(392 days)
The CONMED ABC D-Flex Probes are intended for use with a CONMED ABC Generator for delivery of argon gas and electrosurgical current for non-contact ablation and hemostasis at the operative site. The ABC D-Flex Probes are indicated for use during general, urological, and gynecological laparoscopic surgical procedures when manipulated by CONMED manual laparoscopic graspers or similar manual instruments.
CONMED ABC® D-Flex Probes™ are monopolar, electrosurgical devices indicated for non-contact ablation and hemostasis of the operative site in laparoscopic surgery. The CONMED ABC® D-Flex Probes™ are composed of a catheter tube, ceramic tip, the D-Flex attachment, insufflation seal, and a shrink tube. The CONMED ABC® D-Flex Probes™ are provided sterile for single use only and are controlled by the appropriate ABC® footswitch used in conjunction with compatible CONMED ABC generators.
The ABC® D-Flex Probes™ are intended for use with a CONMED ABC® Generator for delivery of argon gas and electrosurgical current for non-contact ablation and hemostasis at the operative site. The probes should be used with a maximum output of 6.5kV at a power setting of 80W.
The provided document is a 510(k) summary for the CONMED ABC D-Flex Probes, an electrosurgical device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information related to specific acceptance criteria for diagnostic performance (such as sensitivity, specificity, accuracy), nor does it describe a study involving human readers, ground truth establishment by experts, or sample sizes related to AI performance evaluation.
The "Performance Data" section (Section I) refers to:
- Compliance with standards: AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-2-2:2009, ANSI/AAMI ST67:2011, and ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation). These are general safety, essential performance, and biocompatibility standards, not diagnostic performance metrics.
- Benchtop verification testing: Grasping, release, manipulation, axial pull force, and argon flow.
- Functionality testing: Beam initiation, non-contact ablation, and reliability.
- Ex-vivo comparison testing: Assessment of thermal spread depth at comparable power settings.
These tests are designed to demonstrate the physical and functional aspects of the electrosurgical device itself, not an AI or diagnostic algorithm. Therefore, I cannot extract the requested information in the format provided, as it is not present in the document.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy (e.g., sensitivity, specificity).
- Sample sizes for test sets or data provenance for an AI study.
- Number or qualifications of experts used for establishing ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Results from a standalone (algorithm only) performance study.
- Type of ground truth used for AI-related evaluation.
- Sample size for a training set.
- How ground truth for a training set was established.
This document pertains to the regulatory clearance of a physical medical device (electrosurgical probes) based on established electrical safety, biocompatibility, and functional performance, rather than the evaluation of a diagnostic AI system.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
CONMED Corporation Ms. Lisa Anderson Regulatory Affairs Specialist 525 French Road Utica, New York 11502
Re: K151229
Trade/Device Name: ABC D-Flex Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 22, 2015 Received: December 24, 2015
Dear Ms. Anderson:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151229
Device Name
ABC D-Flex Probes
Indications for Use (Describe)
The CONMED ABC D-Flex Probes are intended for use with a CONMED ABC Generator for delivery of argon gas and electrosurgical current for non-contact ablation and hemostasis at the ABC D-Flex Probes are indicated for use during general, urological and gynecological laparoscopic surgical procedures when manipulated by CONMED manual laparoscopic graspers or similar manual instruments.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
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510(k) Summary of Safety and Effectiveness
CONMED ABC® D-Flex Probes™
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. CONMED Corporation is hereby submitting the 510(k) Summary for 510(k) number K151229 as of June 1, 2016.
A. Submitter
CONMED Corporation 525 French Road Utica, N.Y. 13502 Registration Number: 1320894
B. Company Contact
Lisa Anderson Manager, Regulatory Affairs CONMED Corporation 525 French Road Utica, N.Y. 13502 Phone: 315-624-3371 Fax: 315-624-3225 Email: lisaanderson@conmed.com
C. Device Name
Trade Name: CONMED ABC® D-Flex™ Probes Common Name: ABC® Flexible Laparoscopic Probes Classification Name: Electrosurgical cutting and coagulation device and accessories
D. Predicate Device
Laparoscopic 5mm ABC Probe, K925903 Birtcher Medical Systems acquired by CONMED Corporation Product Code: GEI Requlation Number: 878.440
Reference Device: CONMED ABC Flex Probes, K050161 Omniguide Laser System with FlexGuide Ultra, K140378
E. Device Description
CONMED ABC® D-Flex Probes™ are monopolar, electrosurgical devices indicated for non-contact ablation and hemostasis of the operative site in laparoscopic surgery. The CONMED ABC® D-Flex Probes™ are composed of a catheter tube, ceramic tip, the D-
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Flex attachment, insufflation seal, and a shrink tube. The CONMED ABC® D-Flex Probes™ are provided sterile for single use only and are controlled by the appropriate ABC® footswitch used in conjunction with compatible CONMED ABC generators.
The ABC® D-Flex Probes™ are intended for use with a CONMED ABC® Generator for delivery of argon gas and electrosurgical current for non-contact ablation and hemostasis at the operative site. The probes should be used with a maximum output of 6.5kV at a power setting of 80W.
The Laparoscopic 5mm Argon Beam Coagulation (ABC) Probe is intended to be used through a 5 millimeter (mm) laparoscopic trocar sleeve for coagulation and tissue desiccation only: this device will not cut or dissect tissue. The Laparoscopic ABC Probe is indicated for use only in situations where you would normally use monopolar energy.
Both the proposed and predicate devices are equivalent in their intended use for noncontact ablation and hemostasis, and utilize the same method of access via a cannula to the surgical site.
F. Intended Use of Device / Indications for Use
The ABC® D-Flex Probes are intended for use with a CONMED ABC® Generator for delivery of argon gas and electrosurgical current for non-contact ablation and hemostasis at the operative site. The ABC® D-Flex Probes are indicated for use during general, urological, and gynecological laparoscopic surgical procedures when manipulated by CONMED manual laparoscopic graspers or similar manual instruments.
H. Technological Characteristics
The proposed devices are equivalent to the predicate devices in their technological characteristics and performance. Both are designed for use with electrosurgical generators with ABC and monopolar high frequency current.
Both devices are designed to be activated using a foot control and to be used thru a laparoscopic cannula. However, the ABC D-Flex Probes are designed to be held by manual laparoscopic instruments compared to the Laparoscopic 5mm ABC probes which are hand-held devices.
l. Performance Data
Both devices are designed to comply with AAMI / ANSI ES60601-1:2005/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-2-2:2009, and ANSI/AAMI ST67:2011. Materials analysis demonstrates the ABC® D-Flex Probe™ materials comply with the requirements of ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices Evaluation and Testing within a Risk Management Process. Benchtop
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verification testing included grasping, release, manipulation, axial pull force, and argon flow. Functionality testing included beam initiation, non-contact ablation, and reliability. Ex-vivo comparison testing included an assessment of thermal spread depth at comparable power settings. The test results demonstrate the ABC® D-Flex Probes™ are safe and effective for their intended use and are substantially equivalent to the predicate devices.
J. Substantial Equivalence
The differences between the predicate device and the proposed device do not raise any new issues of safety or efficacy. Supporting documentation per this premarket submission confirms that ABC® D-Flex Probes™ are substantially equivalent in design, manufacturing materials, intended use, principals of operation, and technical characteristics to the Laparoscopic 5mm ABC Probes.
§ 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.