(36 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the device for cutting and coagulation, with no mention of AI or ML capabilities.
No
The device is a surgical instrument used for cutting and coagulating tissues during various surgical procedures, not for treating a disease or condition itself.
No
Explanation: The device is indicated for soft tissue incisions, bleeding control, and coagulation, functioning as a surgical tool, not for diagnosis.
No
The device description clearly outlines a physical instrument with a handle, blade, clamp arm, and controls, designed for surgical procedures. It is a hardware device that utilizes electrical and mechanical energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The HARMONIC FOCUS™ Shears are described as a surgical instrument used for cutting and coagulating soft tissue and vessels during open surgical procedures. It operates by converting electrical energy to mechanical energy to achieve these effects.
- Lack of Biological Sample Analysis: The description and intended use do not involve the analysis of any biological samples taken from the patient. The device is used directly on the patient's tissues during surgery.
Therefore, the HARMONIC FOCUS™ Shears fall under the category of surgical instruments rather than in vitro diagnostics.
N/A
Intended Use / 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
Product codes (comma separated list FDA assigned to the subject device)
LFL, GEI
Device Description
The Harmonic FOCUS™ Curved Shears is 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 FOCUS Shears are designed for use with a generator capable of providing electrical energy to the FOCUS device and with a handpiece that converts the electrical energy to mechanical energy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue incisions, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The design of the Harmonic FOCUS Shears is essentially unchanged and the performance data provided in K063192 is still applicable to the device. The Harmonic FOCUS shears device will seal vessels up to and including 5mm in diameter.
Clinical Literature: An assessment of published clinical literature demonstrates that there is a considerable body of knowledge and experience that show the use of ultrasonic Harmonic technology in otorhinolaryngological (ENT) procedures is as safe and effective as predicate technology for use.
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 FOCUSTM shears (K063192), Harmonic Blades (K060245, K012176, K990362), Olympus Ultrasonic Surgical System (K031305), Conmed Electrosurgical Pencils (K041868), ArthroCare ENT Coblator/Plasma Wands (K070374. K030108)
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
APR - 7 2010
Ethicon Endo-Surgery, LLC Traditional 510(k) Premarket Notification Harmonic FOCUS shears
K 100595
· 510(k) Summary
| Company: | Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo, PR 00969 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Marcia Arentz, RAC
Regulatory Affairs Portfolio Leader
Ethicon Endo-Surgery
4545 Creek Road
Cincinnati, OH 45242
Tel: (513) 337-1066
Fax: (513) 337-1122
Email: marentz5@its.jnj.com |
| Date Prepared: | March 1, 2010 |
| Device Name: | Trade Name: Harmonic FOCUSTM shears
Common or Usual Name: Ultrasonic Surgical Instrument
Classification Name: Electrosurgical Cutting and Coagulation
Device [21 CFR 878.4400 (GEI/LFL)]
Device Class: Class II |
| Predicate Devices: | Harmonic FOCUSTM shears (K063192)
Harmonic Blades (K060245, K012176, K990362)
Olympus Ultrasonic Surgical System (K031305)
Conmed Electrosurgical Pencils (K041868)
ArthroCare ENT Coblator/Plasma Wands (K070374. K030108) |
Purpose of Submission: To modify the Indications for Use Statement to include the specific indication to use the device in otorhinolaryngology procedures. The device design is essentially unchanged from the previously cleared FOCUS device.
Device Description: The Harmonic FOCUS™ Curved Shears is 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 FOCUS Shears are designed for use with a generator capable of providing electrical energy to the FOCUS device and with a handpiece that converts the electrical energy to mechanical energy.
ﺴﺘﻌ
1
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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
Technological Characteristics: The Harmonic FOCUSTM Curved Shears is the same device as the prodicate Harmonic FOCUS™ Curved Shears with minor changes to the design and assembly drawings. The function and intended use of the device have not been changed. The FOCUS shears are designed for use with the Harmonic® Scalpel Generator and the Harmonic Handpiece. The generator provides electrical energy to the Handpiece which creates ultrasonic vibration (55,500 Hz) in the blade. The mechanical energy of the moving blade is converted into thermal energy which is used to cut and coagulate soft tissues.
The Harmonic FOCUS 1M device is similar in design and utilizes the same ultrasonic technology as the predicate Harmonic FOCUS device, the predicate Harmonic Scalpel Blades and the predicate Olympus Ultrasonic Surgical System shears. The Harmonic FOCUS device is also similar to electrosurgical devices such as the Conmed electrosurgical Pencils and the Arthrocare ENT Coblator/Plasma wands because they all use electrical energy to cut and coagulate tissues.
Performance Data: The design of the Harmonic FOCUS Shears is essentially unchanged and the performance data provided in K063192 is still applicable to the device. The Harmonic FOCUS shears device will seal vessels up to and including 5mm in diameter.
Clinical Literature: An assessment of published clinical literature demonstrates that there is a considerable body of knowledge and experience that show the use of ultrasonic Harmonic technology in otorhinolaryngological (ENT) procedures is as safe and effective as predicate technology for use.
Substantial Equivalence
In establishing substantial equivalence of the Harmonic FOCUS shears to the predicate devices, Ethicon Endo-Surgery evaluated the intended use, the indications for use, the technological characteristics and the energy requirements of the systems. The Harmonic FOCUS is substantially equivalent to the predicatcs because they share the same intended use and technological characteristics. The use of Harmonic FOCUS shears in otorhinolaryngologic (ENT) procedures does not raise any new types of questions of safety and effectiveness compared with predicate devices currently used for these procedures.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 7 2010
Ethicon Endo-Surgery, LLC % Ms. Marcia Arentz, RAC -Regulatory Affairs Portfolio Leader 4545 Creek Road Cincinnati, Ohio 45242
Re: K100597
Trade/Device Name: Harmonic FOCUS™ Shears Regulatory Class: Unclassfied Product Code: LFL, GEI Dated: March 01, 2010 Received: March 02, 2010
Dear Ms. Arentz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Marcia Arentz, RAC
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 100597
Device Name: Harmonic FOCUSTM Shears
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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
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)
Neil R.P. Ogden for mxm
DIVISION Sion-Of Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
(Posted November 13, 2003)
510(k) Number K100597