HARMONIC SCALPEL BLADES AND SHEARS by ETHICON ENDO-SURGERY, INC.

The Harmonic 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 and endoscopic procedures.

The Harmonic Scalpel 5mm Instruments with Protective Sleeve 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 in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

The Harmonic Scalpel 10cm Sharp Curved Blade Instruments 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, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.

The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used 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, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

The Harmonic Scalpel 5 mm Instruments 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, exposure to orthopedic structures (such as spine and joint space), plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

The Harmonic Scalpel 10 mm LaparoSonic Instruments 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, gynecologic, and exposure to orthopedic structures (such as spine and joint space).

Device Description

The Harmonic Scalpel Blades and Shears are ultrasonic surgical instruments for the cutting and coagulation of soft tissue incisions when bleeding control and minimal thermal injury are desired. The device system has three essential parts: the generator/ footswitch, the hand piece and the instruments, which are available in various lengths shapes and types. The selection of the appropriate instrument is a matter of surgeon preference.

AI/ML Overview

This document, K060245, is a 510(k) premarket notification for the Harmonic Scalpel Blades and Shears by Ethicon Endo-Surgery, Inc. It seeks to demonstrate substantial equivalence to a predicate device for an expanded set of indications for use.

Based on the provided text, a traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device submission (which would typically involve performance metrics like sensitivity, specificity, AUC, etc.) are not applicable.

This device is a surgical instrument (ultrasonic surgical device), not an AI/ML algorithm. The performance data presented is in the form of a clinical literature search, not a study with specific acceptance criteria that an AI algorithm would need to meet. The submission is focused on demonstrating the device's substantial equivalence to a legally marketed predicate device based on its technological characteristics and proposed expanded indications for use.

Therefore, the specific questions related to AI/ML device performance, such as sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, cannot be answered from the provided text because these elements are not relevant to this type of device submission.

Here's how to interpret the provided information in the context of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: For this type of device (ultrasonic surgical instrument), the "acceptance criteria" for regulatory clearance are primarily focused on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness for its intended use. This typically involves showing that the technological characteristics are the same, and that any new or expanded indications for use are supported by existing clinical evidence or the predicate's established safety profile.
Reported Device Performance: The primary "performance data" cited is a clinical literature search.

Acceptance Criteria (Implied for Substantial Equivalence of Surgical Instrument)	Reported Device Performance (as stated in 510(k) Summary)
Device has same technological characteristics as predicate.	"The Harmonic Scalpel Blades and Shears technological characteristics are the same as the predicate device. No changes (materials construction, specifications, manufacturing or sterilization processes) to the currently marketed device." (Page 1)
Device is safe and effective for its intended uses.	"A clinical literature search was performed to show the use of the devices in providing exposure to orthopedic structures such as the hip, knee, shoulder, and spine." (Page 1)
Expanded indications for use are supported.	"The device differs only in the indications." (Page 1). The literature search supports the use in orthopedic structures for the expanded indications.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device, so there isn't a "test set" in the computational sense. The "performance data" is a literature review, not a specific data set. The provenance of the literature is not specified beyond being "a clinical literature search."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "test set" for an AI/ML algorithm. The "ground truth" for the device's safety and effectiveness for its intended use is established through its technological equivalence to a predicate device and existing clinical literature.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process as understood for AI/ML performance assessment.

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: Not applicable. This is a surgical instrument, not an AI-assisted diagnostic or therapeutic device for human readers.

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: For this submission, the "ground truth" for demonstrating substantial equivalence is based on the technological characteristics of the device being identical to the predicate, and existing clinical literature supporting the safety and efficacy of the technology (ultrasonic surgical instruments) for the stated indications, particularly the newly expanded ones involving orthopedic structures.

8. The sample size for the training set: Not applicable. This is not an AI/ML device, and there is no "training set."

9. How the ground truth for the training set was established: Not applicable. There is no "training set" or explicit ground truth establishment process in the AI/ML sense for this device.

Summary

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510(k) Summary

Company	Ethicon Endo-Surgery, Inc.
	4545 Creek Road
	Cincinnati, OH 45242

Contact Elizabeth Miller Regulatory Affairs Associate II Telephone: (513) 337-7146 (513) 337-1444 Fax: Email: Imiller12@eesus.mi.com
Date Prepared January 30, 2006
Trade Name: Harmonic Scalpel Blades and Shears Device Name Common or Usual Name: Instrument, Ultrasonic Surgical Classification Name: Electrosurgical Cutting and Coagulation Device [21 CFR 878.4400 (LFL)]
Predicate Device Harmonic Scalpel Blades and Shears

Device Description The Harmonic Scalpel Blades and Shears are ultrasonic surgical instruments for the cutting and coagulation of soft tissue incisions when bleeding control and minimal thermal injury are desired. The device system has three essential parts: the generator/ footswitch, the hand piece and the instruments, which are available in various lengths shapes and types. The selection of the appropriate instrument is a matter of surgeon preference.

Indications for Use The Harmonic 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 and endoscopic procedures.

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Technological Characteristics The Harmonic Scalpel Blades and Shears technological characteristics are the same as the predicate device. No changes (materials construction, specifications, manufacturing or sterilization processes) to the currently marketed device. The device differs only in the indications.

Performance Data A clinical literature search was performed to show the use of the devices in providing exposure to orthopedic structures such as the hip, knee, shoulder, and spine.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

7 2006 APR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon Endo-Surgery Inc. c/o Ms. Elizabeth Miller Regulatory Affairs Associate II 4545 Creek Road Cincinnati, Ohio 45242

Re: K060245

Trade/Device Name: Harmonic Scalpel Blades and Shears Regulatory Class: Unclassified Product Code: LFL Dated: January 30, 2006 Received: January 31. 2006

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. Iisting 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, 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); 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 - Ms. Elizabeth Miller

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, permits 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

'O'Malle

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): _KOGO245

Harmonic Scalpel Blades and Shears Device Name:

Indications for Use:

The Harmonic 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, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Prescription Use (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)

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Concurre") profits is is and Neurological Devices

KO60845 4100k) Number

Regulation Number and Section

N/A