(36 days)
Not Found
No
The summary describes a surgical instrument with manual power controls and mentions "Adaptive Tissue Technology" but provides no details suggesting AI/ML is used for this adaptation. The performance studies focus on biocompatibility, electrical safety, and preclinical evaluations, not AI/ML performance metrics. There is no mention of AI, ML, DNN, image processing, or training/test sets.
Yes
This device is a surgical instrument used for cutting and coagulating soft tissue during surgery, which falls under the definition of a therapeutic device designed to treat a medical condition or disease.
No
The device is described as a surgical instrument used for cutting and coagulation of soft tissue, not for diagnosis.
No
The device description clearly describes a physical surgical instrument with a handle, hand controls, and a working blade, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical instrument used for cutting and coagulating soft tissue during various surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a surgical instrument with a handle, controls, and a working blade. This is a physical tool used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The HARMONIC FOCUS® Shears + Adaptive Tissue Technology 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Product codes
LFL
Device Description
The Ethicon Endo-Surgery HARMONIC FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical 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's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical and Preclinical Performance Testing:
Biocompatibility studies, electrical safety testing, and EMC testing were performed. The results demonstrate the HARMONIC FOCUS Shears + Adaptive Tissue Technology device performance was equivalent to the predicate. In addition, preclinical laboratory evaluations in an animal model were performed, which included acute and 30-day chronic survival studies. The results of those evaluations demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology effectively cut and coagulated vessels 1 to 5mm in diameter.
Clinical Performance:
This premarket notification does not rely on data from human clinical trials to demonstrate substantial equivalence. Clearance was based on non-clinical and preclinical testing.
Conclusion:
The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary
| Company | Ethicon Endo-Surgery, LLC |
|---|---|
| 475 Calle C | |
| Guaynabo, PR 00969 |
- Brian Godwin. RAC Contact Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati. OH 45242 Telephone: (513) 337-3623 Fax: (513) 337-4366 Email: bgodwin@its.jnj.com
DEC 0 3 2013
Date Prepared 20 November 2013
Device Name
Trade Name: HARMONIC FOCUS Shears + Adaptive Tissue Technology Common Name: Instrument, Ultrasonic Surgical
Classification Name
Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)
Predicate Device
HARMONIC FOCUS® Shears, cleared under K100597 on 07 April 2010
Device Description
The Ethicon Endo-Surgery HARMONIC FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical 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's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.
Indications for Use
The HARMONIC FOCUS Shears + Adaptive Tissue Technology 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
1
K133314 Page 2 of 2
Technological Characteristics
.
The HARMONIC FOCUS Shears + Adaptive Tissue Technology use an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC FOCUS Shears + Adaptive Tissue Technology. Adaptive Tissue Technology refers to the power output algorithm that is utilized by the devices. During use, the Adaptive Tissue Technology algorithm parameters stored on the device EEPROM are read by the generator and used to reduce the power (current) to the instrument and provide a secondary, higher pitched generator activation tone as Adaptive Tissue Technology regulates the delivery of energy. To do this the generator monitors the thermal condition of the blade during device activation.
Performance Data
Non-clinical and Preclinical Performance Testing
Biocompatibility studies, electrical safety testing, and EMC testing were performed. The results demonstrate the HARMONIC FOCUS Shears + Adaptive Tissue Technology device performance was equivalent to the predicate. In addition, preclinical laboratory evaluations in an animal model were performed, which included acute and 30-day chronic survival studies. The results of those evaluations demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology effectively cut and coagulated vessels 1 to 5mm in diameter.
Clinical Performance
This premarket notification does not rely on data from human clinical trials to demonstrate substantial equivalence. Clearance was based on non-clinical and preclinical testing.
Conclusion
The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC FOCUS Shears + Adaptive Tissue Technology are as safe and effective and perform as well as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
Ethicon Endo-Surgery, Inc. Mr. Brian Godwin. RAC Senior Regulatory Affairs Associate 4545 Creek Road Cincinnati. Ohio 45242
December 3, 2013
Re: K133314
Trade/Device Name: HARMONIC FOCUS & Shears + Adaptive Tissue Technology Regulatory Class: Unclassified Product Code: LFL Dated: October 25, 2013 Received: October 29, 2013
Dear Mr. Godwin:
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 cither 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. I'DA 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 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.
3
Page 2 - Mr. Brian Godwin
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting 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.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133314
Device Name:
HARMONIC FOCUS® Shears + Adaptive Tissue Technology
Indications for Use:
The HARMONIC FOCUS® Shears + Adaptive Tissue Technology 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, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, 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)
Long H. Chen .- A
for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number K133314