(310 days)
Not Found
No
The description focuses on the mechanical and ultrasonic properties of the device and its components, with no mention of AI or ML algorithms for data processing, decision-making, or control.
Yes
The device is used for soft tissue incisions and coagulation, which are therapeutic medical interventions.
No
The device is described as an instrument for cutting, dissecting, and coagulating tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a titanium blade, handpiece, generator, and footswitch. It is a physical surgical instrument system, not a software-only device.
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 such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The HARMONIC Hook instrument is a surgical tool used for cutting and coagulating soft tissue during surgical procedures. It operates mechanically using ultrasonic energy.
- Intended Use: The intended use clearly states it's for "soft tissue incisions" and is used "in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), and thoracic surgery." This describes a surgical intervention, not a diagnostic test performed on a sample outside the body.
- Device Description: The description focuses on the physical components of the surgical instrument and how it works to cut and coagulate tissue. There is no mention of analyzing biological samples.
Therefore, the HARMONIC Hook instrument is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HARMONIC Hook instrument is 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, exposure to orthopedic structures (such as spine and joint space), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
Product codes
LFL
Device Description
The HARMONIC Hook instrument is a sterile, single patient use instrument, consisting of a 5 mm titanium blade. The instrument allows for the cutting of soft tissue and coagulation of vessels up to and including 2 mm in diameter. The working length of the HARMONIC Hook instrument is 32 cm.
The HARMONIC Hook instrument works with the Generator G11 as part of a system. The device system has four essential parts: the Generator G11 (GEN11), the footswitch (FSW11), the handpiece (HPBLUE), and the HARMONIC Hook (HARBH32). The HARMONIC Hook has an internal torque wrench for assembly to the HPBLUE handpiece. The HPBLUE handpiece connects the HARMONIC Hook device to the Generator G11, and converts electrical energy into mechanical motion (ultrasonic energy). The high-frequency mechanical vibration at 55.5 kHz of the HARMONIC Hook blade transects, dissects, and coagulates tissue, sealing vessels up to 2 mm. This ultrasonic vibration, a form of mechanical energy, does not allow electricity to pass to or through the patient.
The HARMONIC Hook can be operated using the 360° circumferential activation switch on the handle housing or the right footswitch pedal (MAX) of the footswitch (FSW11). Only the right footswitch pedal is active when using the device; the left footswitch pedal (MIN) is not active when using HARMONIC Hook.
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), Internal Mammary Artery (IMA).
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
Bench testing and laboratory evaluations were conducted to demonstrate that the HARMONIC Hook performed as intended.
Biocompatibility Testing: Evaluation conducted in accordance with ISO 10993:2009 and FDA Blue Book Memorandum #G95-1. Passed tests: ISO Cytotoxicity, ISO Sensitization, ISO Intracutaneous Reactivity, ISO Acute System Toxicity.
Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1-2:2007 for EMC and IEC 60601-1:2005 for electrical safety.
Bench Testing: Blade amplitude and frequency evaluated for HARMONIC Hook to support substantial equivalence to predicate device. Data met predetermined acceptance criteria.
Acute Animal Testing: Performed in an acute study with the HARMONIC Hook vs. the predicate device to demonstrate that the tissue effects were not different than the predicate device. Results demonstrated the ability of the subject device (HARBH32) to create tissue planes, dissect tissue, and provide hemostasis in different tissue types.
Clinical Studies: The premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with three intertwined strands and a single wing on each side. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
Ethicon Endo-Surgery, LLC Mr. Brian Godwin Senior Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242
Re: K151136 Trade/Device Name: HARMONIC Hook Regulatory Class: Unclassified Product Code: LFL Dated: February 2, 2016 Received: February 3, 2016
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 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 of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
к151136
Device Name
HARMONIC® Hook
Indications for Use (Describe)
The HARMONIC Hook instrument is 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, exposure to orthopedic structures (such as spine and joint space), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
- Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
- Contact Brian Godwin, RAC 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
Date Prepared 28 April 2015
Device Name
Trade Name: HARMONIC® Hook Common Name: Instrument, Ultrasonic Surgical Catalog Code: HARBH32
Classification Name
Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)
Regulatory Class Unclassified
Predicate Device
HARMONIC 5mm instrument, cleared under K990362 on 17 September 1999 HARMONIC 5mm Instrument, last cleared under K060245 on 7 April 2006
The predicate device characteristics are described in K990362 when it was first cleared. The predicate device had an indication expansion in K060245.
Device Description
The HARMONIC Hook instrument is a sterile, single patient use instrument, consisting of a 5 mm titanium blade. The instrument allows for the cutting of soft tissue and coagulation of vessels up to and including 2 mm in diameter. The working length of the HARMONIC Hook instrument is 32 cm.
The HARMONIC Hook instrument works with the Generator G11 as part of a system. The device system has four essential parts: the Generator G11 (GEN11), the footswitch (FSW11), the handpiece (HPBLUE), and the HARMONIC Hook (HARBH32). The HARMONIC Hook has an
4
internal torque wrench for assembly to the HPBLUE handpiece. The HPBLUE handpiece connects the HARMONIC Hook device to the Generator G11, and converts electrical energy into mechanical motion (ultrasonic energy). The high-frequency mechanical vibration at 55.5 kHz of the HARMONIC Hook blade transects, dissects, and coagulates tissue, sealing vessels up to 2 mm. This ultrasonic vibration, a form of mechanical energy, does not allow electricity to pass to or through the patient.
The HARMONIC Hook can be operated using the 360° circumferential activation switch on the handle housing or the right footswitch pedal (MAX) of the footswitch (FSW11). Only the right footswitch pedal is active when using the device; the left footswitch pedal (MIN) is not active when using HARMONIC Hook.
Indications for Use
The HARMONIC Hook instrument is 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, exposure to orthopedic structures (such as spine and joint space), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
Technological Characteristics
The subject and predicate devices use the same ultrasonic technology to perform their intended use. The handpiece converts electrical energy into ultrasonic vibration. The HARMONIC Hook uses the HPBLUE handpiece while the predicate device uses the HP054 handpiece and the handswitch adaptor HSA08. Both the HPBLUE handpiece and the HP054 handpiece serve the same functional purpose to convert electrical energy from the Generator G11 to mechanical energy (ultrasonic energy) at the end effector for each device.
A few technological differences were identified between the subject and predicate devices. attributable to the respective design of each. Of the differences, three were noted in the submission, summarized below. These differences were found to not affect safety or effectiveness through demonstration of effective performance and equivalency to relevant aspects of the predicate device, conformance to industry safety and performance standards, and bench and preclinical evaluations.
Blade Frequency/Displacement
The blade frequency and displacement between the subject and predicate devices are slightly different, but is not clinically relevant with regards to tissue effect.
Sterilization
The subject devices are sterilized via ethylene oxide and the predicate devices are sterilized via gamma radiation; both devices are sterilized to the same sterility assurance level.
Performance Data
Bench testing and laboratory evaluations were conducted to demonstrate that the HARMONIC Hook performed as intended.
Biocompatibility Testing
5
The biocompatibility evaluation for HARMONIC Hook was conducted in accordance with the following standards: ISO 10993:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The device passed the following tests:
- ISO Cytotoxicity
- ISO Sensitization ●
- ISO Intracutaneous Reactivity ●
- ISO Acute System Toxicity ●
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the HARMONIC Hook device; the system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 for electrical safety.
Bench Testing
Blade amplitude and frequency were evaluated for HARMONIC Hook to support substantial equivalence to the predicate device. The maximum and minimum values, standard deviation and the mean were recorded for both blade frequency and amplitude. Data generated from this evaluation met the predetermined acceptance criteria.
Acute Animal Testing
Testing was performed in an acute study with the HARMONIC Hook vs. the predicate device to demonstrate that the tissue effects were not different than the predicate device. The results of the study demonstrated the ability of the subject device (HARBH32) to create tissue planes, dissect tissue, and provide hemostasis in different tissue types.
Clinical Studies
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Conclusion
The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC Hook is as safe and effective and performs as well as the identified legally marketed predicate device for cutting and coagulating soft tissue and sealing vessels up to 2 mm in diameter, as measured in situ.