(62 days)
Not Found
No
The summary describes a standard electrosurgical generator with basic cutting and coagulation modes. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on compliance with electrical safety and performance standards, not AI/ML model validation.
Yes
The device is an electrosurgical generator designed for cutting and coagulation at the operative site, which are therapeutic interventions.
No
The device description clearly states its purpose is for "cutting and coagulation at the operative site" and for "delivery of RF (radio frequency) electrosurgical content". There is no mention of diagnostic functions or the acquisition of information about the patient's condition.
No
The device description clearly states it is an "electrosurgical generator unit" that supplies "high frequency (HF) electrosurgical current" and is used with "accessory hand pieces" and "accessory electrode". This indicates a hardware device that generates and delivers energy, 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 is for "cutting and coagulation at the operative site" using RF electrosurgical energy. This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The description details how the device delivers energy to an electrode for surgical effects (cutting and coagulation). This is a direct intervention on the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. There is no mention of analyzing samples or providing diagnostic information in the provided text.
The device is clearly described as a surgical tool used for therapeutic purposes during surgery.
N/A
Intended Use / Indications for Use
The CONMED® Sabre Genesis™ and CONMED® HyfreSurg OP™ Electrosurgical Generators are intended for use in open and laparoscopic surgery and in office based surgical procedures.
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory hand piece for delivery of RF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The CONMED® Sabre Genesis™ and CONMED® HyfreSurg™OP Electrosurgical Generators are electrosurgical generators with the basic modes of operational electrosurgical cutting and coagulation. The devices consist of a single electrosurgical generator unit for each model to supply high frequency (HF) electrosurgical current to accessory hand pieces to produce the clinical effect. When cutting, the subject device provides the energy to the active electrode which is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the subject device provides the energy to the active electrode which may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result.
The subject devices (Sabre Genesis and HyfreSurg OP) are of the same construction in components and assembly. The difference is the HyfreSurg OP does not have the Pulse Cut functionality and the control panel is altered accordingly.
Use of these products for unintended applications could lead to an unsafe condition.
The device utilizes previously cleared/marketed and required accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
operative site
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)
Where applicable, specific testing performed was in conformance with the requirements of the following standards:
- IEC 60601-1:1998, Medical electrical equipment -- 2nd Ed. plus amendments 1 and 2 - also representing UL60601-1, EN60601-1, CSA C22.2 No. 60601-1 except for national deviations.
- IEC 60601-1-1: 2000, Medical Electrical Equipment Part 1-1 General Requirements faor Safety . - Collateral Standard: Safety Requirements for Medical Electrical Systems.
- IEC 60601-1-2: 2005, Medical Electrical Equipment -- Part 1-2 General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-1-4: 2000, Medical Electrical Equipment Part 1-4 Medical electrical equipment -. Part 1-4: General requirements for safety - Collateral Standard: Programmable electively systems.
- IEC60601-1-6: 2004, Medical electrical equipment - Part 1-6: General requirements for safety -Collateral standard: Usability.
- IEC60601-1-8: 2005, Medical electrical equipment Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for salam systems in medical electrical equipment and medical electrical systems.
- IEC 60601-2-2: 2006, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
Performance characteristics of the subject devices are equivalent to the subject devices and have been verified to meet the requirements above as well as performance requirements defined in design inputs. Design verification and validation activities demonstrated the subject devices to be equivalent where applicable to the predicate devices.
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
Image /page/0/Picture/0 description: The image shows the logo for ConMed Electrosurgery. The logo consists of a stylized "C" shape in a square to the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "ELECTROSURGERY" in smaller letters. The logo is simple and professional, and it is likely used to represent a company that manufactures or sells electrosurgical equipment.
510k Summary of Safety and Effectiveness
CONMED® Sabre Genesis™ Electrosurgical Unit CONMED® HyfreSurg OPTM Electrosurgical Unit
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Electrosurgery is hereby submitting the 510(s) Summary of Safety and Effectiveness for the 510(k) Number __________________________________________________________________________________________________________________________________________
A. Submitter
ConMed Electrosurgery 14603 E. Fremont Ave. Centennial, Colorado 80112
B. Company Contact
Shawn Riedel Vice President, Quality Assurance and Regulatory Affairs 14603 E. Fremont Ave. Centennial, Colorado 80112
Phone: 303-269-8224 Fax: 303-699-9854 e-mail: shawn riedel@es.conmed.com
C. Device Name
| Trade Name: | CONMED® Sabre Genesis™ Electrosurgical Unit
CONMED® HyfreSurg OPTM Electrosurgical Unit | | |
|----------------------|--------------------------------------------------------------------------------------------|-----------------|--|
| Common Name: | Electrosurgical unit and accessories | | |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories | | |
| Regulation Number: | 21 CFR 878.4400 | Class II 79 GEI | |
| Panel: | General and Plastic Surgery | | |
D. Predicate Device Name
CONMED® System 2450™ Electrosurgical Unit ConMed Electrosurgery 510(k) K052009 CONMED® System 5000™ Electrosurgical Unit ConMed Electrosurgery
510(k) K020186
Sabre Genesis l-lyfreSurg OP 03665
FEB 1 6 201
1
E. Device Description
The CONMED® Sabre Genesis™ and CONMED® HyfreSurg™OP Electrosurgical Generators are electrosurgical generators with the basic modes of operational electrosurgical cutting and coagulation. The devices consist of a single electrosurgical generator unit for each model to supply high frequency (HF) electrosurgical current to accessory hand pieces to produce the clinical effect. When cutting, the subject device provides the energy to the active electrode which is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the subject device provides the energy to the active electrode which may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result.
The subject devices (Sabre Genesis and HyfreSurg OP) are of the same construction in components and assembly. The difference is the HyfreSurg OP does not have the Pulse Cut functionality and the control panel is altered accordingly.
Use of these products for unintended applications could lead to an unsafe condition.
The device utilizes previously cleared/marketed and required accessories.
F. Intended Use
The CONMED® Sabre Genesis™ and CONMED® HyfreSurg OP™ Electrosurgical Generators are intended for use in open and laparoscopic surgery and in office based surgical procedures.
G. Indications for use
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory hand piece for delivery of RF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.
H. Technological Characteristics
The technological characteristics of the proposed device are identical to the predicate devices. Any differences represent limitations of previously cleared technology. The device has been designed to comply with numerous applicable standards.
I. Safety Information
Questions of safety and effectiveness are the same for this device as they are for the predicated devices and other electrosurgical generators on the market. There are no new technologies incorporated into the device. The device provides alarms for conditions that could pose a risk to the patient. The operator sets the appropriate mode and output settings for the device.
J. Biocompatibility
The subject devices do not have direct patient contact.
K. Performance Testing
Where applicable, specific testing performed was in conformance with the requirements of the following standards:
2
- 사 IEC 60601-1:1998, Medical electrical equipment -- 2nd Ed. plus amendments 1 and 2 - also representing UL60601-1, EN60601-1, CSA C22.2 No. 60601-1 except for national deviations.
- IEC 60601-1-1: 2000, Medical Electrical Equipment Part 1-1 General Requirements faor Safety . - Collateral Standard: Safety Requirements for Medical Electrical Systems.
- IEC 60601-1-2: 2005, Medical Electrical Equipment -- Part 1-2 General Requirements for Safety 포 - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-1-4: 2000, Medical Electrical Equipment Part 1-4 Medical electrical equipment -. Part 1-4: General requirements for safety - Collateral Standard: Programmable electively systems.
- 트 IEC60601-1-6: 2004, Medical electrical equipment - Part 1-6: General requirements for safety -Collateral standard: Usability.
- IEC60601-1-8: 2005, Medical electrical equipment Part 1-8: General requirements for safety - 미 Collateral standard: General requirements, tests and guidance for salam systems in medical electrical equipment and medical electrical systems.
-
IEC 60601-2-2: 2006, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
L. Subject vs. Predicate Device
The subject device(s) are of the same inherent technology and construction as the predicate devices. The chasis and the bezel for the devices are essentially the same dimensionally and are fabricated from the same materials. The subject devices have a universal power supply not found in the predicate devices.
Performance characteristics of the subject devices are equivalent to the subject devices and have been verified to meet the requirements above as well as performance requirements defined in design inputs. Design verification and validation activities demonstrated the subject devices to be equivalent where applicable to the predicate devices.
Specific differences between the subject and predicate devices are found in the substantial equivalence table.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
ConMed Electrosurgery % Mr. Shawn Riedel Vice President of Quality Assurance and Regulatory Affairs 14603 East Fremont Avenue Centennial, Colorado 80112
FEB 1 6 201
Re: KI03665
Trade Name: CONMED® Sabre Genesis™ Electrosurgical Generator CONMED® HyfreSurg™ OP Electrosurgical Genertaor Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 1, 2010 Received: December 16, 2010
Dear Mr. Riedel:
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
.
4
Page 2 - Mr. Shawn Riedel
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
A. B. R
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: CONMED® Sabre Genesis™ Electrosurgical Generator CONMED® HyfreSurg™OP Electrosurgical Generator
Indications for Use:
... ...
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
12n-C Division of Surgical, Orthopedic, and Restorative Devices
Page of of
510(k) Number K103665