(29 days)
Not Found
No
The summary describes a surgical instrument for cutting and coagulating tissue and does not mention any AI or ML components or functionalities.
Yes
The device is described as cutting and coagulating soft tissues to control bleeding and minimize thermal injury, acting as an adjunct or substitute for other surgical tools, which are all therapeutic actions.
No
Explanation: The provided text describes the Harmonic Scalpel and Ultracision Instruments as devices for cutting and coagulating soft tissues, used as an adjunct or substitute for other surgical tools. There is no mention of these devices being used to diagnose conditions or process diagnostic information.
No
The device description explicitly mentions a "Hand Piece," which is a physical, hand-held component, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Harmonic Scalpel and Ultracision Instruments are used to "cut and coagulate soft tissues." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "hand-held component" for "cutting and coagulating soft tissues." This further reinforces its use in surgical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. The description of this device does not involve any such specimen analysis.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The Ultracision Hand Piece is the hand-held component of the Ultracision Instrumentation. The instrument is for cutting and coagulating soft tissues.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ultracision Hand Piece with air cooling (K952726
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 Road
Cincinnati, OH 45242 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ruth Ann Wood |
| Date: | February 12, 1999 |
| Device Name: | Instrument, Ultrasonic, Surgical
Ultracision® 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 cutting
and 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.
1
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.
2
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.
3
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
4
15:53
Page ર્ડ
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