(63 days)
Not Found
Not Found
No
The summary describes a system for integrating and controlling electrosurgical devices and a smoke evacuation unit, activated by a foot control. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of AI/ML.
No
The device integrates and controls electrosurgical devices and manages smoke evacuation, but it does not directly treat or diagnose a medical condition.
No
The device integrates and controls electrosurgical devices and a smoke evacuation unit, which are therapeutic and operational functions, not diagnostic.
No
The device description explicitly mentions "electrosurgical devices," "foot control," and a "smoke evacuation activation unit," all of which are hardware components. The system integrates these hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device's function is to integrate and control electrosurgical devices and manage smoke evacuation during surgical procedures. This is a surgical tool used on the patient during a procedure, not a device used to analyze samples from the patient in a lab setting.
- Intended Use: The intended use is for surgical procedures in hospitals or outpatient clinics, not for laboratory testing.
Therefore, the Gemini Surgical Control & Display System and the SurgiClear smoke evacuation activation unit are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Gemini Surgical Control & Display System is indicated for use in any surgical procedure where single or multiple electrosurgical (unipolar, harmonic scalpel, etc.) devices that with a foot control are used. The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices.
The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments.
Product codes
GEI
Device Description
Not Found
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
The system is intended for use in hospitals or outpatient clinics.
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)
Not Found
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.
Not Found
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the eagle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2005
Mr. David A. Alexander President/CTO Applied Surgical, LLC 300 Riverchase Parkway East Birmingham, Alabama 35244
Re: K051831
Trade/Device Name: Gemini Surgical Control & Display System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 18, 2005 Received: August 22, 2005
Dear Mr. Alexander:
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.
1
Page 2- Mr. David A. Alexander
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/dsma/dsmamain.html
Sincerely vours.
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Indications For Use | |
|---|---|
| 510(k) Number: | K051831 |
Device Name: Gemini Surgical Control & Display System
Indications For Use:
The Gemini Surgical Control & Display System is indicated for use in any surgical procedure where single or multiple electrosurgical (unipolar, harmonic scalpel, etc.) devices that with a foot control are used. The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices.
The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments.
The system is intended for use in hospitals or outpatient clinics.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
currence of CDRH. Office of Device Evaluation (ODE) meeting for the Kerson Division Sign-Off) Division of General, Restorative,
Page 1 of 1
510(k) Number K051831
and Neurological Devices