(150 days)
Unify Multifunction Energy Platform and Unify Cart: The CONMED UNIFY is indicated for surgical procedures for the cutting and/or coagulation of tissue when hemostasis is desired. This generator can be used with compatible resectoscopes for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. This generator, when used with compatible vessel sealing devices, is indicated for the ligation and division of tissue bundles, lymphatics, and vessels in open and laparoscopic procedures. Reference instructions for use (IFU) for applicable vessel sealing devices. The vessel sealing function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.
CleanSeal Vessel Sealers: CONMED CleanSeal Vessel Sealers are intended to be used in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 7 mm vessels (arteries and veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, and vascular. These procedures include, but are not limited to, hysterectomies, oophorectomies, colectomies, Nissen fundoplication, and adhesiolysis. The CleanSeal Vessel Sealer has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CleanSeal Vessel Sealer for these procedures.
Unify Bipolar Resection Cables: The ConMed UNIFY Bipolar Resection Cables are used to connect compatible accessories to the ConMed UNIFY ESU. UNIFY Bipolar Resection Cables are used in conjunction with the Bipolar Resection capabilities of the UNIFY ESU for the removal or coagulation of tissue in 0.9% NaCl solution as the irrigation medium. The ConMed UNFY Bipolar Resection Cables are intended for use with only compatible resectoscopes (refer to Compatibility for details). Maximum rated voltage 750 V.
Unify Wireless Footswitch: The Wireless Footswitch Kit is intended for use with the ConMed UNIFY™ Advanced Energy Generator for the operation of foot-controlled RF devices.
The Unify Multifunction Energy Platform (Unify MEP) is composed of an electrosurgical generator (Unify ESU) with CleanSeal Technology and CleanSeal Vessel Sealing handpieces. The Unify generator is designed with a touchscreen graphic user interface (GUI) display which allows the user to select monopolar and bipolar modes of operation, choose power settings, adjust user settings options, and create, edit, or delete user programs. The Unify ESU is designed for enhanced control of bleeding and for the electrosurgical destruction of the tissue in multispecialty procedures in the operating room or endoscopy suite. This equipment, in conjunction with connected accessories, is intended to produce high-frequency electrical energy for the controlled destruction of tissue. The CleanSeal Vessel Sealers are designed to seal vessels up to and including 7mm vessels, tissue bundles, and lymphatics. Unify Bipolar Resection Cables are provided to connect between Unify ESU and compatible resectoscopes.
This is not an AI/ML device, so much of the requested information to describe the acceptance criteria and study proving the device meets the criteria is not applicable. The provided text describes a 510(k) premarket notification for an electrosurgical device, which is not an AI/ML product. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing, biocompatibility, and a chronic animal study.
Here's a breakdown of the relevant information from the document as it pertains to the device's validation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the performance testing by stating:
"The Unify MEP has been tested according to the applicable requirements listed in FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' and 'Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery'. Benchtop and ex-vivo comparison testing, in-vivo simulated use testing, and chronic animal studies support that the ConMed Unify MEP is substantially equivalent to the ConMed HelixAR and Valleylab FT10 Electrosurgical Generators in intended use, technology, and system performance."
"Mechanical and electrical verification activities and software validation demonstrate the Unify Multifunction Energy Platform complies with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-1-2, and IEC 62304. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Unify Multifunction Energy Platform are mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the Unify MEP outweigh the residual risks."
The document also provides specific biocompatibility test endpoints and methods, with the reported performance being that the device "met the acceptance criteria":
| Test Endpoint | Test Method | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity | Met acceptance criteria |
| Intracutaneous Irritation | ISO 10993-10: 2010 Standard, Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization. | Met acceptance criteria |
| Sensitization | ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization. | Met acceptance criteria |
| Acute Systemic and Material Mediated Pyrogenicity | ISO 10993-11: 2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity. | Met acceptance criteria |
For the chronic animal study, the performance criterion was effective sealing of treated vessels, and the reported performance was:
"After 21 days in the porcine model, the treatment of vascular structures (i.e., arteries, veins, and arterio-venous [A/V] bundles) with the ConMed Unify ESU with the CleanSeal 5mm Maryland vessel sealing hand piece was determined to result in the effective sealing of treated vessels."
2. Sample Size Used for the Test Set and Data Provenance:
- Chronic Animal Study: "porcine model" is specified. The exact number of animals or sealed vessels is not provided, but it is an in-vivo prospective study.
- Benchtop and ex-vivo comparison testing, in-vivo simulated use testing: The document mentions these tests were conducted but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
- Biocompatibility Testing: The number of samples tested for biocompatibility is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as this is not an AI/ML device that requires expert-established ground truth on a test set. The validation relies on technical specifications, ex-vivo, in-vivo, and animal studies.
4. Adjudication Method:
Not applicable, as this is not an AI/ML device requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable, as this is not an AI/ML device that assists human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable, as this is not an AI/ML device. The device itself is the "standalone" product being tested. The studies evaluate the performance of the electrosurgical unit and its accessories.
7. Type of Ground Truth Used:
- Functional Ground Truth: For the chronic animal study, the "ground truth" was the observed effective sealing of treated vessels after 21 days in the porcine model, which is an outcomes-based ground truth in an animal model.
- Compliance with Standards: For mechanical, electrical, and software validation, the "ground truth" is adherence to recognized industry standards (AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 62304, ISO 14971) and FDA guidance for electrosurgical devices.
- Biocompatibility: Adherence to ISO standards (ISO 10993-5, -10, -11).
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device that uses a "training set."
§ 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.