(422 days)
Not Found
No
The description focuses on EMG analysis and a simple scoring system (Bscore 0-3) based on the total number of muscle contractions. There is no mention of AI, ML, or complex algorithms that would typically be associated with such technologies.
No
The device is described as a "disposable diagnostic device" intended to "aid in the evaluation" and "monitor" nocturnal masticatory muscle activity. It provides a "quantitative measure" and a "single number" (Bscore) to indicate muscle contraction severity, which are all diagnostic functions, not therapeutic.
Yes
The 'Device Description' section explicitly states, "The BiteStrip is a disposable diagnostic device."
No
The device description explicitly states "The BiteStrip is a disposable diagnostic device" and describes a physical display ("The BiteStrip display gives an indication of muscle contraction severity as a single number"). This indicates a hardware component is integral to the device's function.
Based on the provided text, the BiteStrip is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- BiteStrip Function: The BiteStrip directly monitors the electrical activity of the masseter muscle (EMG) on the surface of the skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes the device as aiding in the evaluation and management of nocturnal masticatory muscle activity disorders by monitoring muscle contractions during sleep. This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the BiteStrip falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BiteStrip is generally indicated for use by orofacial pain professionals or dentists, to aid in the evaluation and management of nocturnal masticatory muscles activity disorders, which may be related to the patient's bruxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.
Product codes (comma separated list FDA assigned to the subject device)
KZM
Device Description
The BiteStrip is a disposable diagnostic device. The device is intended for use in monitoring masseter muscle contractions during sleep. It is generally indicated for use by physicians to aid in the evaluation of the presence and severity of bruxism, to determine the need for treatment, and for treatment follow-up. The BiteStrip is specifically indicated to obtain a quantitative measure of masseter muscle contractions during sleep, which correlates with bruxism severity derived from formal sleep lab studies. The BiteStrip is intended for adult users during an overnight sleep episode, i.e., 4-6 hours.
The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Where 0 is very low count, and 3 is high count) depending on the total number of masseter muscle contraction episodes that the patient performs for the duration of the test. This number is referred to as the Bscore. While both Bscore and traditional bruxism score are very similar, and have good correlation, the terms differ because the bruxism score is measured using sleep lab EMG and additional physiological measures (not only EMG signals), while the Bscore is obtained by EMG analysis alone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
masseter muscle
Indicated Patient Age Range
adult users
Intended User / Care Setting
orofacial pain professionals or dentists, physicians
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.
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
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle. Inside the circle is a stylized image of an eagle with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
Mr. Noam Hadas S.L.P., Inc. 18 Hazfira St. Tel-Aviv, Israel 67779
Re: K030869 Trade/Device Name: BiteStrip Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: KZM Dated: February 17,2004 Received: February 23,2004
Dear Mr. Hadas
This letter corrects our substantially equivalent letter of May 14, 2004, 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 Register.
1
Page 2 - Mr. Noam Hadas
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 (OS) 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,
Chiu S. Lin, PhD
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
2
INDICATIONS FOR USE STATEMENT
510(k) Number: K030869
BiteStrip Device Name:
Indications for Use:
The BiteStrip is generally indicated for use by orofacial pain professionals or dentists, to aid in the evaluation and management of nocturnal masticatory muscles activity disorders, which may be related to the patient's bruxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.
(P1.F.A.SE DO NOT WRITE BELOW THIS LINE.CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
510(k) Number
Prescription Use (Per 21 CFR 801.109) Over the Counter Usc
Susa Rumm
(Division Sign-Off)
esiology. General Hospital on Control, Dental
510(k) Number: kc30869
3
MAY 1 4 2004
510(K) SUMMARY
BiteStrip
510(k) Number K030869
Applicant's Name: S.L.P Ltd. 18 Hazfira Street Tel-Aviv 67779, Israel Tel: 972-3-537-1281 Fax: 972-3-537-1282
| Contact Person: | Tamar Shochat
S.L.P Ltd.
18 Hazfira Street
Tel-Aviv 67779, Israel
Tel: 972-3-537-1281
Fax: 972-3-537-1282 |
| ----------------- | -------------------------------------------------------------------------------------------------------------------------- |
|---|
Trade Name:
BitcStrip
Classification Name:
Muscle Monitoring Device
Classification:
The FDA has classified Muscle Monitoring Device as class II devices (product code KZM, Regulation No. unknown) and they are reviewed by the Dental Panel.
4
Predicate Device:
- Model K6-I Diagnostic System (Myotronics-Noromed. Inc. USA) cleared . under K992694
- . SleepStrip® Influent Ltd., Israel cleared under K002135
- . ELECTROENCEPHALOGRAPH, (Nihon-Kohden America). cleared under K874796
Performance Standards:
The BiteStrip complies with the following recognized standards: EN 60601-1-1:90 + A1(93) + A11(93) + A12(93) + A2(95) + A13(96) EN 60601-1-2: 1993, EN 55011:1998 + A1:1999 class B
Intended Use:
The BiteStrip is intended as an aid in the evaluation of excessive nocturnal jaw muscle activity The device is generally indicated for use by orofacial pain professionals or dentists, to evaluate nocturnal masticatory muscle activity level. which may be related to the patient's braxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.
Device Description:
The BiteStrip is a disposable diagnostic device. The device is intended for use in monitoring masseter muscle contractions during sleep. It is generally indicated for use by physicians to aid in the evaluation of the presence and severity of bruxism, to determine the need for treatment, and for treatment follow-up. The BiteStrip is specifically indicated to obtain a quantitative measure of masseter muscle contractions during sleep, which correlates with bruxism severity derived from formal sleep lab studies. The BiteStrip is intended for adult users during an overnight sleep episode, i.e., 4-6 hours.
The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Where 0 is very low count, and 3 is high count) depending on the total number of masseter muscle contraction episodes that the patient performs for the duration of the test. This number is referred to as the Bscore. While both Bscore and traditional bruxism score are very similar, and have good correlation, the terms differ because the bruxism score is measured using sleep lab EMG and additional physiological measures (not only EMG signals), while the Bscore is obtained by EMG analysis alone.