(76 days)
Not Found
No
The description explicitly states that the "assist software enables the trained human professional... to verify the results of the study and generate a report," indicating human analysis is required and no mention of AI/ML is made.
No
The device is a diagnostic tool used to record physiological signals during sleep for the purpose of identifying sleep disorders, not to provide therapy.
Yes
The device is used to record physiological signals during sleep, with the data downloaded for a "trained human professional... to verify the results of the study and generate a report". This process of collecting and analyzing data to aid in understanding a patient's condition for the purpose of identifying or characterizing a disease or condition (sleep disorders in this case) is characteristic of a diagnostic device.
No
The device description explicitly states that the MediByte™ is a "palm-sized recording device" that acquires and stores physiological signals from FDA-cleared sensors. This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the MediByte™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MediByte™ Function: The MediByte™ records physiological signals from the patient's body during sleep (EMG, EKG, effort, airflow, snoring, position, SpO2, pulse rate). It does not analyze samples taken from the body.
- Intended Use: The intended use is to record physiological signals for sleep disorder studies, with analysis performed by a trained human professional. This is a direct measurement of bodily functions, not an analysis of a biological specimen.
Therefore, the MediByte™ falls under the category of a medical device that directly measures physiological parameters, not an IVD.
N/A
Intended Use / Indications for Use
The MediByte™ is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the assist software enables the trained human professional typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report.
Target Population: Children and adult patients who are screened during sleep disorder studies.
Environment of Use: The majority of the screenings occur either in the home at in a clinical setting.
The MediByte™ is intended to be used only by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
MNR, DQA
Device Description
The MediByte™ is a palm-sized recording device capable of acquiring and storing physiological signals from FDAcleared sensors and transmitting the physiological data to a computer through the Universal Serial Bus (USB) port.
The MediByte™ records up to 8 channels of physiological signals: either electromyogram (EMG), or electrocardiogram (EKG); as well as chest effort; abdominal effort; airflow pressure; snoring; body position; arterial oxygen saturation (SpO2); and pulse rate. The signals cannot be viewed in real time, but can be downloaded after collection for assisted analysis by a human professional trained in the analysis and reporting of sleep disorders medicine.
The MediByte™ is powered by one ½ AA battery and connects to a computer via the MediByte™ USB communication cable. The MediByte™ and sensors are both typically worn by the patient during the recording and all patient contact materials consist of latex-free biocompatible material.
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
Children and adult patients
Intended User / Care Setting
The majority of the screenings occur either in the home at in a clinical setting.
The MediByte™ is intended to be used only by or on the order of a physician.
The data is downloaded after the recording is completed and the assist software enables the trained human professional typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report.
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)
Functional testing was performed to confirm that the MediByte™ is capable of meeting its stated performance specifications and that the device output is readable. MediByte™ passed all tests.
All software testing was performed in accordance with the May 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. The MediByte™ passed all tests.
All software verification and validation testing was performed in accordance with the January 11, 2002 "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." The MediByte™ passed all tests.
All environmental and electrical safety testing was performed in accordance with the November 03, 1997 "Electroencephalograph Devices Guidance for 510(k) Content." The MediByte™ passed all tests.
Analysis of overnight studies supports a substantial equivalence determination. The MediByte™ was run to verify that readable, appropriate signals were being recorded. Simulation tests comparing the MediByte™ to the MediPalm® were also performed to gather comparative performance data. The performance of the BRAEBON Medical Corporation MediByte™ (subject device) was identical to that of MediPalm® (predicate device).
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.
K031202, K984431, K982216, K020312
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
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
31 Ford St. Extension
1-120 Walgreen Drive RR#3 Carp Ontario, Canada KOA 1LO Tel: 613.831.6690 Fax: 613.831.6699 www.braebon.com
K 061764
510(K) Summary
SEP - 6 2006
BRAEBON Medical Corporation MediByte ™
August 23, 2006
The following safety and effectiveness summary has been prepared according to the requirement for 510(k) summaries specified in 21 CFR 807.92c.
1.0 Manufacturer Name
BRAEBON Medical Corporation Suite 1, 120 Walgreen Drive RR#3 Carp, Ontario Canada, K0A 1L0
2.0 Proprietary Name of Device
MediByte™M
3.0 Common Name of Device
Polysomnograph / Portable Sleep Data Recorder
4.0 Device Classification
Devices of this type have been class II by the Anesthesiology Devices Panel. Devices of this classification have a classification code of MNR, Ventilatory Effort Recorder (21 CFR 868.2375).
5.0 Intended Use
The MediByte™ is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the assist software enables the trained human professional typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report.
Target Population: Children and adult patients who are screened during sleep disorder studies.
Environment of Use: The majority of the screenings occur either in the home at in a clinical setting.
The MediByte™ is intended to be used only by or on the order of a physician.
6.0 Device Description
The MediByte™ is a palm-sized recording device capable of acquiring and storing physiological signals from FDAcleared sensors and transmitting the physiological data to a computer through the Universal Serial Bus (USB) port.
1
BRAEBON
MEDICAL
CORPORATION
2981 Ford St. Extension shura NY
1-120 Walgreen Drive RR#3 Carp Ontario, Canada KOA 1LO Tel: 613.831.6690 Fax: 613.831.6699 www.braebon.com
The MediByte™ records up to 8 channels of physiological signals: either electromyogram (EMG), or electrocardiogram (EKG); as well as chest effort; abdominal effort; airflow pressure; snoring; body position; arterial oxygen saturation (SpO2); and pulse rate. The signals cannot be viewed in real time, but can be downloaded after collection for assisted analysis by a human professional trained in the analysis and reporting of sleep disorders medicine.
The MediByte™ is powered by one ½ AA battery and connects to a computer via the MediByte™ USB communication cable. The MediByte™ and sensors are both typically worn by the patient during the recording and all patient contact materials consist of latex-free biocompatible material.
7.0 Predicate Device Equivalence
We are claiming substantial equivalence to the following devices all manufactured and sold by BRAEBON Medical Corporation:
- MediPalm®: K031202, Braebon Medical Corporation 1.
- Ultima Airflow Pressure Sensor; K984431, BRAEBON Medical Corporation 2.
- Ultima Respiratory Effort Sensor; K982216, Braebon Medical Corporation 3.
- Ultima Snore Microphone; K020312, Braebon Medical Corporation 4.
| Intended Use | No difference |
|---|---|
| Indications Statement | No difference |
| Method of Connection to Patient | No difference |
| Power Source | No difference. The MediByte™, like the predicate devices, is battery |
| powered. | |
| Safety Characteristics | No difference. |
| Reuse and Hygiene Characteristics | No difference. |
| Design | No difference. The MediByte™ is smaller than the MediPalm® predicate |
| device. | |
| Performance Data Conclusions | No difference. |
8.0 Similarities and Differences Between Subject and Predicate Devices
9.0 Performance Testing
Functional testing was performed to confirm that the MediByte™ is capable of meeting its stated performance specifications and that the device output is readable. MediByte™ passed all tests.
All software testing was performed in accordance with the May 2005 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. The MediByte™ passed all tests.
All software verification and validation testing was performed in accordance with the January 11, 2002 "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." The MediByte™ passed all tests.
All environmental and electrical safety testing was performed in accordance with the November 03, 1997 "Electroencephalograph Devices Guidance for 510(k) Content." The MediByte™ passed all tests.
Analysis of overnight studies supports a substantial equivalence determination. The MediByte™ was run to verify that readable, appropriate signals were being recorded. Simulation tests comparing the MediByte™ to the
2
Image /page/2/Picture/0 description: The image shows the logo for BRAEBON MEDICAL CORPORATION. The word "BRAEBON" is in large, bold, sans-serif font on the top line. Below that, "MEDICAL CORPORATION" is written in a smaller, sans-serif font.
02-2981 Ford St. Extension gdensburg, NY 69-3474
MediPalm® were also performed to gather comparative performance data. The performance of the BRAEBON Medical Corporation MediByte™ (subject device) was identical to that of MediPalm® (predicate device).
10.0 Conclusions
We conclude that MediByte™ is equivalent in safety and performance to the legally marketed predicate devices. The MediByte™ meets its stated performance specifications and the criteria outlined in the Reviewers Guidance publication specified above, and the MediByte™ will operate safely in the intended environment and fulfill its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard A. Bonato, Ph.D. Braebon Medical Corporation 120 Walgreen Drive, Suite 1, RR#3 Carp, Ontario CANADA KOA 1L0
SEP -6 2006
Re: K061764
Trade/Device Name: MediByteTM Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR, DQA Dated: August 23, 2006 Received: August 25, 2006
Dear Dr. Bonato:
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 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 adulteration.
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.
4
Page 2 - Dr. Bonato
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin 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) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
| 510(k) Number: | K061764 |
|---|---|
| Device Name: | MediByte™ |
| Indications for Use: | The MediByte™ is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. The data is downloaded after the recording is completed and the auto assist software enables the trained human professional - typically a Registered Sleep Technologist or Medical Doctor - to verify the results of the study and generate a report. |
| Target Population: | Children and adult patients who are screened during sleep disorder studies. |
| Environment of Use | The majority of the screenings occur either in the home at in a clinical setting. |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
lue Syricom
...cion Sign-Off)
Lasion of Anesthesiology, General Hospital,
ccuon Control, Dental Devices
anda) Mumb
Page 1 of 1