(72 days)
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by:
- Unconsciousness
- Absence of breathing, and
- Absence of pulse and other signs of circulation
When the victim is less than 8 years old or weighs less than 55 lb. (25kg), use ZOLL pedi-padz® II pediatric electrodes. Use adult electrodes for patients 8 years of age or weight 55 lb. (25kg) or greater.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
The ZOLL AEDPRO with See-Thru CPR enables the user to see a close approximation of the patient's underlying ECG rhythm while performing CPR in conjunction with ZOLL CPR-D•padz™ electrodes in manual mode.
The ZOLL AEDPRO® with See-Thru CPR™ is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AEDPRO acquires and analyzes an adult or pediatric patient's ECG Signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.
See-Thru CPR uses a filter that relies on the correlation between CPR compressions, as detected by the ZOLL CPR-Dypadz electrodes, and the CPR artifact to remove CPR related artifact from the ECG signal. See-Thru CPR filtering continues as long as the CPR-Dpadz electrodes are attached to the patient and CPR compressions are detected. If CPR compressions are not detected, filtering stops, unfiltered ECG signals are displayed, and the unit removes the CPR FLTR message from the LCD screen.
In this 510(k) summary for the ZOLL AEDPRO® with See-Thru CPR™, the information provided is very limited regarding specific acceptance criteria and detailed study results. The document emphasizes functional testing to ensure the new feature (See-Thru CPR) does not degrade existing performance and that the device is substantially equivalent to predicate devices. However, it does not present quantifiable acceptance criteria or detailed methodologies for a "study that proves the device meets the acceptance criteria" in the way a clinical trial or a robust performance study would.
Based on the provided text, here's an analysis addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific, quantifiable acceptance criteria or detailed performance metrics. It generally claims the device "performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| See-Thru CPR™ effectively filters CPR artifact. | "See-Thru CPR uses a filter that relies on the correlation between CPR compressions...and the CPR artifact to remove CPR artifact to remove CPR related antiact from the ECG signal." "The functionality (See-Thru CPR) being added...uses a filter to help remove the artifact from the ECG signal." |
| Modifications do not degrade other features/functions. | "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." |
| Substantial equivalence to predicate devices. | "Extensive performance testing ensures that the ZOLL AEDPRO with See-Thru CPR performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." "Testing...demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample sizes for a test set (e.g., number of patients, number of ECG recordings). It states "Extensive performance testing" and "Functional testing," which usually implies internal lab testing rather than a clinical study with a defined dataset. The data provenance is also not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts or any process for establishing ground truth related to study data. The testing described appears to be internal functional and performance testing, not a clinical validation requiring expert review of data.
4. Adjudication Method
The document does not describe any adjudication method, as there's no mention of expert review or clinical trial data requiring such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The focus is on the functional performance of the filtering technology itself and its substantial equivalence to other ZOLL devices, not on the improvement of human reader performance with the AI (which "See-Thru CPR" is not explicitly defined as, though it is an algorithm).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document describes "See-Thru CPR" as a filter that automatically removes CPR artifact from the ECG signal displayed to the user. This function operates "algorithm only" in the sense that the filtering process itself is automatic. The study mentioned, "Extensive performance testing," would likely have assessed the effectiveness of this filtering algorithm in a standalone capacity (i.e., how well it removes artifact from recorded ECGs) and in the context of the device's overall operation. However, no specific details of such a standalone study or its results are provided.
7. Type of Ground Truth Used
Given the nature of the device (artifact filtering) and the described "functional testing," the ground truth for such testing would likely involve:
- Simulated ECG signals with controlled artifact: Using laboratory equipment to generate known ECG rhythms and superimpose various levels and types of CPR-like artifact.
- Known performance specifications: Comparing the filtered output against expected performance targets for artifact reduction and preservation of the underlying ECG signal.
- Comparison to predicate devices: Ensuring the filtering performance is equivalent to, or better than, that of previously cleared devices with similar technology.
The document does not specify "expert consensus," "pathology," or "outcomes data" as ground truth sources.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This suggests the technology might be based on established signal processing principles rather than a machine learning model that requires a large training dataset in the modern sense.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is also not described.
In summary: The provided 510(k) summary focuses on the functional validity and substantial equivalence of the ZOLL AEDPRO with See-Thru CPR. It indicates that "extensive performance testing" and "functional testing" were conducted to ensure the new filtering technology works as intended and does not compromise other device features, aligning its performance with predicate devices. However, it lacks the detailed quantitative metrics, clinical study designs, sample sizes, and expert ground truth establishment that would typically be found in a more comprehensive clinical or performance study report. This suggests that the nature of this submission was primarily focused on demonstrating the non-inferiority and functional integrity of an added feature to an already cleared device, relying on internal engineering and performance testing rather than new clinical trials.
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07/025 pg 1 of 2
ZOLL Medical Corporation
Worldwide Headquarters 269 Mill Road Chelmsford, Massachusetts 01824-4105 U.S.A.
978 421-9655
978 421-0025 Main Fax
JUN 2 2 2007
Image /page/0/Picture/5 description: The image shows the logo for ZOLL Medical Corporation. The logo consists of the word "ZOLL" in large, bold, black letters. Below the company name is the tagline "Advancing Resuscitation. Today.", and below the tagline is a curved line.
510(k) Summary:
Submitter's Name and Address:
ZOLL Medical Corporation 269 Mill Road Chelmsford, MA 01824-4105 (978) 421-9655
Contact Person:
Eileen M. Boyle (978) 421-9655, Ext. 9171
Date Summary Prepared:
February 14, 2007
Device:
ZOLL AEDPRO® with See-Thru CPR™
Classification:
Defibrillator, Low-energy - DC: Class II (21 CFR 870.5300)
Automatic External Defibrillators have been considered Class III devices by FDA.
Cardiac Monitors (including Cardiotachometers and Rate alarms): Class II (21 CFR 870.2300)
Description:
The ZOLL AEDPRO with See-Thru CPR enables the user to see a close approximation of the patient's underlying ECG rhythm while performing CPR in conjunction with ZOLL CPR-D•padz™ electrodes in manual mode.
The ZOLL AEDPRO® with See-Thru CPR™ is a portable, battery powered automated external defibrillator (AED) that uses voice prompts and visual messages to provide feedback to a user attempting a cardiac arrest rescue. The AEDPRO acquires and andlyzes an adult or attemption is but nation fessue. "The AcDerico acquires and recommends of poulatio pation o EOG Signal and, if a shockable migri
recommends delivery of a defibrillation shock via voice and visual prompts.
See-Thru CPR uses a filter that relies on the correlation between CPR compressions, as detected by the ZOLL CPR-Dypadz electrodes, and the CPR artifact to remove CPR artifact to remove CPR related antiact from the ECG signal. See-Thru CPR filtering continues as long as the CPR-Drom the Lock agains. See-Thu OFF illiening communism are detected, filtering stops, unfiltered ECG signals are displayed, and the unit removes the CPR FLTR message from the LCD screen.
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K071025 pg 2 of 2
Intended Use:
The functionality (See-Thru CPR) being added to the ZOLL AEDPRO uses a filter to help remove the artifact from the ECG signal.
Substantial Equivalence:
The features and functions of the ZOLL AEDPRO with See-Thru CPR are identical to other ZOLL Defibrillators equipped with this technology.
Comparison of Technological Characteristics
The ZOLL AEDPRO with See-Thru CPR uses a filter that relies on the correlation between the CPR compressions, as detected by the ZOLL CPR-Drpadz electrodes, and the ECG signal to remove CPR related artifact from the ECG signal.
Performance Testing:
Extensive performance testing ensures that the ZOLL AEDPRO with See-Thru CPR performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications.
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
Testing of the ZOLL AEDPRO with See-Thru CPR demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ZOLL Medical Corporation c/o Ms. Eileen M. Boyle Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824-4105
JUN 2 2 2007
Re: K071025
Trade Name: ZOLL AEDPO® with See-Thru CPR™ Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: April 13, 2007 Received: May 22, 2007
Dear Ms. Boyle:
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 - Ms. Eileen M. Boyle
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 (OS) 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,
Blymmma for
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): K071025
ZOLL AEDPRO® with See-Thru CPR™ Device Name:
Indications for use
Indications for use
Use of the device for defibrillation is indicated on victims of cardiac arrest with apparent lack of circulation as indicated by:
- . Unconsciousness
- . Absence of breathing, and
- Absence of pulse and other signs of circulation
When the victim is less than 8 years old or weighs less than 55 lb. (25kg), use 20LL pedi-padz® Il pediatric When the victim is less than o years one of weight food than bo 121 (2005), we shart age or weight.
The device is also intended for use when ECG monitoring is indicated to evaluate the patient's heart rate or ECG morphology.
Contraindications for Use
Defibrillation
َ Never use the AEDPRO unit for defibrillation when the patient:
ls conscious s breathing, or Has a detectable pulse or other sign of circulation
Nonitoring
f monitoring function is not intended for use on patients under 8 years of age.
801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
ffice of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071025
§ 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.