(102 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical and electrical energy conversion for cutting and coagulation, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is indicated for soft tissue incisions with bleeding control and minimal thermal injury, and can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in various surgical procedures, which are therapeutic applications.
No
The device description indicates it is a surgical tool used for cutting and coagulation of tissue, not for diagnosis.
No
The device description clearly details physical hardware components (shears, hand piece, cord, generator) and their mechanical functions, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for cutting and coagulating soft tissue during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The description details a surgical instrument with a blade, clamp arm, and hand controls, designed for direct interaction with tissue during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples), diagnostic testing, or providing information about a patient's health status based on sample analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for therapeutic purposes during a procedure.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, orthopedic structures (such as spine and joint space)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench and preclinical testing was performed to evaluate the performance of the intended use of the new device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HARMONIC Scalpel Shears and Hand Piece
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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.
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.
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.
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.
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:
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.
| 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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