(250 days)
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No
The summary describes a physiological recorder for basic vital signs and does not mention any AI/ML terms or functionalities.
No
The device is described as a "physiological recorder" intended to display and record various physiological parameters, not to treat any condition.
Yes
The device is a physiological recorder that displays and records various physiological parameters (respiratory effort, airflow, oxygen saturation, pulse rate, 0-1 volt DC signal). This data collection and display of physiological signs are indicative of a diagnostic device, as such information is used by healthcare professionals to diagnose medical conditions related to sleep and respiratory function.
No
The device description explicitly states it is a "Portable Sleep Data Recorder," implying a physical hardware component for recording physiological data. The intended use also lists parameters like respiratory effort, airflow, oxygen saturation, and pulse rate, which typically require sensors and hardware to measure.
Based on the provided information, this device 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.
- Device Function: The PSDR system records physiological signals directly from the patient's body (respiratory effort, airflow, oxygen saturation, pulse rate, and a DC signal). It does not analyze samples taken from the body.
- Intended Use: The intended use describes recording and displaying physiological data, not performing diagnostic tests on biological samples.
Therefore, the PSDR system falls under the category of a physiological monitoring or recording device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PSDR system is a physiological recorder intended to display and to record for later playback, the following physiological parameters: nasal/oral airflow, thoracic and abdominal respiratory effort, heart rate, oxygen saturation, pulse rate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.
Product codes
MNR
Device Description
Portable Sleep Data Recorder
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Supervised (hospital/institutional) or unsupervised (home) environment, Prescription Use.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
JUN 3 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pro-Tech Services, Incorporated C/O Ms. Laura Danielson Responsible Third Party Official TÜV America, Incorporated 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112-1891
Re: K033402
Trade/Device Name: Portable Sleep Data Recorder Regulation Number: 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: June 24, 2004 Received: June 25, 2004
Dear Ms. Danielson:
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 Eederal Register.
1
Page 2 -Ms. Danielson
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 mode that to any Federal statutes and regulations administered by other Federal agencies. or the Fet of all your 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 and ifsuing (2) 2011 11:14 quality systems (QS) regulation (21 CFR Part 820); and if requirents as lectronic 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) I mis letter mtification. The FDA finding of substantial equivalence of your device to a premainer leted 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), 11 you deatte the Office of Compliance at (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
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
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Portable Sleep Data Recorder
Indication for Use:
The PSDR system is a physiological recorder intended to display and to record for later pay dack of The PSDR system is a prysiclogical reborder interace and abdominal respiratory offer on whiles and oxygen Saturation, pulse Tate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input.
The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use __ XX__OR
(Pcr 21 CFR 801 .109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Indications For Use
Qur Sulion
(Division Sign-O y, General Hospital. Division of Anesth Infection Control. 510(k) Number: