(36 days)
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.
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.
This document is a 510(k) premarket notification for the Harmonic FOCUSTM shears, specifically requesting a modification to the Indications for Use statement to include otorhinolaryngology procedures. It is not a study proving device performance against acceptance criteria in the manner requested (e.g., in terms of sensitivity, specificity, or other quantitative performance metrics usually associated with AI/software devices).
The device is a surgical instrument, and its performance evaluation for this 510(k) relies on showing substantial equivalence to previously cleared predicate devices, rather than a de novo clinical study with specific acceptance criteria and performance reporting as one might see for diagnostic AI.
Therefore, much of the requested information cannot be directly extracted from the provided text. I will address what can be inferred and explicitly state what is not available.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of quantitative performance metrics (e.g., a specific success rate, accuracy, etc.) for the device itself or for its application in otorhinolaryngology. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices.
The key performance claim related to the device's function is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to seal vessels | "The Harmonic FOCUS shears device will seal vessels up to and including 5mm in diameter." |
| Safety and effectiveness in otorhinolaryngology (ENT) procedures | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission relies on prior performance data (K063192) and clinical literature assessment for the safety and effectiveness in ENT procedures, rather than a new test set for this specific 510(k) modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. There was no new "test set" in the context of diagnostic performance that would require expert adjudication. The "ground truth" for the device's performance (e.g., vessel sealing capability) would have been established through engineering tests or animal/cadaver studies during the predicate device's clearance. For the literature review, the "experts" are the authors of the published clinical literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the reasons stated above.
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
This information is not applicable. This device is a surgical instrument, not an AI or diagnostic software that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the claims in this submission is implicit:
- Vessel sealing capability: Likely established through pre-clinical (e.g., in vitro, cadaver, or animal) studies, along with standard engineering and functional testing.
- Safety and effectiveness in ENT: Established through published clinical literature on ultrasonic Harmonic technology, comparing it to predicate technologies. This would primarily rely on outcomes data reported in those studies (e.g., bleeding control, thermal injury, surgical efficacy, patient safety).
8. The sample size for the training set
This information is not applicable/provided. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated above.
Summary of Approach for This 510(k):
The manufacturer's strategy for this 510(k) was to demonstrate substantial equivalence to existing, legally marketed predicate devices. This involves showing that the modified device has the "same intended use, the indications for use, the technological characteristics and the energy requirements of the systems." For the specific inclusion of otorhinolaryngology, they relied on existing "clinical literature" to show that ultrasonic Harmonic technology (the core technology) is already proven safe and effective in this field. They explicitly state, "The design of the Harmonic FOCUS Shears is essentially unchanged and the performance data provided in K063192 is still applicable to the device."
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APR - 7 2010
Ethicon Endo-Surgery, LLC Traditional 510(k) Premarket Notification Harmonic FOCUS shears
K 100595
· 510(k) Summary
| Company: | Ethicon Endo-Surgery, LLC475 Calle CGuaynabo, PR 00969 |
|---|---|
| Contact: | Marcia Arentz, RACRegulatory Affairs Portfolio LeaderEthicon Endo-Surgery4545 Creek RoadCincinnati, OH 45242Tel: (513) 337-1066Fax: (513) 337-1122Email: marentz5@its.jnj.com |
| Date Prepared: | March 1, 2010 |
| Device Name: | Trade Name: Harmonic FOCUSTM shearsCommon or Usual Name: Ultrasonic Surgical InstrumentClassification Name: Electrosurgical Cutting and CoagulationDevice [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.
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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.
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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
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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
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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
N/A