(239 days)
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Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, or related concepts. The description focuses solely on the therapeutic application of ultrasound for specific medical conditions.
Yes
The device is described as being used for "application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions," indicating its purpose is therapeutic.
No
The "Intended Use / Indications for Use" section describes the device's purpose as applying "therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions" to relieve pain, muscle spasms, and joint contractures. This describes a therapeutic, not a diagnostic, function.
No
The provided text only describes the intended use of an ultrasound device for therapeutic deep heat. It lacks any description of the device itself, making it impossible to determine if it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the application of therapeutic deep heat for treating various medical conditions. This is a therapeutic application, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
The information provided clearly indicates a device used for physical therapy or pain relief, which falls under the category of therapeutic medical devices, not IVDs.
N/A
Intended Use / Indications for Use
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
-
Relief of pain, muscle spasms and joint contractures
-
Relief of pain, muscle spasms and joint contractures that may be associated with:
a) Adhesive capsulitis
b) Bursitis with slight calcification
c) Myositis
d) Soft tissue injuries
c) Shortened tendons due to past injuries and scar tissues
- Relief of sub-chronic and chronic pain and joint contractures resulting from:
a) Capsular tightness
b) Capsular scarring
Product codes
IMI
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): 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.
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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.
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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).
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§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy 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.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy 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 that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues 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 ultrasonic diathermy 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 ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Mr. Mick Davis Regulatory Analyst Chattanooga Group A Division of Encore Medical 4717 Adams Road P.O. Box 489 Hixson, Tennessee 37343-0489
Re: K031116
Trade Name: Vectra (Intelect) Genisys Ultrasound Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: September 9, 2003 Received: September 10, 2003
Dear Mr. Davis:
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 10 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 adultcration.
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Mick Davis
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse organ finding of substantial equivalence of your device to a legally premaince hotmeation "The elassification 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 If you dosire specific acreoliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.hunl
Sincerely yours,
Sincerely yours,
Mark N Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K031116
Vectra (Intelect) Genisys Ultrasound Device Name:
For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
-
Relief of pain, muscle spasms and joint contractures
-
Relief of pain, muscle spasms and joint contractures that may be associated with:
a) Adhesive capsulitis
b) Bursitis with slight calcification
c) Myositis
d) Soft tissue injuries
c) Shortened tendons due to past injuries and scar tissues
- Relief of sub-chronic and chronic pain and joint contractures resulting from:
a) Capsular tightness
b) Capsular scarring
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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