(30 days)
The UltraCision 5mm Instruments are intended for the cutting and coagulation of soft tissues.
The UltraCision 5mm Instruments 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, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The UltraCision® 5mm Instruments as described in this special premarket notification are hand held instruments available in a 10cm, 14cm, and 32cm Curved Blade configuration and a 10cm and 14cm Sharp or Dissecting Hook Blade configuration. An optional blade grip is included in the 14cm configurations. When attached to the ultrasonic hand piece and generator, ultrasonic activation of the blade allows the instrument to cut and coagulate tissue.
The provided text does not contain specific acceptance criteria or a study that evaluates a device against such criteria in the manner requested. The document is a 510(k) Summary of Safety and Effectiveness for the UltraCision® 5mm Instruments, which describes the device, its intended use, and indicates that preclinical testing was performed to ensure the device performs as intended. However, it does not provide details about the specific acceptance criteria, performance metrics, study design, sample sizes, ground truth establishment, or expert involvement as outlined in the request.
Instead, the document primarily focuses on establishing substantial equivalence to previously marketed predicate devices.
Therefore, I cannot provide the requested information.
{0}------------------------------------------------
OCT 21 1998
Image /page/0/Picture/1 description: The image shows the handwritten text "K 983316". The text appears to be written with a dark ink on a white background. The numbers are written in a cursive style, and there is a period after the last digit.
Appendix A: 510(k) Summary of Safety and Effectiveness
| Statement | Information supporting claims of substantial equivalence, as defined under theFederal Food, Drug and Cosmetic Act, respecting safety and effectiveness issummarized below.For the convenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule "...510(k) Summaries and 510(k)Statements..." (21 CFR §807) and can be used to provide a substantialequivalence summary to anyone requesting it from the Agency. | Performancedata | Preclinical testing was performed to ensure the device performs as intended.All studies demonstrated satisfactory performance in the areas of cutting,coagulation, access, visibility, blunt and fine dissection, and ease of use. |
|---|---|---|---|
| Devicedescription | The UltraCision® 5mm Instruments as described in this special premarketnotification are hand held instruments available in a 10cm, 14cm, and 32cmCurved Blade configuration and a 10cm and 14cm Sharp or Dissecting HookBlade configuration. An optional blade grip is included in the 14cmconfigurations. When attached to the ultrasonic hand piece and generator,ultrasonic activation of the blade allows the instrument to cut and coagulatetissue. | Contact | Chuck TabriEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
| Intended use | The UltraCision 5mm Instruments are intended for the cutting and coagulationof soft tissues. | Date | September 18, 1998 |
| Indicationsstatement | The UltraCision 5mm Instruments are indicated for soft tissue incisions whenbleeding control and minimal thermal injury are desired. The instruments canbe used as an adjunct to or substitute for electrosurgery, lasers, and steelscalpels in general, gynecologic, and thoracic surgery, including mobilization | ||
| Technologicalcharacteristics | The technological characteristics of the UltraCision® 5mm Instruments are thesame as the predicate devices. Ultrasonic technology is the method ofactivation. | ||
| Continued on next page |
UltraCision® 5mm Instruments Ethicon Endo-Surgery, Inc
{1}------------------------------------------------
Appendix A: 510(k) Summary of Safety and Effectiveness,
Continued
のお気になる。
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
OCT 21 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chuck Tabri Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839
Re: K983316 UltraCision® 5mm Instrument Trade Name: Regulatory Class: II Product Code: LFL Dated: September 18, 1998 September 21, 1998 Received:
Dear Mr. Tabri:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic
{3}------------------------------------------------
Page 2 - Mr. Chuck Tabri
Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colin M. Wittner, Ph.D.
Ph.D., M.D. Celia M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Appendix B: Indications for Use Statement
Indications for Use Statement: Statement
510(k) Number: K_98 33 16
Device Name: UltraCision® 5mm Instrument
Indications for Use: The UltraCision 5mm Instruments 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, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
Prescription Use (Per 21 CFR 801.109)
Dcoellfa
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number
UltraCision® 5mm Instruments Ethicon Endo-Surgery, Inc
N/A