The HARMONIC FOCUS™ Shears 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, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

The HARMONIC Blue Hand Piece, when used in conjunction with the HARMONIC Scalpel Instrument, 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 FOCUS™ Curved Shears are a sterile, single patient use 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 has a curved blade and clamp arm with Teflon pad. The instruments working length is 9cm with a 16mm active blade length. The FOCUS instrument allows for the cutting and coagulation of vessels up to and including 5mm in diameter.

The HARMONIC Blue Hand Piece is designed to convert electrical energy from the HARMONIC Generator to mechanical motion for the instrument blade. The Blue Hand Piece is intended for use exclusively with the HARMONIC Scalpel Generator 300 (Model GEN04). The Blue Hand Piece is permanently attached to a blue cord, which connects to the front of the Generator.

AI/ML Overview

The provided 510(k) summary for the HARMONIC FOCUS™ Curved Shears and Blue Hand Piece does not contain detailed acceptance criteria or the specific results of a study proving the device meets these criteria in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the information provided, here's a summary of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated	"Bench and preclinical testing was performed to evaluate the performance of the intended use of the new device. The testing shows that the HARMONIC FOCUS™ Curved Shears and the HARMONIC Blue Hand Piece is equivalent to the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench and preclinical testing" but does not specify the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The study mentioned is "Bench and preclinical testing," which typically does not involve human expert consensus for ground truth as it relates to evaluating device performance against pre-defined engineering or biological parameters.

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

This information is not provided and is generally not applicable to bench and preclinical testing of a surgical instrument.

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

No such study was mentioned or performed. This type of study (MRMC, AI assistance) is not relevant to the evaluation of a surgical instrument like the HARMONIC FOCUS™.

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

This concept is not applicable to a surgical instrument. The HARMONIC FOCUS™ is a physical device used by a human surgeon, not an algorithm.

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

The "ground truth" for the bench and preclinical testing would likely be based on established engineering standards for device function (e.g., cutting efficacy, coagulation effectiveness, thermal spread, mechanical integrity) and biological tissue responses in preclinical models. Specific details are not provided.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device requiring a training set.

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

This is not applicable as this is not an AI/ML device requiring a training set.

Summary of what the submission does indicate regarding performance:

The submission states that "Bench and preclinical testing was performed to evaluate the performance of the intended use of the new device." The conclusion drawn from this testing is that "the HARMONIC FOCUS™ Curved Shears and the HARMONIC Blue Hand Piece is equivalent to the predicate device." This implies that the device met performance standards comparable to, or as good as, the predicate device in relevant testing scenarios, but the specific acceptance criteria and the detailed results are not disclosed in this summary. The focus is on demonstrating "substantial equivalence" to legally marketed predicate devices rather than providing a detailed performance study against explicit acceptance criteria in the requested format.

Summary

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K063192

510(k) Summary

Ethicon Endo-Surgery, LLC Company Angora Industrial Park, Building G Caguas, Puerto Rico 00725

Contact Elizabeth Miller Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-7146 Fax: (513) 337-1444 Email: Imiller12@eesus.jnj.com

Date Prepared October 19, 2006

Device Name Trade Name: HARMONIC FOCUS™ Curved Shears and Blue Hand Piece Common or Usual Name: Instrument, Ultrasonic Surgical Classification Name: Electrosurgical Cutting and Coagulation Device [21 CFR 878.4400 (LFL)]

Predicate Device HARMONIC Scalpel Shears and Hand Piece

Device Description The HARMONIC FOCUS™ Curved Shears are a sterile, single patient use 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 has a curved blade and clamp arm with Teflon pad. The instruments working length is 9cm with a 16mm active blade length. The FOCUS instrument allows for the cutting and coagulation of vessels up to and including 5mm in diameter.

Indications for Use The HARMONIC FOCUS™ Curved Shears 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, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

99
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Technological Characteristics The HARMONIC FOCUS™ Curved Shears with Hand Control is similar to the design and function of the predicate device, the HARMONIC ACE™ Curved Shears with Scissor Handle and Hand Control and the Ultracision Curved LCS/CS Shears.

The HARMONIC Blue Hand Piece is similar to the design of the predicate device, the HARMONIC Scalpel Hand Piece.

Performance Data Bench and preclinical testing was performed to evaluate the performance of the intended use of the new device. The testing shows that the HARMONIC FOCUS™ Curved Shears and the HARMONIC Blue Hand Piece is equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three curved lines forming its body and wings. The text "OF HEALTH & HUMAN SERVICES - USA" is arranged in a semi-circle above the eagle, indicating the department's name and country.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon Endo-Surgery, LLC. % Ethicon Endo-Surgery, Inc., S.A. Elizabeth Miller, RAC Regulatory Affairs Associate II 4545 Creek Road Cincinnati, Ohio 45242-2839

JAN 3 0 2007

Re: K063192

Trade/Device Name: HARMONIC FOCUS™ Shears and Blue Hand Piece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: LFL Dated: January 12, 2007 Received: January 26, 2007

Dear Ms. Miller:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, TDA 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); 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 -- Elizabeth Miller, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, pervotte your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrhindustry/support/index.html l

Sincerely yours,

Mark N. Melin

ನ್ನು

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K06319 2

HARMONIC FOCUS™ Shears and Blue Hand Piece Device Name:

Indications for Use:

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

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

Concurrence on CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Page 1 of 1 (Posted November 13, 2003)

Division of General, Restorative, and Neurological Devices

510(k) Number	14063092
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Regulation Number and Section

N/A