(38 days)
The Harmonic ACE™ Curved Shears with Pistol 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, pediatric, gynecologic, urologic and other open and endoscopic procedures.
The Harmonic ACE™ Curved 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 adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures.
The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control are a sterile, single patient use instrument consisting of a grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The grip housing has an integrated audible/tactile mechanism for indicating full trigger closure. The instruments have a rotating shaft with a curved blade and clamp arm and is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instruments are available in 14 cm (scissor handle only), 23 cm and 36 cm lengths with a shaft diameter of 5.5 mm and a 15 mm active bladc length.
The provided text outlines the 510(k) premarket notification for the "Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control" and "Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control" devices.
Here's an analysis of the acceptance criteria and study information, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Bench testing was performed to demonstrate that the devices perform as intended." However, it does not explicitly list specific acceptance criteria in terms of quantitative or qualitative thresholds. It also does not provide detailed reported device performance metrics from these bench tests. The FDA's substantial equivalence determination implies that the device met the necessary performance expectations compared to its predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The implication is that performance should be equivalent to the predicate device. | "Bench testing was performed to demonstrate that the devices perform as intended." (No specific results or metrics are given.) |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Bench testing was performed." It does not specify the sample size used for these tests. The country of origin and whether the data was retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not mention the use of experts to establish ground truth for the bench testing. The testing appears to be objective performance testing rather than expert-derived ground truth.
4. Adjudication Method for the Test Set
Since experts are not mentioned in relation to ground truth, an adjudication method is not applicable and not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or described in the provided text. The device is a surgical instrument, not an interpretive diagnostic tool that typically involves human readers.
6. Standalone Performance (Algorithm Only Without Human-in-The-Loop Performance)
This question is not applicable as the device is a physical surgical instrument, not an algorithm or AI. The concept of "standalone performance" in this context would refer to the instrument's functional effectiveness without human manipulation, which is inherent in surgical tools (i.e., it doesn't "perform" on its own). The bench testing would assess its functional capabilities.
7. Type of Ground Truth Used
Based on the description of "bench testing" for a surgical instrument, the ground truth would likely be objective physical measurements and observations related to the device's functional characteristics (e.g., cutting efficacy, coagulation properties, thermal spread, mechanical integrity, etc.) as defined by engineering specifications and predicate device performance. No specific type of ground truth is explicitly stated.
8. Sample Size for the Training Set
This question is not applicable as the device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical surgical instrument, not an AI/ML algorithm.
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Ethicon Endo-Surgery, Inc.
Ethicon Endo-Burger 3, the 510(t) I renal Rev Notheduon ACE™ Curved Shears with Scissor Handle and Hand Control
Harmonic ACETM Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Rachel D. Austin Associate I, Regulatory Affairs
Date Prepared:
April 22, 2005
Name of Device
Trade Name: Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control
Classification Name: Electrosurgical Cutting and Coagulation Device
Predicate Devices:
Harmonic ACE with Hand Control cleared under K042777 on 12/01/2004
Device Description
The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control are a sterile, single patient use instrument consisting of a grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The grip housing has an integrated audible/tactile mechanism for indicating full trigger closure. The instruments have a rotating shaft with a curved blade and clamp arm and is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instruments are available in 14 cm (scissor handle only), 23 cm and 36 cm lengths with a shaft diameter of 5.5 mm and a 15 mm active bladc length.
Indications for Use
The Harmonic ACE™ Curved Shears with Pistol 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, pediatric, gynecologic, urologic and other open and endoscopic procedures.
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Ethicon Endo-Surgery, Inc.
Ethicon Endo-Surgery, Inc.
510(k) Premarket Notification for Harmonic ACE™ Curved Shears World Cantre 510(K) Premarket Notification of Harmonic A C
page 2 of 2
The Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control is indicated The Harmonte ACE - Ourved blessing control and minimal thermal injury are desired. The instrument can be used as adjunct to or substitute for electrosurgery, lasers, and I he instrument van be abou as an agynecologic, urologic and other open and endoscopic procedures.
Technological Characteristics
The Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and The Trainonic ACE™ Curved Shears with Scissor Handle and Hand Control are similar to the predicate devices with respect to design and intended use.
Performance Data
I er ormance Data
Bench testing was performed to demonstrate that the devices perform as intended.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the circumference of the circle.
JUN 2 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rachel D. Austin Associate I, Regulatory Affairs Ethicon Endo-Surgery Incorporated 4545 Creek Road Cincinnati, Ohio 45242-2839
Re: K051036
Trade/Device Name: Harmonic Ace™ Curved Shears with Pistol Handle and Hand Control and the Harmonic Ace™ Curved Shears with Scissor Handle and Hand Control Regulatory Class: Unclassified
Product Code: LFL Dated: April 22, 2005 Received: April 25, 2005
Dear Ms. Austin:
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 (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. 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
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Page 2 - Ms. Rachel D. Austin
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting 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):
Device Name:
Harmonic ACE™ Curved Shears with Pistol Handle and Hand Control and the Harmonic ACE™ Curved Shears with Scissor Handle and Hand Control
Indications for Use:
The Harmonic ACE™ Curved Shears with Pistol 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, pediatric, gynecologic, urologic and other open and endoscopic procedures.
The Harmonic ACE™ Curved 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, pediatric, gynecologic, urologic and other open and enoscopic procedures.
× Prescription Use (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)
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tive
N/A