(148 days)
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No
The summary describes a multi-parameter patient monitor and does not mention any AI or ML capabilities.
No
The device is intended to monitor physiological parameters (ECG, HR, NIBP, SpO2, PR, RR, Temp, IBP, EtCO2, InCO2) rather than provide treatment or therapy.
Yes
Explanation: The device is described as monitoring multiple physiological parameters (ECG, HR, NIBP, SpO2, PR, RR, Temp, IBP, capnography), which are routinely used to assess a patient's health status and aid in diagnosis.
No
The device description is not provided, but the intended use clearly lists monitoring of various physiological parameters (ECG, NIBP, SpO2, etc.) which typically requires hardware sensors and components to acquire the data. The name "Colin Press Mate, Model BP S510" also suggests a physical device.
Based on the provided information, the Colin Press Mate, Model BP S510 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes monitoring various physiological parameters (ECG, HR, NIBP, SpO2, PR, RR, Temp, IBP, EtCO2, InCO2) directly from the patient. IVD devices, on the other hand, are intended for the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens in the intended use or device description.
- Focus on Patient Monitoring: The device is clearly designed for real-time monitoring of a patient's vital signs.
Therefore, the Colin Press Mate, Model BP S510 falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO2 and InCO2 ).
Product codes
MHX, DSK, DPS, DXN, DQA and CCK
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
adults and pediatrics of at least 14 years of age and weighing more than 35 kg and infants can only be monitored with the oscillometric cuff.
Intended User / Care Setting
Environment of use: All areas of a hospital and hospital type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.
Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
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
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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.
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2007
Mr. Ranndy Kellogg Vice President Marketing and Medical Sales Omron Healthcare, Incorporated 1200 Lakeside Drive Bannockburn, Illinois 60015
Re: K063690
Trade/Device Name: Colin Press Mate, Model BP S510 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia, Detector and Alarm (including ST-Segment Measurement and Alarm) Regulatory Class: II Product Code: MHX, DSK, DPS, DXN, DQA and CCK Dated: April 12, 2007 Received: April 13, 2007
Dear Mr. Kellogg:
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.
1
Page 2 - Mr. Kellogg
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 vour 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
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Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name:
Colin Press Mate, Model BP S510
Indications for Use:
The Colin Press Mate, Model BP S510 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (systolic, diastolic and mean arterial pressures) (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration (RR), body temperature (Temp), invasive blood pressure (IBP) and capnography (EtCO2 and InCO2 ).
The intended patient populations are: adults and pediatrics of at least 14 years of age and weighing more than 35 kg and infants can only be monitored with the oscillometric cuff.
Environment of use: All areas of a hospital and hospital type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.
Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
Prescription Use XX (Part 21 CFR 801 Subpart D) Over-the-counter use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chutto
on of Anesthesiology, General Hospital, Jon Control, Disntal Lievices '(k) Number: "
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