K Number
K973914
Device Name
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
Date Cleared
1998-06-30

(259 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications for use of the PulStarFRAS include: musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain.
Device Description
Not Found
More Information

Not Found

Not Found

No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and lack of detailed device description do not suggest AI/ML is involved.

Yes
The “Intended Use / Indications for Use” section explicitly states that the device is indicated for various medical conditions, such as musculoskeletal pain, restricted joint mobility, myofascial spasm, and ligamentous strain, which are conditions that therapeutic devices address.

No
The provided information describes the PulStarFRAS's indications for use relating to musculoskeletal pain, which points to a therapeutic purpose, not a diagnostic one. There is no mention of assessment, imaging, or analysis for the purpose of identifying a condition.

Unknown

The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.

Based on the provided information, the PulStarFRAS is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • PulStarFRAS Intended Use: The intended use of the PulStarFRAS is described as addressing musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, and ligamentous strain. These are conditions related to the physical structure and function of the body, not conditions diagnosed through analysis of bodily samples.

The description clearly indicates a device used for physical treatment or assessment related to musculoskeletal issues, which falls outside the scope of in vitro diagnostics.

N/A

Intended Use / Indications for Use

musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain.

Product codes

LXM

Device Description

Not Found

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

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)

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.

Not Found

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

N/A

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1998

Joseph M. Evans, Ph.D. · President Sense Technology Inc. 3251 Old Frankstown Road Pittsburgh, Pennsylvania 15239

Re: K973914 Trade Name: PulStarFRAS Regulatory Class: Unclassified Product Code: LXM Dated: May 15, 1998 Received: May 26, 1998

Dear Dr. Evans:

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 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). 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 (Premarket Approval), 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 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 comply with 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.

1

Page 2 - Joseph M. Evans, Ph.D

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,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Image /page/2/Picture/0 description: The image shows the logo for Sense Technology Inc. The logo features a stylized "STI" in bold, black font, with the words "SENSE TECHNOLOGY INC." in a smaller, serif font to the right of the letters. The letters "STI" are stacked vertically, with each letter having a series of horizontal lines running through it.

Image /page/2/Picture/1 description: The image shows a bar graph with 10 bars. The bars are all vertical and have the same width. The height of the bars varies, with the tallest bar being the third from the left. The bars are all filled with a dark gray color. The bars appear to be increasing in height from left to right, then decreasing, and then increasing again.

K973914

Indications for Use

Indications for use of the PulStarFRAS include: musculoskeletal pain due to joint subluxation, restricted joint mobility, myofacial spasm, ligamentous strain.

Prescription Use
(Per 21 CFR 801.109)

Piccolo

Divisio Sian-Off Division of General Restorative Devices 510(k) Num

6/29/98