The 12-Lead ECG Analysis is useful in the diagnosis and treatment of patient with acute myocardial infarction (AMI). The analysis is also useful in the interpretation and documentation of other transient cardiac arrhythmias that may occur. When used in the prehospital setting, the analysis results can be of assistance to the clinician in preparing for the patient has arrived in the hospital emergency department.

Device 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.

AI/ML Overview

The provided text describes ZOLL M Series 12SL™ Analysis Option, an enhancement to existing ZOLL M Series products. However, it does not include detailed acceptance criteria or a specific study proving the device meets said criteria.

The submission focuses on establishing substantial equivalence to a predicate device (ZOLL M Series 12SL™ Analysis Option, K991556, cleared 2/28/2000) rather than presenting a de novo performance study against explicit acceptance criteria.

Therefore, I cannot populate the table with acceptance criteria or describe a study that explicitly proves the device meets those criteria from the provided text.

Here's what can be inferred or stated as "not found" based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device.
Reported Device Performance: Not explicitly reported as quantifiable metrics against acceptance criteria. The document states "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." This is a general statement, not specific performance data.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

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

Sample Size: Not specified.
Data Provenance: Not specified.

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

Not applicable, as a specific performance study against a ground truth is not detailed. The submission relies on substantial equivalence.

4. Adjudication method for the test set

Not applicable, as a specific performance study against a ground truth is not detailed.

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

No MRMC study is mentioned. The device is an analysis option using the GE/Marquette 12SL™ Algorithm, which is an interpretive tool, not an AI assistance for human readers in the context of comparative effectiveness.

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

The document implies standalone performance of the algorithm for "interpretation and documentation of other transient cardiac arrhythmias" and "diagnosis of patients with acute myocardial infarction (AMI)" when it states that the "12SL™ Analysis Option using the GE/Marquette 12SL™ Algorithm is useful in the diagnosis... and is useful in the interpretation and documentation." However, no specific study details are provided.

7. The type of ground truth used

Not explicitly stated because a specific performance study against ground truth is not detailed. The intended use "useful in the diagnosis of... AMI" and "interpretation and documentation of other transient cardiac arrhythmias" suggests a comparison to clinical diagnosis, but the methodology is not provided.

8. The sample size for the training set

Not applicable. The device utilizes the GE/Marquette 12SL™ Algorithm, which is a pre-existing algorithm. The document doesn't discuss the training of this algorithm.

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

Not applicable. The document doesn't discuss the ground truth for the training of the GE/Marquette 12SL™ Algorithm.

Summary

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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 (978) 421-9655

Contact Person:

Sean Reynolds (978) 421-9655, 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:

{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.

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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 (240) 276-0295. 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 (800) 638-2041 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

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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 _

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.