The HARMONIC FOCUS® Shears + Adaptive Tissue Technology are 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Device Description

The Ethicon Endo-Surgery HARMONIC FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.

AI/ML Overview

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The provided 510(k) summary for the HARMONIC FOCUS Shears + Adaptive Tissue Technology does not explicitly list acceptance criteria in a quantitative table format or a detailed study protocol for performance. However, based on the Performance Data section, the general acceptance criteria are:

Equivalence to the predicate device: The HARMONIC FOCUS Shears + Adaptive Tissue Technology device performance was equivalent to the predicate (HARMONIC FOCUS® Shears, K100597) in terms of safety and effectiveness.
Effective cutting and coagulation: The device effectively cuts and coagulates soft tissue and seals vessels up to 5 mm in diameter.
Biocompatibility: The device is biocompatible.
Electrical safety and EMC compliance: The device meets electrical safety and electromagnetic compatibility (EMC) standards.

The study that proves the device meets these acceptance criteria is described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Performance Goal	Reported Device Performance
Equivalence to Predicate	Overall safety and effectiveness comparable to HARMONIC FOCUS® Shears (K100597).	"The results demonstrate the HARMONIC FOCUS Shears + Adaptive Tissue Technology device performance was equivalent to the predicate." "The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ."
Functional Performance	Effective cutting and coagulation of soft tissue and vessels up to 5 mm.	"The results of those evaluations demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology effectively cut and coagulated vessels 1 to 5mm in diameter." "The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ."
Material Safety	Biocompatibility	"Biocompatibility studies... were performed." (Implies positive outcome indicating compliance).
Electrical Safety	Electrical safety compliance	"electrical safety testing... were performed." (Implies positive outcome indicating compliance).
EMC Compliance	Electromagnetic compatibility (EMC) compliance	"EMC testing were performed." (Implies positive outcome indicating compliance).

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

Sample Size: Not explicitly stated for either bench testing or animal models. The document refers to "laboratory evaluations in an animal model" and "biocompatibility studies, electrical safety testing, and EMC testing" without specifying the number of samples or animals used.
Data Provenance: The studies were preclinical laboratory evaluations and non-clinical bench testing. The country of origin of the data is not specified but is typically internal to the company or contracted labs. The studies were prospective in nature, designed specifically to test the new device.

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

Not applicable. This submission does not involve human clinical data or expert visual/interpretive assessment of medical images/data. The "ground truth" for this device's performance relies on objective measurements from bench testing (e.g., power output, blade temperature, vessel sealing strength, cutting speed) and direct observation/assessment in animal models.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" for performance was based on objective measurements and direct observation in controlled environments (bench and animal labs), there was no need for an adjudication method by human experts for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "This premarket notification does not rely on data from human clinical trials to demonstrate substantial equivalence. Clearance was based on non-clinical and preclinical testing." This type of study is typically used for diagnostic devices involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence. The performance studies described (biocompatibility, electrical safety, EMC, bench testing, and animal model evaluations) assess the device's inherent mechanical and electrical functionality, including its "Adaptive Tissue Technology" algorithm, in a standalone manner without human subjective input affecting the outcome of the performance metrics. The algorithm's function (reducing power, providing a secondary tone) is evaluated by observing its effect on the physical performance of the instrument.

7. Type of Ground Truth Used

Objective Measurements and Direct Observation/Assessment:
- Bench Testing: Mechanical properties, electrical characteristics, thermal profiles, cutting efficacy, coagulation performance (e.g., burst pressure for sealed vessels).
- Animal Models: In vivo assessment of cutting and coagulation effectiveness on vessels of specific diameters (1-5mm), observation of acute and 30-day chronic healing responses, and assessment of thermal injury.

8. Sample Size for the Training Set

Not applicable/Not specified. This device uses an "Adaptive Tissue Technology algorithm" but the 510(k) summary does not indicate that this algorithm was "trained" in the typical machine learning sense using a specific dataset. It refers to "power output algorithm that is utilized by the devices" and "algorithm parameters stored on the device EEPROM." It is more likely a rule-based or control algorithm designed based on engineering principles and validated through the performance studies rather than a machine learning model requiring a discrete "training set."

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

Not applicable. As described in section 8, a "training set" in the context of machine learning is not implied or specified for this device's algorithm. The "ground truth" for developing the algorithm's parameters would have been established through engineering design, material science, and possibly iterative prototyping and testing to optimize the power delivery for different tissue conditions.

Summary

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510(k) Summary

Company	Ethicon Endo-Surgery, LLC
	475 Calle C
	Guaynabo, PR 00969

Brian Godwin. RAC Contact 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
DEC 0 3 2013

Date Prepared 20 November 2013

Device Name

Trade Name: HARMONIC FOCUS Shears + Adaptive Tissue Technology Common Name: Instrument, Ultrasonic Surgical

Classification Name

Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)

Predicate Device

HARMONIC FOCUS® Shears, cleared under K100597 on 07 April 2010

Device Description

Indications for Use

The HARMONIC FOCUS Shears + Adaptive Tissue Technology are 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

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K133314 Page 2 of 2

Technological Characteristics

The HARMONIC FOCUS Shears + Adaptive Tissue Technology use an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC FOCUS Shears + Adaptive Tissue Technology. Adaptive Tissue Technology refers to the power output algorithm that is utilized by the devices. During use, the Adaptive Tissue Technology algorithm parameters stored on the device EEPROM are read by the generator and used to reduce the power (current) to the instrument and provide a secondary, higher pitched generator activation tone as Adaptive Tissue Technology regulates the delivery of energy. To do this the generator monitors the thermal condition of the blade during device activation.

Performance Data

Non-clinical and Preclinical Performance Testing

Biocompatibility studies, electrical safety testing, and EMC testing were performed. The results demonstrate the HARMONIC FOCUS Shears + Adaptive Tissue Technology device performance was equivalent to the predicate. In addition, preclinical laboratory evaluations in an animal model were performed, which included acute and 30-day chronic survival studies. The results of those evaluations demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology effectively cut and coagulated vessels 1 to 5mm in diameter.

Clinical Performance

This premarket notification does not rely on data from human clinical trials to demonstrate substantial equivalence. Clearance was based on non-clinical and preclinical testing.

Conclusion

The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

December 3, 2013

Re: K133314

Trade/Device Name: HARMONIC FOCUS & Shears + Adaptive Tissue Technology Regulatory Class: Unclassified Product Code: LFL Dated: October 25, 2013 Received: October 29, 2013

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 cither 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. I'DA 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 device-related 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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Page 2 - Mr. Brian Godwin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For 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): K133314

Device Name:

HARMONIC FOCUS® Shears + Adaptive Tissue Technology

Indications for Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen .- A

for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number K133314

Regulation Number and Section

N/A