(9 days)
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.
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.
The provided document is a 510(k) premarket notification for the CONMED System 7500-B ESU and ABCFlex™ Probe. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria studies, such as:
- A table of acceptance criteria and reported device performance (in the sense of a clinical outcome study).
- Sample sizes used for test sets, data provenance, ground truth establishment, or expert qualifications.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Training set details.
Instead, the submission relies on demonstrating technological characteristics equivalency and compliance with recognized standards to establish substantial equivalence.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in the form of performance metrics from a clinical study or a table demonstrating specific clinical outcomes. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by:
- Compliance with recognized voluntary standards:
- ANSI/AAMI American National Standard for Electrosurgical Devices HF-18
- International Electrotechnical Commission Standard for Electrosurgical Devices (IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-2-2)
- ISO 11135 (for sterilization)
- ISO 10993 (for biocompatibility)
- Demonstration of substantial equivalence to a predicate device:
The reported device performance is implicitly that the device functions according to its intended use (destruction of human tissue, non-contact superficial ablation, and hemostasis) and meets the safety and performance requirements outlined in the above standards, making it substantially equivalent to the cleared predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was a 510(k) submission demonstrating substantial equivalence through technological characteristics and compliance with standards, not typically clinical performance studies with "test sets" in the context of AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment for test sets is not detailed as this submission doesn't describe clinical performance studies with human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrosurgical unit, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" would relate to engineering specifications, electrical performance, biocompatibility, and sterilization effectiveness as verified against the recognized standards, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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| Submitted by: | CONMED Electrosurgery Division14603 East Fremont AvenueCentennial, CO 80112 USATelephone: 303-699-7600Facsimile: 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-1998ABC ® 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.
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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.
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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
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| 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
§ 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.