(530 days)
JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.
The document is an FDA 510(k) clearance letter for the "JETT PLASMA Medical II" device. It primarily discusses:
- The FDA's determination of substantial equivalence to a predicate device.
- Regulatory requirements the manufacturer must follow.
- The indications for use of the device: "removal and destruction of skin lesions and coagulation of tissue."
It does not include:
- A table of acceptance criteria or reported device performance metrics.
- Details on specific studies, sample sizes, data provenance, or ground truth establishment.
- Information about expert adjudication, MRMC studies, or standalone algorithm performance.
To provide the information you've requested, I would need a different type of document, such as a clinical study report, a performance validation report, or a summary of safety and effectiveness from the 510(k) submission itself (which often contains more technical details than the clearance letter).
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March 14, 2023
Compex, Spol. s.r.o % Robert Packard President Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K213247
Trade/Device Name: JETT PLASMA Medical II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: QVJ Dated: September 29, 2021 Received: September 30, 2021
Dear Robert Packard:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm product submissions. 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,
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including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| MarkTrumbore -S | Digitally signed byMark Trumbore -SDate: 2023.03.1410:37:09 -04'00' |
|---|---|
| Mark W. Trumbore, Ph.D. | |
| Assistant Director | |
| DHT4A: Division of General Surgery Devices | |
| OHT4: Office of Surgical | |
| and Infection Control Devices | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health |
Enclosure
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Indications for Use
510(k) Number (if known) K213247
Device Name JETT PLASMA Medical II
Indications for Use (Describe)
JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.
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.