K Number

Device Name

Manufacturer

BIO-RESEARCH ASSOCIATES, INC.

Date Cleared

1998-09-15

(137 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Indications for Use:

At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made,

Sufficient normative data have not been collected to support such population-based measurements as "frean electromyographic clench," "standard deviation (Jaw Tracking) of freeway space," "integral (sonograph) of sound intensity" "average jaw tracing of chewing," etc., for non diseased individuals as well as for patients having various disease entitles that are now lumped within the terminology known as "TemporomandIbular Disorders and Associated Orofacial Pain (TMD/MPD)."

Jaw Tracking

To track mandibular movement and position
To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing [instability of occlusion]
To identify mandibular rest position and to identify interocclusal distance and freeway space
To monitor the position of the jaw in three dimensions
To represent the spatial position of the mandibular incisal edge relative to the skull
To provide Baseline measurements for future reference

Electromyography

To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric
To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by recording the electrical activity of the muscles of the stomatognathic system.
To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest
To measure relative (intra-patient) levels of activity of several muscles during a functional act
To provide Baseline measurements for future reference

Sonography, joint vibration (sound) recording

To record and display sounds / vibrations from the temporomandibular joint
To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in various standard plots
To aid the clinician in companing a parient's current standard plots to previous recordings before, during and after treatment
To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations allowing intra-bationt commissions (only) by the clinician
To provide Baseline measurements for future reference

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) summary letter from the FDA for a device called the "BioPak Measurement System." It outlines the device's classification, indications for use, and general regulatory information.

This document does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

A table of acceptance criteria or reported device performance.
Details about sample sizes for test sets, data provenance, or training sets.
Information about experts used for ground truth, adjudication methods, or MRMC studies.
Results from standalone performance studies.
The type of ground truth used.
How ground truth for training data was established.

This letter is a regulatory approval document, not a scientific study report or clinical trial summary. To find the information you're looking for, you would typically need to refer to the device's 510(k) submission itself (which often includes performance data and clinical studies), or scientific publications related to the device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 - 2005

Mr. John Radke Bio-Research Associates, Inc. 9275 North 49th Street Brown Deer, Wisconsin 53223

Re: K981563 Trade/Device Name: Biopak Measurement System Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: KZM and NFS and NFQ Dated: August 12, 1998 Received: August 14, 1998

Dear Mr. Radke

This letter corrects our substantially equivalent letter of September 15, 1998, regarding the classification of your device which was incorrectly identified as "unclassified."

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 (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 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 Rerister.

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);

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Page 2 – Mr. John Radke

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 continue marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance'at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (301) 443-6597 or at its internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Qenite H. Michie MD

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number: K981563 Device Name: BioPak Measurement System Indications for Use:

22:25 1:30 10

= ADI

At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made,

Jaw Tracking

09703: 85

To track mandibular movement and position 1.
[]=OUT

002/002

To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing [instability of occlusion] 2.
To identify mandibular rest position and to identify interocclusal distance and freeway space rt
To monitor the position of the jaw in three dimensions 4.
To represent the spatial position of the mandibular incisal edge relative to the skull ડ .
To provide Baseline measurements for future reference 6.

Electromyography

To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter 1. and digastric
To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by 2. recording the electrical activity of the muscles of the stomatognathic system.
To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest 3.
To measure relative (intra-patient) levels of activity of several muscles during a functional act 4.
To provide Baseline measurements for future reference ર -

Sonography, joint vibration (sound) recording

To record and display sounds / vibrations from the temporomandibular joint 1 .
To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in 2. various standard plots
To aid the clinician in companing a parient's current standard plots to previous recordings before, during ਤੇ . and after treatment
1. To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations allowing intra-bationt commissions (only) by the clinician
To provide Baseline measurements for future reference ನ.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm
(Division Sign-Off)

( - - telefon of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infection of

510(k) Number .

Prescription Use Y (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).