ZOLL M SERIES NIBP OPTION by ZOLL MEDICAL CORP.

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.

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.

AI/ML Overview

The provided text describes ZOLL Medical Corporation's 510(k) submission for the M Series NIBP Option (K032363), a non-invasive blood pressure measurement device. The submission asserts substantial equivalence to the predicate device, Protocol Systems, Inc. Propaq CS Vital Signs Monitor (K012451), based on performance information and compliance with various standards.

Here's the breakdown of the acceptance criteria and study information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Met)	Reported Device Performance (Compliance)
ANSI/AAMI SP-10-1992, Electronic or Automated Sphygmomanometers	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
EN 1060-1:1996, Non-invasive sphygmomanometers Part 1: General requirements	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
EN 1060-3:1997. Non-invasive sphygmomanometers - Part3: Supplementary requirements for electro-mechanical blood pressure measuring systems	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
EN 60601-1:1990; Amd 1 1992; Amd 2 1995; Amd 13 1995; Medical Electrical Equipment - Part 1: General Requirements for Safety	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
IEC 60601-1-2; 2001, Medical Electrical Equipment Part 1: General Requirements for Safety; Electromagnetic Compatibility	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
IEC 60601-2-4; 2001, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
EN 60601-2-30; 2000, Medical Electrical Equipment Part 2: Automatic Cycling Indirect Blood Pressure Monitoring Equipment	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
AAMI DF2; 1996, Cardiac Defibrillator Devices	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards
AAMI DF39; 1993, AED and Remote Control Defibrillators	Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards

2. Sample size used for the test set and the data provenance

The provided text does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation. It only states that 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." This implies that the performance was assessed against these standards, but the details of the study (e.g., number of subjects, type of data) are not included.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The provided text does not mention experts used to establish ground truth or their qualifications. The evaluation appears to be based on compliance with established engineering and performance standards for NIBP devices, rather than a clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The provided text does not describe any adjudication method. This type of detail is typically associated with studies involving human interpretation or subjective assessments, which are not explicitly detailed here for the NIBP device performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. This study type is usually relevant for AI-powered diagnostic tools where human interpretation is involved. The ZOLL M Series NIBP Option is a measurement device, and its performance evaluation is framed around compliance with technical standards.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The provided text suggests that the performance evaluation was primarily focused on the device's technical specifications and its compliance with relevant standards (ANSI/AAMI SP-10-1992, EN 1060 series, IEC 60601 series, AAMI DF2, AAMI DF39). This implies a standalone assessment of the device's accuracy and safety against pre-defined benchmarks, without explicit mention of human operators in the loop influencing the measurement performance reported for regulatory submission. The device is used by humans, but the performance testing described focuses on its intrinsic measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is implicit in the standards it aims to comply with. For blood pressure measurement devices, this typically refers to a reference method (e.g., direct arterial measurement or a highly accurate auscultatory method) against which the automated device's readings are compared. The text explicitly lists various ANSI/AAMI, CEN, and IEC standards for automated noninvasive blood pressure, defibrillator, and monitor systems. These standards define the expected accuracy and performance limits, which serve as the "ground truth" or reference for the device's validation.

8. The sample size for the training set

The provided text does not mention a training set or its size. This is typical for medical devices that are not "learning" algorithms in the modern sense (e.g., AI/ML). The NIBP module is an established technology, and its performance is validated against engineering and clinical standards rather than being "trained" on data.

9. How the ground truth for the training set was established

Since no training set is mentioned, the method for establishing its ground truth is not applicable based on the provided text.

Summary

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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:

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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:

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.

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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.

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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:

(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

Regulation Number and Section

§ 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).