(36 days)
No
The 510(k) summary describes a standard bipolar forceps for electrosurgery and makes no mention of AI or ML technology in the intended use, device description, or performance studies.
No
Explanation: The device is used for coagulation and tissue cauterization to achieve hemostasis, which are surgical procedures, not therapeutic treatments. It's an electrosurgical instrument.
No
The device is described as bipolar forceps intended for coagulation and tissue cauterization to achieve hemostasis, which are therapeutic functions, not diagnostic ones.
No
The device description clearly indicates a physical medical device (bipolar forceps) made of stainless steel or titanium alloy with a non-stick coating and connecting pins, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "coagulation and or tissue cauterization to achieve hemostasis" during "general surgery procedures." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description details a surgical instrument (forceps) used with an electrosurgical generator. This aligns with a surgical device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically alter tissue through coagulation and cauterization during surgery.
N/A
Intended Use / Indications for Use
The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps are intended for use attached by cable to a standard electrosurgical bipolar generator in any general surgery procedure that requires coagulation and or tissue cauterization to achieve hemostasis.
Product codes
GEI
Device Description
The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps family are similar in design to the predicate devices. They have various tip lengths and configurations, and are available in insulated and non-insulated versions. They are made from a stainless steel or Titanium alloy with a proprietary non-stick coaling. The proximal end has a protective plastic insulator sheath with industry standard clectrosurgery cable connecting pins. Forceps are packaged individually, sold non-sterile, and intended for steam, and EtO sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioner / general surgery procedure
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
Comparison tests following written protocols were conducted using the ITI devices and the predicate devices. The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Bipolar forceps met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended.
Key Metrics
Not Found
Predicate Device(s)
Ethicon Inc. Non-Stick Bipolar Forceps K973384
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Rev2
8 1998 SEP
ITI Medical Technologies, Inc.
2452 Armstrong Street Livermore, CA 94550 (925) 371-8305 FAX (925) 371-8222
1982702
SUMMARY OF SAFETY AND EFFECTIVENESS
July 31, 1998
| Contact Person: | Roger W. Werne, Ph.D., President | |
|---|---|---|
| Common or Usual Name: | Bipolar Forceps | |
| Proprietary Name: | Midas Touch™ Bipolar Forceps | |
| Classification Name: | Unit, Electrosurgical and Coagulation with accessories | |
| 21 CFR § 878.4400 | ||
| Class and Panel: | Regulatory Class II | |
| Product Code: GEI General and Plastic Surgery 79 | ||
| Predicate Devices: | Ethicon Inc. Non-Stick Bipolar Forceps | K973384 |
The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Description of Device: Forceps family are similar in design to the predicate devices. They have various tip lengths and configurations, and are available in insulated and non-insulated versions. They are made from a stainless steel or Titanium alloy with a proprietary non-stick coaling. The proximal end has a protective plastic insulator sheath with industry standard clectrosurgery cable connecting pins. Forceps are packaged individually, sold non-sterile, and intended for steam, and EtO sterilization.
Statement of intended use: The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps are intended for use attached by cable to a standard electrosurgical bipolar generator in any general surgery procedure that requires coagulation and or tissue cauterization to achieve hemostasis.
The intended use is identical to that of the predicate devices, i.e. a standard bipolar forceps for use by a trained medical practitioner. There are no differences in the devices concerning intended use or the safety or effectiveness when used as labeled.
1
Statement of technological characteristics:
The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps incorporate no significant change in design, materials, energy source or other technological characteristics than those found in the predicate devices. Their form factors are similar to the predicate devices. They can be used with the same standard bipolar electrosurgical generator units and cables as the predicate devices.
The only difference between the Midas Touch™ Bipolar Forceps and the predicate devices, other than minor shape differences, is the type of non-stick coating. The ITI forceps are made from a stainless steel or Titanium alloy having ITI's own non-stick coating as compared to the predicate devices: Kirwan, Nickel forceps and Valleylab, Titanium forceps.
Special Controls: Although there are no performance standards established by the FDA for bipolar forceps devices, the ITI Medical Technologies. Inc. Bipolar Forceps have been designed to comply with, and are manufactured to pertinent parts of the following standards:
ANSI/AAMI American National Standard HF18-1993 Electrosurgical devices
In addition, the device and its development process also comply with pertinent parts of:
- FDA, CDRH, ODE DGRD: October 19, 1993, 510(k) Guideline General Surgical . Electrosurgical Devices and;
- FDA, CDRH, ODE DRAERD: August 16, 1995 510(k) Checklist for Endoscopic . Electrosurgical Unit (ESU) and Accessories used in Gastroenterology and Urology.
- FDA CDRH ODE March 1995 DRAFT: Labeling Reusable Medical Devices for . Reprocessing in Health Care Facilities: FDA Reviewer Guidance
Data regarding special controls are summarized in the submission, and support the safety and efficacy of the device.
Comparison tests following written protocols were conducted using the ITI devices and the predicate devices.
The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Bipolar forceps met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1998 SEP
Dr. Roger W. Werne President and CEO ITI Medical Technologies, Inc. 2452 Armstrong Street Livermore, California 94550
Re: K982705
Trade Name: Midas Touch Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: August 3, 1998
Dear Dr. Werne:
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 - Dr. Roger W. Werne
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) 594-4595. 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.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
ITI Medical Technologies, Inc. Bipolar Forceps 510(k) Premarket Notification PREFACE - Page 3 rev2
510(k) Number (if known): 982705
Device Name: Midas Touch™ Bipolar Forceps
Statement of intended use:
The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps are intended for use attached by cable to a standard electrosurgical bipolar general surgery procedure that requires coagulation and or tissue cauterization to achieve hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | K982705 |
| 510(k) Number |
| Prescription Use X
| (Per 21 CFR 801.109) | OR | Over - The - Counter - Use ______ |
|---|---|---|
| (Optional Format 1-2-9) |