(256 days)
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No
The provided text describes a multi-modality therapy system using electrical stimulation and ultrasound for various physical therapy indications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical modalities and their intended uses.
Yes
The device is used for therapeutic purposes, as evidenced by its indications for use, which include pain relief, muscle re-education, prevention of disuse atrophy, and increased circulation.
No
The provided text lists indications for use that are therapeutic (e.g., pain relief, muscle relaxation, increasing range of motion), not diagnostic (i.e., identifying or determining the nature of a disease or condition).
No
The device description is not provided, but the intended use clearly describes a "Stimulator" and "Ultrasound Transducer(s)," which are hardware components. The summary does not indicate that the device is solely software controlling existing hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device function: The provided text describes a system that uses electrical stimulation and ultrasound therapy applied directly to the patient's body for therapeutic purposes (muscle relaxation, pain relief, increasing range of motion, etc.).
- No mention of specimen analysis: There is no indication that this device analyzes any biological specimens.
Therefore, based on the provided information, this device falls under the category of therapeutic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use:
- · Relaxation of muscle spasms
- · Re-education of muscle
- · Prevention or retardation of disuse atrophy
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Increases local circulation
- · Maintains or increases range of motion
Stimulator waveforms: IFC, LVPC, and VMS:
· Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury.
Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use:
- Relieves pain
- · Decreases joint stiffness and contractures
- · Reduction of muscle spasm
- · Increases local circulation
- · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues
- · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring
Product codes
IMG, IPF, GZJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz 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. The device also passes electrical currents through the body area to stimulate or relax muscles.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Accelerated Care Plus (ACP) Patrick Parker VP of Biomedical Operations and QA, FDA Official Correspondent For ACP 4999 Aircenter Circle. Ste. 103 Reno, Nevada 89502
Re: K153559
Trade/Device Name: OmniVersa™ Multi-Modality Therapy System Omnistim® FX2 Professional Therapy System Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and Muscle Stimulator Regulatory Class: Class II Product Code: IMG, IPF , GZJ Dated: July 14, 2016 Received: July 26, 2016
Dear Mr. Parker:
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
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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 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.
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 yours,
Michael J.Hoffmann -A
- for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153559
Device Name
OmniVersa™ Multi-Modality Therapy System Omnistim® FX2 Professional Therapy System
Indications for Use (Describe)
The OmniVersa™ Multi Modality Therapy and Omnistim® FX2 Professional Therapy Systems by ACP use the Omnistim® FX2 Stimulator for the following indications for use:
- · Relaxation of muscle spasms
- · Re-education of muscle
- · Prevention or retardation of disuse atrophy
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Increases local circulation
- · Maintains or increases range of motion
Stimulator waveforms: IFC, LVPC, and VMS:
· Symptomatic relief and management of chronic intractable pain and as an adjunctive treatment of acute pain, post-surgical pain and pain associated with post-traumatic injury.
Electrical muscle stimulator devices should be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The OmniVersa™ Multi-Modality Therapy System also uses Omnisound® Ultrasound Transducer(s) for the following indications for use:
- Relieves pain
- · Decreases joint stiffness and contractures
- · Reduction of muscle spasm
- · Increases local circulation
- · Relief of pain, muscle spasms, and joint contractures that may be associated with: adhesive capsultiis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons due to past injuries and scar tissues
- · Relief of sub-chronic, chronic pain and joint contractures resular tightness, capsular scaring
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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