMONIC Hook instrument is 32 cm.

The HARMONIC Hook instrument works with the Generator G11 as part of a system. The device system has four essential parts: the Generator G11 (GEN11), the footswitch (FSW11), the handpiece (HPBLUE), and the HARMONIC Hook (HARBH32). The HARMONIC Hook has an internal torque wrench for assembly to the HPBLUE handpiece. The HPBLUE handpiece connects the HARMONIC Hook device to the Generator G11, and converts electrical energy into mechanical motion (ultrasonic energy). The high-frequency mechanical vibration at 55.5 kHz of the HARMONIC Hook blade transects, dissects, and coagulates tissue, sealing vessels up to 2 mm. This ultrasonic vibration, a form of mechanical energy, does not allow electricity to pass to or through the patient.

The HARMONIC Hook can be operated using the 360° circumferential activation switch on the handle housing or the right footswitch pedal (MAX) of the footswitch (FSW11). Only the right footswitch pedal is active when using the device; the left footswitch pedal (MIN) is not active when using HARMONIC Hook.

AI/ML Overview

The provided text describes a medical device called the HARMONIC Hook and its premarket notification to the FDA. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data for an AI/algorithm-based device.

Therefore, many of the requested details, such as those pertaining to AI/algorithm performance, ground truth establishment, expert adjudication, and multi-reader multi-case studies, are not applicable and not found in the provided text, as the HARMONIC Hook is a physical surgical instrument, not an AI or software-based device.

However, based on the non-AI related performance data mentioned, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "predetermined acceptance criteria" for blade amplitude and frequency during bench testing, and that the data "met" these criteria. However, the specific numerical values for these criteria and the reported performance are not provided.

Acceptance Criteria	Reported Device Performance
Blade Amplitude (Specific values not provided)	Met predetermined acceptance criteria
Blade Frequency (Specific values not provided)	Met predetermined acceptance criteria
Ability to create tissue planes	Demonstrated
Ability to dissect tissue	Demonstrated
Ability to provide hemostasis in different tissue types	Demonstrated
Vessel sealing up to 2 mm in diameter	Demonstrated

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

Bench Testing (Blade Amplitude/Frequency): The sample size is not specified. The provenance is laboratory evaluations.
Acute Animal Testing: The sample size (number of animals) is not specified. It was an acute study (implying prospective). The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable in the context of an AI device. For the physical device testing, the "ground truth" was likely established by direct measurement during bench testing and observation/histology in animal studies by qualified personnel, but the number and qualifications of these individuals are not specified.

4. Adjudication Method for the Test Set:

Not applicable as there's no mention of subjective interpretation of results requiring adjudication in the context of AI. For the physical device, results were likely directly measured or observed.

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

No. Not applicable to this type of device. The study described was an animal model comparison to a predicate device, focusing on physical tissue effects. The document explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence."

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

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

7. The Type of Ground Truth Used:

Bench Test: Direct physical measurements (e.g., of blade amplitude and frequency).
Acute Animal Testing: Direct observation of tissue effects (creation of tissue planes, dissection, hemostasis) and sealing of vessels up to 2mm. This could have been confirmed by gross observation and potentially histology, though not explicitly stated for the animal study.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires 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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with three intertwined strands and a single wing on each side. The text is arranged in a circular pattern around the symbol.

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

March 4, 2016

Ethicon Endo-Surgery, LLC Mr. Brian Godwin Senior Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242

Re: K151136 Trade/Device Name: HARMONIC Hook Regulatory Class: Unclassified Product Code: LFL Dated: February 2, 2016 Received: February 3, 2016

Dear Mr. Godwin,

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 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 -A

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)

к151136

Device Name

HARMONIC® Hook

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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510(k) Summary

Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact Brian Godwin, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-3623 Fax: (513) 337-4366 Email: bgodwin@its.jnj.com

Date Prepared 28 April 2015

Device Name

Trade Name: HARMONIC® Hook Common Name: Instrument, Ultrasonic Surgical Catalog Code: HARBH32

Classification Name

Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)

Regulatory Class Unclassified

Predicate Device

HARMONIC 5mm instrument, cleared under K990362 on 17 September 1999 HARMONIC 5mm Instrument, last cleared under K060245 on 7 April 2006

The predicate device characteristics are described in K990362 when it was first cleared. The predicate device had an indication expansion in K060245.

Device Description

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internal torque wrench for assembly to the HPBLUE handpiece. The HPBLUE handpiece connects the HARMONIC Hook device to the Generator G11, and converts electrical energy into mechanical motion (ultrasonic energy). The high-frequency mechanical vibration at 55.5 kHz of the HARMONIC Hook blade transects, dissects, and coagulates tissue, sealing vessels up to 2 mm. This ultrasonic vibration, a form of mechanical energy, does not allow electricity to pass to or through the patient.

Indications for Use

Technological Characteristics

The subject and predicate devices use the same ultrasonic technology to perform their intended use. The handpiece converts electrical energy into ultrasonic vibration. The HARMONIC Hook uses the HPBLUE handpiece while the predicate device uses the HP054 handpiece and the handswitch adaptor HSA08. Both the HPBLUE handpiece and the HP054 handpiece serve the same functional purpose to convert electrical energy from the Generator G11 to mechanical energy (ultrasonic energy) at the end effector for each device.

A few technological differences were identified between the subject and predicate devices. attributable to the respective design of each. Of the differences, three were noted in the submission, summarized below. These differences were found to not affect safety or effectiveness through demonstration of effective performance and equivalency to relevant aspects of the predicate device, conformance to industry safety and performance standards, and bench and preclinical evaluations.

Blade Frequency/Displacement

The blade frequency and displacement between the subject and predicate devices are slightly different, but is not clinically relevant with regards to tissue effect.

Sterilization

The subject devices are sterilized via ethylene oxide and the predicate devices are sterilized via gamma radiation; both devices are sterilized to the same sterility assurance level.

Performance Data

Bench testing and laboratory evaluations were conducted to demonstrate that the HARMONIC Hook performed as intended.

Biocompatibility Testing

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The biocompatibility evaluation for HARMONIC Hook was conducted in accordance with the following standards: ISO 10993:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The device passed the following tests:

ISO Cytotoxicity
ISO Sensitization ●
ISO Intracutaneous Reactivity ●
ISO Acute System Toxicity ●

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the HARMONIC Hook device; the system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 for electrical safety.

Bench Testing

Blade amplitude and frequency were evaluated for HARMONIC Hook to support substantial equivalence to the predicate device. The maximum and minimum values, standard deviation and the mean were recorded for both blade frequency and amplitude. Data generated from this evaluation met the predetermined acceptance criteria.

Acute Animal Testing

Testing was performed in an acute study with the HARMONIC Hook vs. the predicate device to demonstrate that the tissue effects were not different than the predicate device. The results of the study demonstrated the ability of the subject device (HARBH32) to create tissue planes, dissect tissue, and provide hemostasis in different tissue types.

Clinical Studies

This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.

Conclusion

The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC Hook is as safe and effective and performs as well as the identified legally marketed predicate device for cutting and coagulating soft tissue and sealing vessels up to 2 mm in diameter, as measured in situ.

Regulation Number and Section

N/A