(29 days)
The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels.
The Ultracision Instruments are indicated for soft tissue inclaions when bleeding control and minimal thermal injury are desired. The instruments aan be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels.
The Ultracision Hand Piece is the hand-held component of the Ultracision Instrumentation. The instrument is for cutting and coagulating soft tissues.
This document (K990430) is a 510(k) premarket notification for a medical device called the "Ultracision® Harmonic Scalpel® Hand Piece." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information typically requested for acceptance criteria and device performance.
Therefore, many of the requested fields cannot be filled.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All studies demonstrated satisfactory performance in the areas of cutting, coagulation and ease of use." (Quantitative details, specific metrics, or thresholds are not provided.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. (The submitting company is Ethicon Endo-Surgery, Inc., Cincinnati, OH, USA, but this doesn't confirm the data's origin.)
- Retrospective or Prospective: Not specified.
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)
- Not applicable as no details on expert review or ground truth establishment for a test set are provided. The device testing appears to be functional performance testing, not diagnostic accuracy testing that would require expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for the type of device testing described.
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
- Not applicable. This is not an AI/diagnostic device; it's a surgical instrument. An MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the typical sense for diagnostic devices. The "ground truth" for a surgical instrument's performance would be the direct measurement of its physical properties and effects (e.g., cutting efficacy, coagulation depth, thermal spread). The document states "Testing was performed to ensure the device performs as intended" but doesn't detail the methodology for establishing ground truth for these performance aspects.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/machine learning model.
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Image /page/0/Picture/0 description: The image shows the date 3/12/99 at the top. Below the date is the logo for Ethicon Endo-Surgery, Inc., a Johnson & Johnson company. The logo includes a stylized graphic to the left of the company name. The text is in a simple, sans-serif font.
4545 CREFK ROAD CINCINNATI, OH 45242-2839
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Ethicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, OH 45242 |
|---|---|
| Contact: | Ruth Ann Wood |
| Date: | February 12, 1999 |
| Device Name: | Instrument, Ultrasonic, SurgicalUltracision® Harmonic Scalpel® Hand Piece |
| Device Classification: | Class II |
| Device Description: | The Ultracision Hand Piece is the hand-held component of the Ultracision Instru-mentation. The instrument is for cuttingand coagulating soft tissues. |
| Predicate Device: | Ultracision Hand Piece with air cooling (K952726 |
Intended Use:
The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels.
Technological Characteristics:
The technological characteristics of the hand piece are the same as the predicate devices. Ultracision technology is the method of activation. The Hand Piece is constructed wholly of biocompatible materials that are in compliance with ISO 10993-1 for their intended patient contact profile.
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Performance Data:
Testing was performed to ensure the device performs as intended. All studies demonstrated satisfactory performance in the areas of cutting, coagulation and ease of use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1999
Ms. Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati. Ohio 45242
Re: K990430
Trade Name: Ultracision® Harmonic Scalpel® Hand Piece Regulatory Class: II Product Code: LFL Dated: February 10, 1999 Received: February 11, 1999
Dear Ms. Wood:
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 action. In addition, FDA may publish further announcements 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 Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -- Ms. Ruth Ann Wood
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 vour 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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Ce lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SIO (k) NUMBER (IF KARDWN) = 990430
DEVICE NAME: Ultracision Hand Piece
INDICATIONS FOR USE:
The Ultracision Instruments are indicated for soft tissue inclaions when bleeding control and minimal thermal injury are desired. The instruments aan be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels.
(PLEASE DO NOT KRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-U
(Optional Format
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number: K990430
N/A