(294 days)
Regenesis Model 42
Not Found
No
The description focuses on hardware components, power delivery, and infection control via RFID. There is no mention of algorithms, data processing for decision making, or any features typically associated with AI/ML.
Yes
The device is intended for the "palliative treatment of postoperative pain and edema," which clearly indicates a therapeutic purpose.
No
The "Intended Use / Indications for Use" states that the device is for "palliative treatment of postoperative pain and edema," which describes a therapeutic function, not a diagnostic one.
No
The device description explicitly details hardware components including a Control Unit, Treatment Applicator, and Disposable Applicator Covers, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue." This describes a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system that delivers energy to the body via a Treatment Applicator. This is consistent with a therapeutic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
The device is clearly intended for direct application to the patient's body for treatment purposes.
N/A
Intended Use / Indications for Use
The Provant System is intended for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
ILX
Device Description
Much like the predicate Regenesis Model 42 device, the new Provant System 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 predicate Provant System contains the same components.
The Control Unit for the Provant 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 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 its 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 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)
Bench testing data demonstrates that the technological differences between the Provant System and its predicate do not raise new questions of safety or effectiveness. These data also demonstrate that the Provant System delivers the same amount of energy to the subject and is therefore as safe and as effective as its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Regenesis Model 42
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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:
While the device submitted and cleared through K091791 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus. The caduceus is depicted as a stylized bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Regenesis Biomedical, Inc. % Mr. William H. Ouirk 755 East Mulberry Avenue Suite 200 San Antonio, TX 78212
Re: K091791
Trade/Device Name: Provant System Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: III Product Code: ILX Dated: April 1, 2010 Received: April 6, 2010
APR 0 7 2010
Dear Mr. Quirk:
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. Iisting 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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Indications for Use
510(k) Number (if known): K091791
Device Name: Provant System
INDICATIONS FOR USE:
The Provant System is intended for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091791
3
510(k) Summary
.
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Regenesis Biomedical, Inc. |
| Contact Person | William H. Quirk
755 E. Mulberry, Suite 200
San Antonio, Texas 78212
(210) 240-9881 |
| Date Prepared | 10 June 2009 |
| Product Name | Provant System |
| Common Name | Short-wave diathermy device |
| Device
Classification | Class III |
| Predicate
Device(s) | Regenesis Model 42 |
| Performance
Standards | Performance standards have not been established by the FDA under section
514 of the Federal, Food, Drug and Cosmetic Act. |
| Device
Description | Much like the predicate Regenesis Model 42 device, the new Provant System
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 predicate Provant
System contains the same components.
The Control Unit for the Provant 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 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. |
| Device
Description
(continued) | 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 its 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 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. |
| Indications for
Use | The Provant System and its predicate are both intended for adjunctive use in
the palliative treatment of postoperative pain and edema in superficial soft
tissue. |
| Technological
Characteristics | Both the Provant System and the predicate device use shortwave radio
frequency energy to treat postoperative superficial pain and edema. The
proposed Provant System has similar features and
technological
characteristics as the predicate. |
| Nonclinical
Performance | Bench testing data demonstrates that the technological differences between
the Provant System and its predicate do not raise new questions of safety or
effectiveness. These data also demonstrate that the Provant System delivers
the same amount of energy to the subject and is therefore as safe and as
effective as its predicate. |
| Clinical Data | Although the reusable portions of the Provant System have extensive clinical
experience, this 510(k) Notice does not rely upon clinical data. |
| Conclusion | The Provant System and the predicate device have the same intended use and
similar technological characteristics. The results of bench testing further
demonstrate that the Provant System does not raise any new questions of
safety or effectiveness as compared to its predicate device.
Thus. the
Provant System is substantially equivalent to its predicate device. |
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