The HARMONIC® Blue Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.

The HARMONIC® Gray Hand Piece, when used in conjunction with the HARMONIC® Instruments, is 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.

Device Description

The HARMONIC® Blue Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blade. The Blue Hand Piece is intended for use exclusively with a compatible HARMONIC Generator. The Blue Hand Piece is permanently attached to a blue cord which connects to the front of the Generator.

The Blue Hand Piece is a re-useable instrument with a limited service life. The Blue Hand Piece is programmed with a counter to limit the service life to 100 procedures. The generator will give a Hand Piece error after 100 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.

The HARMONIC® Gray Hand Piece is designed to convert electrical energy from a compatible Ethicon Generator to mechanical motion for the instrument blades. This Hand Piece is intended for use with a compatible Ethicon Generator.

The Hand Piece is permanently attached to a cord which connects to the front of the Generator.

The Hand Piece is a re-useable instrument with a limited service life. The Hand Piece is programmed with a counter to limit the service life to 95 procedures. The generator will give a Hand Piece error after 95 procedures are completed. The number of activations during a procedure is not limited, and the counter will not log a procedure until the Hand Piece is unplugged from the generator or the generator is powered down. The number of remaining procedures is indicated on the display of the generator in the Systems Settings screen. The Hand Piece is compatible with generator software 2018-1 or later.

The Hand Piece is packaged with a Blade Wrench and Test Tip. The Blade Wrench is used to secure instrument blades to the Hand Piece. The Hand Piece. Blade Wrench, and Test Tip are packaged non-sterile and must be sterilized per their insert instructions prior to use.

AI/ML Overview

This document describes a 510(k) premarket notification for two medical devices: the HARMONIC® Blue Hand Piece and the HARMONIC® Gray Hand Piece. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., specific force, temperature, or bleed control thresholds). Instead, the acceptance criteria are implicitly defined by demonstrating that the modified devices maintain the same safety and effectiveness as their predicate devices and that the changes do not raise new questions of safety or effectiveness.

The reported device performance section focuses on the verification that the modifications do not negatively impact the existing performance or introduce new risks.

Acceptance Criteria (Implicit)	Reported Device Performance and Study Findings
Maintain identical Indications for Use as predicate devices.	Identical: The Indications for Use for both the HARMONIC® Blue Hand Piece and HARMONIC® Gray Hand Piece are stated to be identical to their respective predicate devices. They are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired, and can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
Maintain identical Contraindications as predicate devices.	Identical: Contraindications are stated to be identical to the predicate devices.
Maintain non-sterile, single-patient use characteristics.	Identical: Both new hand pieces are stated to be Non-Sterile, Single Patient Use, consistent with the predicate devices.
Bio-Compatibility of Materials: All tissue-contacting materials comply with ISO 10993-1.	Compliant: Bio-Compatibility evaluation was conducted, and all tissue-contacting materials are reported to comply with ISO 10993-1, consistent with the predicate devices.
Maintain identical Packaging Method.	Identical: The Packaging Method is stated to be identical to the predicate devices, with the addition of a new protective end cap for the Gray Hand Piece in packaging which does not alter the fundamental packaging method to ensure sterility or protection during transport.
Maintain identical Device Operation.	Identical: Device Operation is stated to be identical to the predicate devices, despite some internal technological differences such as the connector interface, software compatibility, EEPROM upgrade, and cable design harmonization and component modification. The fundamental operational principle of converting electrical energy to mechanical motion for the instrument blade remains unchanged.
Device modifications (connector, software compatibility, EEPROM, cable design, cable components, protective end cap) do not introduce risks or degrade safety/effectiveness.	Confirmed: Risk analyses for each device modification were provided and concluded that the risk profile of the new devices has not changed. Verification testing, Biocompatibility evaluation, and Electrical testing were conducted to confirm that the modifications do not raise new issues of safety or effectiveness.

Study Information:

Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" in the context of a clinical study or a separate performance evaluation on patient data.
- The evaluation primarily involved verification testing, biocompatibility evaluation, and electrical testing on the modified devices. These tests would have been performed on a sample of the manufactured devices, but the specific number of units tested is not provided.
- The data provenance is implied to be from laboratory and engineering testing of the devices themselves, rather than clinical patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No information is provided about experts used to establish ground truth. This is not a clinical study involving interpretation of medical images or patient outcomes. The evaluation is focused on engineering and performance validation against internal specifications and regulatory standards.
Adjudication method for the test set:
- No adjudication method is described, as the studies conducted are not clinical studies requiring expert consensus on ground truth. The evaluation likely involved objective measurements and comparisons against established engineering specifications and regulatory standards.
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. This document describes a 510(k) submission for surgical hand pieces, not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with AI assistance is not applicable and was not conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical instrument and does not involve an algorithm with standalone performance.
The type of ground truth used:
- The ground truth in this context is based on engineering specifications, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and the established safety and effectiveness profile of the predicate devices. The aim was to ensure that the modified devices adhered to these objective standards and did not deviate from the performance of the predicate.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "training" here refers to the design and manufacturing processes guided by established engineering principles and prior device knowledge.
How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there isn't a training set in that sense. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory requirements, which are developed through years of research, testing, and clinical experience with similar medical devices.

Summary

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May 21, 2021

Ethicon Endo-Surgery, LLC % Ms. Ruth James, MSc, RAC Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery, LLC. 4545 Creek Road Cincinnati, OHIO 45242

Re: K211273

Trade/Device Name: Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray Regulatory Class: Unclassified Product Code: LFL Dated: April 26, 2021 Received: April 27, 2021

Dear Ms. James:

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.

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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 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 (QS) 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-device-safety/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 Advice (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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Indications for Use

510(k) Number (if known) K211273

Device Name HARMONIC® Blue Hand Piece HARMONIC® Gray Hand Piece

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969

K211273

510(k) Summary

Submitter Information:	Ethicon Endo-Surgery, LLC475 Calle StreetGuaynabo, PR 00969
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Application Correspondent

Ms. Ruth James MSc, RAC. Sr. Regulatory Affairs Program Lead Ethicon Endo-Surgery, LLC. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-3118 Fax: (513) 337-1122 Email: rjames15@its.jnj.com

Date Prepared May 20, 2021

Device Trade Name:	HARMONIC® Blue Hand PieceHARMONIC® Gray Hand Piece
Models:	HARHPBL, HARHPBLCN (Blue)HARHPGR, HARHPGRCN(Gray)
Device Class:	Unclassified
Panel:	II
Classification (Product) Code:	79, General & Plastic SurgeryLFL

Legally Marketed Predicate Devices:

. HARMONIC® Hand Piece, Blue (K063192)
. HARMONIC® Hand Piece, Gray (K002906)

This predicate has not been subject to a design-related recall.

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Device Description

HARMONIC® Blue Hand Piece

HARMONIC® Gray Hand Piece

The Hand Piece is permanently attached to a cord which connects to the front of the Generator.

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Indications for Use for new devices (identical to predicates)

Comparison of technological characteristics with the predicate device

At a high level, the new and predicate devices are based on the following same technological elements:

Characteristic	New Devices	Legally marketed PredicateDevicesK063192, K002906
Indications for Use	Identical	Identical
Contraindications	Identical	Identical
Non-Sterile, Single Patient Use	Yes	Identical
Bio-Compatibility of Materials:All tissue-contacting materials complywith ISO 10993-1.	Yes	Yes
Packaging Method	Identical	Identical
Device Operation	Identical	Identical

The following technological differences exist between the new and predicate devices:

. The new Hand Pieces have a standard connector (tear-drop) interface to GEN11 generators.
. The new Hand Pieces are only compatible with GEN11 operating 2018-1 software and later generators.
. The Electrically erasable programmable read-only memory (EEPROM) in the Hand Pieces has been upgraded with cybersecurity improvements.
. The cable design has been harmonized for both Blue and Gray Hand Pieces.
. The cable components have been modified to improve hand activation durability
. There is a new protective end cap, used in packaging, for the Gray Hand Piece.

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Performance Data

Risk analyses for each device modification are provided. Verification testing, Biocompatibility evaluation and Electrical testing were conducted to confirm device modifications do not raise new issues of safety or effectiveness.

Clinical studies were not required to demonstrate substantial equivalence.

Conclusions

Risk analyses show that the risk profile of the new devices has not changed as a result of the described changes while having the same intended use as the predicate devices. Verification testing, Biocompatibility evaluation and Electrical testing conducted, confirm the performance of the new devices is consistent with the predicate devices and does not raise any new questions of safety and effectiveness.

Regulation Number and Section

N/A