(52 days)
Not Found
No
The description focuses on the mechanical and power control aspects of a surgical instrument, with no mention of AI or ML capabilities. The "Adaptive Tissue Technology" is mentioned in the predicate device but not described in a way that suggests AI/ML.
No
The device is described as an instrument for surgical incisions, cutting, and coagulation of vessels, rather than for treating or curing a disease or condition.
No
The device description indicates it is a surgical instrument for cutting and coagulation of tissue, not for diagnosing medical conditions.
No
The device description clearly outlines a physical surgical instrument with a handle, blade, clamp arm, and hand controls, indicating it is a hardware device, not software-only.
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 therapeutic and surgical function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details a surgical instrument with a blade, clamp arm, and hand controls for power levels. This aligns with a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The HARMONIC FOCUS® Long 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, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
Product codes
LFL
Device Description
The HARMONIC FOCUS+ Long 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. Measured from the blade tip to the MAX hand control power button, the instrument is 17 cm in length with a 16 mm active blade length. The HARMONIC FOCUS+ Long Shears 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
Not Found
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)
Ex-vivo tests were performed to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed against the design requirements, and included process verification, design verification, and design validation.
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping profiles facing right, with a design element resembling a wing or ribbon extending from the first profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2015
Ethicon Endo-Surgery, LLC Mr. Brian Godwin Ethicon Endo-Surgery Incorporated 4545 Creek Road Cincinnati, Ohio 45242
Re: K151340
Trade/Device Name: HARMONIC FOCUS® Long Shears + Adaptive Tissue Technology Regulatory Class: Unclassified Product Code: LFL Dated: June 23, 2015 Received: June 24, 2015
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. Isting 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 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/Resourcesfor You/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 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 -S
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
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Indications for Use
510(k) Number (if known)
Device Name
HARMONIC FOCUS® Long Shears + Adaptive Tissue Technology
Indications for Use (Describe)
The HARMONIC FOCUS® Long 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, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
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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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 15 May 2015
Device Name
| Trade Name: | HARMONIC FOCUS® Long Shears + Adaptive Tissue Technology |
|---|---|
| Common Name: | Instrument, Ultrasonic Surgical |
| Model Number: | HAR17F |
Classification Name
Instrument, Ultrasonic Surgical (Unassigned, Product Code LFL)
Predicate Device
HARMONIC FOCUS® Shears + Adaptive Tissue Technology, cleared under K133314 on 03 December 2013
Device Description
The HARMONIC FOCUS+ Long 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. Measured from the blade tip to the MAX hand control power button, the instrument is 17 cm in length with a 16 mm active blade length. The HARMONIC FOCUS+ Long Shears instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.
Indications for Use
The HARMONIC FOCUS Long 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.
4
Technological Characteristics
The subject and predicate devices use the same ultrasonic technology to perform their intended use. Both devices use the HPBLUE handpiece to convert electrical energy into ultrasonic vibration.
The ergonomic differences between the subject and predicate devices are attributable to the respective design of each. Additionally, the subtle difference in the blade frequency upper bound is due to the increased blade length and has no clinical relevance with regards to tissue effect. These differences were found to not affect safety or effectiveness via design verification activities.
Performance Data
Ex-vivo tests were performed to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed against the design requirements, and included process verification, design verification, and design validation.
Clinical Studies
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Conclusion
This modification of the predicate device revealed no new issues of safety or efficacy as demonstrated through design validation and verification studies. The HARMONIC Focus Long 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.