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

The Harmonic Scalpel Shears 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, plastic, pediatric, gynecologic, urologic and other open and endoscopic procedures.

The Harmonic Scalpel 5 mm 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, 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, 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, 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, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

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

The provided 510(k) summary for the Ethicon Harmonic Scalpel Blades and Shears does not include information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for a diagnostic AI/ML device.

This 510(k) pertains to a surgical instrument, not a diagnostic AI/ML device. The "Performance Data" section explicitly states: "A clinical literature search was performed to show the use of the devices in plastic surgery." This indicates that the regulatory submission relied on existing clinical evidence for similar devices and the proven safety and effectiveness of the underlying technology, rather than new performance studies with specific statistical endpoints and acceptance criteria as would be required for an AI/ML diagnostic.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable to this particular device submission.

Here's a breakdown of what can be extracted and what is not applicable based on the provided text:

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

Not Applicable. The submission does not define specific performance metrics with acceptance criteria (e.g., sensitivity, specificity, AUC) for the device. The "performance" is implicitly related to its intended surgical function (cutting and coagulation with minimal thermal injury and bleeding control), which is demonstrated through established clinical practice and existing literature for 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)

Not Applicable. There was no specific "test set" in the context of a diagnostic performance study. The "Performance Data" section refers to a "clinical literature search." The "sample size" would therefore be the aggregate patient population across the studies identified in that literature, but specific numbers and provenance are not provided as it's not a de novo study.

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)

Not Applicable. There was no "test set" requiring ground truth established by experts in the context of a diagnostic evaluation.

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

Not Applicable. There was no test set or adjudication process for diagnostic performance.

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 device is a surgical instrument, not an AI-assisted diagnostic tool.

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

Not Applicable. This device is a surgical instrument, not an algorithm.

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

Not Applicable. No explicit ground truth was established for a performance study. The "ground truth" for the device's efficacy is based on established surgical outcomes and clinical experience with ultrasonic surgical instruments, as demonstrated by the literature search.

8. The sample size for the training set

Not Applicable. This device is a physical surgical instrument, not an AI/ML algorithm that requires a training set.

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

Not Applicable. There is no training set for this device.

Summary

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K053056

510(k) Summary

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

Contact Elizabeth Miller Regulatory Affairs Associate II Telephone: (513) 337-7146 Fax: (513) 337-1444 Email: Imiller12@eesus.jnj.com
Date Prepared October 28 , 2005
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 UltraCision 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 Scalpel Shears 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, plastic, pediatric, gynecologic, urologic 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 plastic surgery.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC." The symbol in the center appears to be a stylized representation of a human figure or a caduceus-like design, consisting of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

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

Re: K053056

Trade/Device Name: Harmonic Scalpel Blades and Shears Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Il Product Code: LFL Dated: October 28, 2005 Received: October 31, 2005

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, 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. 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/industry/support/index.html.

Sincerely vours

Barbara Buehrs
for

Mark N. Melkerson Acting 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): ____________________________________________________________________________________________________________________________________________________

Device Name:

Harmonic Scalpel Blades and Shears

Indications for Use:

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The Harmonic Scalpel 5 mm Instruments are indicated for soft tissue incisions when bleeding control and I he frammome Dealped 3 mill risk antersonents can be used as an adjunct to or substitute for mintmal mermal may a beel scalpels in general, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices
(Posted November 13, 2003)

510(k) Number	K053056
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Regulation Number and Section

N/A