(654 days)
Not Found
No
The summary describes a shortwave diathermy device that applies RF energy. There is no mention of AI, ML, image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is described as an "adjunctive use in the palliative treatment of post-operative pain and edema," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The description explicitly states its intended use is for "palliative treatment of post-operative pain and edema," which are therapeutic applications, not diagnostic ones. It applies electromagnetic energy for treatment, not for identifying a condition or disease.
No
The device description explicitly states that the SofPulse devices are "shortwave diathermy medical devices" that "apply to the body electromagnetic energy" via "inductive coupling with an applicator coil." This indicates the presence of hardware components that deliver energy to the patient, making it a hardware device, not software-only.
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 post-operative pain and edema in superficial soft tissue." This describes a therapeutic treatment applied directly to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "shortwave diathermy medical device" that applies "electromagnetic energy" to the body. This is a physical therapy modality, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to treat symptoms (pain and edema) directly on the patient.
N/A
Intended Use / Indications for Use
Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
ILX
Device Description
SofPulse (912-M10, Roma3 and Torino II) devices are shortwave diathermy medical devices which apply to the body electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The SofPulse models were designed to deposit mean radio frequency energy in tissue which is equivalent to that of the predicate MRT device. All of the SofPulse options deliver the RF signal to the tissue farget via inductive coupling with an applicator coil. SofPulse devices are portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.
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
Prescription Use
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)
Equivalence of performance of the SofPulse and MRT was demonstrated with bench testing in saline tissue equivalents and with an animal model validated for evaluation of pain and edema.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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 K070541 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2008
Ivivi Technologies % Andre DiMino 224 Pegasus Avenue. Northvale, New Jersey 07647
Re: K070541
Trade Name: Ivivi Sofpulse, Models 912-M10, Roma3, and Torino II Regulatory Class: III Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Product Code: ILX Dated: November 6, 2008 Received: November 7, 2008
Dear Mr. DiMino:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 mav 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
2
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nilthe. Oglun
Mark Melkerson, M.S Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K070541
Device Name: Ivivi Sofpulse, Models 912-M10, Roma3, and Torino II
Indications For Use:
Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Page 1 of ______ |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K070541 |
4
Image /page/4/Picture/0 description: The image shows a handwritten sequence of characters. The sequence appears to be 'K070541'. The characters are written in a simple, somewhat crude style, with varying stroke thicknesses. The image has a white background.
Image /page/4/Picture/1 description: The image shows the logo for IVIVI, which includes the text "IVIVI" in large, bold letters. Above the text, there is a circle containing two dots, and a single dot is placed above each of the two "I" letters. Below the main text, the phrase "THE TECHNOLOGY OF LIFE" is written in a smaller font size. The logo has a simple, clean design with a focus on the company name and its tagline.
lvivi Technologies, Inc.
224-S Pegasus Avenue, Northvale, NJ 07647 201-784-8168 FAX 201-784-0620 www.ivivitechnologies.com
DEC 1 1 2008
Premarket Notification [510(k)] Summary
Date Prepared: December 9, 2008
Trade Name: Ivivi SofPulse: Models 912-M10, Roma3 and Torino II
Common Name: Shortwave Diathermy
Classification Name: Shortwave diathermy for all other uses (per 21 CFR Section 890.5290(b)); Product Code ILX (Diathermy, shortwave, for use other than applying therapeutic deep heat)
| Manufacturer's Name: | IVIVI, TECHNOLOGIES, INC. |
|---|---|
| Address: | 224-S Pegasus Avenue |
| Northvale, New Jersey 07647 | |
| Corresponding Official: | Mr. Andr é DiMino |
| Title: | Executive Vice President |
| Title: | Executive Vice Pres |
|---|---|
| Telephone: | 201-767-6040 |
| Fax: | 201-784-0620 |
Predicate Device: MRT (K903675), Product ,Code: ILX (per 21 CFR Section 890.5290(b))
Device Description: SofPulse (912-M10, Roma3 and Torino II) devices are shortwave diathermy medical devices which apply to the body electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The SofPulse models were designed to deposit mean radio frequency energy in tissue which is equivalent to that of the predicate MRT device. All of the SofPulse options deliver the RF signal to the tissue farget via inductive coupling with an applicator coil. SofPulse devices are portable and treatment can occur directly through dressings, clothing, casts, compression garments or supports.
Intended Use/Indications For Use: Adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
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Technological Characteristics:
| Device | MRT (K903675) | SofPulse (K070541) |
|---|---|---|
| Underlying Technology | ||
| [ILX/890.5290(b)] | Deposit athermal RF | |
| energy in tissue | Deposit athermal RF | |
| energy in tissue | ||
| How Energy Deposited | Induction (coil applicator) | Induction (coil applicator) |
| Non-thermal | Yes | Yes |
| Risk | Low | Negligible |
| (via Risk Analysis) | ||
| Carrier Frequency | 27.12 MHz | 27.12 MHz |
| Mean Duty Cycle | 2.3% | 2.5% |
| Energy Deposited Per Pulse | 6.8 $\mu$ Ws/cm3 | 6.5 $\mu$ Ws/cm3 |
| Treatment Duration | 5 - 30 min | 5 - 30 min |
| Battery/Mains Power | Mains only | Battery or Mains |
| Portable | Yes | Yes |
The SofPulse models have the same intended use/indications for use and safety characteristics as the predicate device. Equivalence of performance of the SofPulse and MRT was demonstrated with bench testing in saline tissue equivalents and with an animal model validated for evaluation of pain and edema.