(92 days)
No
The summary describes a standard non-invasive blood pressure monitoring device and does not mention any AI or ML components or capabilities.
No.
The device is used for noninvasive measurement of arterial blood pressure, which is a diagnostic function to monitor and assess physiological characteristics, not to treat a condition.
Yes
The device measures physiological characteristics (blood pressure and pulse rate) to monitor and assess the patient, which falls under the definition of a diagnostic device.
No
The device description explicitly states that the NIBP Option incorporates a hardware module (SunTech Medical Instruments Advantage OEM BP™ Model 2 Module) into a physical device (M Series Defibrillator/Monitor/Pacemaker). This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device is described as a noninvasive blood pressure monitor. It measures arterial blood pressure directly on the patient's body, which is an in vivo measurement.
- The "Intended Use" and "Device Description" clearly state it measures blood pressure non-invasively on resting patients. There is no mention of analyzing samples or performing tests outside the body.
Therefore, the ZOLL M Series NIBP Option is a medical device, but it falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ZOLL M Series NIBP Option is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.
Product codes
DXN
Device Description
The ZOLL M Series NIBP Option non-invasively measures arterial blood pressure and pulse rate in resting adult, neonate and pediactric patients. By incorporating the SunTech Medical Instruments Advantage OEM BP™ Model 2 Module into the M Series Defibrillator/Monitor/Pacemaker devices, the option facilitates the ability to monitor and assess the physiological characteristics of the indicated patient populations.
The ZOLL M Series products (K972241) combine a defibrillator, ECG display, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 3-, 5- and 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) and Invasive Blood Pressure and Temperature (K011865), data printing and recording in a single instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial
Indicated Patient Age Range
adult, pediatric, and neonatal patients.
Intended User / Care Setting
critical care and transport
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)
The 510(k) includes documentation related to the performance of the incorporated NIBP module and compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards.
- . ANSI/AAMI SP-10-1992, Electronic or Automated Sphygmomanometers.
- EN 1060-1:1996, Non-invasive sphygmomanometers Part 1: General ● requirements
- . EN 1060-3:1997. Non-invasive sphygmomanometers - Part3: Supplementary requirements for electro-mechanical blood pressure measuring systems
- EN 60601-1:1990; Amd 1 1992; Amd 2 1995; Amd 13 1995; Medical . Electrical Equipment - Part 1: General Requirements for Safety.
- IEC 60601-1-2; 2001, Medical Electrical Equipment Part 1: General . Requirements for Safety; Electromagnetic Compatibility.
- IEC 60601-2-4; 2001, Medical Electrical Equipment Part 2: Particular . Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors.
- EN 60601-2-30; 2000, Medical Electrical Equipment Part 2: Automatic . Cycling Indirect Blood Pressure Monitoring Equipment.
- AAMI DF2; 1996, Cardiac Defibrillator Devices. .
- . AAMI DF39; 1993, AED and Remote Control Defibrillators.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Sean Reynolds (978) 421-9655, Ext. 9386
Date Summary Prepared:
July 30, 2003
Device:
ZOLL M-Series NIBP Option
Classification:
System, Measurement, Blood-Pressure, Non-Invasive: Class II (21 CFR 870.1130)
The previously approved NIBP Option (K002029) was established as a Class III device due to its combination with the ZOLL Defibrillator/Pacer/Monitor which was classified as being Class III under 510(k) application number K972241. The proposed update to the NIBP Option would maintain a Class III status due to the same configuration.
Description:
The ZOLL M Series NIBP Option non-invasively measures arterial blood pressure and pulse rate in resting adult, neonate and pediactric patients. By incorporating the SunTech Medical Instruments Advantage OEM BP™ Model 2 Module into the M Series Defibrillator/Monitor/Pacemaker devices, the option facilitates the ability to monitor and assess the physiological characteristics of the indicated patient populations.
The ZOLL M Series products (K972241) combine a defibrillator, ECG display, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 3-, 5- and 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) and Invasive Blood Pressure and Temperature (K011865), data printing and recording in a single instrument.
1
Substantial Equivalence:
The features and functions of the proposed update to the M Series NIBP Option (K002029) are substantially equivalent to those of the Protocol Systems, Inc. Propaq CS Vital Signs Monitor: 510(k) no.K012451, cleared 8/20/2001.
Indications for Use:
The ZOLL M Series NIBP Option is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.
Summary of Performance Information:
The 510(k) includes documentation related to the performance of the incorporated NIBP module and compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards.
- . ANSI/AAMI SP-10-1992, Electronic or Automated Sphygmomanometers.
- EN 1060-1:1996, Non-invasive sphygmomanometers Part 1: General ● requirements
- . EN 1060-3:1997. Non-invasive sphygmomanometers - Part3: Supplementary requirements for electro-mechanical blood pressure measuring systems
- EN 60601-1:1990; Amd 1 1992; Amd 2 1995; Amd 13 1995; Medical . Electrical Equipment - Part 1: General Requirements for Safety.
- IEC 60601-1-2; 2001, Medical Electrical Equipment Part 1: General . Requirements for Safety; Electromagnetic Compatibility.
- IEC 60601-2-4; 2001, Medical Electrical Equipment Part 2: Particular . Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors.
- EN 60601-2-30; 2000, Medical Electrical Equipment Part 2: Automatic . Cycling Indirect Blood Pressure Monitoring Equipment.
- AAMI DF2; 1996, Cardiac Defibrillator Devices. .
- . AAMI DF39; 1993, AED and Remote Control Defibrillators.
The information in this 510(k) demonstrates that the proposed update to the M Series NIBP Option (K002029) is substantially equivalent to the predicate device with respect to safety, effectiveness, and performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
ZOLL Medical Corporation c/o Mr. Sean Reynolds Regulatory Affairs Engineer 269 Mill Road Chelmsford, MA 01824
Re: K032363
Trade Name: ZOLL M Series NIBP Option Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 17, 2003 Received: September 23, 2003
Dear Mr. Reynolds:
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.
3
Page 2 - Mr. Sean Reynolds
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 (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,
tsusehu
Bram D/ uckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1_of 1
510(k) Number (if known): K032363
Device Name: ZOLL M Series NIBP Option
Indications For Use:
The ZOLL M Series NIBP Option is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dua Leixhe
(Division Sign-Off)
Division of Cardiovascular Devices
(Optional Format 3-10-98)
510(k) Number K032363