(15 days)
Not Found
No
The document describes a data acquisition and recording device for physiological signals, with no mention of analysis or interpretation capabilities that would typically involve AI/ML. The analysis is performed on a separate, FDA-cleared polysomnographic analysis station.
No
The device is described as a "portable data recorder" intended for collecting, recording, and transmitting physiological data from sensors for analysis, not for treating conditions.
No.
The device is a data recorder that collects and transmits physiological data for analysis by a separate, FDA-cleared polysomnographic analysis station. It does not perform the analysis itself.
No
The device description explicitly states it is a "hand-held recording device" and mentions a "built-in LCD," indicating it includes hardware components beyond just software.
Based on the provided text, the BRAEBON Medical Corporation MEDIPalm-20™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- MEDIPalm-20™ Function: The MEDIPalm-20™ collects and records physiological data from FDA-cleared sensors attached to the patient (EEG, EOG, EMG, EKG, chest effort, abdominal effort, airflow pressure, snoring, body position, SaO2, pulse rate). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to collect and transmit physiological data for analysis on a separate polysomnographic analysis station. This analysis is based on the electrical and physical signals from the body, not on the examination of bodily fluids or tissues.
Therefore, the MEDIPalm-20™ is a physiological signal recorder, not an IVD.
N/A
Intended Use / Indications for Use
The BRAEBON Medical Corporation MEDIPalm-20™ is intended for use in collecting, recording and disclaying physiological data from FDA-cleared sensors during studies in both a cinical and home environment and for transmitting this data to an electrically isolated FDA-cleared polysomnographic analysis station for analysis.
The target population of the MEDIPalm-20TM is all children and adult patients who are screened during sleep disorder studies. The majority of the screenings occur at a sleep laboratory but may occur at the patient's house through the use of the MEDIPalm-20TM.
The MEDIPalm-20™ is intended to be used only by or on the order of a physician.
The MEDIPalm-20™ is a portable data recorder used to collect physiological signals for transfer to an FDA-cleared polysomnographic analysis station capable of reading European Data Format (.edf) files.
Product codes (comma separated list FDA assigned to the subject device)
OLV
Device Description
The MEDIPalm-20™ is a hand-held recording device capable of acquiring and storing physiological signals from FDA-cleared sensors and transmitting the physiological data to a computer through the Universal Serial Bus (USB) port.
The MEDIPalm-20™ records up to 16 channels of physiological signals: any combination of eight differential analog channels of electroencephalogram (EEG), electronyogram (EOG), electrocardiogram (EMG), and electrocardiogram (EKG) signals; as well as chest effort; abdominal effort; airflow pressure; snoring; body position; arterial oxygen saturation (SaO2); pulse rate; and SaO2 probe status. The signals can be viewed in real time on a built-in LCD or on a remote computer. The data can be downloaded after collection for analysis on any FDA-deared polysomnographic analysis station capable of reading European Data Formatted files.
The MEDIPalm-20™ is powered by either two standard AA batteries, a Medical Grade IEC 60601-1 compliant AC/DC power supply, or an electrically isolated computer that uses an IEC 60601-1 compliant isolation transformer and connects to the MEDIPalm-20™ via the MEDIPalm USB data and power cable. To protect the patient when the MEDIPalm-20™ is used with a computer, the computer and all its peripherals must be connected to an IEC 60601-1 compliant isolation fransformer. The sensors connect to the patient and the MEDIPalm-20™ does not contain any patient contacting materials.
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
Used only by or on the order of a physician. The majority of the screenings occur at a sleep laboratory, hospital or at the patient's home.
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 MEDIPalm-20™ is stated performance specifications and that the device output is readable. MEDIPalm-20™ passed all tests.
All software testing was performed in accordance with the May 29, 1998 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. The MEDIPalm-20™ 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 MEDIPalm-20TM passed all tests.
All environmental and electrical salety lesting was performed in accordance with the November of the may and graph Devices Guidance for 510(k) Content." The MEDIPalm-20TM passed all tests.
No clinical studies were required to support a substantal equivalence determination. The MEDIPalm-2014 was connected to a healthy person and was run to verify that readable, appropriate signals were being recorded. Simulation lests comparing the MEDIPalm-20™ and the Sandman Digital were also performed to gather comparative performance of the BRAEBON Medical Corporation MEDIPalm-20™ (subject device) was identical to that of Sandman Digital Recording System (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.
K001013, K003154, K990565, K002690, K001743, K984431
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/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 in a smaller, sans-serif font. The text is black on a white background.
800 Proctor Avenue
Ogdensburg, NY
13669
MAY - 1 2003
120 Walgreen Drive Suite 1, RR#3 Carp, Ontario Canada, KOA 1LO Tel: 613.831.6690 Fax: 613.831.6699 www.braebon.com
031202
510(K) Summary
BRAEBON Medical Corporation MEDIPalm-20™
March 20, 2003
The following safely 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 120 Walgreen Drive Suite 1, RR#3 Carp. Ontario Canada, KOA 1LO
2.0 Proprietary Name of Device
MEDIPalm-20TM
3.0 Common Name of Device
Electroencephiograh/polysomnograph
4.0 Device Classification
Devices of this type have been class II by the Neurology Devices Panel. Devices of this classification have a classification code of OLV. Electroencephalograph (21 CFR 882.1400).
5.0 Intended Use
The BRAEBON Medical Corporation MEDIPalm-20™ is intended for use in collecting, recording and disclaying physiological data from FDA-cleared sensors during studies in both a cinical and home environment and for transmitting this data to an electrically isolated FDA-cleared polysomnographic analysis station for analysis.
The target population of the MEDIPalm-20TM is all children and adult patients who are screened during sleep disorder studies. The majority of the screenings occur at a sleep laboratory but may occur at the patient's house through the use of the MEDIPalm-20TM.
The MEDIPalm-20™ is intended to be used only by or on the order of a physician.
1
Image /page/1/Picture/0 description: The image shows the logo for BRAEBON MEDICAL CORPORATION. The text is in all caps and is black on a white background. The word "BRAEBON" is in a larger font than the words "MEDICAL CORPORATION."
800 Proctor Avenue
Ogdensburg, NY
13669
120 Walgreen Drive Suite 1, RR#3 Carp, Ontario Canada, KOA 1LO Tel: 613.831.6690 Fax: 613.831.6699 www.braebon.com
6.0 Device Description
The MEDIPalm-20™ is a hand-held recording device capable of acquiring and storing physiological signals from FDA-cleared sensors and transmitting the physiological data to a computer through the Universal Serial Bus (USB) port.
The MEDIPalm-20™ records up to 16 channels of physiological signals: any combination of eight differential analog channels of electroencephalogram (EEG), electronyogram (EOG), electrocardiogram (EMG), and electrocardiogram (EKG) signals; as well as chest effort; abdominal effort; airflow pressure; snoring; body position; arterial oxygen saturation (SaO2); pulse rate; and SaO2 probe status. The signals can be viewed in real time on a built-in LCD or on a remote computer. The data can be downloaded after collection for analysis on any FDA-deared polysomnographic analysis station capable of reading European Data Formatted files.
The MEDIPalm-20™ is powered by either two standard AA batteries, a Medical Grade IEC 60601-1 compliant AC/DC power supply, or an electrically isolated computer that uses an IEC 60601-1 compliant isolation transformer and connects to the MEDIPalm-20™ via the MEDIPalm USB data and power cable. To protect the patient when the MEDIPalm-20™ is used with a computer, the computer and all its peripherals must be connected to an IEC 60601-1 compliant isolation fransformer. The sensors connect to the patient and the MEDIPalm-20™ does not contain any patient contacting materials.
7.0 Predicate Device Equivalence
We are claiming substantial equivalence to the following devices:
| Airsep Corp. | Monet | K001013 |
|---|---|---|
| EB Neuro. S.P.A. | Sandman Digital | K003154 |
| Nellcor Puritan Bennett | Suzanne | K990565 |
| Nonin Medical, Inc. | PalmSAT, Model 2500 Pulse Oximeter with finger probes | K002690 |
| BRAEBON Medical Corporation | Ultima Smartbelt | K001743 |
| BRAEBON Medical Corporation | Ultima Airflow Pressure Sensor | K984431 |
8.0 Similarities and Differences Between Subject and Predicate Devices
| Intended Use | No difference |
|---|---|
| Indications Statement | No difference |
| Method of Connection to Patient | No difference |
| Power Source | No significant difference. The MEDIPalm-20TM, like the predicate devices, is powered by |
| batteries or a Medical Grade IEC 60601-1 compliant AC/DC power supply. The | |
| MEDIPalm-20TM can also be powered using the MEDIPalm Universal Serial Bus (USB) | |
| data cable. When using the MEDIPalm-20TM with the computer, the computer and all its | |
| peripherals must be connected to an IEC 60601-1 compliant isolation transformer to | |
| protect the patient. | |
| Safety Characteristics | No difference. |
| Reuse and Hygiene Characteristics | No difference. |
| Design | No difference. The MEDIPalm-20TM incorporates the headbox, respiratory effort sensor, |
| airflow pressure sensor, and pulse oximeter into one palm-sized case rather than | |
| multiple cases. | |
| Performance Data Conclusions | No difference. |
2
9.0 Performance Testing
Functional testing was performed to confirm that MEDIPalm-20™ is stated performance specifications and that the device output is readable. MEDIPalm-20™ passed all tests.
All software testing was performed in accordance with the May 29, 1998 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. The MEDIPalm-20™ 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 MEDIPalm-20TM passed all tests.
All environmental and electrical salety lesting was performed in accordance with the November of the may and graph Devices Guidance for 510(k) Content." The MEDIPalm-20TM passed all tests.
No clinical studies were required to support a substantal equivalence determination. The MEDIPalm-2014 was connected to a healthy person and was run to verify that readable, appropriate signals were being recorded. Simulation lests comparing the MEDIPalm-20™ and the Sandman Digital were also performed to gather comparative performance of the BRAEBON Medical Corporation MEDIPalm-20™ (subject device) was identical to that of Sandman Digital Recording System (predicate device).
10.0 Conclusions
We conclude that MEDIPalm-20™ is equivalent in safely and performance to the legally marketed predicate devices. The MEDIPalm-20™ meets its stated performance specifications and the Reviewers Guidance publication specified above, and the MEDIPalm-20™ 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 U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Braebon Medical Corporation % Mr. Neil E. Devine, Jr. Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
APR
Re: K031202
Trade/Device Name: MEDIPalm-20TM Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV Dated (Date on orig SE ltr): April 16, 2003 Received (Date on orig SE ltr): April 16, 2003
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of May 1, 2003.
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.
4
Page 2 - Mr. Neil E. Devine, Jr.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melvin R. Fudelman, M.D.
Malvina B. Eydelman Director Division of Ophthalmic. Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510 (k) Number_K 031202-(To be assigned)
| Device Name: | MEDIPalm-20™ |
|---|---|
| Indications for Use: | The MEDIPalm-20™ is a portable data recorder used to |
| collect physiological signals for transfer to an FDA-cleared | |
| polysomnographic analysis station capable of reading | |
| European Data Format (.edf) files. | |
| Target Population: | Children and adult patients who are screened during sleep |
| disorder studies | |
| Environment of Use: | The majority of the screenings occur at a sleep laboratory, |
| hospital or at the patient's home. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031202
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use_