(74 days)
The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.
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This document is a FDA 510(k) clearance letter for the joimax Endovapor 2, an electrosurgical device. It primarily focuses on regulatory approval and does not contain specific details about acceptance criteria, study data, or performance metrics in the way a clinical study report or a more detailed technical submission would.
Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.
Here's what can be stated based on the provided text:
- Device Name: joimax® Endovapor®2
- Regulation Number: 21 CFR 878.4400
- Regulation Name: Electrosurgical cutting and coagulation device and accessories
- Regulatory Class: Class II
- Product Code: GEI
- 510(k) Number: K170358
- Indications for Use: The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.
The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. This implies that the device met the necessary criteria for substantial equivalence, which typically involves demonstrating that the new device is as safe and effective as the predicate device. However, the specific technical or clinical performance data used to support this determination are not detailed in this clearance letter.
Therefore, I cannot provide the requested information for the following points as they are not present in the provided document:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance (This device is an electrosurgical tool, not an AI diagnostic device, so this is unlikely to apply in the traditional sense).
- If a standalone performance study (algorithm only without human-in-the-loop performance) was done (Again, this is not an AI diagnostic device).
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2017
Joimax Gmbh % Mr. Gary Mocnik Gary S. Mocnik and Associates 49 Coastal Oak Aliso Viejo, California 92656
Re: K170358
Trade/Device Name: joimax Endovapor 2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 1, 2017 Received: February 6, 2017
Dear Mr. Mocnik:
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 of medical devicerelated 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.
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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, Jennifer R. Stevenson -S 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) K170358
Device Name joimax® Endovapor®2
Indications for Use (Describe)
The joimax® Endovapor®2 RF device is intended for the generation of electrical power for monopolar and bipolar cutting and coagulation on tissue structures in surgical operations.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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.