(9 days)
Not Applicable
No
The description focuses on electrosurgical and argon beam coagulation technology, with no mention of AI or ML capabilities.
Yes
The "Intended Use" section explicitly states that the device is "used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit."
No
The device is described as being used for "destruction of human tissue in surgical procedures to provide a therapeutic benefit" and for "non-contact superficial ablation and hemostasis." It is an electrosurgical generator used for cutting, coagulation, and argon beam coagulation, with the purpose of treating tissue, not diagnosing conditions.
No
The device description clearly outlines hardware components including an electrosurgical generator, an Argon Beam Coagulation (ABC) capability, an ABCFlex™ Probe with a connector, internal cable, tungsten electrode tip, ceramic tip, and a switching element. These are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "destruction of human tissue in surgical procedures to provide a therapeutic benefit." This describes a surgical intervention performed directly on the patient's body for treatment.
- Device Description: The device is an "electrosurgical generator with Argon Beam Coagulation (ABC) capability" used to apply electrosurgical current and argon gas to tissue. This is a therapeutic device used during surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly designed for direct surgical intervention and therapeutic treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFlex™ Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.
Product codes
GEI
Device Description
The System 7500 -B is an electrosurgical generator with Argon Beam Coagulation (ABC) capability. The basic modes of operation are conventional electrosurgical cutting, coagulation plus argon beam coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode or argon beam 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 ABCFlex™ Probe has applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas. The device consists of a connector for delivering argon gas to the operative site as well as an internal cable to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during the coagulation procedure. Current and gas flow is controlled by the surgeon activating and deactivating a switching element part of the System 7500 -B ESU.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
| Submitted by: | CONMED Electrosurgery Division
14603 East Fremont Avenue
Centennial, CO 80112 USA
Telephone: 303-699-7600
Facsimile: 303-699-9854 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pamela L. Vetter |
| Date Prepared: | January 24, 2005 |
| Proprietary Name: | System 7500 ® -B ESU and ABCFlex ™ Probe |
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories (21 CFR 878.4400)
79 GEI |
| Predicate Device: | System 7500 ® Electrosurgical Unit, K981220, cleared 27-April-1998
ABC ® Probe for Flexible Endoscopes, K990586, cleared 17-May-1999 |
K 050161
Summary of Safety and Effectiveness
Device Description: The System 7500 -B is an electrosurgical generator with Argon Beam Coagulation (ABC) capability. The basic modes of operation are conventional electrosurgical cutting, coagulation plus argon beam coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode or argon beam 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 ABCFlex™ Probe has applications in endoscopic surgical procedures such as upper and lower gastroenterology and bronchoscopy to provide a means of coagulation using electrosurgical current and argon gas. The device consists of a connector for delivering argon gas to the operative site as well as an internal cable to carry high frequency (HF) electrosurgical current to a tungsten electrode tip at the end of the tubing. A ceramic tip insulates the thermal plastic tubing from the heat generated during coagulation. The electrode is positioned in the ceramic tip such that it cannot contact the patient's tissue during the coagulation procedure. Current and gas flow is controlled by the surgeon activating and deactivating a switching element part of the System 7500 -B ESU.
Intended Use of Device: The System 7500 -B is used for the destruction of human tissue in surgical mended OSE of Device. The Oystem 7000 - B is about the BBCFlex™ Probe is intended for use with the System 7500 -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.
Technological Characteristics: The proposed devices are equivalent to the identified predicate devices with respect to technological characteristics and function. The devices have been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-2, Sterilization of health care products -Requirements for validation and routine control of Ethylene Oxide Sterilization, ISO 11135 and Biocompatibility, ISO 10993.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
FEB - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Pamela Vetter Manager of Regulatory Affairs Conmed Electrosurgery 14603 E. Fremont Avenue Centennial, Colorado 80112
Re: K050161
K050161
Trade/Device Name: System 7500® -B Electrosurgical Unit and ABCFlex™ Probe Regulation Number: 21 CFR 878.4400 Regulation Number. 21 CFX 876. 1788
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 24, 2005 Received: January 25, 2005
Dear Ms. Vetter:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained is substantially equivalent (for the indications
referenced above and have determined the device merketed in interstate referenced above and have decembiled the arrested predicate devices marketed in interstate for use stated in the enclosure) to regary manced promoted in the Federal Food. Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Dr commerce prior to May 28, 1970, the enactions of the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMA devices that have been reclassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the device, sucject to the general stars and segistration, listing of general controls provisions of the free necesses of the same of the misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it class III (PMA). it if your device is classified (sec above) nils existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controls. Extrong may - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - be found in the Code of Pederal Regarations)
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination costs of the Atl Please be advised that FDA s issuation of a bacewice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a determination that Jour are Federal agencies. You must or any Federal statutes and regulations and intel to: registration and listing (21 l comply with an the Act s requirements, mercesses, " CFR Part 807), labeling (21 CFR Part 800), god and fapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Ms. Pamela Vetter
This letter will allow you to begin marketing your device as described in your Section 510(k) This icticle witi anow you to begin mailing of substantial equivalence of your device to a legally premarket notineation: The PDF intembers on 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 If you desire specific acrice for your as (240) 276-0115. Also, please note the regulation entitled, Contact the Office of Compilancemarket notification" (21CFR Part 807.97). You may obtain Misolanding by reference to premainters within the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Marke A. Mellers
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| 510(k) Number (if known): | K050161 |
|---|---|
| --------------------------- | --------- |
Device Name:
Indications for Use:
The System 7500® -B is used for the destruction of human tissue in surgical procedures to provide a therapeutic benefit. The ABCFlex™ Probe is intended for use with the System 7500® -B for non-contact superficial ablation and hemostasis through a flexible endoscope to the operative site.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
—
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millmann
for
-1017) |
and Neurologi