The Harmonic™ 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 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).

Device Description

The Harmonic TM 10 cm Combination Hook Blade is a sterile, single patient use instrument consisting of a titanium blade with a non-removable sheath. The working instrument length is 10 cm and the outer shaft diameter tapers from 8.5 mm proximally to 5.5 mm distally. The Harmonic™ 10 cm Combination Hook Blade must be used with the 5 mm Adaptor or Hand Switching Adaptor and connected to the Harmonic Hand Piece and Generator prior to use. The Harmonic™ 10 cm Combination Hook Blade is designed for use exclusively with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Hand Piece (HP054), packaged separately. The Harmonic™ Generator 300 System User Manual should be referenced before using these instruments. The Harmonic™ 10 cm Combination Hook Blade allows for the coagulation of vessels up to and including 2 mm in diameter.

AI/ML Overview

The provided 510(k) summary describes a surgical instrument, the HARMONIC™ 10 cm Combination Hook Blade, not an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study methodologies, ground truth establishment, expert adjudication, and comparative effectiveness studies for AI/ML-based devices is not applicable to this submission.

This document focuses on demonstrating substantial equivalence to predicate devices through bench and animal testing for physical and functional characteristics, and biocompatibility.

Here's a breakdown of the relevant information from the provided text:

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

The document does not provide a specific table of quantitative acceptance criteria with corresponding performance data in the typical sense for an AI/ML device. Instead, it describes performance through qualitative statements and refers to testing demonstrating intended use and substantial equivalence.

Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Design Parameters	Function as intended and be substantially equivalent to predicate devices.	Bench testing was performed to evaluate design parameters and demonstrate substantial equivalence to the HARMONIC™ Dissecting Hook and HARMONIC™ Sharp Curved Blade.
Hemostasis	Adequately achieve hemostasis for vessels up to and including 2mm in diameter.	Animal (porcine acute) study used to evaluate the device for hemostasis of vessels up to and including 2mm in diameter. The animal studies support the transection of vessels up to and including 2mm in diameter.
Transection	Adequately achieve transection for vessels up to and including 2mm in diameter.	Animal (porcine acute) study used to evaluate the device for transection of vessels up to and including 2mm in diameter. The animal studies support the transection of vessels up to and including 2mm in diameter.
Biocompatibility	Meet ISO10993-1: Biological Evaluation of Medical Device requirements for the appropriate level of tissue contact.	Manufactured with materials that meet ISO10993-1. Biocompatibility for limited patient contacting materials established through history of use in other marketed Ethicon Endo-Surgery medical devices.

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- Bench Test: Not specified.
- Animal Testing: Not specified, other than it was a "porcine acute study."
Data Provenance:
- Animal Testing: Porcine (pig) model.
- Biocompatibility: Based on material certification (ISO10993-1) and history of use in other Ethicon Endo-Surgery devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is a surgical instrument. "Ground truth" in the context of AI/ML diagnostic devices (e.g., expert consensus on images) is not relevant here. The evaluation involves physical performance and biological safety.

4. Adjudication method for the test set

N/A. Adjudication methods like "2+1" are for AI/ML diagnostic output interpretation. For this device, the evaluation would likely involve objective measurements and observations during bench and animal testing, performed by qualified personnel, consistent with Good Laboratory Practice (GLP).

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

N/A. This is not an AI/ML device, so MRMC studies where human "readers" interact with AI assistance are not applicable.

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

N/A. This is a physical surgical instrument, not an algorithm.

7. The type of ground truth used

Bench Testing: Engineering measurements, functional tests to compare against predicate device performance specifications.
Animal Testing: Direct observation of hemostasis and transection in a biological model (porcine tissue).
Biocompatibility: Conformance to ISO standards and established material safety profiles.

8. The sample size for the training set

N/A. This is not an AI/ML device, so there is no "training set."

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

N/A. Not an AI/ML device.

Summary

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07 2203

SEP 2 5 2007

510(k) Summary

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

Contact Elizabeth Miller Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-7000 (513) 337-2123 Fax: Email: lmiller12@eesus.jnj.com

Date Prepared August 7, 2007

Device Name Trade Name: HARMONICTM 10 cm Combination Hook Blade Common or Usual Name: Instrument, Ultrasonic Surgical Classification Name:

(LFL)

Predicate Device HARMONICTM Dissecting Hook Blade HARMONICTM Sharp Curved Blade

Device Description The Harmonic TM 10 cm Combination Hook Blade is a sterile, single patient use instrument consisting of a titanium blade with a non-removable sheath. The working instrument length is 10 cm and the outer shaft diameter tapers from 8.5 mm proximally to 5.5 mm distally.

The Harmonic™ 10 cm Combination Hook Blade must be used with the 5 mm Adaptor or Hand Switching Adaptor and connected to the Harmonic Hand Piece and Generator prior to use.

The Harmonic™ 10 cm Combination Hook Blade is designed for use exclusively with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Hand Piece (HP054), packaged separately. The Harmonic™ Generator 300 System User Manual should be referenced before using these instruments. The Harmonic™ 10 cm Combination Hook Blade allows for the coagulation of vessels up to and including 2 mm in diameter.

Indications for Use The Harmonic™ 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 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).

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Technological Characteristics The HARMONIC™ 10cm Combination Hook Blade is similar in materials and function to the predicate devices HARMONIC™ Dissecting Hook and HARMONIC™ Sharp Curved Blade. The HARMONIC™ 10cm Combination Hook Blade, end effector design is different in that it incorporates a dissection hook and a flat blade.

Performance Data Bench and animal testing was performed to demonstrate the new device performs as intended. The bench test was conducted to evaluate design parameters on the HARMONIC 10 cm Combination Hook Blade device and demonstrate substantially equivalence to the HARMONIC™ Dissecting Hook and HARMONICTM Sharp Curved Blade. The animal testing used to evaluate this device consisted of a porcine acute study. This study was used to evaluate the use of the device for hemostasis and transection of vessels up to and including 2mm in diameter. The animal studies support the transection of vessels up to and including 2mm in diameter.

HARMONIC™ 10 cm Combination Hook Blade is manufactured with materials that meet the ISO10993-1: Biological Evaluation of Medical Device-Part 1: Evaluation and Testing biocompatibility requirements for the appropriate level of tissue contact. The materials used in these devices are classified as either non-patient contacting or externally communicating device components with tissue or bone contact of less than 24 hours limited patient contacting. All tests were performed in accordance with FDA Good Laboratory Practice regulations, 21 CFR 58. Biocompatibility for both limited patient contacting contacting materials have been established through history of use in other marketed Ethicon Endo-Surgery medical devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human form or a caduceus-like design. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

SEP 2 5 2007

Re: K072203

Trade/Device Name: HARMONIC™ 10cm Combination Hook Blade Regulatory Class: Unclassified Product Code: LFL Dated: August 7, 2007 Received: August 8, 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, 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 - Elizabeth Miller, MST, 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, 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vou

for P.O.D. D.C.
24/07

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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K072203

Indications for Use

510(k) Number (if known):

Device Name:

HARMONICTM 10cm Combination Hook Blade

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)

Page 1 of 1 (Posted November 13, 2003)

Orvision of General, Restorative, and Neurological Devices

20(k) Number K072203

Regulation Number and Section

N/A