ZOLL M SERIES 12SL ANALYSIS OPTION

K051475 · ZOLL Medical Corporation · MKJ · Jun 24, 2005 · Cardiovascular

Device Facts

• Record ID: K051475
• Device Name: ZOLL M SERIES 12SL ANALYSIS OPTION
• Applicant: ZOLL Medical Corporation
• Product Code: MKJ · Cardiovascular
• Decision Date: Jun 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Pediatric

Intended Use

The ZOLL M Series with 12SL™ is intended for the recording and automated analysis of 12-Lead ECG signals acquired from adult and pediatric patients in the supine, resting position.

Device Story

ZOLL M Series 12SL™ Analysis Option integrates into M Series defibrillator/monitor platform. Device acquires 12-lead ECG signals via 10-wire cable and standard electrodes; processes signals using GE/Marquette 12SL™ algorithm to provide automated ECG interpretation. Includes ACI-TIPI and TPI decision aids for clinician use in AMI diagnosis. Data stored to memory or transmitted via cellular, RS232, or Bluetooth™. Used by clinicians in pre-hospital and hospital settings to assist in cardiac arrhythmia interpretation and AMI management. Output provides diagnostic information to support clinical decision-making, potentially improving patient outcomes through rapid cardiac assessment.

Clinical Evidence

Bench testing only. Performance and safety testing confirmed the device meets functional requirements and complies with recognized industry standards. No clinical trial data presented.

Technological Characteristics

10-wire ECG cable assembly; standard 12-lead configuration. Connectivity via cellular, RS232, or Bluetooth™. Software utilizes GE/Marquette 12SL™ interpretive algorithm. Class II device (21 CFR 870.2340).

Indications for Use

Indicated for adult and pediatric patients in supine, resting position for recording and analysis of 12-Lead ECG signals. Useful for diagnosis and treatment of acute myocardial infarction (AMI) and interpretation/documentation of transient cardiac arrhythmias. Includes ACI-TIPI and TPI decision aids for qualified clinicians in adult patients.

Regulatory Classification

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.

Predicate Devices

• M Series 12SL™ Analysis Option (K991556)

Reference Devices

• ZOLL M Series (K972241)
• Pulse Oximetry (K982992)
• End Tidal CO2 (K993036)
• Non-Invasive Blood Pressure measurement (K002029)
• Invasive Blood Pressure and Temperature (K011865)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "ZOLL Medical Corporation" on the bottom left. On the top right, the text "K051475 P 1/2" is present. The text appears to be handwritten and is likely a reference number or code.

Worldwide Headquarters 269 Mill Road Chelmsford, Massachusetts 01824-4105 U.S.A. 978 421-9655 978 421-0025 Main Fax

JUN 2 4 2005

# 510(k) Summary:

Submitter's Name and Address:

ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 [phone]

Contact Person:

Sean Reynolds [phone], Ext. 9386

Date Summary Prepared:

May 16, 2005

Device:

ZOLL M Series 12SL™ Analysis Option

Classification:

Electrocardiograph: Class II (21 CFR 870.2340) Automactic External Defibrillators: Class III (21 CFR 870.5310)

Description:

The ZOLL M Series products (K972241) combine a defibrillator, ECG Monitor, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) Invasive Blood Pressure and Temperature (K011865) and data printing and recording in a single instrument.

The 12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the diagnosis of patients with acute myocardial infarction (AMI) and is useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. The 12-Lead ECG Analysis is indicated for the recording and analysis of 12 Lead ECG signals acquired from adult and pediatric patients in the supine, resting position. The Acute Cardiac Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) are decision aids for qualified clinicians who may currently wish to calculate ACI-TIPI and TPI in adult patients.

{1}------------------------------------------------

Intended Use:

The ZOLL M Series with 12SL™ is intended for the recording and automated rne 2022 w Johns with signals acquired from adult and pediatric patients in the supine, resting position.

Substantial Equivalence:

The features and functions of the proposed enhancement to the M Series 12SL™ Analysis Option are substantially equivalent to the current features and functions of the M Series 12SL™ Analysis Option (K991556), cleared for use on 2/28/2000.

## Comparison of Technological Characteristics

The ZOLL M Series 12SL™ Analysis Option utilizes the same interpretive features and functions to those of the currently marketed ZOLL M Series 12SL™ Analysis Option (K991556). The device acquires an ECG signal through a 10wire cable assembly and commonly used patient electrodes placed in a standard 12-Lead configuration. The device is also capable of storing that data to memory and/or transmitting that data via cellular telephone, RS232 port, or wirelessly using Bluetooth™ technology.

### Performance Testing:

Extensive performance testing ensures that the ZOLL M Series 12SL™ Analysis Option 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.

#### Conclusion

Performance and safety testing of the ZOLL M Series 12SL™ Analysis Option demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three wing strokes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol.

JUN 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zoll Medical Corporation Worldwide Headquarters c/o Mr. Sean Reynolds Regulatory Affairs Engineer 269 Mill Road Chelmsford, MA 01824-4105

Re: K051475

Trade Name: Zoll M Series 12SL™ Analysis Option Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: MKJ Dated: May 26, 2005 Received: June 3, 2005

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 Please be advised that FDA s issualited on a substitution with other requirements of the Act
that FDA has made a determination that your device addressions . You must that FDA has made a delemination and your creat by other Federal agencies. You must or any Federal statutes and regulations administered or registration and listing (21
comply with all the Act's requirements, including, but not limited to: registration as se comply with all the Act S requirements, michaeling practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeing (21 CFR Pat 607); good manager (21); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Sections 991 - 12 - 25 - 25 - 2016)
This letter will allow you to begin marketing your device of the of the regal This letter will allow you to begin marksmig your artial equivalence of your device to a legally
premarket notification. The FDA finding of sybstantial equivalence of your d premarket notification. I the FDA inding of substantial equive 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
rs the received by and and 1200 - Alance descripts the reculation entitled If you desire specific advice for your do not one one one mote the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note them move obtain contact the Office of Complance at (210) = 16 con (21CFR Part 807.97). You may obtain " Misbranding by reference to premance to premainters in Act from the Division of Small other general information on your responsionnes and its toll-free number [phone] or and Manufacturers, International and Consulter Fristians of the markets of the new online world index.html.

Sincerely yours,

Blummenfor fer

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

Enclosure

{4}------------------------------------------------

# Section 4 - Indications for Use

510(k) Number (if known): __________________________________________________________________________________________________________________________________________________

ZOLL M Series 12SL™ Analysis Option Device Name:

Indications for Use:

The 12-Lead ECG Analysis is useful in the diagnosis and treatment of patient with The 12-Lead ECG Analysis is useful in this diagnetiss is also useful in the acute myocardial marchon (AMI). interpretation and Gocdmentation of other transfort our analysis results can be of occur. When used in the prenospital octing, the lating the patient has arrived in the hospital emergency department.

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)

Blommer

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K051475

Page 1 of 1 _