(70 days)
The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control 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, pediatric, gynecologic, urologic, exposure of orthopedic structures (such as spine and joint space) and other open procedures.
The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control is a sterile, single patient use instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instrument has a straight blade and clamp arm and is designed to function through an incision without the use of a trocar. The instrument is 18cm long with a shaft diameter of 8.5mm and an active blade length of 18mm.
The provided text describes a 510(k) submission for the Harmonic WAVE™ Coagulating Shears. It outlines the device's description, indications for use, and a brief summary of performance data. However, it does not contain detailed information about specific acceptance criteria or a dedicated study report that "proves the device meets the acceptance criteria" in the way a clinical or in-vitro diagnostic study would.
The relevant section, "Performance Data," states: "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device performs as intended. In vivo animal testing has shown the ability of the Harmonic WAVE™ Coagulating Shears to seal arteries less than or equal to 5mm in diameter."
From this, we can infer a single performance metric and an implied acceptance criterion based on the animal testing.
Here's the information derived from the provided text, along with clear indications of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to seal arteries ≤ 5mm in diameter (implied) | "In vivo animal testing has shown the ability of the Harmonic WAVE™ Coagulating Shears to seal arteries less than or equal to 5mm in diameter." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document only mentions "in vivo animal testing."
- Data Provenance: "in vivo animal testing" (implies preclinical, likely laboratory setting). The country of origin is not specified, but the submission is to the US FDA.
- Retrospective/Prospective: Not specified, but animal testing is typically prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. The described testing is "in vivo animal testing" focused on a direct physiological outcome (artery sealing). There is no mention of human expert interpretation for establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe an MRMC study. The device is a surgical instrument, not an AI or imaging diagnostic tool that would typically undergo such a study. There is no mention of human readers or AI assistance in the context of performance improvement.
6. Standalone (Algorithm Only) Performance Study
- No. This is a physical surgical device, not an algorithm. Standalone performance as typically understood for AI algorithms is not relevant here.
7. Type of Ground Truth Used
- Direct Physiological Outcome/Observation: The ground truth for the animal testing would be the direct observation of successful artery sealing (or lack thereof) in the animal models, likely assessed by surgical observers or pathologists.
8. Sample Size for the Training Set
- Not Applicable. This is a hardware device; the concept of a "training set" for an algorithm is not relevant.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
In summary, the provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a predicate device for a surgical instrument. It includes minimal, high-level performance data from preclinical animal testing rather than a detailed study report with explicit acceptance criteria, statistical analysis, or complex ground truth establishment as would be present for a diagnostic AI device.
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510(k) Summary
| Company | Ethicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, OH 45242 |
|---|---|
| Contact | Carol Wash, RACAssociate II, Regulatory AffairsTelephone: (513) 337-3792Fax: (513) 337-1444Email: cwash4@eesus.jnj.com |
SEP 25 2006
Date Prepared July 12, 2006
| Device Name | Trade Name: | Harmonic WAVE™ Coagulating Shears withScissor Handle and Hand Control |
|---|---|---|
| Common or Usual Name: | Instrument, Ultrasonic Surgical | |
| Classification Name: | Unclassified |
Predicate Devices Harmonic Blades and Shears Expanded Indication
Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control
Device Description The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control is a sterile, single patient use instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instrument has a straight blade and clamp arm and is designed to function through an incision without the use of a trocar. The instrument is 18cm long with a shaft diameter of 8.5mm and an active blade length of 18mm.
Harmonic 5mm Curved Shears with Scissor Grip
Indications for Use The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control 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, pediatric, gynecologic, urologic, exposure of orthopedic structures (such as spine and joint space) and other open procedures.
Technological Characteristics The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control is similar to the design of the predicate device, the Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control. The new device is different from the predicate device in that it is designed for efficiency in performance of open surgical procedures.
Performance Data. Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device performs as intended. In vivo animal testing has shown the ability of the Harmonic WAVE™ Coagulating Shears to seal arteries less than or equal to 5mm in diameter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2006
Ethicon Endo-Surgery, Inc % Carol Walsh, RAC Associate II, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242
Re: K062000
Trade/Device Name: Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control Regulation Name: Unclassified Product Code: LFL Dated: July 12, 2006 Received: July 17, 2006
Dear Ms. Walsh:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Carol Wash, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological 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 062000
Device Name: Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control
Indications for Use:
The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control 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, 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K06 2000
N/A