K Number

Device Name

ZOLL M SERIES WITH REAL CPR HELP

Manufacturer

ZOLL MEDICAL CORPORATION

Date Cleared

2007-02-28

(183 days)

Product Code

MKJ

Regulation Number

870.5310

Intended Use

The M Series with Real CPR Help is intended to provide visual and audio feedback to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage the compression depth of greater than 1.5 to 2 inches for adult patients. The CPR monitoring function is not intended for use on paients under 8 years of age

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not specified in text

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on real-time feedback based on sensor data and pre-defined parameters (AHA/ERC guidelines), not on learning or adaptive algorithms.

Therapeutic

Yes

The device aids in performing CPR effectively, which is a life-saving intervention. It is also indicated for defibrillation, noninvasive transcutaneous pacing, and monitoring of vital signs, all of which are direct therapeutic or diagnostic interventions.

Diagnostic

Yes

The device aids in monitoring patient vital signs (ECG, Pulse Oximetry, etCO2, NIBP) and CPR performance, which are all diagnostic functions to assess a patient's physiological state.

SaMD (Software as a Medical Device)

The device description explicitly states it is used "in conjunction with ZOLL CPR-D-padz™ and CPR Stat-padz™ Multi-function Electrodes" and utilizes a "unique sensor assembly" to relay data. This indicates the device includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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 ZOLL M Series with Real CPR Help is a medical device used for defibrillation, pacing, monitoring vital signs (ECG, SpO2, etCO2, NIBP), and providing feedback on CPR performance.
Lack of Sample Analysis: The device does not analyze samples taken from the body. Its functions involve external monitoring and intervention (defibrillation, pacing) and providing real-time feedback based on external measurements (CPR compression).

Therefore, the device's intended use and functionality clearly fall outside the scope of in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ZOLL M Series with Real CPR Help™ provides 'real-time' user CPR assistance when used in conjunction with ZOLL CPR-D-padz™ and CPR Stat-padz™ Multi-function Electrodes. CPR feedback is provided via ZOLL's unique sensor assembly that relays user compression data to the ZOLL. M Series. The ZOLL M Series with Real CPR Help™ provides a metronome to encourage rescuers to perform CPR at the AHA/ECR recommended rate of 100 compressions per minute (CPM). The ZOLL M Series additionally provides chest compression performance feedback to the user through displayed symbols, text messages and voice prompts. The ZOLL M Series Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL M Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patient populations in a critical care environment. The device is light weight and easy to carry for transport. The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing a patient's ECG signal via the Advisory feature on the device. The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user to provide therapy in the event of a shock advised determination. The user will be prompted to re-assess the patient in the event a no shock advised determination is returned.

The M Series with Real CPR Help™ provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

Defibrillator Function
Intended Use - Manual Operation: Use of the M Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
Intended Use - Semiautomatic Operation (AED): The M Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. The M Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, Absence of pulse. Specifications for the ECG rhythm analysis function are provided at the end of this section.

External Pacemaker (Pacer Version Only)
Intended Use -- Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.
The purposes of pacing include:
Resuscitation from standstill or bradycardia of any etiology:
Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidine, digitalis, b- blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.
As a standby when standstill or bradycardia might be expected:
Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.
Suppression of tachycardia:
Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.
Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL. pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Intended Use - Real CPR Help™: The ZOLL M Series with Real CPR Helo™ is intended to provide visual and audio feedback to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of greater than 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

Product codes (comma separated list FDA assigned to the subject device)

MKJ

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult patients.
Not intended for patients under 8 years of age.
Pediatric patients weighing 33lbs / 15kg or less (for pacing).

Intended User / Care Setting

Qualified medical personnel who are trained and authorized to respond to medical emergencies.
Emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator.

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)

Extensive performance testing ensures that the ZOLL M Series with Real CPR Help™ performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures the device complies with applicable sections of recognized industry and safety standards. Functional testing of the device's features and functions was conducted to ensure that the modifications to the software did not degrade or impact other product features, functions or performance specifications. Performance and safety testing of the ZOLL M Series with Real CPR Help™ demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

The features and functions of the ZOLL M Series with Real CPR Help™ are identical to those of the M Series Defibrillator, with the exception of the incorporation of Real CPR Help™. The characteristics, features and functions of the Real CPR Help™ are substantially equivalent to other ZOLL Defibrillators equipped with CPR Feedback. (predicate K/DEN not specified in text for M Series Defibrillator).

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.

Not Found

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).

Not Found

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

Summary

Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string appears to be "K062537". The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the numbers being slightly slanted.

Image /page/0/Picture/1 description: The image shows the word "ZOLL" in large, bold letters at the top. Below the word, the phrase "Advancing Resuscitation. Today." is written in a smaller font. The text is black and the background is white.

ZOLL Medical Corporation

Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824-4 U.S.A

978 421-9655
978 421-0025 Main Fax

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:

August 1, 2006

Device:

ZOLL M Series with Real CPR Help™

Classification:

Automactic External Defibrillators: Class III (21 CFR 870,5310)

Cardiopulmonary Resuscitation Aid: Class III (21 CFR 870.5200)

Description:

The ZOLL M Series Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL M Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability

FEB 2 8 2007

to monitor and assess the physiological characteristics of the indicated patient populations in a critical care environment. The device is light weight and easy to carry for transport.

The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing a patient's ECG signal via the Advisory feature on the device. The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user to provide therapy in the event of a shock advised determination. The user will be prompted to re-assess the patient in the event a no shock advised determination is returned.

Intended Use:

The CPR monitoring function is not intended for use on patients under 8 years of age.

Substantial Equivalence:

Comparison of Technological Characteristics

The ZOLL M Series with Real CPR Help™ acquires compression depth and rate signals from the CPR sensor incorporated in the currently marketed ZOLL CPR-D.padz™ and CPR Stat padz™ Multi-function Electrodes. The acquired depth and rate signals are used to provide CPR compression performance feedback to the user through displayed symbols, text messages and voice prompts which are equivalent to other ZOLL defibrillators with user CPR feedback.

Performance Testing:

Functional testing of the device's features and functions was conducted to ensure that the modifications to the software did not degrade or impact other product features, functions or performance specifications.

Conclusion

Performance and safety testing of the ZOLL M Series with Real CPR Help™ demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness.

SECTION 4 - INDICATIONS FOR USE

510(k) Number (if known):

ZOLL M Series Device Name:

Defibrillator Function

Intended Use - Manual Operation

Use of the M Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

Unconsciousness .
. Absence of breathing
. Absence of pulse.

This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

Intended Use - Semiautomatic Operation (AED)

The M Series products are designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.

They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.

The M Series products must be prescribed for use by a physician or medical advisor of an emergency response team.

Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by:

Unconsciousness .
t Absence of breathing
. Absence of pulse

Specifications for the ECG rhythm analysis function are provided at the end of this section

(continued on next page)

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

External Pacemaker (Pacer Version Only)

Intended Use -- Pacemaker

This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.

Note: This device must not be connected to internal pacemaker electrodes.

The purposes of pacing include:

Resuscitation from standstill or bradycardia of any etiology:

Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidine, digitalis, b- blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.

As a standby when standstill or bradycardia might be expected:

Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.

Suppression of tachycardia:

Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.

Pediatric Pacing

Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL. pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Image /page/3/Figure/14 description: The image shows the text "Intended Use - Real CPR Help™". The text is black and appears to be part of a document or label. A partial circle is drawn around the text.

The ZOLL M Series with Real CPR Helo™ is intended to provide visual and audio feedback to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of greater than 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients.

The CPR monitoring function is not intended for use on patients under 8 years of age.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces to the right. 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

FEB 2 8 2007

Zoll Medical Corporation C/O Sean Reynolds Regulatory Affairs Engineer 269 Mill Road Chelmsford, MA 01824

Re: K062537 Trade/Device Name: M Series with Real CPR Help Regulation Number: 21 CFR 870.5310 Regulatory Class: Class III Product Code: MKJ Dated: February 16, 2007 Received: February 16, 2007

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 (sec 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act

Page 2 - Mr. Reynolds

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 (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.

Blymmman for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known):_K062537

Device Name:__M Series with Real CPR Help

Indications For Use: The M Series with Real CPR Help is intended to provide visual and audio feedback to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage the compression depth of greater than 1.5 to 2 inches for adult patients. The CPR monitoring function is not intended for use on paients under 8 years of age

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (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)

Bhumima