(52 days)
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.
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.
This document is a 510(k) premarket notification for a medical device, the HARMONIC FOCUS® Long Shears + Adaptive Tissue Technology. It is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report designed to "prove" the device meets these criteria in the way one might expect for a novel AI device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not directly applicable or available in this type of submission. The submission relies heavily on design verification and validation activities rather than clinical study-style performance metrics.
Here's an attempt to extract and interpret the information based on the provided text, while also noting where information is not present or not relevant to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Design Specifications" and "Performs as Intended") | Reported Device Performance (From "Performance Data" and "Conclusion") |
|---|---|
| Performs cutting and coagulation of vessels. | Performs cutting and coagulation of vessels up to and including 5 mm in diameter. |
| Produces minimal thermal injury. | Produces minimal thermal injury. |
| Maintains bleeding control. | Maintains bleeding control. |
| Operates using ultrasonic technology. | Operates using ultrasonic technology (HPBLUE handpiece for ultrasonic vibration). |
| Does not have safety or effectiveness affected by design differences from predicate. | Design verification activities confirmed no effect on safety or effectiveness from ergonomic or subtle blade frequency differences. |
| Meets design specifications. | Device performance assessed against design requirements; included process verification, design verification, and design validation. |
| As safe and effective as predicate devices. | As safe and effective as identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter. |
Explanation: The "acceptance criteria" for this type of device are primarily implicit in its intended use, design specifications, and the demonstration of substantial equivalence to a predicate. The "reported device performance" are the general claims made about the device based on the verification and validation activities. Specific quantitative metrics are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as this was not a clinical trial. The "ex-vivo tests" and "design verification and validation" activities would have involved testing a certain number of devices or tissues, but the precise sample sizes for these internal engineering tests are not disclosed in this 510(k) summary.
- Data Provenance: Not applicable. The data comes from internal company testing (ex-vivo tests, design verification, design validation) rather than patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for this engineering-focused 510(k) submission is derived from engineering design specifications, performance standards, and comparison to the predicate device's known performance, rather than expert interpretation of medical images or case outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. There was no clinical test set requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an AI-powered diagnostic tool, so such a study would not be relevant.
- Effect Size of Human Readers: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a surgical instrument that inherently requires human interaction for its function. It is not an AI algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this context is the design specifications and performance requirements established by the manufacturer, along with the known performance characteristics of the predicate device. The goal of the testing was to demonstrate that the subject device met these engineering and performance standards and was substantially equivalent to the predicate.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
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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.
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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, LLC475 Calle CGuaynabo, 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.
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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.
N/A