(99 days)
Not Found
No
The summary describes a hardware expansion system for an electrosurgical unit with software for mode selection, but there is no mention of AI or ML algorithms, data processing for learning, or performance metrics typically associated with AI/ML.
Yes.
It is intended to deliver argon gas for argon plasma coagulation on tissue, for the enhanced control of bleeding and the electrosurgical destruction of tissue in multispecialty procedures.
No
The device description indicates its purpose is for "enhanced control of bleeding and the electrosurgical destruction of tissue," and it "delivers argon gas for argon plasma coagulation on tissue." These are clearly therapeutic functions, not diagnostic ones.
No
The device description explicitly states it consists of four major assemblies integrated into one system: Main Unit, Universal Cart, the Argon Module, and Accessories, indicating it is a hardware system with integrated software, not a software-only device.
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 delivering argon gas for argon plasma coagulation on tissue. This is a therapeutic procedure performed directly on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system used in surgical and endoscopic procedures for controlling bleeding and destroying tissue. This aligns with a therapeutic device used in a clinical setting, not a diagnostic device used in a laboratory or point-of-care setting to analyze 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 entirely focused on a therapeutic intervention.
N/A
Intended Use / Indications for Use
The EES 100 with Accessories is intended to deliver argon plasma coagulation on tissue when use in conjunction with a Electrosurgical Generator and applicators or probes.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The EES 100 is an expansion system for the electrosurgical unit (ESU). The EES 100 is not a generator. It is designed for the enhanced control of bleeding and the electrosurgical destruction of tissue in multispecialty procedures in the operating room or endoscopy suite. The EES 100 equipped with the argon module is used in combination with a high-frequency generator and an electrosurgical handpiece and the users can select appropriate operation modes: Pulse, Endo or Ar-cut mode to fulfill various argon surgical requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room or endoscopy suite.
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)
The Hazard Analysis of the device is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices. The performance of product has been tested and verified by users.
The Safety of General Requirement, EMC, Software, Usability and Alarm of the device are in compliance with following standards: IEC60601-1, IEC60601-1-2, IEC 60601-1-4, IEC60601-1-6, IEC60601-1-8, And the device is also in compliance with ANSI/AAMI HF18: Standard for Electrosurgical Instruments.
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.
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
KI220/2
510(k) Summary
Submitter's Information
| Company: | Medrange Corporation
480 Apollo Street
Suite D
Brea, CA 92821 |
|----------|------------------------------------------------------------------------|
| Contact: | Kuofang Huang |
| Phone: | (714) 784 - 5202 |
| Fax: | (714) 255 - 1531 |
| Email: | kuofang@medrange.com |
Device Identification
| Device Classification Name: | Electrosurgical cutting and coagulation device and accessories |
|---|---|
| Device Name: | Electrosurgical Expansion System with accessories |
| Mod el Name: | EES 100 |
| Device Classification: | Class II, according to regulation number 21 CFR 878.4400 |
| Product Code: | GEI |
Predicate Device Information
| Predicate Device1: | Conmed CE 600 |
|---|---|
| 510(k) number: K081678 | |
| Predicate Device2: | ERBE VIO APC 2 |
| 510(k) number: K024047 | |
| Predicate De vice 3: | Force Argon II |
| 510(k) number: K964636 |
Device Description
The E ES 100 is an expa nsion system for the el ectrosurgical unit (E SU). The EE S 100 is not a generator. It is designed for the enhanced control of bleeding and the electrosurgical destruction of tissue in multispecialty procedures in the operating room or endoscopy suite. The EES 100 equipped with the argon module is use d in com bination with a hi gh-frequency generator a nd an electrosurgical handpiece and the users can select app ropriate operation modes: Pulse, Endo or Ar-cut mode to fulfill various argon surgical requirements.
1
Indication for Use
The EES 100 with Accessories is intended to deliver argon plasma coagulation on tissue when use in conjunction with a Electrosurgical Generator and applicators or probes.
Technological Characteristics
The device consists of four major assemblies integrated into one system: Main Unit, Universal Cart, the Argon Module, Accessories. The EES 100 provides finer maneuverability and fits a variety of s urgical equipments, endoscopes and instruments. The Software is equipped in the device. Dispense with setting or modification for the user. Dispense with training before using the device.
Performance Data
The Hazard Analysis of the device is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices. The performance of product has been tested and verified by users.
The Safety of General Requirement, EMC, Software, Usability and Alarm of the device are in compliance with following standards: IEC60601-1, IEC60601-1-2, IEC 60601-1-4, IEC60601-1-6, IEC60601-1-8, And the device is also in compliance with ANSI/AAMI HF18: Standard for Electrosurgical Instruments.
Conclusion
Since EES 100 has the same intended use, principles of operation, technological characteristics and functional capabilities as the predicate devices which have 510k cleared. The EES 100 with accessories represents good substantial equivalence to its predicate devices. And the EES 100 raises no new issues of safety or effectiveness.
Section 2 - 510(k) Summary
2
Image /page/2/Picture/1 description: The image shows the 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 faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
OCT
23 2012
MedRange Corporation % Mr. Kuofang Huang Treasurer 480 Apollo Street, Suite D Brea, California 92821
Re: K122092
Trade/Device Name: Electrosurgical Expansion System with accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 05, 2012 Received: September 11, 2012
Dear Mr. Huang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Kuofang Huang
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm:
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number : K122092
Device Name: Electrosurgical Expansion System with accessories Model Name: EES 100
Indications for use:
The EES 100 with Accessories is intended to deliver argon gas for argon plasma coagulation on tissue when used in conjunction with an Electrosurgical Generator and applicators or probes.
V Prescription Use
AND/OR
Over-The-Counter Use
(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 Surgical, Orthopedic,
and Restorative Devices
510(k) Number K122092