(292 days)
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No
The document describes standard physiological monitoring and alarm functions without mentioning AI or ML.
No
The device is indicated for monitoring physiological parameters and detecting arrhythmias, but not for providing therapy or treatment.
Yes
The device monitors physiological parameters (heart rate, blood pressure, blood oxygen saturation, respiration) and detects arrhythmias, producing alarms when parameters vary beyond preset limits. This fits the definition of a diagnostic device as it gathers information to identify or assess the presence, absence, or severity of a disease or condition.
No
The description explicitly mentions connecting to an "R50 Bedside recorder" and a "Saad Patient Monitoring network (SPMS)". These are hardware components that the software interacts with and relies upon for data acquisition and potentially processing, indicating it is not a standalone software-only device.
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 description clearly states that the SPM device is for monitoring physiological parameters like heart rate, blood pressure, blood oxygen saturation, and respiration. It also monitors and detects arrhythmia, pacer, and QRS. These are all measurements taken directly from the patient's body, not from a sample in vitro (in glass/outside the body).
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples.
Therefore, the SPM device falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SPM is indicated for monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric and neonatal populations.
SPM is indicated for monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatic populations only (not intended for use on neonatal populations).
SPM will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits at which point timed or alarm recordings will be produced. SPM connects to an R50 Bedside recorder, or via the Saad Patient Monitoring network (SPMS).
SPM does NOT perform ST Segment analysis and it is not intended to be used in transport or ambulatory environments.
MR Environment Compatibility Statement:
The Saad Patient Monitors are not compatible for use in an MR Environment (MR Unsafe).
Product codes (comma separated list FDA assigned to the subject device)
MHX
Device Description
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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
Adult, pediatric and neonatal populations.
Intended User / Care Setting
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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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§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or fabric.
Auqust 6, 2014
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
Hanin Medical Services Co. Ltd Raymond Kelly 57 Lazy Brook Road Monroe, CT 06468 US
Re: K133222
Trade/Device Name: Saad Patient Monitor (SPM) Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Monitor Regulatory Class: Class II Product Code: MHX Dated: July 23, 2014 Received: July 24, 2014
Dear Mr. Kelly,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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. 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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 vours.
Image /page/1/Picture/6 description: The image shows a logo with the text "Köl" in a stylized font. Below the logo, the text "Ken Skodacek for" is present. The background of the image is plain white, and the logo and text are in black. The logo appears to be a signature or brand mark.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133222
Device Name
Saad Patient Monitor (SPM)
Indications for Use (Describe)
SPM is indicated for monitoring heart rate, invasive blood pressure, blood oxygen saturation, and respiration on adult, pediatric and neonatal populations.
SPM is indicated for monitoring and detecting arrhythmia, pacer, and QRS on adult and pediatic populations only (not intended for use on neonatal populations).
SPM will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits at which point timed or alarm recordings will be produced. SPM connects to an R50 Bedside recorder, or via the Saad Patient Monitoring network (SPMS).
SPM does NOT perform ST Segment analysis and it is not intended to be used in transport or ambulatory environments.
MR Environment Compatibility Statement:
The Saad Patient Monitors are not compatible for use in an MR Environment (MR Unsafe).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) ( Signature ) |
|---|
| --------------------------------------------------------------------------------------- |
Ken Skodacek for
Bram Zuckerman
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