(88 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or training/test sets for algorithms. The device description is for a standard therapeutic ultrasound.
Yes
The device is explicitly described as a "Therapeutic Ultrasound device" and "therapeutic ultrasound" in the intended use and device description sections, which indicates its purpose is for therapy.
No
This device is described as a "Therapeutic Ultrasound" for providing deep heating effects for the treatment of various conditions, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states "The XLTek Ultra V is a Therapeutic Ultrasound," which is a hardware device that emits ultrasound waves. The summary does not mention any software-only components or functions.
Based on the provided information, the Ultra V Therapeutic Ultrasound device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a therapeutic device that applies ultrasound energy to the body for the treatment of pain and contractures. This is a therapeutic application, not a diagnostic one.
- Device Description: It is described as a "Therapeutic Ultrasound."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Using reagents or assays.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ultra V device directly interacts with the body to provide therapy.
N/A
Intended Use / Indications for Use
The Ultra V Therapeutic Ultrasound device provides 1 and 3 MHz ultrasound therapy to provide deep heating effects for the treatment of pain and contractures associated with the chronic and sub-chronic conditions of:
- Adhesive capsulitis, bursitis, bursitis with slight calcification, and myositis.
- Soft tissue injuries and shortened tendons due to past injuries and scar tissue
- Joint contractures resulting from capsular tightness and scarring.
Product codes (comma separated list FDA assigned to the subject device)
IMG
Device Description
The XLTek Ultra V is a Therapeutic Ultrasound
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
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.
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
§ 890.5860 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.
0
Image /page/0/Picture/0 description: The image contains the logo for "XLTEK" in bold, stylized font. Below the logo, the text "510(k) NOTIFICATION OF A NEW DEVICE" is present, indicating the document's purpose. To the right of the logo is a circular symbol with a triangle inside.
Ultra V Therapeutic Ultrasound APRIL 7, 2000
Section E- 510(k) Summary
$\kappa001166$
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR § 807.92.
| Name: | Cameron Mahon
Director of R & D |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Excel Tech, Ltd.
2568 Bristol Circle
Oakville, Ontario
Canada, L6H 5S1 |
| Telephone: | (905) 829-5300 |
| Fax: | (905) 829-5304 |
| E-mail: | research@xltek.com |
| Common Names: | Therapcutic Ultrasound |
| Classification Name: | Stimulator, Ultrasound and Muscle, for use in
applying Therapeutic Deep Heat |
| Predicate Devices: | Excel Tech Ultra Max [510(k) K944065,
formerly called Ultra SX]. |
| Description: | The XLTek Ultra V is a Therapeutic Ultrasound |
| Substantial Equivalence: | The Ultra V is similar in design and function to
the Excel Tech Ultra SX [510(k) K923076, also
known as the Ultra Max]. |
| Indications for Use: | The Ultra V Therapeutic Ultrasound device
provides 1 and 3 MHz ultrasound therapy to
provide deep heating effects for the treatment of
pain and contractures associated with the chronic
and sub-chronic conditions of: |
| | Adhesive capsulitis, bursitis, bursitis with
1.
slight calcification, and myositis.
Soft tissue injuries and shortened tendons
2.
due to past injuries and scar tissue
Joint contractures resulting from capsular
3.
tightness and scarring. |
·
・・
: .
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
JUL - 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Camerom Mahon, P. Eng., M. H. Sc. Director of R & D Excel Tech, Ltd. 2568 Bristol Circle Oakville, Ontario, Canada L6H 5S1
Re: K001166
Trade Name: Ultra V Therapeutic Ultrasound Regulatory Class: II Product Code: IMG Dated: April 7, 2000 Received: April 10, 2000
Dear Mr. Mahon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the enoredure) to ice ice Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general morelors, marions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remancer ripp. Charge of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moponently the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
2
Page 2 - Camerom Mahon, P. Eng., M. H. Sc.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
DmnR Vachner.
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
3
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Ultra V Therapeutic Ultrasound APRIL 7, 2000
510(K) NOTIFICATION OF A NE
rent of indications Section Destate
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
XLTek Ultra V Therapeutic Ultrasound Device Name:
The Ultra V provides 1 and 3 MHz ultrasound therapy to Indications for Use: provide deep heating effects for the treatment of pain and contractures associated with the chronic and subchronic conditions of:
- Adhesive capsulitis, bursitis, bursitis with slight 】. calcification, and myositis.
-
- Soft tissue injuries and shortened tendons due to past injuries and scar tissue
- Joint contractures resulting from capsular 3. tightness and scarring.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmns R. lochner
Division Sign-Off
(Division Sign-Off) · Division of General Restorative Devices >10(k) Number_KUQULLe
Prescription Use
(Per 21§ CFR 801.109)
Over-The Counter Use __ OR
(Optional Format 1-2-96)