(168 days)
No
The document describes a physical therapy system with a control unit and applicator, focusing on its similarity to a predicate device and the removal of a contraindication. There is no mention of AI or ML in the device description, intended use, or performance studies. The RFID tag is for infection control, not AI/ML functionality.
Yes
The device is indicated for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue," which describes a therapeutic purpose.
No
The device is indicated for "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue," which describes a therapeutic rather than a diagnostic function.
No
The device description explicitly details hardware components including a Control Unit, Treatment Applicator, and Disposable Applicator Covers, indicating it is not solely software.
Based on the provided information, the Provant Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the palliative treatment of postoperative pain and edema in superficial soft tissue. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system that applies therapy (likely some form of energy or stimulation, although the specific mechanism isn't explicitly stated) to the body. It does not involve analyzing samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample handling, or analysis of biological specimens.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The Provant Therapy System's function is to treat a condition, not to diagnose or analyze biological samples.
N/A
Intended Use / Indications for Use
The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
Product codes
ILX
Device Description
The Provant Therapy System is nearly identical to the previously cleared Provant System Model 4201 (cleared under K091791), except for the device labeling. Specifically, unlike the Provant System Model.4201, the Provant Therapy System does not include a contraindication for use in patients with metal implants. The device includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces for the patient. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant Therapy case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into a Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant Therapy System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superficial soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Provant Therapy System was tested using a validated tissue phantom with a variety of metal implants of different sizes, shapes and materials under worst case conditions (no dissipation of heat from circulation). No clinically significant rise in temperature of metal implants was noted. Retrospective analysis of the FDA MDR/MAUDE database, Regenesis and other industry complaint data from over 175,000 patients and over 3,000,000 treatments, and the medical literature demonstrates that heating from implanted metal is a theoretical risk with no actual reported adverse events. This information further supports removal of the metal implant contraindication and that use of the Provant Therapy without this contraindication is as safe and as effective as use of the predicate Provant System Model 4201.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
0
A final order reclassifying shortwave diathermy (SWD) intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here: https://www.federalregister.gov/documents/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-
diathermy-for-all-other-uses-henceforth-to
While the device submitted and cleared through K131979 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.
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Image /page/1/Picture/0 description: The image shows a logo with text and a symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around a symbol. The symbol consists of three curved lines that resemble a stylized caduceus or a representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service .
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2013
Regenesis Biomedical, Inc. Richard Isenberg, MD 5301 North Pima Road, Suite 150 Scottsdale, Arizona 85250
Re: K131979
Trade/Device Name: Provant Therapy System, Model 4201 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class III Product Code: ILX Dated: November 8, 2013 Received: November 12. 2013
Dear Dr. Isenberg:
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
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Page 2 - Dr. Richard Isenberg
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device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for Use
510(k) Number (if known): K131979
Device Name: Provant Therapy System
Indications For Use:
The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
Prescription Use __ X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)